A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Other Agents in Participants With Advanced Renal Cell Carcinoma (RCC) (ROSETTA RCC-208)
Condition(s) studied
Investigational drug(s) / intervention(s)
Pumitamig: Specified dose on specified days
Ipilimumab: Specified dose on specified days
Cabozantinib: Specified dose on specified days
Casdatifan: Specified dose on specified days
Study summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of Pumitamig alone or in combination with other agents in participants with advanced Renal Cell Carcinoma (RCC)
Eligibility
Primary outcome measure(s)
- Number of participants with adverse events (AEs) — Up to approximately 2 years from end of treatment
Phase 1 - Number of participants with serious adverse events (SAEs) (as per Common Terminology Criteria for Adverse Events v5 (CTCAE v5)) — Up to approximately 2 years from end of treatment
Phase 1 - Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria — Up to day 21 from first dose
Phase 1 - Number of participants with AEs leading to discontinuation — Up to approximately 2 years from end of treatment
Phase 1 - Number of participants with AEs leading to death — Up to approximately 2 years from end of treatment
Phase 1 - Objective response rate (ORR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment — Up to approximately 2 years from end of treatment
Phase 2
Trial sites (95)
| Facility | City | Region | Status |
|---|---|---|---|
| Local Institution - 0178 | Palo Alto | California | Not Yet Recruiting |
| Local Institution - 0117 | New Haven | Connecticut | Not Yet Recruiting |
| Sibley Memorial Hospital | Washington D.C. | District of Columbia | Recruiting |
| Local Institution - 0177 | Miami | Florida | Not Yet Recruiting |
| Local Institution - 0126 | Orlando | Florida | Not Yet Recruiting |
| Local Institution - 0170 | Fort Wayne | Indiana | Not Yet Recruiting |
| University Of Iowa Hospitals And Clinics | Iowa City | Iowa | Recruiting |
| Johns Hopkins Hospital | Baltimore | Maryland | Recruiting |
| Local Institution - 0176 | Big Rapids | Michigan | Not Yet Recruiting |
| Washington University School of Medicine | St Louis | Missouri | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | Recruiting |
| Local Institution - 0135 | Cincinnati | Ohio | Not Yet Recruiting |
| Cleveland Clinic | Cleveland | Ohio | Recruiting |
| MUSC Hollings Cancer Center | Charleston | South Carolina | Recruiting |
| Carolina Urologic Research Center, LLC | Myrtle Beach | South Carolina | Recruiting |
| Local Institution - 0158 | Salt Lake City | Utah | Withdrawn |
| Local Institution - 0095 | Seattle | Washington | Not Yet Recruiting |
| Asociación de Beneficencia Hospital Sirio Libanés | Ciudad Autonoma de Buenos Aires | Buenos Aires | Recruiting |
| Instituto Medico Especializado Alexander Fleming | Buenos Aires | Argentina | Recruiting |
| Local Institution - 0156 | Buenos Aires | Argentina | Not Yet Recruiting |
| Macquarie University | North Ryde | New South Wales | Recruiting |
| GenesisCare St Leonards | St Leonards | New South Wales | Recruiting |
| Mater Misericordiae Limited | Brisbane | Queensland | Recruiting |
| Local Institution - 0011 | Herston | Queensland | Not Yet Recruiting |
| Local Institution - 0004 | Heidelberg | Victoria | Not Yet Recruiting |
| Cabrini Hospital - Malvern | Malvern | Victoria | Recruiting |
| Local Institution - 0007 | Calgary | Alberta | Not Yet Recruiting |
| Local Institution - 0189 | Edmonton | Alberta | Not Yet Recruiting |
| Local Institution - 0109 | Montreal | Quebec | Withdrawn |
| Local Institution - 0009 | Montreal | Quebec | Not Yet Recruiting |
| Local Institution - 0006 | Québec | Quebec | Not Yet Recruiting |
| Local Institution - 0105 | Santiago | Santiago Metropolitan | Not Yet Recruiting |
| Bradfordhill | Santiago | Santiago Metropolitan | Recruiting |
| Local Institution - 0163 | Santiago | Chile | Not Yet Recruiting |
| Local Institution - 0143 | Beijing | Beijing Municipality | Not Yet Recruiting |
| Local Institution - 0157 | Beijing | Beijing Municipality | Not Yet Recruiting |
| Local Institution - 0182 | Guangzhou | Guangdong | Not Yet Recruiting |
| Local Institution - 0145 | Tianjin | Hebei | Not Yet Recruiting |
| Local Institution - 0187 | Harbin | Heilongjiang | Not Yet Recruiting |
| Local Institution - 0183 | Changsha Shi | Hunan | Not Yet Recruiting |
+ 55 more sites — see the full list on the official registry below.
On this site
📄 Cabometyx (cabozantinib) drug profile →More Bristol-Myers Squibb trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07293351 on ClinicalTrials.gov ↗ ← All trials in Italy