A Randomized, Double-Blind, Active-Control, Multicenter Phase 3 Trial of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma

Date Added
March 27th, 2026
PRO Number
Pro00146919
Researcher
Thai Ho

List of Studies

Keywords
Cancer, Cancer/Genitourinary, Drug Studies
Summary

This study is testing whether adding a new drug, casdatifan, to cabozantinib works better than cabozantinib alone in adults with advanced kidney cancer (clear cell renal cell carcinoma) that has gotten worse after previous immunotherapy. It will compare the two treatments in patients around the world to see which is more effective. A total of 8 patients will be enrolled locally over the course of 26 months, and participants may be in the study for up to five years. Before joining, patients will complete a screening process with tests and assessments to determine eligibility. If eligible, participants will be randomly assigned to one of two groups: casdatifan plus cabozantinib or placebo plus cabozantinib. There is a 2 in 3 chance of being in the casdatifan group and a 1 in 3 chance of being in the placebo group. Both drugs are taken by mouth in pill form each day. During the study, patients will have assessments such as blood tests, imaging scans, heart monitoring, physical exams, biopsies, questionnaires, and a drug diary. Participants will visit the study site two times each 28-day cycle for the first two cycles, then once per cycle thereafter. The most important risks include low blood counts, low oxygen levels, fatigue, gastrointestinal problems, skin reactions, high blood pressure, weight loss, voice changes, and bleeding.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

ROSETTA RCC-208: A Phase 1/2 Open-label, Multi-center, Randomized Study of Pumitamig Alone or in Combination with Ipilimumab or Cabozantinib in Participants with Advanced Renal Cell Carcinoma (RCC)

Date Added
March 24th, 2026
PRO Number
Pro00150045
Researcher
Thai Ho

List of Studies

Keywords
Cancer, Drug Studies, Kidney, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with diagnosed with unresectable, locally advanced, recurrent or metastatic renal cell carcinoma (RCC). The study is testing investigational drugs called pumitamig."Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The main purpose of this study is to evaluate the safety and tolerability, and to determine the recommended phase 2 dose (RP2D), of pumitamig administered in combination with ipilimumab or cabozantinib. The study drug is given by infusion. Participants in this study can expect to be in this study for about 4 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinicaltrials@musc.edu

SHORT TERM INTENSIFIED PEMBROLIZUMAB (KEYTRUDA) AND TIVOZANIB FOR HIGH-RISK RENAL CELL CARCINOMA - STRIKE

Date Added
August 12th, 2025
PRO Number
Pro00146260
Researcher
Thai Ho

List of Studies

Keywords
Cancer, Cancer/Genitourinary, Drug Studies
Summary

This study is patients that have been diagnosed with high-risk renal cell carcinoma. This study will compare disease free survival (DFS) in patients treated with adjuvant pembrolizumab and tivozanib versus those receiving pembrolizumab alone. Participants can expect to remain in the study for 10years. There will be a total of 14 patient enrolled locally.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu



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