Kidney/Renal Cancer

Condition: Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05468697

Sponsor: Merck Sharp & Dohme LLC

Phase: Phase 1/Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• Has a histologically confirmed diagnosis of unresectable Stage IV (per American Joint Committee on Cancer [AJCC], 8th Edition) RCC with clear-cell component
• Has had disease progression on or after having received at least 2 systemic treatments for unresectable Stage IV RCC with prior anti-programmed cell death 1 ligand 1 (PD-1/L1) and a vascular endothelial growth factor-tyrosine kinase inhibitor (VEGF-TKI) in sequence or in combination
• Has measurable disease per RECIST 1.1 as assessed by the investigator and verified by blinded independent central review (BICR)
• Has recovered from all AEs due to previous therapies

Exclusion Criteria:

• Has hypoxia, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
• Has known central nervous system (CNS) metastases and/or carcinomatous meningitis
• Has clinically significant cardiac disease
• Has moderate to severe hepatic impairment
• Has a known history of human immunodeficiency virus (HIV) infection
• Has a history of hepatitis B (HBV) or known active hepatitis C (HCV) infection
• Has received prior treatment of belzutifan or palbociclib
• Has received prior radiotherapy ≤2 weeks prior to first dose of study intervention. Participants must have recovered from all radiation-related toxicities and not require corticosteroids
• Has had major surgery ≤3 weeks prior to first dose of study intervention
• Has received colony-stimulating factors (eg, granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF], or recombinant erythropoietin [EPO]) ≤28 days prior to the first dose of study intervention

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Condition: ccRCC, Clear Cell Renal Cell Carcinoma, Kidney Cancer, Kidney Neoplasms, Renal Cancer, Renal Neoplasms, Recurrent Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma, Refractory Renal Cell Carcinoma, Advanced Renal Cell Carcinoma, Hypoxia, Renal Cell Carcinoma, Hypoxia Inducible Factor (HIF), HIF2α Inhibitor, Hypoxia Inducible Factor 2 Alpha (HIF-2 Alpha), Hypoxia Inducible Factor 2α (HIF-2α), Clear Cell

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05119335

Sponsor: NiKang Therapeutics, Inc.

Phase: Phase 1/Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Criteria: Patients must meet all of the following criteria to be enrolled in this study. 1. Has the ability to understand and willingness to sign a written informed consent form before the performance of any study procedures 2. Has locally advanced or metastatic ccRCC and has progressed during treatment, are relapsed, refractory and not amenable to curative therapy or standard therapy and has progressed during treatment with at least 1 prior therapeutic regimen 3. Must have measurable disease per the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) 4. Is of age ≥ 18 years 5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 6. Has a life expectancy of ≥ 3 months 7. Has adequate organ function defined as follows: 1. Bone marrow: ANC ≥ 1.0 × 10^9/L; Hgb level ≥ 10 g/dL without transfusion or erythropoietin support within 2 weeks prior to first dose; platelet count ≥ 75,000/μL 2. Hepatic: transaminase levels (AST/ALT) ≤ 2.5 × ULN (≤ 5 × ULN if liver metastases is present); total bilirubin (TBILI) ≤ 1.5 × ULN in the absence of Gilbert's disease 3. Renal: serum creatinine level ≤ 2.0 × ULN or calculated creatinine clearance (CrCL) ≥ 40 mL/min (Cockcroft-Gault formula) 8. If a female patient of child-bearing potential, has a negative serum pregnancy test result within 7 days before first study drug administration 9. If a female patient, must be surgically sterile, must be post-menopausal, or must agree to use physician-approved method of birth control during screening, during the study, and for a minimum of 6 months after the last study drug administration; or if a male patient with a female partner, must agree to use physician-approved method of birth control during screening, during the study, and for a minimum of 6 months after the last study drug administration 10. Female patients of childbearing potential must meet all of the following criteria: 1. Not pregnant (negative serum pregnancy test during Screening) 2. Not breast feeding 3. Willing to use a protocol-recommended method of contraception or to abstain from heterosexual intercourse from the start of treatment or until at least 6 months after the last dose of treatment. Note: A female patient is considered to be of childbearing potential unless she has had a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy; has medically documented ovarian failure (with serum estradiol and follicle-stimulating hormone levels within the institutional laboratory postmenopausal range and a negative serum or urine beta human chorionic gonadotropin); or is menopausal (amenorrhea for 12 months). 11. Male patients who can father a child must meet all of the following criteria: 1. Willing to use a protocol-recommended method of contraception or to abstain from heterosexual intercourse with females of childbearing potential from the start of treatment until at least 6 months after the last dose of treatment, and 2. Willing to refrain from sperm donation from the start of treatment until at least 6 months after the last dose of treatment. Note: A male patient is considered able to father a child unless he has had a bilateral vasectomy with documented aspermia or a bilateral orchiectomy. 12. Able to swallow oral medications. 13. Ambulatory subjects need to take a six-minute walk test. Walking distance needs to be at least 400 meters and the change of oxygen saturation needs to be within 5% range. Patients will be excluded from this study if they meet any of the following criteria. 1. Known symptomatic brain metastases requiring > 10 mg/day of prednisone (or its equivalent). Patients with previously diagnosed brain metastases are eligible if they have completed their treatment, have recovered from the acute effects of radiation therapy or surgery prior to the start of NKT2152 treatment, fulfill the above steroid requirement for these metastases, and are neurologically stable based on central nervous system imaging ≥ 4 weeks after CNS-directed treatment. 2. Having one or more of the following conditions: 1. A pulse oximetry reading less than 95% at screening; 2. Any current requirement for intermittent or chronic supplemental oxygen; 3. Any chronic lung condition which has required supplemental oxygen in the past; 4. Evidence of impending airway compromise (such as endobronchial tumor, lymphangitic spread, significant extrinsic compression of major airway) per investigator; 5. Ascites requiring drainage within 28 days prior to W1D1 3. History of another malignancy except for the following: adequately treated local basal cell or squamous carcinoma of the skin, in situ cervical cancer, adequately treated papillary noninvasive bladder cancer, other adequately treated Stage 1 or Stage 2 cancers currently in complete remission, or any other cancer that has been in complete remission for ≥ 2 years 4. Has failed to recover from the effects of prior anticancer therapy to baseline level or Grade 1 severity (except for alopecia) per NCI CTCAE; patients with treatable adverse effects such as hypothyroidism or hypertension may be enrolled if the adverse effect is controlled with treatment 5. Significant cardiovascular disease, including myocardial infarction, arterial thromboembolism, or cerebrovascular thromboembolism, within 6 months prior to start of NKT2152 treatment; symptomatic dysrhythmias or unstable dysrhythmias requiring medical therapy; angina requiring therapy, symptomatic peripheral vascular disease; New York Heart Association Class 3 or 4 congestive heart failure; ≥ Grade 3 hypertension (diastolic blood pressure ≥ 100 mmHg or systolic blood pressure ≥160 mmHg) despite adequate use of anti-hypertensives; or history of congenital prolonged QT syndrome or repeated demonstration of a QTc interval > 480 ms; ejection fraction < 40%; clinically significant pericardial or pleural effusion in the opinion of the investigator. 6. Has received prior investigational therapy or standard therapy within 5 half-lives of the agent or 4 weeks before the first administration of study drug, whichever is shorter 7. Has a bleeding diathesis or coagulopathy 8. Deep vein thrombosis (DVT)/pulmonary embolism are allowed as long as patient is not symptomatic and received 2 weeks or more of adequate anticoagulation 9. Has manifestations of malabsorption due to prior gastrointestinal (GI) surgery or GI disease 10. Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results 11. Has had major surgery within 4 weeks before first study drug administration; the following procedures are not considered to be major surgeries: thoracentesis, port placement, laparoscopy, thoracoscopy, bronchoscopy, endoscopic or ultrasonographic procedures, mediastinoscopy, skin biopsy, incisional biopsy, image-guided biopsy for diagnostic purposes, and routine dental procedures 12. Has known human immunodeficiency virus (HIV) 13. Has an active infection requiring systemic treatment 14. Is actively participating in another therapeutic clinical trial

