A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Ipilimumab or Cabozantinib in Participants With Advanced Renal Cell Carcinoma (RCC) (ROSETTA RCC-208)

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Bristol-Myers Squibb
Study ID
NCT07293351
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Renal Cell Carcinoma (RCC)

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to evaluate the safety, tolerability, and efficacy of Pumitamig alone or in combination with Ipilimumab or Cabozantinib in participants with advanced Renal Cell Carcinoma (RCC)

Key Dates

Start date
Mar 26, 2026
Status verified
May 2026
Primary completion
Nov 28, 2029
Completion
Nov 26, 2031

Study Design

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

Arms

  • Experimental: Part 1A: Arm A
  • Experimental: Part 1A: Arm B
  • Experimental: Part 1B: Arm G
  • Experimental: Part 1B: Arm H
  • Experimental: Part 2A: Arm C
  • Experimental: Part 2A: Arm D
  • Experimental: Part 2B: Arm I
  • Experimental: Part 2B: Arm J
  • Experimental: Part 2C: Arm M

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 (13)

FacilityCityStateZIPSite coordinators
Local Institution - 0117New HavenConnecticut06510
Site 0117
Sibley Memorial HospitalWashington D.C.District of Columbia20016
Yasser Ged, Site 0134
410-570-9410
Local Institution - 0126OrlandoFlorida32803
Site 0126
Local Institution - 0124Iowa CityIowa52242
Site 0124
Johns Hopkins HospitalBaltimoreMaryland21287
Yasser Ged, Site 0123
410-570-9410
Washington University School of MedicineSt LouisMissouri63110
Melissa Reimers, Site 0094
314-362-5740
Local Institution - 0096HauppaugeNew York11788
Site 0096
Local Institution - 0135CincinnatiOhio45219
Site 0135
Local Institution - 0127ClevelandOhio44195
Site 0127
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

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By research site
Local Institution - 0117· New Haven, CTSibley Memorial Hospital· Washington D.C., DCLocal Institution - 0126· Orlando, FLLocal Institution - 0124· Iowa City, IAJohns Hopkins Hospital· Baltimore, MDWashington University School of Medicine· St Louis, MO