Kidney/Renal Cancer

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].

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Condition: Renal Tumor, Wilms Tumor

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03810651

Sponsor: Children's Hospital of Philadelphia

Phase: Early Phase 1

Eligibility:

• Age: minimum 0 Years maximum 30 Years
• Gender: All

Inclusion Criteria:

• Less than 30 years of age
• Diagnosis a. Any patient with Wilms tumor or clear cell sarcoma of the kidney who would require radiation therapy as standard of care including 1. Any patient with favorable histology (FH), stage III disease 2. Any patient with focal or diffuse anaplasia 3. Any patient with CCSK
• The patient is a candidate for external beam radiotherapy based on standard of care for treatment of Wilms tumor or CCSK

Exclusion Criteria:

• Prior radiotherapy to the region of the study cancer
• Chemotherapy administered for diagnosis of Wilms tumor or CCSK
• Pregnant or breastfeeding

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Condition: Kidney Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03571438

Sponsor: University Hospital, Grenoble

Eligibility:

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

Inclusion Criteria:

• major patient treated at the University Hospital of Grenoble for a renal tumor with suspected or confirmed malignancy.This includes non-metastatic patients undergoing renal lumpectomy, partial nephrectomy or total nephrectomy, as well as metastatic or locally advanced cancer patients undergoing cytoreductive surgery who are eligible for medical treatment at the same time

Exclusion Criteria:

• Contaminated patients with HIV and /or HBV (hepatitis B virus) and / or HCV (hepatitis C virus) positive serology.
• Absence or withdrawal of the informed consent of the patient.
• Tumors smaller than 2 cm on preoperative imaging

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Condition: Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03341845

Sponsor: The Netherlands Cancer Institute

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

• Signed and written informed consent
• Male or female patients age ≥ 18 years
• Histologically confirmed diagnosis of non-metastatic clear-cell renal cell carcinoma of intermediate to high risk with completely resectable primary tumours.
• World Health Organization performance status of 0-1.
• Adequate coagulation function as defined in protocol
• Adequate hematological function as defined in protocol
• Adequate hepatic function as defined in protocol
• Adequate renal function as defined in protocol
• Negative serum pregnancy test at screening for women of childbearing potential.
• Highly effective contraception for both male and female subjects if the risk of conception exists.

Exclusion Criteria:

• Renal tumors of low risk or M1
• Non-clear cell histology at biopsy
• Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product
• Corrected QT interval (QTc) > 480 msecs
• History of any of the cardiovascular conditions defined in the protocol within the past 6 months
• Poorly controlled hypertension
• History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
• Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer
• Evidence of active bleeding or bleeding diathesis.
• Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.
• Unable or unwilling to discontinue use of prohibited medications to be listed in protocol for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study
• Treatment with any of the following anti-cancer therapies: chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of axitinib or avelumab
• Administration of any non-oncologic investigational drug within 30 days or 5 half lives whichever is longer prior to receiving the first dose of study treatment
• Prior organ transplantation, including allogeneic stem cell transplantation
• Significant acute or chronic infections as defined in protocol
• Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
• Known severe hypersensitivity reactions to monoclonal antibodies
• Pregnancy or lactation
• Known alcohol or drug abuse

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Condition: Adult Cystic Nephroma, Anaplastic Kidney Wilms Tumor, Angiolipoma, Cellular Congenital Mesoblastic Nephroma, Classic Congenital Mesoblastic Nephroma, Clear Cell Sarcoma of the Kidney, Congenital Mesoblastic Nephroma, Cystic Partially Differentiated Kidney Nephroblastoma, Diffuse Hyperplastic Perilobar Nephroblastomatosis, Extrarenal Rhabdoid Tumor, Kidney Medullary Carcinoma, Kidney Neoplasm, Kidney Oncocytoma, Kidney Wilms Tumor, Metanephric Adenofibroma, Metanephric Adenoma, Metanephric Stromal Tumor, Metanephric Tumor, Mixed Congenital Mesoblastic Nephroma, Ossifying Renal Tumor of Infancy, Papillary Renal Cell Carcinoma, Renal Cell Carcinoma, Renal Cell Carcinoma Associated With Xp11.2 Translocations/TFE3 Gene Fusions, Rhabdoid Tumor of the Kidney, Wilms Tumor

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT00898365

Sponsor: Children's Oncology Group

Phase:

Eligibility:

• Age: minimum N/A maximum 29 Years
• Gender: All

Inclusion Criteria:

