Kidney/Renal Cancer

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Talazoparib and Avelumab in Genomically Defined Metastatic Renal Cell Carcinoma


Condition: Metastatic Renal Cell Carcinoma, Fumarate Hydratase Deficient Renal Cell Carcinoma, Succinate Dehydrogenase Deficient Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04068831

Sponsor: Memorial Sloan Kettering Cancer Center

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Biopsy proven, histological confirmed renal cell carcinoma (RCC) or renal medullary carcinoma (RMC).. Patients with surgery and biopsy at outside institutions will be eligible for this protocol once archival material is reviewed and the above diagnosis confirmed by genitourinary pathology review at Memorial Sloan Kettering Cancer Center (MSKCC). Cohort 1: (Closed to Accrual)
  • Presence of VHLalteration by next-generation sequencing (NGS) with a stateapproved assay
  • Patients must have radiographic evidence of disease progression after treatment with at least one prior PD-1 or PD-L1 agent, and one prior VEGF inhibitor
  • Maximum 3 prior lines of therapy Cohort 2:
  • For FH/SDH patients FH- or SDH- expression-loss by immunohistochemistry (IHC) or alteration (somatic or germline) in FH or SDH per NGS with a state-approved assay
  • For Renal Medullary Carcinoma (RMC) patients: histologic confirmation of RMC (no IHC/NGS criteria required)
  • At least one prior line of therapy:
  • For FH/SDH patients Patients must have radiographic evidence of disease progression after treatment with at least one prior line of therapy (one prior PD-1/PD-L1 and/or VEGF inhibitor).
  • For Renal Medullary Carcinoma (RMC) patients prior radiographic evidence of disease progression on/after at least one line of chemotherapy (e.g. carboplatin / paclitaxel, carboplatin / paclitaxel / bevacizumab, carboplatin / gemcitabine, and gemcitabine / doxorubicin).
  • No maximum lines of therapy Both Cohorts 1 & 2
  • Adequate Hematologic Function
  • Absolute Neutrophil Count ≥ 1.5 x 10^9 / L
  • Platelet Count ≥ 100 x 10^9 / L
  • Hemoglobin ≥ 9 g/dL
  • No transfusion of packed red blood cells or platelets within 21 days of Cycle 1 Day 1
  • Adequate Renal Function ≥ 30 ml/min according to the Cockcroft-Gault Equation
  • Patients with moderate renal impairment (creatinine clearance 30-59 by Cockcroft-Gault EquationI) will start with a reduced dose of talazoparib.
  • Adequate Hepatic Function including:
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
  • AST ≤ 3 x upper limit of normal (ULN) without liver metastasis
  • ALT ≤ 3 x upper limit of normal (ULN) without liver metastasis
  • AST or ALT ≤ 5 x upper limit of normal (ULN) for patients with liver metastasis
  • Patients with known Gilbert's syndrome may be included if total bilirubin ≤ x 3 ULN
  • Eastern Cooperative Group (ECOG) Performance Status 0-2.
  • Patients must have measurable disease by RECIST v1.1. At least one measurable lesion should not have been previously irradiated.
  • Women of childbearing potential must have negative serum pregnancy testing at screening. All women will be considered childbearing potential unless meeting criteria including:
  • Achieved post-menopausal status as defined by cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have follicular stimulation hormone showing postmenopausal state. Women who have been amenorrhoeic for ≥12 months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anorexia, low body weight, ovarian suppression, anti-estrogen therapy or other medically inducible reasons.
  • Documented hysterectomy or bilateral oophorectomy surgery
  • Medically confirmed ovarian failure
  • Sexually active participants and their partners must agree to use medically accepted methods of contraception (i.e. barrier methods including condoms, female condom, or diaphragm with spermicidal gel) during the study and for 7 months after the last dose of the study treatment for females, and 4 months for males.
  • Recovery of baseline CTCAE v5.0 grade ≤1 toxicities related to prior study treatments unless adverse events are clinically non-significant and/or stable on supportive therapy if needed.
  • Patients must be willing and able to comply with trial protocol. This includes adhering to the treatment plan, scheduled visits, laboratory and other study procedures.

Exclusion Criteria:

  • Patients < 18 years old
  • Patients who are pregnant or breast-feeding. Fertile patients who are unwilling or unable to use two methods of contraception (at least one of which considered highly effective) for duration of study and after 7 months after last dose of study treatment for female, and 4 months for males.
  • Patients who had prior immune checkpoint blockade therapy (either anti-PD-1, anti- PD-L1 and/or anti-CTLA-4) discontinued due to development of an immune related adverse event.
  • Prior diagnosis of myelodysplastic syndrome (MDS) or diagnosis of other malignancy that requires anti-cancer directed therapy within the last 24 months. Exclusions include those cancers that are considered cured by local therapy (i.e.Basal cell carcinoma, squamous cell carcinoma, ducal carcinoma in situ of breast, bladder of cervix) or other cancers that have low malignant potential and do not require systemic therapy (i.e. Gleason-grade <6 prostate adenocarcinoma, borderline ovarian malignancy / low malignant potential).
  • Prior treatment with talazoparib or other agents that target PARP
  • Treatment with anti-cancer therapies within 21 days or five half-lives, whichever shorter, of start date, including monoclonal antibody, cytotoxic therapy, or another investigational agent. There is no specific time window between last PD-1/PD-L1 therapy and start date of new therapy on protocol.
  • Significant vascular disease (i.e. aortic aneurysm requiring surgical repair, recent arterial thrombosis) within 6 months prior to first dose of therapy.
  • Evidence of bleeding diathesis or significant unexplained coagulopathy (i.e. absent of anticoagulation)
  • Clinical signs or symptoms of gastrointestinal obstruction requirement parenteral hydration, parenteral nutrition, or feeding tube.
  • Uncontrolled effusion management (pleural effusion, pericardial effusion, or ascites) which requires recurrent drainage procedures.
  • Patients treated with systemic immunosuppressants; except for 1. chronic physiologic replacement of ≤ 10mg prednisone (or equivalent) for treatment of adrenal insufficiency; Steroids required for pre-medication reactions 2. Local steroid use is permitted (e.g. intranasal, topical, inhaled, or local steroid injection, i.e. intra-articular)
  • Patients with autoimmune disease that may worsen during immune checkpoint blockade therapy are excluded. Patients with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requirement immunosuppressive treatment as above are eligible.
  • Prior organ transplantation including allogeneic stem cell transplant.
  • No active infection requiring parenteral antibiotic therapy.
  • Prior diagnosis of HIV/AIDS
  • History of either positive HCV RNA viral load or anti-HCV antibody screening detectable; HBV infection with HBV surface antigen detection and/or positive HBV DNA viral load.
  • Known hypersensitivity to talazoparib or avelumab, or any component in formulations. Patients with known hypersensitivity to monoclonal antibodies (Grade ≥3 by CTCAE v5.0)
  • Live vaccination within 4 weeks of first dose of therapy. All vaccines except inactivated are prohibited while on study.
  • Severe acute or chronic medical conditions which may significantly increase the risk of study participants, per treating investigator's discretion
  • Radiation therapy to any site (including bone) <2 weeks prior to the first dose of therapy. Patients with clinically relevant ongoing complications from prior radiation therapy, per investigators' assessment, are not eligible.
  • Symptomatic brain metastasis or leptomeningeal disease requiring steroid use. Patients are eligible if they neurologically stable for 4 weeks, and have completed radiation therapy or surgery, and recovered from side effects. Patients must have discontinued steroid therapy for at least 2 weeks prior to first dose of study treatment.
  • Current or anticipated use of potent P-gp inhibitors within 7 days prior to randomization or anticipated use during the study. Please see Appendix 5 for a list of potent P-gp inhibitors.
  • Inability to swallow capsules, known intolerance to talazoparib or its excipients, known malabsorption syndrome, or other conditions which impair intestinal absorption.
  • Investigator site staff members directly involved in study conduct, including but not limited to their family members, or patients who are Pfizer members, including their family members, who are directly involved in study conduct.

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Cabozantinib in Adult Patients With Advanced Renal Cell Carcinoma Following Prior Systemic Check Point Inhibition Therapy: a Retrospective, Non-interventional Study


Condition: Advanced Renal Cell Carcinoma (All Subtypes), Metastatic Renal Cell Carcinoma (All Subtypes)

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT04147143

Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Phase:

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
  2. Patients with advanced or metastatic renal cell carcinoma, including all subtypes
  3. Age ≥ 18 years
  4. Completion of treatment with nivolumab or nivolumab / ipilimumab combination therapy (any line of therapy) directly followed by cabozantinib treatment

Exclusion Criteria:

  1. Patients who are unable to consent because they do not understand the nature, significance and implications of the observational trial
  2. Involvement in the planning and / or conduct of the study (applies to both Ipsen staff and/or staff of sponsor and study site)

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REPLICA: Real Patient Life Treatment With Cabozantinib in Patients With Advanced or Metastatic RCC: A Descriptive and Prospective Non-Interventional Study


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® for advanced or metastatic renal cell carcinoma
  • Decision to treat patients with Cabometyx® has to be taken prior to and independent from participation in the clinical study
  • Provision of written informed consent

Exclusion Criteria:

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

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A Phase II Randomized Trial of Radium-223 Dichloride and Cabozantinib in Patients With Advanced Renal Cell Carcinoma With Bone Metastasis (RadiCal)


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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TRACERx Renal (TRAcking Renal Cell Carcinoma Evolution Through Therapy (Rx)) CAPTURE: COVID-19 Antiviral Response in a Pan-tumour Immune Study


Condition: Renal Cell Carcinoma, Cancer, Healthy Volunteers

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03226886

Sponsor: Royal Marsden NHS Foundation Trust

Phase:

Eligibility:

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

Inclusion Criteria:

  • Age 18- years or older
  • Patients with histopathologically confirmed renal cell carcinoma, or suspected renal cell carcinoma, proceeding to neoadjuvant therapy and/or nephrectomy/metastasectomy, or identified as having progressive disease
  • Or in patients undergoing nephrectomy for non-malignant disease
  • Medical and/or surgical management in accordance with national and/or local guidelines
  • Written informed consent Exclusion Criteria:
  • Any concomitant medical or psychiatric problems which, in the opinion of the investigator, would prevent completion of treatment or follow-up
  • Lack of adequate tissue CAPTURE Inclusion criteria
  • Documented informed consent
  • Age 18 years or older
  • Confirmed cancer diagnosis (irrespective of cancer type, disease burden or treatment)
  • Group A: Suspected infection with SARS-CoV-2 or positive test for SARS-CoV-2
  • Group B: no clinical indication to test for SARS-CoV-2 (by current Trust guidelines*) or tested negative for SARS-CoV-2
  • Group C: Volunteers without cancer with SARS-CoV-2 (symptomatic and asymptomatic) and those without clinical indication (current national guidelines*) for SARS-CoV-2 testing or tested negative for SARS-CoV-2

Exclusion Criteria:

  • Any concomitant medical or psychiatric problems which, in the opinion of the investigator, would prevent completion of treatment or follow-up
  • Lack of adequate tissue CAPTURE Inclusion criteria
  • Documented informed consent
  • Age 18 years or older
  • Confirmed cancer diagnosis (irrespective of cancer type, disease burden or treatment)
  • Group A: Suspected infection with SARS-CoV-2 or positive test for SARS-CoV-2
  • Group B: no clinical indication to test for SARS-CoV-2 (by current Trust guidelines*) or tested negative for SARS-CoV-2
  • Group C: Volunteers without cancer with SARS-CoV-2 (symptomatic and asymptomatic) and those without clinical indication (current national guidelines*) for SARS-CoV-2 testing or tested negative for SARS-CoV-2 Exclusion criteria • Medical or psychological condition that would preclude informed consent

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Study of the Predictive Impact of MMP2 and MMP9 Levels for Patients With Metastatic Kidney Cancer Treated With Anti-angiogenic Agents Compared to Patients Not Treated With Antiangiogenic (Localized Kidney Cancer and Oligometastatic)


Condition: Kidney Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03185039

Sponsor: Institut Paoli-Calmettes

Eligibility:

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

Inclusion Criteria:

  • 1. Patient male or female, aged of more than 18 years 2. Patient with any of the following conditions:
  • Kidney cancer localized at diagnosis.
  • Metastatic kidney cancer when anti-angiogenic therapy is initiated by Sunitinib or Pazopanib
  • Oligometastatic kidney cancer without systemic treatment (local treatment) 3. ECOG = 0 to 2 4. Patient affiliated to, or beneficiary of, the national social security. 5. Patient having signed informed consent

Exclusion Criteria:

  1. Patient previously treated with anti-angiogenic agents.
  2. Person in an emergency situation, adult subject to a legal protection measure (a guardian, guardianship or safeguard of justice), or unable of expressing his / her consent.
  3. Impossibility to undergo the medical follow-up of the trial for geographical, social or psychological reasons
  4. History of malignant disease in the 5 years prior to inclusion (except basal cell carcinoma of the skin or epithelioma of the cervix in situ, or prostate cancer with a good prognosis (stage T <3 and Gleason <7)) accidentally discovered during the histological analysis of the tumor sample. 5- Pregnant or nursing women 6- Contraindications to the procedure of the study

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UroCCR Database: French Research Network for Kidney Cancer (National Multidisciplinary Clinical and Biological Database on Kidney Cancer)


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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TFE Renal Cell Carcinoma: A Prospective Registry and Translational Research Initiative


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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Prospective, Post Marketing Surveillance to Observe Safety and Effectiveness of CABOMETYX™ Under the Real Practice Setting in Patients With Renal Cell Carcinoma and Patients With Hepatocellular Carcinoma in Korea.


Condition: Renal Cell Carcinoma, Hepatocellular Carcinoma

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03776123

Sponsor: Ipsen

Phase:

Eligibility:

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

Inclusion Criteria:

  • Patients who meet 'Indications' of Cabometyx™ label
  • Patients who are treated with Cabometyx™ for the first time according to Cabometyx™ label
  • Patients who are aged 18 years or older
  • Patients who are willing to provide written consent after being informed of this surveillance

Exclusion Criteria:

  • Patients who are contraindicated for Cabometyx™ based on Cabometyx™ label

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BrUOG 354: A Phase II Randomized Trial of Nivolumab +/- Ipilimumab for Ovarian and Extra-renal Clear Cell Carcinomas


Condition: Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, Extra Renal Origin, Clear Cell Adenocarcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03355976

Sponsor: Brown University

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Patients must have a recurrent, advanced, or metastatic pure clear cell carcinoma of ovarian, fallopian tube, primary peritoneal, or extra-renal origin.
  • All patients must submit representative tissue from their malignancy.
  • Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam.
  • Patients with a clear cell carcinoma of ovarian, fallopian or primary peritoneal origin must have progressed after at least one prior platinum and taxane based chemotherapy regimen. Patients with extra-renal clear cell cancer (including other GYN) cancers must have progressed after at least one prior regimen for advanced/metastatic disease. Radiation therapy (including the use of chemotherapy as a radiosensitizer) will not count as a prior systemic regimen.
  • No prior anti-PD-1, PD-L1 or CTLA-4 antibody.
  • Age ≥ 18
  • ECOG performance status 0 to 1
  • Participants must have normal organ and marrow function as defined below: leukocytes ≥3,000/mcL absolute neutrophil count ≥1,500/mcL platelets ≥100,000/mcL total bilirubin within normal institutional limits EXCEPTIONS: conjugated hyperbilirubinemia; Gilbert's syndrome, both of which will allow a total bilirubin <3.0mg/dL <5xULN is liver metastases are present A value below the LLN is acceptable if confirmed appropriate by the treating MD AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal creatinine ≤ 1.5 X ULN (upper limit of normal) OR creatinine clearance ≥50 mL/min
  • Adequate thyroid function within 28 days prior to registration defined as serum TSH in normal range. Patients on thyroid hormone supplementation are allowed provided the serum TSH is within normal limits.
  • Subjects must have a resting baseline O2 saturation by pulse oximetry of ≥92% at rest. This should be documented within two weeks of registration.
  • Reproductive status:
  • Women of childbearing potential (WOCBP) must use method(s) of contraception. Given there is insufficient information to assess teratogenicity (preclinical studies have not been done), a highly effective method(s) of contraception (failure rate of less than 1% per year) is required as determined by the treating investigator. WOCBP must follow instructions for birth control. For all women who discontinue protocol treatment, contraception should be continued for five months following the last dose of therapy.
  • WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to the start of registration.
  • Women who are not of childbearing potential (ie, who are postmenopausal (lack of menses > 24 months) or surgically sterile) and azospermic men do not require contraception.
  • Women must not be breastfeeding (document for all).
  • Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1 % per year. The investigator shall review contraception methods and the time period that contraception must be followed.
  • Men that are sexually active with WOCBP must follow instructions for birth control when the half life of the investigational drug is greater than 24 hours, contraception should be continued for a period of 7 months after discontinuation of treatment.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Participants who have had prior therapy with nivolumab or with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune check point pathways.
  • Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study. Patients using endocrine therapy as treatment for their index cancer must be off of treatment for one week (7 days) prior to entering the study.
  • Participants who have not recovered from clinically significant adverse events to
  • Participants who are receiving any other investigational agents.
  • Participants with known brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • History of severe hypersensitivity reaction to any monoclonal antibody.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring antibiotics, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women are excluded from this study
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer are excluded if there is any evidence of other malignancy being present within the last three years. However, patients with a malignancy that is not-likely to require treatment in the next 2 years, such as a completely resected, early stage breast cancer, are eligible.
  • Patients who have received prior chemotherapy within the last three years for any other cancer other than for clear cell cancer.
  • In order for patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) to be eligible, they must be on a stable highly active antiretroviral therapy (HAART) regimen, have CD4 counts > 350, with no detectable viral load on quantitative PCR within 4 weeks of registration.
  • Patients with treated hepatitis virus infections (Hepatitis B or Hepatitis C) are eligible if they have been definitively treated for 6 months, have no detectable viral load on quantitative PCR, and LFTs meet eligibility requirements within 4 weeks of screening.
  • Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded.
  • Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of day 1 study drug administration.
  • Any other medical condition that will prevent the safe administration of study drugs in the opinion of the treating physician.
  • Planned concomitant, non-protocol directed anti-cancer therapy during the trial.
  • Grade ≥2 peripheral neuropathy

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REAL-WORLD CLINICAL PATTERNS OF CARE AND OUTCOMES AMONG PATIENTS IN AFRICA MIDDLE EAST (AFME) WITH METASTATIC RENAL CELL CARCINOMA (MRCC) RECEIVING SUNITINIB AS FIRST LINE THERAPY (OPTIMISE).


Condition: Metastatic Renal Cell Carcinoma

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03140176

Sponsor: Pfizer

Phase:

Eligibility:

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

Inclusion Criteria:

  1. Patients being treated with SU as 1st line treatment according to the approved therapeutic indication.
  2. Histologically confirmed diagnosis of mRCC (clear cell RCC as well as nonclear cell RCC) with measurable disease according to RECIST 1.1
  3. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

  1. Patients being treated with cytokines or any other treatment other than SU in 1st line setting
  2. Patients presenting with a known hypersensitivity to SU or its metabolites will not be included in the study per the label.

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Diagnostic Value of Multiparametric MR Imaging of Small Solid Renal Tumors (IRMK01)


Condition: Renal Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03470285

Sponsor: University Hospital, Bordeaux

Eligibility:

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

Inclusion Criteria:

  • Age ≥ 18;
  • Performance Index ≤ 2 (WHO);
  • Non hereditary solid renal tumors;
  • Indication of renal surgery or renal biopsy for suspicion of malignancy of the tumor
  • Size of renal mass between 1,5 and 4 cm;
  • Single Renal mass;
  • Discovered incidentally by US and / or CT-scan;
  • IRMK01 and UroCCR Informed consents signed.
  • Affiliated or beneficiary of French social security
  • All women of childbearing potential must have effective contraception from the time of screening until MRI. Acceptable methods of contraception include combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal), progestogen-only hormonal contraception (oral, injectable, implantable) intrauterine device, intrauterine hormonereleasing system, bilateral tubal occlusion, vasectomized partner and sexual abstinence

Exclusion Criteria:

  • Patent signs of malignancy (metastasis, lymphadenopathy, thrombus ...);
  • Cystic lesions according to the Bosniak classification;
  • Lesions with macroscopic fat on ultrasound or CT-scan;
  • Multiple or bilateral renal tumors;
  • Histological evidence available initially;
  • History of renal neoplasia whatever the location or family context (Von Hippel Lindau, Bourneville sclerosis);
  • Moderate to terminal renal impairment documented (creatinine clearance <30 mL / min according MDRD or CKD-EPI);
  • Impossibility to perform MRI :
  • heart pacemakers (especially older types)
  • insulin pumps
  • implanted hearing aidsIRMK01 Version no.3.0 of 28/10/2020 Page 12 of 83
  • neurostimulators
  • intracranial metal clips
  • metallic bodies in the eye
  • Contraindication to gadolinium salt.
  • Patient's refusal of surgery, biopsy if necessary;
  • Minor
  • Person deprived of liberty
  • Person under trusteeship
  • Person under curatorship
  • Person under legal guardianship
  • Pregnant or nursing women.
  • Adults unable to express their consent
  • Females of child-bearing potential without a negative pregnancy test prior to MRI exam
  • Clinical follow-up not possible for psychological, family, social or geographic reasons.

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A Confirmatory, Prospective, Open-label, Multi-centre Phase 3 Study to Evaluate Diagnostic Performance of Zirconium-labelled Girentuximab to Non-invasively Detect ccRCC by PET/CT Imaging in Patients With Indeterminate Renal Masses


Condition: Clear Cell Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03849118

Sponsor: Telix International Pty Ltd

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  1. Written and voluntarily given Informed Consent
  2. Male or female ≥18 years of age
  3. Imaging evidence of a single indeterminate renal mass of ≤7cm in largest diameter (tumour stage cT1) , on CT or MRI with and without contrast agent, suspicious for ccRCC
  4. Scheduled for lesion resection as part of regular diagnostic work-up within 90 days from planned 89Zr-TLX250 administration
  5. Negative serum pregnancy tests in female patients of childbearing potential (at Screening and within 24 hours prior to receiving investigational product)
  6. for patients included in France only, verification and confirmation of their affiliation with a social security
  7. Sufficient life expectancy to justify nephrectomy
  8. Consent to practice double-barrier contraception until a minimum of 42 days after 89Zr-TLX250 administration

Exclusion Criteria:

  1. Bioptic procedure (rather than a partial or total nephrectomy) planned for histological species delineation of IRM
  2. Renal mass known to be a metastasis of another primary tumour
  3. Active non-renal malignancy requiring therapy during the time frame of the study participation
  4. Chemotherapy, radiotherapy or immunotherapy within 4 weeks prior to the planned administration of 89Zr-TLX250 or continuing adverse effects (> grade 1) from such therapy (Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
  5. Planned antineoplastic therapies (for the period between administration of 89 Zr-TLX250 and imaging)
  6. Exposure to murine or chimeric antibodies within the last 5 years
  7. Previous administration of any radionuclide within 10 half-lives of the same
  8. Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune or metabolic) that may interfere with the objectives of the study or within the safety of compliance of the subjects as judged by the Investigator
  9. Mental impairment that may compromise the ability to give Informed Consent and comply with the requirements of the study
  10. Exposure to any experimental diagnostic or therapeutic drug within 30 days from the date of planned administration of 89Zr-TLX250
  11. Women who are pregnant or breastfeeding
  12. Known hypersensitivity to Girentuximab or DFO (Desferrioxamine)
  13. Renal insufficiency with glomerular filtration rate (GFR) ≤ 60 millilitres/min/1.73m2
  14. Vulnerable patients (e.g being in detention)

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Evaluation of Urinary Exosomes Presence From Clear Cell Renal Cell Carcinoma


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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Surgical Treatment of Pancreatic Metastases From Renal Cell Carcinoma


Condition: Surgical Procedure, Disease Free Survival, Overall Survival

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT04245410

Sponsor: Universidad de Extremadura

Phase:

Eligibility:

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

Inclusion Criteria:

  • Patients with resecable pancreatic metastases from RCC

Exclusion Criteria:

  • Unresecable pancreatic metastases

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Preventing Immune-Related Adverse Events in Renal Cell Carcinoma Patients Treated With Combination Immunotherapy Using Fecal Microbiota Transplantation


Condition: Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04163289

Sponsor: Lawson Health Research Institute

Phase: Phase 1

Eligibility:

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

Inclusion Criteria:

  • Patients must have histologically confirmed diagnosis of advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) renal cell carcinoma
  • Intermediate or poor risk RCC as defined by International Metastatic RCC Database Consortium (IMDC criteria, Heng et al 2009):
  • Karnofsky performance status (KPS) < 80%
  • Less than 1 year form initial RCC diagnosis (including original localized disease if applicable) to systemic treatment
  • Hemoglobin < lower limit of normal (LLN)
  • Corrected calcium > 10 mg/dL
  • Absolute neutrophil count (ANC) > upper limit of normal (ULN)
  • Platelet count > ULN
  • Age ≥ 18 years.
  • Karnofsky Performance Status (KPS) ≥70%
  • Evaluable disease determined by the Investigator
  • Ability to ingest capsules
  • Able to provide written informed consent
  • Understand non-infectious risks associated with FMT administration and that the long term data regarding safety risks of FMT are lacking
  • Recovery to baseline or ≤ Grade 1 CTCAE v 4.0 from toxicities related to any prior treatments, unless AEs are clinically non-significant
  • Adequate organ and marrow function, based upon meeting all the following laboratory parameters: 1. Absolute neutrophil count (ANC) ≥ 1500/μL (≥ 1.5 x 109/L) without granulocyte colony-stimulating factor support within 4 weeks before screening laboratory sample collection. 2. White blood cell count ≥ 2000/μL (≥ 2.0 x 109/L) 3. Platelets ≥ 100,000/μL (≥ 100 x 109/L) without transfusion within 4 weeks before screening laboratory sample collection. 4. Hemoglobin ≥ 9 g/dL (≥ 90 g/L) without transfusion within 4 weeks before screening laboratory sample collection. 5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN. 6. Total bilirubin ≤ 1.5 × ULN (with the exception that total bilirubin for subjects with Gilbert's disease ≤ 3 × ULN). 7. Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance ≥ 40 mL/min (≥ 0.67 mL/sec) using the Cockcroft-Gault equation (see for Cockcroft-Gault formula). 8. Urine protein-to-creatinine ratio (UPCR) ≤ 1 mg/mg (≤ 113.2 mg/mmol), or 24-h urine protein ≤ 1 g

Exclusion Criteria:

  • Prior systemic therapy for unresectable locally advanced or metastatic RCC including investigational agents.
  • Radiation therapy for bone metastasis within 2 weeks, or any other radiation therapy within 4 weeks prior to study entry. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible for the study.
  • Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with signing the informed consent through 6 months after FMT.
  • Diagnosis of immunodeficiency (e.g. HIV, transplantation)
  • Receiving systemic steroid therapy (>10mg prednisone daily or equivalent) or any other form of immunosuppressive therapy prior to trial treatment. Adrenal replacement steroids doses > 10 mg daily prednisone equivalent are permitted. Transient short-term use of systemic steroids for allergic situations (e.g. contrast allergy) is also permitted. Patients who require inhaled, intranasal, intra-articular, or topical steroids are allowed. Intermittent use of bronchodilators or local steroid injections are not excluded from the study
  • Ongoing use of antibiotics or previous use of antibiotics in the last two weeks prior to the initial FMT procedure
  • Presence of a chronic intestinal disease (e.g. Celiac, malabsorption, colonic tumor)
  • Presence of absolute contra-indications to FMT administration
  • Toxic megacolon
  • Severe dietary allergies (e.g. shellfish, nuts, seafood)
  • Inflammatory bowel disease
  • Expected to require any other form of systemic or localized anti-neoplastic therapy while on study. Treatment with either bisphosphonate or denosumab for bone metastatic disease is allowed
  • Known history of a hematologic malignancy, primary brain tumor or sarcoma, or of another primary solid tumor, unless the patient has undergone potentially curative therapy with no evidence of that disease for five years o NOTE: This time requirement also does not apply to patients who underwent successful definitive resection of basal or squamous cell carcinoma of the skin, superficial bladder cancer, in situ cancers including cervical cancer, breast cancer, melanoma, or other in situ cancers.
  • Active central nervous system (CNS) metastases and/or leptomeningeal involvement, unless treated with radiotherapy and/or radiosurgery with stable disease for at least 4 weeks prior to study entry after radiotherapy or at least 8 weeks prior to study entry after major surgery
  • Active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents. o Patients with vitiligo, type I diabetes, resolved childhood asthma/atopy are exceptions to this rule
  • A history of (non-infectious) pneumonitis that required steroids or current pneumonitis
  • Serious concomitant illnesses, such as: cardiovascular disease (uncontrolled congestive heart failure, hypertension, cardiac ischemia, myocardial infarction, and severe cardiac arrhythmia), bleeding disorders, autoimmune diseases, severe obstructive or restrictive pulmonary diseases, active systemic infections, and inflammatory bowel disorders o This includes HIV or AIDS-related illness, or active HBV and HCV
  • Active infection requiring systemic therapy.
  • Patient has received a live vaccine within 4 weeks prior to the first dose of treatment o Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
  • Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

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Cytoreductive Stereotactic Hypofractionated Radiotherapy With Combination Ipilimumab/Nivolumab for Metastatic Kidney Cancer


Condition: Metastatic Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04090710

Sponsor: Ontario Clinical Oncology Group (OCOG)

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  1. Biopsy proven renal cell carcinoma of any histology.
  2. Imaging proven metastatic disease based on CT or MRI within 10 weeks of screening.
  3. Intermediate/poor risk disease based on IMDC criteria (see Appendix II).
  4. Primary kidney lesion amenable to SBRT.
  5. Eligible for standard of care delivery of ipilimumab and nivolumab (I/N) according to approved product monograph.

Exclusion Criteria:

  1. A maximum primary renal lesion size of 20 cm or greater.
  2. Candidate for cytoreductive nephrectomy, unless a patient has refused cytoreductive nephrectomy (in this case, a discussion of cytoreductive nephrectomy and patient refusal must be documented).
  3. Treatment with prior systemic therapy in the adjuvant or metastatic setting for renal cell carcinoma.
  4. Previous abdominal radiation precluding SBRT.
  5. Kanofsky Performance (KPS) score below 60 (see Appendix III).
  6. History of auto-immune disorder precluding treatment with ipilimumab or nivolumab.
  7. History of ataxia telangiectasia or other radiation sensitivity disorders.
  8. Chronic corticosteroid use or other chronic immune suppressive therapy. (Participants are permitted the use of topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Adrenal replacement steroid doses of prednisone ≤ 10 mg daily are permitted).
  9. Use of medicinal herbal preparations (not including medical cannabis) unless prescribed by a treating physician.
  10. Inability to lie flat for at least 30 minutes without moving.
  11. Pregnant or lactating women.
  12. Geographic inaccessibility for follow-up.
  13. Inability to provide informed consent.

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Molecular Dissection of the Renal Cell Carcinoma Tumor Microenvironment for the Discovery of Novel Therapeutic Targets


Condition: Renal Cell Carcinoma

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT04005183

Sponsor: University Health Network, Toronto

Phase:

Eligibility:

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

Inclusion Criteria:

  • Nephrectomy
  • Primary or metastatic disease
  • Any histology

Exclusion Criteria:

  • NA

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High Dose IL-2 in Combination With Anti-PD-1 to Overcome Anti-PD-1 Resistance in Metastatic Melanoma and Renal Cell Carcinoma


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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AURORAX-0087A: Glycosaminoglycan Scores for Surveillance of Recurrence in Leibovich Points ≥5 Non-metastatic Clear Cell Renal Cell Carcinoma


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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