Pathologically confirmed RCC with a component of either clear cell histology or sarcomatoid histology that has not been previously treated in the adjuvant or neoadjuvant setting and classified as being at high risk of RCC recurrence
Histological or cytological confirmation of predominant clear cell renal cell carcinoma (RCC) (original tissue diagnosis of RCC is acceptable)
Unresectable advanced and/or metastatic RCC with component of clear cell histology and/or component of sarcomatoid histology that has not been previously treated with any systemic therapy, including treatment in the adjuvant setting
Has histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features.
Histologically proven mRCC with a clear cell component
Unresectable advanced or metastatic RCC to include both clear cell and non-clear histologies
Patients with histologically or cytologically confirmed metastatic/advanced clear cell RCC, or RCC with a clear cell component, who have received 1 or 2 prior anti-angiogenic therapy regimens (+/- cytokine therapy with interleukin-2 or interferon-alfa) in the advanced or metastatic setting; examples of anti-angiogenic agents include, but are not limited to, sorafenib, sunitinib, pazopanib, axitinib, and bevacizumab
Metastatic kidney cancer; clear cell histology component from primary or metastatic lesion
Histologically confirmed non-metastatic high-risk clear cell RCC (T2a-T4NanyM0 or TanyN1M0)
Documented pathologic diagnosis of RCC; all subtypes eligible including but not limited to clear cell, papillary, chromophobe, collecting duct carcinoma, medullary carcinoma, and unclassified categories; sarcomatoid and rhabdoid differentiation are allowed
Histologically or cytologically confirmed advanced or metastatic RCC with clear cell component
PHASE I: Patients with clear cell RCC must have either declined, be ineligible to receive, have progressed on, or be intolerant to high dose interleukin (IL)-2 , or standard first and second line VEGF, or mechanistic target of rapamycin (mTOR) targeted agents; as there is no standard therapy for metastatic non-clear cell RCC, no prior therapy is required
Pathologic evidence of clear cell RCC
Have histologic confirmation of RCC with a clear cell component
Histological confirmation of RCC with a clear-cell component, including participants who may also have sarcomatoid features
Histologically or cytologically confirmed advanced RCC with predominantly clear cell subtype
Subjects with histological or cytological confirmation of clear cell RCC.
RCC (clear cell), urothelial carcinoma (transitional cell), gastric or gastro-esophageal junctional (GEJ) adenocarcinoma, or K-RAS or N-RAS wild-type EGFR expressing CRC
Cohort A (clear cell RCC cohort) participant must have histologically confirmed diagnosis of clear cell RCC or RCC with clear cell component (with or without sarcomatoid features).
Cohort B (non-clear cell RCC cohort) participant must have histologically confirmed diagnosis of non-clear cell RCC (with or without sarcomatoid features). Participants with tumors that have a component of clear cell histology are not eligible for inclusion in Cohort B.
Diagnosis - Dose Expansion Phase: Histologically or cytologically confirmed advanced RCC with a component of clear cell subtype
Has histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features.
Diagnosis of locally advanced or metastatic RCC that is predominantly clear cell histology
Histologically or cytologically confirmed RCC with a clear cell component (subjects with pure papillary cell tumor or other non-clear cell histologies, including collecting duct, medullary, chromophobe, and unclassified RCC are excluded).
Histologic confirmation of locally advanced or metastatic RCC with a clear-cell component with or without sarcomatoid features.
Newly (<6 months) diagnosed RCC (histological/cytological verification is optional) with at least one (1) CT-verified metastasis ?10mm for which complete metastasectomy is not planned. US patients must have verified clear-cell tumor histology
Histologically- or cytologically-confirmed diagnosis of advanced/unresectable or metastatic MEL or RCC (Part 1A only) with predominantly clear cell elements
Histologically or cytologically confirmed advanced RCC with clear cell component
Phase Ib dose escalation cohort study: subjects with histologically assessed metastatic clear cell RCC (defined as more than 50% clear cell component) after failure of at least one systemic therapy for metastatic disease (including, but not limited to prior therapy with interleukin 2, interferon, bevacizumab, VEGF TKI, and mTOR) for metastatic disease. NOTE: A biopsy to prove metastatic disease is not required.