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Condition: ccRCC, Clear Cell Renal Cell Carcinoma, Kidney Cancer, Kidney Neoplasms, Renal Cancer, Renal Neoplasms, Recurrent Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma, Refractory Renal Cell Carcinoma, Advanced Renal Cell Carcinoma, Carcinoma, Neoplasms, Carcinoma, Renal Cell, Neoplasms, Glandular and Epithelial, Neoplasm by Histology, Adenocarcinoma, Urologic Neoplasms, Urogenital Neoplasms, Neoplasms by Site, Kidney Diseases, Urologic Diseases

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05935748

Sponsor: NiKang Therapeutics, Inc.

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• Must have locally advanced or metastatic ccRCC and have progressed or relapsed after at least 1 prior anti-VEGF/VEGFR systemic therapy and 1 ICI.
• Measurable disease per the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
• KPS score of at least 70%
• Able to swallow oral medications.

Exclusion Criteria:

• Active CNS metastases and/or carcinomatous meningitis
• Has had any major cardiovascular event within 6 months or clinically significant cardiovascular disease
• Major surgery (eg, GI surgery, removal or biopsy of brain metastasis) within 3 months before administration of study drug.
• Has known HIV
• History of hepatitis B or known active hepatitis C infection
• Has received prior treatment with NKT2152, other HIF2α inhibitors, other CDK 4/6 inhibitors, palbociclib, or sasanlimab
• Radiation therapy for bone metastasis within 2 weeks, or any other external radiation therapy within 4 weeks before administration of the first dose of study treatment
• Corrected QT interval calculated by Fridericia formula (QTcF) > 480 ms within 28 days prior to first dose
• Hypoxia or requires intermittent or chronic supplemental oxygen or any chronic lung condition which has required supplemental oxygen in the past
• Has a history of interstitial lung disease
• Has any active or recent history of a known or suspected autoimmune disease

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Condition: Metastatic Papillary Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05411081

Sponsor: National Cancer Institute (NCI)

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• Participants must have a histologically confirmed diagnosis of metastatic papillary renal cell carcinoma (PRCC), either type 1 or type 2. (NOTE: A designation of type 1 or type 2 should be made by the local pathologist if possible but is not required). Mixed histologies which contain type 1 or type 2 along with any other RCC histology/histologies will be allowed provided that they contain a papillary component
• Participants must have measurable disease per RECIST 1.1 criteria. All measurable lesions must be assessed by CT or magnetic resonance imaging (MRI) within 28 days prior to registration. All non-measurable lesions must be assessed by CT or MRI, or nuclear medicine bone scan within 42 days prior to registration. The CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality. If there is clinical suspicion for bone metastases at the time of enrollment (at the discretion of the investigator), bone scan must be performed at baseline (within 42 days prior to registration)
• Participants with new or progressive brain metastases (active brain metastases) must not require immediate central nervous system (CNS) specific treatment at the time of study registration or anticipated during the first cycle of therapy. Patients with leptomeningeal disease are excluded from enrolling
• Participants with measurable disease, per RECIST version (v)1.1, must be present outside the CNS
• Participants must have no history of intracranial hemorrhage or spinal cord hemorrhage
• Participants, if needed, must receive a stable dose of anti-convulsant therapy
• Participants must complete all prior radiation therapy at least 14 days prior to registration. Participants must have recovered to =< grade 1 from all associated toxicities at the time of registration unless the toxicity is determined to be not clinically significant by the registering investigator
• Participants must be >= 18 years of age
• Participants must have a complete physical examination and medical history within 28 days prior to registration
• Participants must have a Zubrod performance status of 0-2
• White blood count (WBC) >= 2 x 10^3/uL (within 28 days prior to registration)
• Absolute neutrophil count (ANC) >= 1.5 x 10^3/uL (within 28 days prior to registration)
• Platelet count >= 100 x 10^3/uL (within 28 days prior to registration)
• Lymphocyte count >= 0.5 x 10^3/uL (within 28 days prior to registration)
• Hemoglobin (>= 9 g/dL) (within 28 days prior to registration). Participants may be transfused to meet this criterion
• Total serum bilirubin =< 1.5 x the institutional upper limit of normal (ULN) unless history of Gilbert's disease (within 28 days prior to registration). Participants with history of Gilbert's disease must have total bilirubin =< 5 x institutional ULN
• Aspartate aminotransferase (AST) must be =< 3 x the institutional ULN unless the liver is involved with the tumor, in which case serum transaminase (SGOT) must be =< 5 x the institutional ULN (within 28 days prior to registration)
• Alanine aminotransferase (ALT), must be =< 3 x the institutional ULN unless the liver is involved with the tumor, in which case serum transaminase (SGPT) must be =< 5 x the institutional ULN (within 28 days prior to registration)
• Participants must have serum creatinine =< 2 x the institutional ULN OR creatinine clearance (either measured or calculated) > 30 mL/min and obtained within 28 days prior to registration
• Participants must have urine protein < 3+ within 28 days prior to registration. If urine protein is 3+ or greater, then urine protein by 24-hour collection must show less than 3 grams of protein
• Participants must have documented blood pressure of systolic blood pressure (SBP) < 150 mm Hg or diastolic blood pressure (DBP) < 100 mm Hg within 14 days prior to registration
• Participants with known human immunodeficiency virus (HIV) must be on effective anti-retroviral therapy at registration and have undetectable viral load within 6 months of registration
• Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy within 6 months prior to registration, if indicated
• Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load within 6 months prior to registration
• Participants must be able to take oral medications (i.e., swallow pills whole). Participants must not have gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures that could in the opinion of the treating investigator affect absorption, or active peptic ulcer disease. Participants with intractable nausea or vomiting are not eligible
• Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
• Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System
• Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
• NOTE: For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
• As a part of the OPEN registration process for OPEN access instructions) the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

