Cabozantinib In Combo With NIVO + IPI In Advanced NCCRCC (NCT04413123) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Cabozantinib In Combo With NIVO + IPI In Advanced NCCRCC
United States60 participantsStarted 2020-11-05
Plain-language summary
This research study will assess whether cabozantinib, nivolumab and ipilimumab in combination are safe and effective in slowing down the growth of kidney cancer(renal cell carcinoma or RCC) that has advanced or spread to other areas the body.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* histologically or cytologically confirmed unresectable advanced or metastatic nccRCC, including but not limited to:
* Papillary RCC, any type
* Unclassified RCC
* Translocation RCC
* Chromophobe RCC
* Collecting duct RCC
* Renal cell carcinoma with 80% or more sarcomatoid features on primary nephrectomy specimen or a biopsy
* Other nccRCC histologies in discussion with principal investigator
* Measurable disease as per RECIST 1.1. See Section 11 for the evaluation of measurable disease.
* Age ≥ 18 years
* ECOG performance status ≤1 (Karnofsky ≥70%, see Appendix A)
* Participants must undergo fresh tumor biopsy after registration but prior to the start of treatment unless medically unsafe or not feasible. If a fresh tumor biopsy is not medically safe or not feasible, confirmation of the availability of archival tumor tissue is required. For archival tissue, a recommended minimum of 20 unstained slides should be obtained.
* Normal organ and marrow function as defined below:
* absolute neutrophil count ≥1,500/mcL
* platelets ≥100,000/mcL
* hemoglobin ≥9g/dL (transfusions allowed)
* total bilirubin ≤2.0 x institutional upper limit of normal with the following exception: patients with known Gilbert disease should have a serum bilirubin ≤ 3 x ULN
* AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal with the following exception: patients with known liver metastases should have AST and ALT ≤ 5 x ULN
* creatinine clearance ≥30…
What they're measuring
1
Overall Response Rate
Timeframe: tart of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started up to 21 Months