Phase II study: subjects with treatment-naïve histologically assessed metastatic clear cell RCC (defined as more than 50% clear cell component) and who are candidates for standard first-line therapy. NOTE: A biopsy to prove metastatic disease is not required.
A retrospective review of all patients entered will be performed to confirm clear cell histology; patients must have recurrent or, progressive clear cell ovarian cancer not solely based on cancer antigen (CA)-125; primary tumors must be at least 50% clear cell histomorphology in order to be eligible or have a histologically documented recurrence with at least 50% clear cell histomorphology; recurrence should be biopsy proven unless the tumor is located in an area deemed unsafe to biopsy by the surgeon; if a biopsy can be obtained without significant risk, then biopsy should be obtained
Histologically or cytologically confirmed advanced RCC with predominantly clear-cell subtype with primary tumor resected
Diagnosis of RCC with clear-cell or predominant clear-cell histology (? 50% other histologic features)
Pathologic confirmation of metastatic or locally advanced RCC with a major clear cell component
Subjects with RCC (clear cell, non-clear cell histology) with or without prior systemic anticancer therapy
Expansion Cohort 1: Subjects with RCC with clear cell histology who have not received prior systemic anticancer therapy
Dose determination cohorts: Histologically confirmed diagnosis of metastatic RCC of either clear cell or non-clear histology.
Dose expansion cohorts: Histologically confirmed diagnosis of metastatic RCC of either clear cell or papillary histology
Renal cell carcinoma (RCC) Cohort: Participants with histologically confirmed incurable, advanced RCC with component of clear cell histology and/or component of sarcomatoid histology not previously treated with anti-PD-L1/PD-1 and/or anti-CTLA-4 (investigational or approved)
Subjects must have a pathologically documented, definitively diagnosed, clear cell RCC that is relapsed/refractory following at least two lines of systemic therapy (one of which must be a tyrosine kinase), or the subject refuses standard therapy
Patient has a pathologically confirmed diagnosis of clear cell RCC
Unresectable advanced or metastatic non-clear cell RCC to include but not limited to:\r\n* Papillary RCC, any type\r\n* Unclassified RCC\r\n* Translocation RCC\r\n* Chromophobe RCC\r\n* Collecting duct RCC\r\n* Medullary RCC\r\n* Clear cell RCC or any histology with >= 20% sarcomatoid features will be eligible\r\n* Other non-clear cell histologies that are not included above need to be discussed with the principal investigator (PI)
Clear cell
No prior systemic therapy for clear cell renal cancer
Histological or cytological diagnosis of renal cell cancer with a clear-cell component
Renal cell carcinoma (clear cell predominant type);
For papillary renal cell carcinoma patients, the following are required:
Documented local confirmation of renal cell carcinoma with a predominantly papillary growth pattern.
Histologically-confirmed renal cell carcinoma (any histologic subtype) without evidence of distant metastatic disease
Biopsy/pathology-proven clear cell renal cell carcinoma (CCRCC) with metastases
Histologically confirmed metastatic renal cell carcinoma with predominantly clear cell histology
Localized clear cell renal carcinoma without evidence of distant metastases
Advanced Renal Cell Carcinoma
Patient has histologically confirmed locally recurrent or metastatic predominantly clear cell renal cell carcinoma.
Renal cell carcinoma without any clear (conventional) cell component
Histological confirmation of renal cell carcinoma (RCC) (any histology)
Histologically confirmed renal cell carcinoma (RCC)
Histological confirmation of renal cell carcinoma (RCC) with a predominantly (> 50%) clear cell component
Histological confirmation of renal cell carcinoma (RCC) with a clear-cell component
Subjects must have a histologic diagnosis of clear cell renal cell carcinoma (pure or mixed) with radiologic or histologic or cytologic evidence of metastatic disease
An archived tissue block with the subject’s renal cell carcinoma must be identified prior to registration
Patients with imaging findings consistent with renal cell carcinoma
Pathologic diagnosis of metastatic renal cell carcinoma (RCC) with clear cell component with progression or intolerance to at least one prior systemic anti-angiogenic therapy (if a previous biopsy of metastatic site within the last 12 months exists and a review of stained slides shows it to be adequate then a pretreatment biopsy is not required)
Cohort C – Renal cell carcinoma (> pT1b); must have radiologic suspicion or histological proof of clear cell renal cell carcinoma >= 4 cm with no evidence of metastatic disease; patient with any degree of tumor extension into the renal vein are not eligible; patients must be candidates for contrast-enhanced ultrasound (CEUS) imaging and agree to undergo this additional imaging technique
Patients must have histologically or cytologically confirmed clear cell renal cell carcinoma (RCC)
Prior systemic therapy for renal cell carcinoma
If a previous biopsy of mass has been done, pathology must be consistent with renal cell carcinoma (RCC)
Patients must not have received prior anticancer therapy with bevacizumab, anti-CLTA-4, or anti-PD1 for renal cell carcinoma; patients receiving any concomitant systemic therapy for renal cell cancer are excluded
RENAL CELL CARCINOMA (RCC) COHORT EXCLUSION CRITERIA: History of other malignancy with concern for renal metastasis and known allergy to technetium or sestamibi
Histological confirmation of non-clear cell renal cancer (including chromophilic [papillary], chromophobic, oncocytic, sarcomatoid, collecting duct [Bellini's duct]), translocation-type carcinoma or medullary renal cell carcinoma
Up to one prior treatment for metastatic non clear cell carcinoma is allowed prior to registration as long as the agent used to treat was not pazopanib
Renal cell cancer
RENAL COHORT: Histological documentation of renal cell carcinoma with a clear cell component in the metastatic renal cell carcinoma cohort
Renal cell cancer
Adult with unresectable locally advanced or metastatic renal cell carcinoma with a clear cell component
Patients must have histologically confirmed renal cell carcinoma (of any subtype) containing any sarcomatoid features; there must be histologic confirmation by the treating center of either the primary or metastatic lesion
1e. Renal Cell Carcinoma Have histologically confirmed diagnosis of predominant clear cell renal cell carcinoma.
Histologically confirmed, advanced, predominantly clear cell renal cell carcinoma (RCC).
Patient must have pathologically confirmed renal cell carcinoma with a clear cell component; pure papillary and chromophobe histologies are excluded; there must be pathologic confirmation of metastatic disease in the resected metastasectomy specimen
Documented histological or cytological diagnosis of renal cell carcinoma with a clear-cell component.
Patients must have histologically or cytologically confirmed renal cell carcinoma (clear cell or non-clear cell allowed, but collecting duct or medullary carcinomas excluded); patients must be considered pathologically either intermediate high risk or very high risk; patients must not have a history of distant metastases; patients with microvascular invasion of the renal vein of any grade or stage (as long as M0) are also eligible
Histologically confirmed diagnosis of Renal Cell Carcinoma with a documented clear cell component (ccRCC)
Histologically confirmed diagnosis of advanced or metastatic clear cell or papillary renal cell carcinoma or histologically confirmed clear cell ovarian carcinoma.
Advanced Renal Cell Carcinoma
Histologically confirmed renal cell carcinoma (RCC) with a clear-cell component.
Evidence that the renal cell carcinoma is advanced or metastatic.
Patient’s with an International Metastatic Renal Cell Carcinoma Database Consortium (IMDC or Heng) score of 3 or less will be included; score greater than 4 will be excluded; 1 point each: requirement of systemic treatment for metastatic disease less than 1 year of original diagnosis of renal cell carcinoma, a serum calcium greater than 10, anemia, neutrophilia, thrombocytosis, ECOG performance status >= 2
Renal Cell Carcinoma
The patient must have a pathologically confirmed diagnosis of clear cell (renal cell) carcinoma, which is currently Stage 4 disease.
Histologically confirmed, locally recurrent or metastatic clear cell renal cell carcinoma
Non clear cell renal cell carcinoma (RCC)
Documented pathologic diagnosis of renal cell carcinoma (RCC); all subtypes eligible including but not limited to clear cell, papillary, chromophobe, collecting duct carcinoma, medullary carcinoma, and unclassified categories; sarcomatoid and rhabdoid differentiation are allowed
Phase II: has had prior therapy for metastatic renal cell carcinoma.
