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)

Part of paid clinical trials in Palo Alto, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT07293351
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Renal Cell Carcinoma (RCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pumitamig — DRUG
    Specified dose on specified days
  • Ipilimumab — DRUG
    Specified dose on specified days
  • Cabozantinib — DRUG
    Specified dose on specified days
  • Casdatifan — DRUG
    Specified dose on specified days

Study Details

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)

Key Dates

First listed
Dec 19, 2025
Start date
Mar 26, 2026
Status verified
Sep 2026
Primary completion
Nov 28, 2029
Completion
Nov 26, 2031

Study Design

Enrollment
474 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1A: 1A-1 Pumitamig + Ipilimumab
  • Experimental: Part 1A: 1A-2 Pumitamig + Ipilimumab
  • Experimental: Part 1B: 1B-1 Pumitamig + Cabozantinib
  • Experimental: Part 1B: 1B-2 Pumitamig + Cabozantinib
  • Experimental: Part 2A: 2A-1 Pumitamig + Ipilimumab
  • Experimental: Part 2A: 2A-2 Pumitamig + Ipilimumab
  • Experimental: Part 2B: 2B-1 Pumitamig + Cabozantinib
  • Experimental: Part 2B: 2B-2 Pumitamig + Cabozantinib
  • Experimental: Part 2C: 2C-1 Pumitamig
  • Experimental: Part 2D: 2D-1 Pumitamig + Casdatifan
  • Experimental: Part 2E: 2E-1 Pumitamig + Ipilimumab + Casdatifan

Primary Outcome Measure

Number of participants with adverse events (AEs) [ Time Frame: Up to approximately 2 years from end of treatment ]

Central Contacts

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain NCT # and Site #.

Locations (17)

FacilityCityStateZIPSite coordinators
Local Institution - 0178Palo AltoCalifornia94305
Site 0178
Local Institution - 0117New HavenConnecticut06510
Site 0117
Sibley Memorial HospitalWashington D.C.District of Columbia20016
Yasser Ged, Site 0134
410-570-9410
Local Institution - 0177MiamiFlorida33136
Site 0177
Local Institution - 0126OrlandoFlorida32803
Site 0126
Local Institution - 0170Fort WayneIndiana46825
Site 0170
University Of Iowa Hospitals And ClinicsIowa CityIowa52242
Fernando Maciel Barbosa, Site 0124
Johns Hopkins HospitalBaltimoreMaryland21287
Yasser Ged, Site 0123
410-570-9410
Local Institution - 0176Big RapidsMichigan49307
Site 0176
Washington University School of MedicineSt LouisMissouri63110
Melissa Reimers, Site 0094
314-362-5740
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Robert Motzer, Site 0096
646-422-4312
Local Institution - 0135CincinnatiOhio45219
Site 0135
Cleveland ClinicClevelandOhio44195
Moshe Ornstein, Site 0127
216-445-6592
MUSC Hollings Cancer CenterCharlestonSouth Carolina29425
Thai Ho, Site 0165
843-792-9300
Carolina Urologic Research Center, LLCMyrtle BeachSouth Carolina29572
Neal Shore, Site 0114
843-449-1010
Local Institution - 0158Salt Lake CityUtah84112-
Local Institution - 0095SeattleWashington98109-1023
Site 0095

Find similar trials in Palo Alto, CA

By research site
Local Institution - 0178· Palo Alto, CALocal Institution - 0117· New Haven, CTSibley Memorial Hospital· Washington D.C., DCLocal Institution - 0177· Miami, FLLocal Institution - 0126· Orlando, FLLocal Institution - 0170· Fort Wayne, IN