Exclusion Criteria:

• Participants must not have undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, or neurosurgical resection within 28 days prior to initiation of study treatment
• Participants must not have ongoing requirements for corticosteroids as therapy for CNS disease
• Participants must not have cavitating pulmonary lesions
• Participants must not have uncontrolled pleural effusions, pericardial effusions, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Participants with indwelling catheters (e.g., PleurX) are allowed
• Participants must not have tumor invading the gastrointestinal (GI) tract or evidence of endotracheal or endobronchial tumor within 28 days prior to registration
• Participants must not have evidence of tumor invading or encasing any major blood vessels
• Participants must not have had major surgery within 28 days prior to registration, and participants must have recovered from any adverse effects of surgery
• Participants must not have had prior treatment with cabozantinib for any reason
• Participants must not have had prior treatment or adjuvant therapy with PD-1/PD-L1 checkpoint inhibitors for any reason within the past 6 months
• Participants must not have received more than one prior systemic therapy for advanced or metastatic renal cell carcinoma with the exception of another VEGF inhibitor Food and Drug Administration (FDA)-approved for advanced RCC (i.e., pazopanib, bevacizumab, sorafenib or axitinib). If a participant develops metastatic disease within six months of discontinuation of adjuvant therapy, this will constitute one prior systemic therapy for advanced or metastatic RCC. If a patient develops metastatic disease and more than six months has elapsed since discontinuation of adjuvant therapy, this will not constitute prior systemic therapy for advanced or metastatic RCC
• Participants must not take within 14 days prior to registration, nor plan to take while on protocol treatment, any strong CYP3A4 inhibitors (e.g. boceprevir, cobicistat, danoprevir, elvitegravir/RIT, fluvoxamine, indinavir, itraconazole, ketoconazole, lopinavir/RIT, nefazodone, nelfinavir, posaconazole, ritonavir, telaprevir, telithromycin, tipranavir/RIT, or voriconazole,); Please refer to https://drug-interactions.medicine.iu.edu/MainTable.aspx for the updated CYP3A4 inhibitors or inducers
• Participants must not take within 14 days prior to registration, nor plan to take while on protocol treatment, any strong CYP3A4 inducers (e.g. avasimibe, phenytoin, rifampin, rifabutin); Please refer to https://drug-interactions.medicine.iu.edu/MainTable.aspx for the updated CYP3A4 inhibitors or inducers
• Participants must not be receiving or planning to receive any other investigational agents at time of registration
• Participants must not have been diagnosed with a clinically significant autoimmune disease, exceptions such as diabetes, eczema, and vitiligo are allowed. Other non-clinically significant autoimmune diseases are allowed if approved by the registering investigator
• Participants must not be on steroid doses > 10 mg prednisone equivalent. Replacement steroid doses for adrenal insufficiency will be allowed. Also, short duration steroid therapy to prevent allergic reactions are acceptable (e.g. prior to CT imaging)
• Participants must not have any clinical evidence of congestive heart failure (CHF) (specifically, New York Heart Association [NYHA] class III [moderate] or class IV [severe]) at the time of registration
• Participants must not have known history of congenital long QT syndrome and must not have experienced unstable angina pectoris, clinically significant cardiac arrhythmias, or stroke (transient ischemic attack [TIA] or other ischemic event) within 90 days prior to registration
• Participants must not have experienced myocardial infarction or thromboembolic event requiring anticoagulation within 90 days of registration, unless clinically stable with ongoing medical management
• Participants must not have had any clinically-significant GI bleeding within 3 months prior to registration and participants must not have a GI disorder which (at the discretion of the investigator) bears a high risk of perforation or fistula (e.g. Crohn's disease)
• Participants must not have had hemoptysis of >= (2.5 mL) of red blood, and do not demonstrate any other signs indicative of pulmonary hemorrhage within 3 months prior registration
• Participants must not be pregnant or nursing, due to VEGF therapy being toxic to embryogenesis. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
• Participants must not be on warfarin, at therapeutic doses. Low dose aspirin for cardio-protection (per local applicable guidelines) and low molecular weight heparin (LMWH) are allowed

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Condition: Advanced or Metastatic Renal Cell Carcinoma

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT04106349

Sponsor: Ipsen

Phase:

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• Males or females aged 18 years and older
• Patients scheduled to receive Cabometyx® in monotherapy or in combination with nivolumabfor advanced or metastatic renal cell carcinoma
• Decision to treat patients with Cabometyx® in monotherapy or in combination with nivolumab has to be taken prior to and independent from participation in the clinical study
• Provision of written informed consent

Exclusion Criteria:

• Participation in another interventional clinical study at the same time
• Previous participation in this clinical study

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Condition: Advanced Renal Cell Carcinoma, Chromophobe Renal Cell Carcinoma, Clear Cell Renal Cell Carcinoma, Collecting Duct Carcinoma, Kidney Medullary Carcinoma, Metastatic Malignant Neoplasm in the Bone, Papillary Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8, Unclassified Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04071223

Sponsor: National Cancer Institute (NCI)

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• Documented histologic or cytologic diagnosis of renal cell cancer (RCC). All subtypes of RCC are eligible including but not limited to clear cell, papillary, chromophobe, translocation, collecting duct carcinoma, medullary carcinoma, and unclassified categories. Enrollment of non-clear cell patients will be limited to 20% of the total sample size (~ 42 patients). Once this goal is met, accrual of non-clear cell patients will be discontinued (a notice will be sent out 2 weeks in advance). Sarcomatoid and rhabdoid differentiation are allowed
• Presence of at least 1 metastatic bone lesion not treated with prior radiation is required.
• The presence of bone metastases can be detected by computed tomography (CT), magnetic resonance imaging (MRI), Tc-99m bone scan or positron emission tomography (PET) (fludeoxyglucose F-18 [FDG] or sodium fluoride [NaF]) imaging. Patients with non-measurable bone-only disease are allowed. Patients may have received prior radiation therapy for bone metastases or other external radiation >= 7 days prior to registration, as long as they still have at least 1 metastatic bone lesion not treated with radiation. Patients with visceral metastases are allowed, as long as they have at least one untreated bone metastases
• No prior treatment with cabozantinib
• No treatment with any type of small molecular kinase inhibitor (including investigational kinase inhibitors) within 2 weeks or 5 half-lives (whichever is shorter) of registration or receipt of any anti-cancer therapy (including investigational therapy, monoclonal antibodies, cytokine therapy) within 3 weeks of registration
• No prior hemibody external radiotherapy
• No prior therapy with radium-223 dichloride or systemic radiotherapy (such as samarium, strontium)
• No major surgery within 6 weeks of randomization. Procedures such as thoracentesis, paracentesis, percutaneous biopsy, Moh's or other topical skin surgery, Lasik eye surgery are not considered major surgery. Patients who have had a nephrectomy may be registered >= 3 weeks after surgery, providing there are no wound-healing complications. Subjects with clinically relevant ongoing complications from prior surgery are not eligible
• Recovery to baseline or =< grade 1 CTCAE version 5.0 from toxicity related to any prior treatment, unless adverse events are clinically nonsignificant and/or stable on supportive therapy
• The use of osteoclast targeted therapy including either bisphosphonates or denosumab is mandated on this study except in patients with contraindications as determined by the treating investigator, including:
• Hypocalcemia
• Hypophosphatemia
• Renal impairment including those with a glomerular filtration rate (GFR) < 35 mL/min using the Cockcroft-Gault equation or acute renal impairment
• Hypersensitivity to drug formulation
• Dental condition or need for dental intervention that per the investigator would increase the risk of osteonecrosis of jaw (ONJ).
• Use of osteoclast targeted therapy or reason against use needs to be recorded in the electronic case report form (eCRF). Additionally, reason for discontinuation of osteoclast targeted therapy need to be appropriately documented in the eCRF
• Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown.
• Therefore, for women of childbearing potential only, a negative urine pregnancy test done =< 28 days prior to registration is required. A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
• Karnofsky performance status >= 60%
• No brain metastases or cranial epidural disease unless adequately treated with radiotherapy, radiosurgery, or surgery and stable for at least 4 weeks prior to registration as documented by MRI or CT imaging or deemed stable by clinical investigator. Treated brain metastases are defined as having no ongoing requirement for steroids and no evidence of progression or hemorrhage after treatment for at least 4 weeks prior to registration as documented by MRI or CT imaging or deemed stable by clinical investigator
• No imminent or established spinal cord compression based on clinical symptoms and/or imaging. In patients with untreated imminent or established spinal cord compression, treatment with standard of care as clinically indicated should be completed at least 2 weeks before registration
• No imminent or impending pathologic fracture based on clinical symptoms and/or imaging. In patients with untreated imminent or impending pathologic fracture, treatment with standard of care as clinically indicated should be completed at least 2 weeks before registration
• No significant, uncontrolled intercurrent or recent illness, including but not limited to the following conditions:
• Cardiovascular disorders: Symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia; uncontrolled hypertension defined as sustained blood pressure > 150 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment; stroke (including transient ischemic attack), myocardial infarction, or other ischemic event, within 6 months before randomization; thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 1 month before randomization
• Gastrointestinal disorders: Disorders associated with a high risk of perforation or fistula formation: active inflammatory bowel disease, active diverticulitis, active cholecystitis, active symptomatic cholangitis or active appendicitis, active acute pancreatitis or active acute obstruction of the pancreatic or biliary duct, or active gastric outlet obstruction; abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess within 3 months before randomization. Note: Complete healing of an intra-abdominal abscess must be confirmed before randomization
• No clinically significant hematuria, hematemesis, or hemoptysis, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 3 months before randomization
• No lesions invading major pulmonary blood vessels
• No other clinically significant disorders:
• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy (with no medications prohibited by this protocol [e.g. drug-drug interactions]) with undetectable viral load within 6 months are eligible for this trial
• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy (with no medications prohibited by this protocol [e.g. drug-drug interactions]), if indicated
• Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load (with no medications prohibited by this protocol [e.g. drug-drug interactions])
• No serious non-healing wound or ulcer
• No malabsorption syndrome
• No uncompensated/symptomatic hypothyroidism
• No moderate to severe hepatic impairment (Child-Pugh B or C)
• No requirements for hemodialysis or peritoneal dialysis
• No history of solid organ transplantation
• No chronic concomitant treatment with strong CYP3A4 inducers or inhibitors. Because the list of these agents is constantly changing, it is important to regularly consult a frequently updated medical reference. Patients may not have received a strong CYP3A4 inducer within 12 days prior to registration nor a strong CYP3A4 inhibitor within 7 days prior to registration
• No concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants include:
• Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).
• Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.
• Absolute neutrophil count (ANC) >= 1,500/mm^3
• Platelet count >= 100,000/mm^3
• Hemoglobin >= 9 g/dl (transfusions allowed)
• Calculated (calc.) creatinine clearance >= 30 mL/min using the Cockcroft-Gault equation
• Total bilirubin =< 1.5 x upper limit of normal (ULN), for patients with Gilberts disease =< 3.0 x ULN
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x ULN
• Urine protein to creatinine (UPC) ratio =< 2 mg/mg OR 24-hr urine protein < 2 g

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Condition: Kidney Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03293563

Sponsor: University Hospital, Bordeaux

Phase:

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• Adult patient with kidney cancer
• Patient with no opposition to collection of its data for the study

Exclusion Criteria:

1. none

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Condition: Renal Cell Carcinoma

Study Type: Observational [Patient Registry]

Clinical Trials Identifier NCT 8-digits: NCT03630536

Sponsor: Children's Hospital Medical Center, Cincinnati

Phase:

Eligibility:

• Age: minimum N/A maximum N/A
• Gender: All

Inclusion Criteria:

• All patients of any age with a suspected diagnosis or confirmed diagnosis of a TFE Renal Cell Carcinoma.
• Unless the patient is deceased, all patients and/or one parent or legal guardian must provide written informed consent as well as HIPAA/release of information consent.

Exclusion Criteria:

• Any patient that has not been diagnosed with TFE Renal Cell Carcinoma

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Condition: Clear Cell Renal Cell Carcinoma

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT04053855

Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Phase:

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• Patients:
• All patients with renal mass requiring surgery (partial or total nephrectomy)
• Social security affiliation
• Signed informed consent Control :
• Patients hospitalized in the urology department without cancer and without known renal mass
• Unscheduled nephrectomy
• Social security affiliation
• Signed informed consent

Exclusion Criteria:

• Insufficient volume of urine sample (< 100 ml)
• Patients with a urinary catheter
• Patients under court-ordered guardianship or curators

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Condition: Melanoma Stage Iv, Renal Cell Carcinoma, Metastatic

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03991130

Sponsor: Gregory Daniels

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• Patient has the ability to understand and the willingness to sign a written informed consent.
• Age ≥ 18 years at the time of consent.
• At least 6 weeks of prior anti-PD-1 therapy with documented clinical or radiographic progression. Last anti-PD-1 therapy must be within 6 months of enrollment.
• Histologically-confirmed diagnosis of unresectable stage III or metastatic (stage IV) melanoma or renal cell carcinoma
• Measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion according to RECIST 1.1, and obtained by imaging within 28 days prior registration for protocol therapy.
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 28 days prior to registration for protocol therapy.
• Adequate hepatic function within 28 days prior to registration for protocol therapy defined as meeting all of the following criteria:
• total bilirubin ≤ 1.5 × upper limit of normal (ULN) OR direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 x ULN (except in patients with Gilbert's syndrome who must have a total bilirubin less than 3.0 mg/dl.)
• and aspartate aminotransferase (AST) ≤ 2.5 × ULN or ≤ 5 × ULN for subjects with known hepatic metastases
• and alanine aminotransferase (ALT) ≤ 2.5 × ULN or ≤ 5 × ULN for subjects with known hepatic metastases
• Adequate renal function within 28 days prior to registration for protocol therapy defined by either of the following criteria:
• Serum creatinine ≤ 1.5 mg/dL
• OR if serum creatinine > 1.5 mg/dL, estimated glomerular filtration rate (GFR) ≥ 50 mL/min
• Adequate hematologic function within 28 days prior to registration for protocol therapy defined as meeting all of the following criteria:
• hemoglobin ≥ 9.0 g/dL
• and absolute neutrophil count (ANC) ≥ 1000/L without the support of filgrastim
• white blood cells (WBC) ≥ 3000/L
• and platelet count ≥ 100 × 109/L
• Adequate coagulation functioning within 28 days prior to registration for protocol therapy defined by either of the following criteria:
• INR < 1.5 × ULN
• OR for subjects receiving warfarin or LMWH, the subjects must, in the investigator's opinion, be clinically stable with no evidence of active bleeding while receiving anticoagulant therapy. The INR for these subjects may exceed 1.5 × ULN if that is the goal of anticoagulant therapy.
• Adequate pulmonary and cardiac function for HD IL-2 (will be assessed clinically)
• Female subjects of childbearing potential must have confirmed negative urine or serum pregnancy test prior to drug administration and be willing to use two methods of birth control.
• Male subjects who are not surgically sterile (vasectomy) must agree to use an adequate method of contraception.
• Subject's toxicities from prior treatments must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo)

Exclusion Criteria:

• Active infection requiring systemic therapy
• Women who are pregnant or breastfeeding.
• Second active malignancy within the past 5 years with the exception of localized basal or squamous cell skin cancer, in situ cervical or bladder cancer, or localized prostate cancer under active surveillance.
• Active symptomatic central nervous system (CNS) metastases. Prior treated metastases or asymptomatic metastases are allowed. Patient can receive radiation between treatments if deemed medically necessary.
• Surgery within 4 weeks prior to study treatment except for minor procedures.
• Uncontrolled or poorly-controlled hypertension (> 160 mmHg systolic or > 100 mmHg diastolic for > 4 weeks) despite standard medical management.
• Serious or non-healing wounds, ulcers, or bone fractures within 28 days prior to initiation of study treatment.
• Any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to initiation of study treatment.
• Has any condition that, in the opinion of the investigator, might jeopardize the safety of the patient or interfere with protocol compliance.
• Has any mental or medical condition that prevents the patient from giving informed consent or participating in the trial.
• Known hypersensitivity to nivolumab or IL-2 or any of their components.
• Known history of active tuberculosis.
• Concurrent systemic steroid therapy with doses above physiologic level (more than 10 mg of prednisone daily).
• Active autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with anti-phospholipid syndrome, granulomatosis with polyangiitis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis requiring treatment. Patients cannot be on immunosuppressive medications other than physiologic replacement doses of prednisone (less than 10 mg per day at enrollment) or equivalent steroid. Asymptomatic patients or those stable on non-immunosuppressive medications are eligible.
• Treatment with any investigational agent within 21 days prior to initiation of study treatment and the subject must have recovered from the acute toxic effects of the regimen with the exception of prior anti-PD-1.

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Condition: Clear Cell Renal Cell Carcinoma

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT04006405

Sponsor: Elypta

Phase:

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• Pre-screening inclusion criteria
• Size of primary tumor >4cm (>cT1a) in greatest dimension on pre-operative abdominal CT-scan
• Size of primary tumor ≤4cm is allowed if pre-operative abdominal CT-scan shows suspected RCCs with radiological sign of venous tumor thrombus (renal vein or caval).
• Pre-operative CT-scan of chest and abdomen show no signs of metastatic disease
• Localized and biopsy proven clear cell RCC (ccRCC) under active surveillance which at timepoint of study recruitment, opted for surgery because of growth rate of primary tumor to a size > 4cm
• Elected for curative intent surgery for RCC Final screening inclusion criteria
• Any gender being 18 years or older at timepoint of final inclusion
• In postoperative pathology report shown to be ccRCC subtype according to 8th Edition of the American Joint Committee on Cancer (AJCC)
• Leibovich points (LP) ≥5 according to Leibovich score system (2003)
• If pathology report shows multiple subtypes in same tumor, as long as the majority of tumor is ccRCC (>50%), participant can be included Exclusion Criteria: Pre-screening exclusion criteria
• TNM-stage T(any) N(any) M1 according to AJCC, i.e. metastatic disease at diagnosis
• Absence of preoperative chest imaging (chest CT) within 60 days prior to primary surgery
• Previous history of curatively treated for other cancers, still not deemed fully cured and participant still under surveillance for said cancer
• Participants offered active surveillance for RCC instead of curative intent surgery
• Participants offered any type of thermal ablation treatment instead of surgery, i.e. LP cannot be assessed Final screening

Exclusion Criteria:

• Pre-screening exclusion criteria
• TNM-stage T(any) N(any) M1 according to AJCC, i.e. metastatic disease at diagnosis
• Absence of preoperative chest imaging (chest CT) within 60 days prior to primary surgery
• Previous history of curatively treated for other cancers, still not deemed fully cured and participant still under surveillance for said cancer
• Participants offered active surveillance for RCC instead of curative intent surgery
• Participants offered any type of thermal ablation treatment instead of surgery, i.e. LP cannot be assessed Final screening exclusion criteria
• Participants with AJCC cN0 status at preoperative imaging in whom a clinically suspicious regional lymph-node metastases (enlarged lymph node(s)) is noted during primary surgery, but who subsequently do not undergo any lymph node dissection. (Note: participants with cN0 status at pre-operative imaging and no clinical signs of regional lymph node metastases during primary surgery can still be included irrespective of lymph node dissection having been performed, i.e. being pN0 or pN1 if it is performed or pNx if it is not performed)
• Participants with AJCC cN1 status at pre-operative imaging in which lymph node dissection is not performed (i.e. pNx).
• Elected for any adjuvant therapy (i.e. systemic therapy) outside or within any clinical study
• Non-clear cell RCC histology or benign tumor (i.e. oncocytoma and angiomyolipoma, which are the most common benign types, but also any other rare types of benign renal tumors) after pathological analysis
• Any hereditary form of RCC (e.g. Von Hippel-Lindau, Birt-Hogg-Dubé, Hereditary Papillary RCC)
• RCC with pure sarcomatoid differentiation, also called sarcoma of the kidney
• Previous history of curatively treated for RCC with a suspected de novo RCC in the remaining kidney tissue
• Prior or current use of instillation therapy with hyaluronic acid and/or chondroitin sulfate (HA-CS).
• Use of heparin, including low molecular weight heparin (e.g. Enoxaparin, Dalteparin, Tinzaparin) for concurrent disease in need of blood dilution (e.g. ongoing deep vein thrombosis or lung emboli). Note: use of of heparin for thrombus prophylaxis in conjunction with primary surgery or postoperatively ≤4 weeks will be allowed.
• Patients who were not radically operated during primary surgery with the exception of histological positive surgical margin in participants who have undergone partial nephrectomy.

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Condition: Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma, Kidney Cancer, Renal Carcinoma, Kidney Cancer Metastatic

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03786796

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum 120 Years
• Gender: All

Inclusion Criteria:

• Willing and able to provide written informed consent. Provision of informed consent is required prior to any study procedures.
• Patients aged 18 years of age or older.
• Histological proof of renal cell carcinoma (both clear cell and non-clear cell allowed).
• Metastatic (AJCC Stage IV) renal cell carcinoma.
• Somatic or germline mutation in BAP-1, ATM, BRCA1, BRCA2, PALB2, CHEK2, BRIP1, RAD51C, BARD1, CDK12, CHEK1, FANCL, PP2R2A, RAD51B, RAD51D, or RAD54L as documented by a clinical CLIA-grade, tissue, saliva or blood-based genetic test.
• At least one prior treatment with an anti-angiogenic agent or immune checkpoint inhibitor.
• Any number of prior systemic therapies is allowed (cytokine, anti-angiogenic, mTOR, immune checkpoint blockage or clinical trial).
• Must have measurable disease as defined by RECIST 1.1 criteria.
• Participants must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
• Hemoglobin ≥ 10.0 g/dL with no blood transfusion in the past 28 days
• Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
• Platelet count ≥ 100 x 10^9/L
• Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
• Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x institutional ULN unless liver metastases are present in which case they must be ≤ 5 x ULN. Note: Patients with elevations in bilirubin, AST, or ALT should be thoroughly evaluated for the etiology of this abnormality prior to entry and patients with evidence of viral infection should be excluded.
• Patients must have a creatinine clearance ≥ 40 mL/min calculated by Cockroft-Gault formula or 24 hour urine test.
• ECOG PS ≤ 1.
• Participants must have a life expectancy ≥ 16 weeks.
• Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1. Postmenopausal is defined as:
• Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments.
• Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post menopausal range for women under 50 years old.
• Radiation-induced oophorectomy with last menses > 1 year ago.
• Chemotherapy-induced menopause with > 1 year interval since last menses.
• Surgical sterilization (bilateral oophorectomy or hysterectomy).
• Male patients must use a condom during treatment and for 3 months after the last dose of olaparib when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential.

Exclusion Criteria:

• Other malignancy unless curatively treated with no evidence of disease for ≥ 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma. Patients with a history of localized triple negative breast cancer may be eligible, provided they completed their adjuvant chemotherapy > 3 years prior to registration, and that the patient remains free of recurrent or metastatic disease.
• Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.
• Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
• Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
• Breast feeding women.
• Use of any prohibited concomitant medications within the prior 2 weeks.
• Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
• Participation in another clinical study with an investigational product during the last 2 weeks.
• Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment.
• Any previous treatment with PARP inhibitor, including olaparib.
• Resting ECG with QTc > 500 ms and/or indication of uncontrolled cardiac conditions, as judged by the investigator (e.g. unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, electrolyte disturbances, etc.), or patients with congenital and/or family history of long QT syndrome.
• Concomitant use of known strong CYP3A inhibitors (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks. During the study, if co-administration of a strong or moderate inhibitor is required because there is no suitable alternative medication, exception to this criterion may be allowed with a suitable dose reduction of olaparib.
• Concomitant use of known strong CYP3A inducers (e.g. phenobarbital, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (e.g. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for phenobarbital or enzalutamide and 3 weeks for other agents.
• Persistent toxicities (> Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia.
• Patients with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
• Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
• Poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.
• Unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
• Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).
• Known hypersensitivity to olaparib or any of the excipients of the product.
• Known active hepatitis (i.e. Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids.
• No packed red blood cells and/or platelet transfusions within the last 28 days prior to study entry.