Histological confirmation of renal cell carcinoma (RCC) with a clear-cell component
Histologically or cytologically-confirmed metastatic renal cell carcinoma of clear cell histology; prior nephrectomy is not a requirement for eligibility
Histologically or cytologically confirmed clear cell renal cell carcinoma (ccRCC); pathology report from the original diagnosis of renal cell carcinoma is acceptable; the component of conventional clear cell type > 50% is mandatory only if there is more than one cell type identified in the tumor tissue
Histologic confirmation of renal cell carcinoma (RCC) with clear-cell component
Patients without sarcoma, renal cell carcinoma, or melanoma
Radiographic evidence of nonmetastatic renal cell carcinoma
Histological verification of clear cell renal cell carcinoma (note: this will be confirmed post informed consent)
Histological or cytological confirmation of renal cell carcinoma (RCC) with a clear-cell component
Patients must have pathological diagnosis of renal cell carcinoma that is metastatic or surgically unresectable; the histology must be clear cell carcinoma or predominant clear cell carcinoma
Patients must have a diagnosis of a metastatic renal cell carcinoma with a >= 50% clear cell component
Receipt of at least two line of prior therapy for metastatic renal cell carcinoma (RCC)
Histologically confirmed diagnosis of predominant clear cell renal cell carcinoma.
Patients with renal cell carcinoma less than 4 cm in maximum diameter, who are poor surgical candidates are eligible for randomization between SBRT and RFA\r\n* Renal cell carcinoma must be pathologically proven
Patients with renal cell carcinoma less than 8 cm in maximum diameter, patients with metastatic RCC who require local palliation or are progressing through systemic disease, patients who are poor surgical candidates and have tumor location not amenable to RFA, or patients who would prefer a noninvasive means of treatment are eligible for the non-randomized SBRT cohort\r\n* Renal cell carcinoma must be pathologically proven
Patients with bilateral renal cell carcinoma
Histologically confirmed carcinoma of the kidney (clear-cell predominance)
Have had at least 2 prior systemic treatments for renal cell carcinoma (RCC)
Have a histologically confirmed diagnosis of predominant clear cell (conventional) Renal Cell Carcinoma (ccRCC).
Part B3: Renal cell carcinoma (any histology)
Must have histologically confirmed renal cell carcinoma of any pathologic subtype.
Documented histological or cytological diagnosis of renal cell carcinoma with a clear-cell component
Patients must have histologically confirmed metastatic or unresectable renal cell carcinoma; predominant clear cell component is required; pure papillary and chromophobe renal cell carcinoma, collecting duct tumors and transitional cell carcinoma are not eligible
Histological or cytological proof of component (any percent) of clear cell RCC (renal cell carcinoma).
Diagnosis of metastatic renal cell carcinoma, either clear cell type or non-clear cell type; the diagnosis must be confirmed by the Laboratory of Pathology of National Cancer Institute (NCI) (there will be no central pathology review)
Histologically or cytologically confirmed diagnosis of metastatic clear-cell renal cell carcinoma (ccRCC)
Participants with histologically confirmed non clear cell renal cell carcinoma (nccRCC) who have not received any chemotherapy for advanced disease. Participants must have one of the following subtypes of nccRCC: papillary, chromophobe, collecting duct carcinoma (CDC), renal medullary carcinoma (RMC), or unclassified.
Predominant clear cell renal cell carcinoma (RCC)
Cytologically or pathologically verified diagnosis of renal cell carcinoma (RCC)
RENAL CANCER: Histologically confirmed renal cell carcinoma (RCC)
If biopsy of mass has been done, pathology must be consistent with renal cell carcinoma (RCC)
Histologically confirmed renal cell carcinoma
Diagnosis of unresectable and/or metastatic clear cell renal cell carcinoma; 10 patients will be enrolled who have had no prior anti-angiogenic therapy; 10 patients will be enrolled who have had one prior anti-angiogenic therapy
Renal Cell Carcinoma: documented histological or cytological diagnosis of renal cell cancer with a clearcell or papillary component; progression following at least two prior lines of standard therapy including a checkpoint inhibitor and an anti-VEGFR inhibitor; archival tissue or fresh tumor biopsy
Histologically confirmed clear cell carcinoma (conventional) with advanced and/or metastatic disease
Patients must have metastatic renal cell carcinoma (RCC)