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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)

Status
Not yet recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-527163-15-00
Enrollment
18
Registered
2026-09-24
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Renal Cell Carcinoma

Brief summary

Phase 1: The main goal of phase 1 will check and count for how many people have side-effects or serious side-effects from the medicine, if anyone must stop taking it because of these side-effects , and if any side-effects cause death., Phase 2: The main goal of phase 2 will be to check and count how many people's kidney cancer gets much smaller or completely goes away with the treatment (OR (Objective Response) (confirmed CR (complete response) or PR (partial response)).

Detailed description

Count how many people have side-effects or serious side-effects from the medicines, including those who stop treatment or die because of them (safety)., See how long people live without the cancer getting worse, and how long the cancer stays smaller or goes away (progression delay (PFS, Progression-Free Survival and duration (DOR, Duration of Response).

Interventions

DRUGIPILIMUMAB
DRUGIpilimumab
DRUGCABOZANTINIB

Sponsors

Bristol-Myers Squibb Services Unlimited Company
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Phase 1: The main goal of phase 1 will check and count for how many people have side-effects or serious side-effects from the medicine, if anyone must stop taking it because of these side-effects , and if any side-effects cause death., Phase 2: The main goal of phase 2 will be to check and count how many people's kidney cancer gets much smaller or completely goes away with the treatment (OR (Objective Response) (confirmed CR (complete response) or PR (partial response)).—

Secondary

MeasureTime frame
Count how many people have side-effects or serious side-effects from the medicines, including those who stop treatment or die because of them (safety)., See how long people live without the cancer getting worse, and how long the cancer stays smaller or goes away (progression delay (PFS, Progression-Free Survival and duration (DOR, Duration of Response).—

Outcome results

None listed

Source: EU CTIS · Data processed: Sep 26, 2026