• Patients with the first occurrence of any tumor of the kidney identified on CT scan or MRI are eligible for this study; histologic diagnosis is not required prior to enrollment but is required for all patients once on study
• Eligible tumors include (but are not limited to):
• Nephroblastic tumors
• Nephroblastoma (Wilms' tumor) (favorable histology, anaplasia [diffuse, focal])
• Nephrogenic rests and nephroblastomatosis
• Cystic nephroma and cystic partially differentiated nephroblastoma
• Metanephric tumors (metanephric adenoma, metanephric adenofibroma, metanephric stromal tumor)
• Mesoblastic nephroma (cellular, classic, mixed)
• Clear cell sarcoma
• Rhabdoid tumor (any malignant rhabdoid tumor occurring outside the central nervous system [CNS])
• Renal epithelioid tumors of childhood (papillary renal cell carcinoma, medullary renal cell carcinoma, renal tumors associated with Xp11.2 translocations, oncocytic renal neoplasms after neuroblastoma)
• Angiolipoma
• Ossifying renal tumor of infancy
• Patients with the first occurrence of the following tumors are also eligible:
• Extrarenal nephroblastoma or extrarenal neprogenic rests
• Malignant rhabdoid tumor occurring anywhere outside the central nervous system
• Required specimens, reports, forms, and copies of imaging studies must be available or will become available for submission and the institution must intend on submitting them as described in the protocol procedures
• For ALL patients, (with exception of bilateral, bilaterally predisposed, multicentric, or unilateral tumor in solitary kidney planning to enroll without biopsy***), the following submissions are required:
• A complete set of recut hematoxylin and eosin (H & E) slides (including from sampled lymph nodes, if patient had upfront nephrectomy)
• * Tissue must be from diagnosis, prior to any renal tumor directed chemotherapy or radiation (only exception is for presumed favorable histology Wilms tumor [FHWT] patients discovered to have diffuse anaplastic Wilms tumor [DAWT] at delayed nephrectomy and plan to enroll at delayed nephrectomy)
• Representative formalin-fixed paraffin-embedded tissue block or if a block is unavailable, 10 unstained slides from a representative block of tumor, if available.
• Tissue must be from diagnosis, prior to any renal tumor directed chemotherapy or radiation (only exception is for presumed FHWT patients discovered to have DAWT at delayed nephrectomy and plan to enroll at delayed nephrectomy)
• Institutional pathology report, Specimen Transmittal Form, and Pre-Treatment Pathology Checklist
• Copies of images and institutional reports of CT and/or MRI abdomen and pelvis, and Pre Treatment Imaging Checklist
• Copies of images and institutional report of chest CT for all malignant tumors
• Institutional surgical report(s) and Pre-Treatment Surgical Checklist
• CRFs: Staging Checklist and Metastatic Disease Form (if metastatic disease is noted on imaging)
• Patients with bilateral, bilaterally predisposed, multicentric, or unilateral tumor in solitary kidney planning to enroll without biopsy via imaging only
• these patients will not have central review or have a risk assignment issued, but may contribute to specimen banking for future research. However, if biopsy is done, tissue must be submitted as for other renal tumors, and initial risk assignment will require pathology and surgical rapid central reviews. The Specimen Transmittal Form and Pre Treatment Pathology Checklist are also needed.
• Please note: if the above required items are not received within 120 days of study enrollment, the patient will be considered off study
• All patients and/or their parents or legal guardians must sign a written informed consent
• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

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Condition: Advanced Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03647878

Sponsor: Ipsen

Phase:

Eligibility:

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

Inclusion Criteria:

• Males or females aged 18 years and older with capacity to consent.
• Subjects receiving cabozantinib as monotherapy or in combination with nivolumab as a first line treatment for advanced or metastatic renal cell carcinoma
• Subjects with the intention to be treated with cabozantinib tablets as monotherapy or in combination with nivolumab according to the current local Summary of Product Characteristics (SmPC); decision has to be taken before entry in the study.
• Signed written informed consent

Exclusion Criteria:

• Participation in an interventional study at the same time and/or within 3 months before baseline.
• Previous participation in this study

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Condition: Aspirin as Adjuvant Therapy in Patients With Surgically Treated High Risk Renal Cell Carcinoma

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03734614

Sponsor: RenJi Hospital

Phase:

Eligibility:

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

Inclusion Criteria:

• Patients must complete radical surgery more than 4 weeks and less than 12 weeks prior to study entry
• Patients must have histologically or cytologically confirmed renal cell carcinoma. Using 2017 (American Joint Committee on Cancer [AJCC] 8th edition) TNM Staging, patients must be one of the following:
• pT2aG3 or G4N0M0
• pT2bG(any)N0M0
• pT3G(any)N0M0
• pT4G(any)N0M0
• pT(any)G(any)N1M0
• Patients must have no clinical or imaging evidence of visible residual lesions or distant metastases (M0) after nephrectomy
• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Patients must be able to swallow pills

Exclusion Criteria:

• Patients with haemorrhagic diathesis (i.e. haemophilia).
• Patients with prior malignant tumors except for kidney cancers in the past 5 years.
• Patients with documented or suspected metastases.
• Patients with serious, nonhealing wound, ulcer, or bone fracture.
• Patients with a history of stroke, coronary arterial disease, angina, or vascular disease.
• Patients who are pregnant, lactating, or not using adequate contraception.
• Patients who have known allergy to NSAID or Aspirin.
• Patients receiving other antiplatelet agents (i.e. clopidogrel, ticlopidine) or anticoagulants (i.e. warfarin, low molecular weight heparins).
• Patients receiving current long term treatment (≥1 month) with Aspirin or other NSAIDs.
• Subject unwilling or unable to comply with study requirements.

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Condition: Renal Tumor

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03747133

Sponsor: University Health Network, Toronto

Eligibility:

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

Inclusion Criteria:

• Solid Kidney Mass (primary RCC or metastasis) amenable to SABR ≤6cm
• Histological or radiological diagnosis of renal tumor
• Inoperable: High risk for surgery or declined surgery
• ECOG performance status of 0-3

Exclusion Criteria:

• ≥5 active metastases
• Sysstemic therapy (except endocrine therapy) wthin 6 days prior to SABR
• Prior abdominal radiotherapy with fields overlap resulting in excessive doses to the involved kidney
• Patients with end stage renal failure > 4(KDOQI guidelines)
• Familial Syndrome: Von Hippel-Lindau disease, Polycystic Kidney Disease, Hereditary Papillary RCC or Tuber Sclerosis

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Condition: Clear Cell Renal Cell Carcinoma, Locally Advanced Pancreatic Cancer, Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Metastatic Renal Cell Carcinoma, Metastatic Urothelial Carcinoma, Metastatic Pancreatic Cancer, Stage III Pancreatic Cancer, Stage III Renal Cell Cancer, Stage IV Pancreatic Cancer, Stage IV Renal Cell Cancer, Endometrial Cancer, Metastatic Castration-resistant Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03682289

Sponsor: Rahul Aggarwal

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

• 1. Patients must provide written informed consent prior to performance of study-specific procedures or assessments. 2. ARID1A Subgroup (N = 39): 1. Histologically confirmed locally advanced or metastatic solid tumor malignancy with progression on at least one prior systemic therapy, including one of the following tumor types:
• Renal cell carcinoma with predominant clear cell histology (Cohort A)
• Urothelial carcinoma (Cohort B)
• All pancreatic cancers (Cohort C)
• Other solid tumors excluding clear cell ovarian cancer and endometrial cancer (Cohort D)
• Endometrial and ovarian cancer (Cohort E) 2. Formalin-fixed paraffin embedded tumor tissue evaluable for BAF250a expression by ARID1A immunohistochemistry. Primary or metastatic tumor tissue is permissible. Patients without evaluable archival tissue may undergo optional tumor biopsy during Screening if other

Eligibility Criteria:

• have been met 3. Measurable disease by RECIST 1.1 3. ATM Loss Subgroup (N = 20): 1. Histologically confirmed locally advanced or metastatic solid tumor malignancy with progression on at least one prior systemic therapy, including one of the following tumor types:
• Metastatic castration resistant prostate cancer (N = 10).
• Patients may have evaluable or measurable disease by RECIST 1.1 criteria.
• Prior treatment with at least one androgen signaling inhibitor (e.g. abiraterone, enzalutamide, apalutamide, darolutamide).
• Patients will be required to maintain castrate levels of testosterone during study treatment with use of Luteinizing hormone-releasing hormone (LHRH) analog (except for patients with history of bilateral orchiectomy).
• Progression by PCWG3 criteria at study entry
• All other solid tumor malignancies (N = 10). Patients are required to have measurable soft tissue disease by RECIST 1.1 criteria. 2. Archival tumor tissue evaluable for ATM expression by immunohistochemistry (IHC) 3. Evidence of ATM loss by either pathogenic ATM mutation in Chemiluminescent immunoassay (CLIA)-approved assay and/or loss of ATM expression by IHC (Ventana Ab). An interim analysis will be performed after 10 patients are enrolled. If less than 50% of tumors have absence of ATM expression by IHC, subsequent enrollment of the remaining 10 patients will be required to have evidence of both ATM mutation and loss of ATM expression (< 5% of tumor cells expressing ATM) using CLIA-certified IHC test (Ventana). 4. Endometrial Cancer Cohort (N = 30): 1. Histologically confirmed endometrial cancer o A minimum of 15 patients must have the presence of pathogenic ARID1A alteration on CLIA-approved next-generation sequencing panel without evidence of microsatellite instability defined by next-generation sequencing and/or presence of intact mismatch repair proteins by immunohistochemistry. 2. Measurable disease by RECIST 1.1. 3. Availability of archival tumor tissue for retrospective testing of BAF250a expression by IHC. 4. Has received at least one prior line of systemic therapy for the treatment of locally advanced or metastatic disease, including progression on at least one prior line of therapy containing an immune checkpoint inhibitor that was administered for a minimum duration of 6 weeks
• Must not have experienced a toxicity that led to permanent discontinuation of prior immune checkpoint inhibitor.
• All adverse events (AE) while receiving prior immune checkpoint inhibitor must have completely resolved or resolved to baseline prior to screening for this study.
• Must not have experienced a >= Grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior immune checkpoint inhibitor. NOTE: Patients with endocrine AE of <=Grade 2 are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic.
• Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of > 10 mg prednisone or equivalent per day. 5. Body weight >30 kg 6. No active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
• Patients with vitiligo or alopecia.
• Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement.
• Any chronic skin condition that does not require systemic therapy.
• Patients without active disease in the last 5 years may be included but only after consultation with the Principal Investigator.
• Patients with celiac disease controlled by diet alone. 5. Evidence of clinical or radiographic progression prior to study entry (except metastatic castrate-resistant prostate cancer (mCRPC) cohort which requires progression by PCWG3 criteria). 6. Age >= 18 years at time of signing informed consent form. 7. Resolution of all prior treatment-related toxicities to grade 1 severity or lower (except alopecia). 8. Patients must be at least 3 weeks or 5 half-lives (whichever is shorter) from last standard or experimental non-cytotoxic therapy prior to first dose of protocol therapy. Patients must be > 21 days from last dose of cytotoxic chemotherapy prior to C1D1. The minimum wash-out period for immunotherapy is 42 days prior to C1D1 with the following exception for the Endometrial cohort: Note: Washout from prior immunotherapy is >=21 days to C1D1 for the Endometrial cohort. 9. Radiation therapy must be completed > 7 days prior to course 1 day 1 (C1D1) or > 28 days prior to C1D1 for patients receiving radiation to more than 30% of bone marrow. 10. Adequate organ function as defined by:
• Hemoglobin (Hgb) >= 9.0 g/dL in the absence of transfusion within 14 days prior to screening laboratory assessment.
• Platelets (Plt) count > 100,000 x 10^9/L.
• Absolute neutrophil count > 1.5 x 10^9/L.
• Estimated glomerular filtration rate (GFR) >= 45 ml/min based on Cockcroft-Gault equation or 24 hour urine collection.
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2.5 x upper limit of normal (ULN) (< 5x ULN in patients with known liver metastases).
• Total bilirubin < 1.5 x ULN (direct bilirubin < 1.5 x ULN in patients with known Gilbert's disease or UGT1A1 homozygote). 11. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 12. The effects of ceralasertib and olaparib on the developing human fetus are unknown. For this reason and because ATR and PARP inhibitors as well as other therapeutic drugs used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use 2 highly effective forms of contraception prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. 1. Male patients who are sexually active must be willing to use barrier contraception for the duration of the study and for 1 week after the last study drug administration, with all sexual partners. Male patients must use a condom during treatment and for 6 months after the last dose of study drug(s) 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 for 6 months after the last dose of study drug(s) if they are of childbearing potential. True abstinence for either sex is an acceptable form of contraception and must be documented as such. 2. Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to C1D1 treatment. Evidence of postmenopausal status or non-child bearing status must be documented. Postmenopausal is defined as:
• Aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments.
• Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation, radiation-induced oophorectomy with last menses > 1 year ago, chemotherapy-induced menopause with > 1 year interval since last menses
• Amenorrhoeic for 12 months and serum follicle-stimulating hormone (FSH), luteinizing hormone (LH) and plasma oestradiol levels in the postmenopausal range for the institution for women under 50. 13. Ability to understand a written informed consent document, and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.

Exclusion Criteria:

• 1. History of secondary malignancy requiring treatment within 1 year prior to screening, with the exception of carcinoma in situ of the cervix, non-melanoma skin carcinoma, low/intermediate risk localized prostate cancer (=< Gleason 7, =< T2N0M0, and prostate-specific antigen (PSA) =< 20 ng/mL at diagnosis) (not applicable for prostate cancer cohort), ductal carcinoma in situ, Stage I uterine cancer, and non-muscle invasive urothelial carcinoma 2. Patients receiving, or having received within 14 days of C1D1, corticosteroids at a dose > 10 mg/day of prednisone (or equivalent). 3. Patients with myelodysplastic syndrome or features suggestive of myelodysplastic syndrome. 4. Prior treatment with ATR inhibitor 5. Major surgical procedures < 28 days prior to C1D1. Patients must have recovered to grade =< 1 for any adverse events related to the surgical procedure. 6. Untreated central nervous system (CNS) metastases. Patients with previously treated central nervous system (CNS) metastases are eligible if:
• No requirement for corticosteroids at study entry
• Radiographically and clinically stable for at least 4 weeks prior to study entry
• No evidence of intra-tumoral hemorrhage
• No evidence of current or prior leptomeningeal disease. 7. Clinically significant gastrointestinal abnormalities that may increase the risk of decreased absorption of medications, including:
• Inability to swallow oral medications
• Active peptic ulcer disease
• Known intra-luminal metastatic lesions
• History of abdominal fistula or bowel perforation
• History of bowel obstruction within 6 months prior to study entry
• Known malabsorption syndrome
• Significant resection of the small bowel. 8. Fridericia's QT correction formula (QTcF) > 470 ms (females) or > 450 ms (males) on screening electrocardiography (ECG), or immediate family history of congenital long QT syndrome or sudden cardiac death at age less than 40. 9. History of any one or more of the following cardiovascular conditions within the past 6 months:
• Myocardial infarction
• Unstable angina
• Transient ischemic attack or cerebrovascular accident
• Uncontrolled arrhythmia. Rate controlled atrial fibrillation/flutter is not an exclusion for the study.
• Class III or IV congestive heart failure or documented left ventricle (LV) ejection fraction of < 50% (screening not required). 10. Uncontrolled hypertension as defined by systolic blood pressure > 160 mm Hg and/or diastolic blood pressure > 100 mm Hg. Adjustment of anti-hypertensive regimen and re-screening is permitted. 11. Relative hypotension with resting blood pressure of less than 90 mm Hg systolic and less than 60 mm Hg diastolic or symptomatic orthostatic hypotension. 12. Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with patient's safety or adherence to study procedures including uncontrolled infection requiring parenteral antibiotics. 13. Concomitant use of strong cytochrome P450, family 3, subfamily A (CYP3A4) inhibitors, strong CYP3A4 inducers, CYP3A4 substrates with narrow therapeutic index, or CYP2B6 substrates with narrow therapeutic index within 21 days or 5 half-lives, whichever is shorter, prior to C1D1 of study treatment
• The use of herbal supplements or 'folk remedies' (and medications and foods that significantly modulate CYP3A activity) should be discouraged. If deemed necessary, such products may be administered with caution and the reason for use documented in the case report form (CRF). 14. A known hypersensitivity to olaparib, ceralasertib, durvalumab (as applicable to the study drugs the patient is receiving), or any excipient of the product or any contraindication to the combination anti-cancer agent as per local prescribing information. 15. A known chronic active hepatitis B or C (defined by positive viral load; screening not required). 16. Immunocompromised patients, including those serologically positive for human immunodeficiency virus (HIV), those receiving chronic immunosuppression, or those with prior allogeneic or cord blood transplantation.

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Condition: Renal Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT02087852

Sponsor: Memorial Sloan Kettering Cancer Center

Phase:

Eligibility:

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

Inclusion Criteria:

• Kidney Cancer Case Cohort:
• Must be ≥ 18 years of age AND
• Must be an English-speaker AND
• Must have a diagnosis or suspicion of kidney cancer Family Member Cohort:
• Must be ≥ 18 years of age AND
• Must be an English-speaker AND
• Must be a blood relative of the proband. Family members of probands including mother, father, sisters, brothers, half-sisters, half-brothers, daughters, sons, grandmothers, grandfathers, as well as aunts and uncles are eligible. These individuals need not have kidney cancer, as they will be used for segregation analysis of suspected variants found in the proband; requesting DNA from relatives is required. Control Cohort:
• Must be ≥ 18 years of age AND
• Must be an English-speaker AND
• Must not have a personal history of cancer, with the exception of nonmelanoma skin cancer, AND
• Must not be a blood relative of any cases or controls enrolled in this study

Exclusion Criteria:

• Patients who, in the opinion of the primary MSKCC clinician or the investigator, have a condition that precludes their ability to provide an informed consent

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Condition: Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03288532