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Condition: Renal Cell Carcinoma, Urothelial Carcinoma

Study Type: Observational [Patient Registry]

Clinical Trials Identifier NCT 8-digits: NCT03374267

Sponsor: iOMEDICO AG

Phase:

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• Female and male patients with aRCC or aUBC (locally advanced, inoperable or metastatic)
• Patients at start of their first-line systemic treatment for aRCC or aUBC
• Written informed consent
• Patients participating in the PRO module: signing of in-formed consent form and completion of baseline questionnaire before start of initial systemic treatment
• Patients not participating in the PRO module: within twelve weeks after start of systemic first-line for aRCC or aUBC
• Age ≥ 18 years

Exclusion Criteria:

• Patients with prior systemic therapy for aRCC or aUBC
• No systemic treatment for aRCC or aUBC

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Condition: Kidney Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03414827

Sponsor: Zealand University Hospital

Phase:

Eligibility:

• Age: minimum N/A maximum N/A
• Gender: All

Inclusion Criteria:

• Patients who have been diagnosed with kidney cancer.

Exclusion Criteria:

• Patients without signs of malignancy at final histology report.
• Incapacitated patients.

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Condition: Metastatic Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03967522

Sponsor: Centre Leon Berard

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• I1. Age ≥ 18 years. I2. Histologically proven metastatic Renal Cell Carcinoma. I3. Brain metastases not requiring corticosteroids at dose > 40 mg/day. I4.At least 1 locally untreated brain lesion ≥8mm in longest diameter or >5mm if > 1 lesion. I5.Not previously treated by cabozantinib. I6.Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1. I7.Life expectancy ≥ 3 months I8.Adequate organ function as defined by the following criteria:
• Total serum bilirubin ≤ 2 x ULN (Gilbert's disease exempted)
• Serum transaminases and alkaline phosphatases ≤ 2.5 x ULN, or in case of liver or bone metastasis ≤ 5.0 x ULN
• Serum creatinine ≤ 2 x ULN OR creatinine clearance ≥ 50 ml/min
• Absolute neutrophil count (ANC) ≥ 1 500/mm3
• Platelets ≥ 100 000/mm3 (100 G/l)
• Hemoglobin ≥ 9.0 g/dl. I9. Covered by a medical/health insurance. I10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. I11. Signed and dated IRB/ICE approved informed consent form. I12. Accepting to use effective contraception (barrier contraceptives) during study treatment and within at least 4 months after final dose of study therapy. Oral contraceptives are not acceptable.

Exclusion Criteria:

1. E
2. Any local previous treatment of current brain metastases. E
3. Any anti-coagulation therapy (except preventive treatment at low dose). E
4. Contra-indication of Magnetic Resonance Imaging (MRI) (i.e. : pace-maker). E
5. Uncontrolled seizures. E
6. Any symptoms of intracranial hypertension. E
7. Any of the following within 12 months prior to treatment initiation: severe/unstable angina, myocardial infarction, coronary artery bypass graft, symptomatic congestive heart failure, ischemic or hemorrhagic stroke including transient ischemic attack. E
8. Uncontrolled hypertension defined as systolic blood pressure >150 mmHg or diastolic pressure >90 mmHg, despite optimal medical treatment. E
9. Ongoing cardiac dysrhythmia of grade ≥ 2, atrial fibrillation of any grade, QTc interval > 0.
10. E
11. Pregnant or breast feeding woman (mandatory negative serum or urinary pregnancy test at study entry for all women of childbearing potential). E
12. Any acute or chronic medical or psychiatric condition or laboratory abnormality that would make the patient unsuited to study participation. E
13. Any second malignancy within the last 3 years with the exception of basal cell carcinoma, in situ cervical cancer and pT1/a bladder cancer with no evidence of recurrent disease for 12 months. E
14. Patients receiving strong inhibitor or inducer of CYP3A4 especially some anti-epileptic drugs. E
15. Psychological, familial, sociological, geographical conditions that would limit compliance with study protocol requirements. E
16. Participation to another clinical trial that might interfere with the evaluation of the main criterion. E
17. Known hypersensitivity to the active substance or to any of the excipients of cabozantinib. E
18. Patient requiring tutorship or curatorship.

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Condition: Advanced Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03229083

Sponsor: University of Rochester

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• Diagnosis of histologically confirmed renal cell carcinoma of any subtype with either pathological or radiographic evidence of metastatic disease
• Greater than 18 years of age
• A participating Wilmot Cancer Center oncologist has determined that candidate should be started on either oral targeted therapy or immunotherapy for treatment of their advanced RCC; this can be for first-line or any subsequent line therapy
• Able to provide written informed consent
• Proficient in the English language and self-reports as literate
• Must have an active email address or access to a smart device on which text messages can be received

Exclusion Criteria:

• Women cannot be breast-feeding
• Does not have regular access to the internet
• Unable to come to the Wilmot Cancer Center for appointments every 3-4 months for routine visits with their primary oncologist
• Subjects who were on the study previously will not be allowed to re-enroll in the event of a treatment change

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Condition: Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04006522

Sponsor: James Brugarolas

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• Patients with suspected renal cell carcinoma with planned surgery or patients with metastatic RCC and a tissue diagnosis. (In standard clinical practice, biopsy is not routinely performed in patients who will be having surgery).
• Ability to understand and the willingness to sign a written informed consent.
• Patient must be able to lie still for a 30 to 60 minute PET/CT scan.
• One of the following: 1. Patients with locally advanced RCC planned for surgery determined to be a high risk of recurrence, defined by presence of at least clinical T2 or TxN1, OR patients with metastatic RCC for whom treatment with cytoreductive nephrectomy and/or metastasectomy is planned by the treating physician. 2. Patients with metastatic RCC for whom immuno-oncology (IO) therapy is planned.
• Women of child-bearing potential must agree to undergo and have documented a negative pregnancy test on the day of 89Zr-DFO-Atezolizumab administration. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

Exclusion Criteria:

• History of severe allergic, anaphylactic, or other hypersensitivity reactions to atezolizumab or any other chimeric or humanized antibodies.
• Uncontrolled severe and irreversible intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
• Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
• Significant autoimmune disease requiring treatment with either prednisone (or steroid equivalent) at a dose > 10 mg/day or other immunosuppressive agents. (Replacement steroid therapy is acceptable).
• Any patient for whom ICI therapy would be contraindicated for other reasons. Patients with adverse reactions to ICI therapy may undergo second 89Zr-DFO-Atezolizumab injection and PET/CT at the discretion of the treating physician considering that the dose of antibody represents 1% of a single therapeutic dose and therefore unlikely to cause adverse events.
• Subjects unable to provide informed consent.
• Subjects who are claustrophobic or have other contraindications to PET/CT.
• Subjects must not weigh more than the maximum weight limit for the table for the PET/CT scanner where the study is being performed. (>200 kg or 440 lbs).

