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