Sponsor: University College, London

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

1. Histologically proven RCC (all cell types of RCC are eligible, except for pure oncocytoma, collecting duct, medullary and transitional cell cancer [TCC]); no evidence of residual macroscopic disease on post-operative CT scan after resection of RCC. Patients with treated bilateral synchronous RCCs are eligible.
2. At the start of recruitment patients with Leibovich score 3-11 will be eligible for randomisation. MRC CTU at UCL will monitor accrual and stop recruiting intermediate risk patients (Leibovich Score 3-5) after three years or when intermediate risk patients contribute 25% of the total accrual target, whichever is earlier. Recruitment of patients with Leibovich Score 6 11 will continue until the accrual target is reached.
3. Patients should have had surgery at least 28 days but no more than 91 days prior to their randomisation date.
4. Post-operative scans should be performed within 28 days prior to randomisation.
5. Patients with microscopically positive resection margins after radical nephrectomy at the nephrectomy bed, renal vein or inferior vena cava are eligible provided the post-operative CT scan shows no evidence of residual macroscopic disease.
6. WHO Performance Status 0 or
7. Patient has archival FFPE pathology tissue available, and agrees to provide at least one sample (FFPE tumour block from nephrectomy, or a minimum of 10 unstained slides), as well as a baseline EDTA blood sample for future translational research).
8. Adequate normal organ and marrow function
9. Haemoglobin ≥9.0g/dL (transfusions will be allowed within 2 weeks prior to randomisation in order to achieve the entry criteria).
10. Absolute neutrophil count (ANC) ≥1.5 x 109/L (≥1500 per mm3).
11. Platelet count ≥100 x 109 (≥100,000 per mm3).
12. Bilirubin ≤1.5 x ULN (This will not apply to subjects with confirmed Gilbert's syndrome (i.e., persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of haemolysis or hepatic pathology), who will be allowed only in consultation with their physician).
13. AST/ALT ≤2.5 x ULN.
14. Calculated Creatinine Clearance level >40mL/min by Cockcroft Gault formula (using actual body weight).
15. 12-lead ECG on which QTcF must be <450 ms. In case of clinically significant ECG abnormalities, including a QTcF value ≥450 ms, two additional 12-lead ECGs should be obtained over a brief period (e.g., 30 minutes) to confirm the finding. Patients are only eligible if a QTcF of <450ms is confirmed
16. Subjects must be ≥18 years of age.
17. Written informed consent obtained from the patient.
18. Both men and women enrolled in this trial must be in agreement with trial policy on contraception during the treatment phase of the study and 6 months afterwards. Egg donation, sperm donation and breastfeeding must be avoided.
19. Evidence of post-menopausal status or negative serum HCG pregnancy test for female pre menopausal patients. Women will be considered post-menopausal if they have been amenorrhoeic for 12 months without an alternative medical cause. The following age specific requirements apply:
20. Women <50 years of age will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinising hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilisation (bilateral oophorectomy or hysterectomy).
21. Women ≥50 years of age will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy induced menopause with last menses >1 year ago, or underwent surgical sterilisation (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).

Exclusion Criteria:

1. Previous diagnosis of RCC.
2. Metastatic or macroscopic residual disease.
3. Patients with positive resection margins after partial nephrectomy.
4. Patients with a single pulmonary nodule ≥5mm diameter are not eligible unless the nodule has had a definite benign diagnosis. Patients with multiple small, less than 5 mm nodules may be eligible if nodules have been shown to be radiologically stable for at least 8 weeks.
5. Prior anticancer treatment (other than nephrectomy) for RCC.
6. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
7. Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
8. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the Study Physician.
9. History of another primary malignancy except for:
10. Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence.
11. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
12. Adequately treated carcinoma in situ without evidence of disease.
13. History of leptomeningeal carcinomatosis.
14. Concurrent enrolment in another clinical study, unless it is an observational (non interventional) clinical study or during the follow up period of an interventional study.
15. Major surgical procedure (as defined by the Investigator) within 28 days prior to the start of treatment. Local surgery of isolated lesions for palliative intent is acceptable.
16. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab or tremelimumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid.
17. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
18. Patients with vitiligo or alopecia
19. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
20. Any chronic skin condition that does not require systemic therapy
21. Patients without active disease in the last 5 years may be included but only after consultation with the RAMPART Trial Management Team
22. Patients with coeliac disease controlled by diet alone
23. A history of immunodeficiency syndrome. Please consult the MRC CTU at UCL on an individual basis if there is any uncertainty.
24. History of allogeneic organ transplant.
25. Uncontrolled intercurrent illness including, but not limited to:
26. Ongoing or active infection of any kind (patients who are exhibiting symptoms consistent with COVID-19, or who have tested positive, should not be randomised into the study until they are asymptomatic and at least 14 days after a positive test)
27. Symptomatic congestive heart failure
28. Uncontrolled hypertension
29. Unstable angina pectoris
30. Uncontrolled cardiac arrhythmia
31. Active peptic ulcer disease or gastritis
32. Active bleeding diatheses
33. Psychiatric illness or social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent.
34. Active infection including
35. Tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice)
36. Hepatitis B (known positive HBV surface antigen (HBsAg) result). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti HBc] and absence of HBsAg) are eligible.
37. Hepatitis C
38. Human immunodeficiency virus (positive HIV 1/2 antibodies). Note: Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
39. Receipt of live attenuated vaccine within 30 days prior to the start of treatment. Note: Patients, if enrolled, should not receive live vaccine while receiving investigational medicinal product and up to 30 days after the last dose of investigational medicinal product.
40. Pregnant or breastfeeding patients.
41. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.
42. Known allergy or hypersensitivity to durvalumab or tremelimumab, or any of their excipients.
43. Previous investigational medicinal product assignment in the present study.
44. Clinically significant pneumonitis or fibrosis.

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Condition: Patients With Any Advanced Solid Tumors

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02856425

Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Phase: Phase 1

Eligibility:

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

Inclusion Criteria:

• 1. Age ≥ 18 2. Patients with advanced/metastatic cancer who have progressed after at least one line of standard therapy or are intolerant to standard therapy. Patients must fit into one of the following groups: Colorectal adenocarcinoma (not mismatch repair deficient by either PCR and/or IHC) Gastric or gastroesophageal adenocarcinoma (not mismatch repair deficient by either PCR and/or IHC Patients with advanced or metastatic Urothelial cancer (UC) Patients with advanced Renal Cell cancer (RCC) Patients with advanced Mesothelioma (MPM) Patients with advanced squamous cell carcinoma in Cervical Cancer (CC) Patients with advanced Hepatocellular (HCC) Patients with advanced Thymic Carcinoma (TC) Patients with advanced cancers and high tumor mutational burden (TMB-High) on their circulating tumor DNA (ctDNA) as defined by more than twenty mutations per megabase (≥20Mut/Mb) on FoundationOne Liquid CDx assay. Patients should be without known therapeutic options to provide clinical benefit. 3. ECOG performance status of score 0 or 1 4. Adequate organ function as defined by the following criteria :
• Proteinuria ≤ Grade 2 NCI CTCAE v4.03
• Serum creatinine ≤1.5 x ULN or calculated creatinine clearance ≥ 40 mL/min
• Total bilirubin within normal range (≤ 1.5 x ULN if HCC)
• AST and ALT ≤ 1.5 x upper limit of normal (ULN); if liver metastases AST and ALT ≤ 2.5 x ULN (≤ 5 x ULN if HCC)
• Coagulation parameter : International normalized ratio (INR) < 2, prothrombin time (PT) and partial thromboplastin time (PTT) < 50% of deviation of ULN
• Absolute Neutrophils count (ANC) ≥ 1000 cells/mm^3
• Platelets ≥100 000 cells/mm^3
• Hemoglobin ≥ 9.0 g/dL 5. At least one measurable lesion according to RECIST v1.1 (Appendix 4) criteria and modified RECIST for mesothelioma only (Appendix 6) or any other baseline prerequisite for the assessment of the principal judgment criteria. 6. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 7 days prior to initiation of treatment. Both sexually active females and males (and their female partners) patients must agree to use two methods of effective contraception, one of them being a barrier method, or to abstain from sexual activity during the study and for at least 4 months after last study drug administration. 7. Signed and dated written informed consent prior to admission to the study 8. Patient affiliated to a social security regimen or beneficiary of the same

Exclusion Criteria:

1. Prior treatment with nintedanib
2. Known hypersensitivity to trial drugs or their excipients, peanut or soya or to contrast media
3. Prior treatment with pembrolizumab or any other anti PD1 or anti-PDL1 agents
4. Concurrent steroid medication (except topical or aerosol steroids). Any steroid medication should have been stopped for more than 7 days prior beginning of therapy.
5. History of autoimmune/immune mediated inflammatory disease, including but not limited to colitis, pneumonitis, hepatitis, hypophysitis, nephritis, hyperthyroidism, systemic lupus erythematous, rheumatoid arthritis, inflammatory bowel disease, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, vasculitis, or glomerulonephritis (see Appendix 3). Patients with a history of auto-immune endocrinopathy (hypo/hyper thyroiditis, type 1 diabetes mellitus, …) and who are stable on hormone replacement therapy are eligible for the study. Patients with a history of vitiligo, pelade, cutaneous psoriasis and grade 1-2 Sjogren syndrome are eligible.
6. Chemo-, hormono-, radio- (except for brain and extremities) or immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 4 weeks or 5 half-life times (whatever the shortest) prior to treatment with the trial drugs.
7. Administration of a live, attenuated vaccine within 4 weeks before registration
8. Treatment with systemic immunosuppressive medications (including but not limited to steroids azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to registration
9. Radiotherapy to the target lesion (unless a progression after radiotherapy has been documented)
10. Persistence of clinically relevant treatment-related toxicity from previous chemotherapy, targeted therapy and/or radiotherapy
11. Active brain metastases or leptomeningeal disease. Clinically asymptomatic brain metastases and clinically asymptomatic leptomeningeal disease are allowed (treatment with steroids prior initiation of the trial is not allowed). Patients with Diffuse Intrinsic Pontine Gliomas, even asymptomatic, are not allowed.
12. Radiographic evidence of cavitary tumors with local invasion of major blood vessels and/or at risk for perforation
13. History of clinically significant hemoptysis within the past 3 months (more than one teaspoon of fresh blood per day)
14. Treatment with other investigational drugs or treatment in another clinical trial within the past 4 weeks before start of therapy or concomitantly with the trial
15. Therapeutic anticoagulation with drugs requiring INR monitoring (except low-dose heparin and/or heparin flush as needed for maintenance of an in-dwelling intravenous devise) or anti-platelet therapy (except for low-dose therapy with acetylsalicylic acid < 325mg per day)
16. Major injuries and/or surgery within the past 4 weeks prior to start of study treatment with incomplete wound healing and/or planned surgery during the on-treatment study period
17. History of clinically significant hemorrhagic or thromboembolic event in the past 6 months
18. Known inherited (genetic) predisposition to bleeding or thrombosis (such deficit in protein C/S) or acquired predisposition to thrombosis (such as anti-phospholipid syndromes)
19. History of significant cardiovascular diseases ( i.e. supraventricular tachycardia, uncontrolled hypertension, unstable angina, history of infarction within the past 12 months prior to start of study treatment, congestive heart failure > NYHA II, serious cardiac arrhythmia, pericardial effusion)
20. Ongoing uncontrolled auto-immune thyroiditis. Ancient thyroiditis currently stable with substitutive therapy should not be excluded from the trial.
21. Other malignancies within the past 5 years other than basal cell skin cancer or carcinoma in situ of the cervix. A history of more than 3 years of local prostate cancer treated by surgery and without PSA elevation since surgery, or local breast carcinoma treated by surgery without relapse are eligible.
22. Active serious infections in particular if requiring systemic antibiotic or antimicrobial therapy
23. Known to be human immunodeficiency virus (HIV) positive;
24. Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug
25. Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the study.
26. Pregnancy or breast feeding,
27. Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule
28. Active alcohol or drug abuse
29. Intake of Ganoderma Lucidum mushroom and/or herbal remedies and/or traditional medicines within the past 4 weeks prior to start of study treatment or concomitantly with the trial

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Condition: Chronic Kidney Disease, Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Chronic Myelogenous Leukemia (CML), Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin's Lymphoma (NHL), Hodgkin Disease, Multiple Myeloma, Myelodysplastic Syndrome (MDS), Aplastic Anemia, AL Amyloidosis, Diamond Blackfan Anemia, Myelofibrosis, Myeloproliferative Disease, Sickle Cell Anemia, Autoimmune Diseases, Thalassemia

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01758042

Sponsor: Massachusetts General Hospital

Eligibility:

• Age: minimum 18 Years maximum 70 Years
• Gender: All

Inclusion Criteria:

• Patients ages 18-70
• Underlying hematological disorder which is potentially curable with allogeneic bone marrow transplantation. This includes, but is not limited to: acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myelogenous leukemia (CML), chronic lymphocytic leukemia (CLL), non-Hodgkin lymphoma (NHL), Hodgkin lymphoma, multiple myeloma (MM), myelodysplastic syndrome (MDS), AL amyloidosis, diamond blackfan anemia, myelofibrosis or other myeloproliferative disease, sickle cell anemia, and thalassemia.
• Existence of haploidentical first degree relative who passes standard donor evaluations for bone marrow and kidney donation
• LVEF > 40% as measured by echocardiography or MUGA
• FEV1, FVC, and DLCO > 50% of predicted as measured by standard PFTs
• Total bilirubin < 2.0 (unless diagnosis of Gilbert's or hemolysis is made) and AST, ALT, alkaline phosphatase all < 5x institutions upper limit of normal
• ABO compatibility in the host vs. graft direction
• Men and women of reproductive potential must agree to use a reliable method of birth control during the treatment, and women should do so for a period of 1 year following the transplant.
• Participants should be on dialysis or have an estimated or measured CrCl < 35 ml/min
• Life expectancy greater than six months.
• Recipient ability to understand and provide informed consent

Exclusion Criteria:

• Active serious infection
• Participation in other investigational drug use at the time of enrollment
• Contraindication to therapy with any one of the proposed agents (e.g., history of allergy to rabbit serum in ATG)
• Serologic positivity for HIV, HCV, or HbsAg positivity
• ABO blood group incompatibility in the host-vs-graft direction
• Active serious infection

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