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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)

ConditionAdvanced Renal Cell Carcinoma (RCC)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBristol-Myers Squibb

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have a histologically confirmed diagnosis of locally advanced, unresectable (not amenable to curative surgery or radiation therapy) or metastatic Renal Cell Carcinoma (RCC).

Participants must have clear cell RCC (ccRCC) or non-clear cell RCC (nccRCC) may be enrolled in Part 1. Note: Part 2 may only enroll participants with ccRCC.

Participants may have favorable, intermediate or poor risk disease categories.

Disqualifiers

Participants must not have any untreated known CNS metastases.

Participants must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of Cycle 1 Day1 (C1D1).

Participants must not have a history of interstitial lung disease or pneumonitis.

Participants must not have an uncontrolled pleural or pericardial effusion requiring recurrent therapeutic drainage procedures.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

474 Participants
are divided into 11 treatment groups

11

Treatment groups

See each treatment group below.

Group A: Part 1A: 1A-1 Pumitamig + IpilimumabExperimental treatment 2 interventions
Group B: Part 1A: 1A-2 Pumitamig + IpilimumabExperimental treatment 2 interventions
Group C: Part 1B: 1B-1 Pumitamig + CabozantinibExperimental treatment 2 interventions
Group D: Part 1B: 1B-2 Pumitamig + CabozantinibExperimental treatment 2 interventions
Group E: Part 2A: 2A-1 Pumitamig + IpilimumabExperimental treatment 2 interventions
Group F: Part 2A: 2A-2 Pumitamig + IpilimumabExperimental treatment 2 interventions
Group G: Part 2B: 2B-1 Pumitamig + CabozantinibExperimental treatment 2 interventions
Group H: Part 2B: 2B-2 Pumitamig + CabozantinibExperimental treatment 2 interventions
Group I: Part 2C: 2C-1 PumitamigExperimental treatment 1 intervention
Group J: Part 2D: 2D-1 Pumitamig + CasdatifanExperimental treatment 2 interventions
Group K: Part 2E: 2E-1 Pumitamig + Ipilimumab + CasdatifanExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Number of participants with adverse events (AEs)

Phase 1

Time frame
Up to approximately 2 years from end of treatment
2

Number of participants with serious adverse events (SAEs) (as per Common Terminology Criteria for Adverse Events v5 (CTCAE v5))

Phase 1

Time frame
Up to approximately 2 years from end of treatment
3

Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria

Phase 1

Time frame
Up to day 21 from first dose
4

Number of participants with AEs leading to discontinuation

Phase 1

Time frame
Up to approximately 2 years from end of treatment

Secondary outcomes

1

Number of participants with AEs

Phase 2

Time frame
Up to approximately 2 years from end of treatment
2

Number of participants with SAEs (as per CTCAE v5)

Phase 2

Time frame
Up to approximately 2 years from end of treatment
3

Number of participants with treatment-related adverse events (TRAEs)

Phase 2

Time frame
Up to approximately 2 years from end of treatment
4

Number of participants with AEs leading to discontinuation

Phase 2

Time frame
Up to approximately 2 years from end of treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bristol-Myers Squibb

Lead sponsor

BioNTech SE

Collaborator

Source ClinicalTrials.gov
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