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Condition: Carcinoma, Renal Cell

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04028245

Sponsor: Columbia University

Phase: Early Phase 1

Eligibility:

• Age: minimum 18 Years maximum 99 Years
• Gender: All

Inclusion Criteria:

• Radiographically consistent with or histologically confirmed clear cell RCC or predominantly clear cell RCC
• Localized non-metastatic RCC T1b-T4NanyM0 or TanyN1M0)
• Schedule to undergo either partial or radical nephrectomy as part of the treatment plan
• Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
• Age ≥ 18 years old at time of consent
• HIV-infected patients who are healthy and have a low risk of AIDS-related outcomes as defined by the following
• Cluster of differentiation 4 (CD4+) T cell counts ≥ 350 cells/microliter OR undetectable HIV viral load
• no history of AIDS-defining opportunistic infection in the last year
• Normal organ and marrow function as defined below:
• White blood cell count (WBC) > 3.0 K/mm3
• Absolute neutrophil count (ANC) ≥ 1.5 K/mm3
• Platelets ≥ 100 K/mm3
• Hemoglobin (Hgb) ≥ 9 g/dL
• Serum total bilirubin: ≤ 1.5 x upper limit of normal (ULN)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 x ULN
• Serum creatinine ≤ 1.5 x ULN or serum creatinine > 1.5
• 3 x ULN if calculated
• creatinine clearance (CrCl) is ≥ 30 mL/min
• For patients with known chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
• For patients with a history of hepatitis C virus (HCV) infection, the infection must be treated and cured
• Willingness to provide written informed consent and HIPAA authorization for the release of personal health information, and the ability to comply with the study requirements (note: HIPAA authorization will be included in the informed consent)
• Willingness to use barrier contraception from the time of first dose of canakinumab and spartalizumab until 120 days after surgical intervention

Exclusion Criteria:

• Presence of distant metastases
• Presence of active, known or suspected autoimmune disease.
• No patients with documented, active infections, treated or untreated, may be included in this study
• Use of any live vaccines against infectious disease within 4 weeks of initiation ot study treatment.
• Prior therapy with experimental anti-tumor vaccines; any T cell co-stimulation or checkpoint pathways
• Prior treatment for RCC including surgery, radiation, thermoablation, or systemic therapy
• Surgery within 28 days of starting study treatment
• Prior treatment with any antibody or drug targeting T cell costimulation or immune checkpoint pathways (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, etc)
• Systemic chronic steroid therapy (≥ 10mg/day prednisone or equivalent) or any immunosuppressive therapy 7 days prior to planned date of first dose of study treatment. Note: Topical, inhaled, nasal and ophthalmic steroids are allowed
• Allogenic bone marrow or solid organ transplant
• History of severe hypersensitivity reactions to other monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction
• History or current interstitial lung disease or non-infectious pneumonitis requiring the use of home oxygen
• History of severe hypersensitivity reaction to other monoclonal antibodies
• Current signs or symptoms of severe progressive or uncontrolled, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, or cardiac disease other than directly related to RCC
• Positive tests for hepatitis B surface antigen or hepatitis C ribonucleic acid (RNA)
• History of known or suspected autoimmune disease with the following exceptions:
• Vitiligo
• Resolved childhood atopic dermatitis
• Psoriasis (with exception of psoriatic arthritis) not requiring systemic treatment (within the past 2 years).
• Patients with Grave's disease or Hashimoto's thyroiditis that are now euthyroid clinically and by laboratory testing.
• History of malignancy within the last 2 years, with the exception of non-melanoma skin cancers and superficial bladder cancer
• Uncontrolled major active infectious, cardiovascular, pulmonary, hematologic, or psychiatric illnesses that would make the patient a poor study candidate

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Condition: Kidney Cancer, Prostate Cancer, Bladder Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT02186925

Sponsor: Meir Medical Center

Phase:

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• All patients with prostate, bladder or kidney cancer that are being treated at the Meir Medical Center and are over 18 years of age.

Exclusion Criteria:

• Patients under the age of 18

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Condition: Renal Cell Carcinoma, Metastatic, Renal Cell Cancer, Recurrent

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03013946

Sponsor: AIO-Studien-gGmbH

Phase: Phase 3

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

1. Written informed consent and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
2. Age ≥ 18 years at time of study entry
3. Advanced or metastatic renal cell carcinoma, not amendable to surgery with curative intent, rendering the patient eligible for Tyrosin Kinase Inhibitor (TKI) treatment with sunitinib
4. Intended first-line treatment with sunitinib
5. Documented progressive disease within 6 months prior to study inclusion
6. Patients with measurable disease (at least one uni-dimensionally measurable target lesion by CT-scan or MRI) according to modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as well as non-measurable disease are eligible.
7. Prior radiotherapy and surgery are allowed if completed 4 weeks (for minor surgery and palliative radiotherapy for bone pain: 2 weeks) prior to start of treatment and patient recovered from toxic effects.
8. Female subjects must either be of non-reproductive potential (ie, post-menopausal by history: ≥60 years old and no menses for ≥1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry.
9. Subject is willing to receive additional concomitant coaching and able to comply with the QoL/PRO (patient-reported outcome) assessments specified in the protocol for the duration of the study including scheduled visits, examinations and follow up.

Exclusion Criteria:

1. Any other anti-cancer treatment aside of sunitinib for mRCC (except palliative radiotherapy)
2. Previous malignancy (other than mRCC) which either progresses or requires active treatment. Exceptions are: basal cell cancer of the skin, pre-invasive cancer of the cervix, T1a or T1b prostate carcinoma, or superficial bladder tumor [Ta, Tis and T1].
3. CNS metastases, unless local therapy has been completed for at least 3 month and patient does not require the use of steroids.
4. Chronic liver disease with Child-Pugh B or C score
5. Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year)
6. Any condition that, in the opinion of the investigator, would interfere with evaluation of the concomitant coaching or QoL assessments or interpretation of patient safety or study results
7. Participation in another clinical study with an investigational product during the last 30 days before inclusion
8. Any previous treatment with a tyrosine kinase inhibitor for metastatic disease. Adjuvant or neoadjuvant therapy for localized disease is permitted, provided that relapse occurred at least 6 months after last exposure
9. Previous enrollment or randomization in the present study (does not include screening failure).
10. Involvement in the planning and/or conduct of the study (applies to both Pfizer staff and/or staff of sponsor and study site)
11. Patient who might be affiliated or otherwise dependent on the sponsor, site or the investigator
12. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities [§ 40 Abs. 1 S. 3 Nr. 4 AMG].
13. Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [§ 40 Abs. 1 S. 3 Nr. 3a AMG].

View trial on ClinicalTrials.gov