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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)

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 96 to 95 Eligibility criteria expanded, about 20 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 20 words
  2. Trial sites expanded: 92 → 96 locationsv12
  3. Enrollment increased: 254 → 474 participants Interventions modified · Trial arms changed: 9 → 11 · Study sites: 91 to 92 · 2 morev11 Show 5 more changesShow less
    • Interventions modified
    • Trial arms changed: 9 → 11
    • Study sites: 91 to 92
    • Eligibility criteria expanded, about 211 words
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites revised (91)v10 See this version in full on ClinicalTrials.gov ↗
  5. Trial sites expanded: 78 → 91 locationsv9
  6. Trial sites expanded: 72 → 78 locationsv8
  7. Trial arms changed: 10 → 9 Enrollment target: 234 to 254 · Interventions: Cabozantinib (Drug), Ipilimumab (Drug), Nivolumab (Drug), Pumitamig (Drug) to Cabozantinib (Drug), Ipilimumab (Drug), Pumitamig (Drug)v7 Show 2 more changesShow less
    • Enrollment target: 234 to 254
    • Interventions: Cabozantinib (Drug), Ipilimumab (Drug), Nivolumab (Drug), Pumitamig (Drug) to Cabozantinib (Drug), Ipilimumab (Drug), Pumitamig (Drug)
  8. Study sites revised (72)v6 See this version in full on ClinicalTrials.gov ↗
  9. Start date changed from estimate of Apr 30, 2026 to Mar 26, 2026 Study sites revised (72)v5 Show 1 more changeShow less
    • Study sites revised (72)

    See this version in full on ClinicalTrials.gov ↗

  10. Start date: Mar 26, 2026 to Apr 30, 2026 Study sites: 71 to 72v4 Show 1 more changeShow less
    • Study sites: 71 to 72
  11. Trial status: Not Yet Recruiting to Recruiting Enrollment target: 264 to 234 · Study sites revised (71) · Study arms: 12 to 10v3 Show 3 more changesShow less
    • Enrollment target: 264 to 234
    • Study sites revised (71)
    • Study arms: 12 to 10

    See this version in full on ClinicalTrials.gov ↗

  12. Study sites: 69 to 71v2
  13. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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)
Trial Details
NCT Number NCT07293351
Lead Sponsor Bristol-Myers Squibb
Collaborators: BioNTech SE
Conditions Advanced Renal Cell Carcinoma (RCC)
Enrollment 474 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov