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)

August 26, 2026 updated by: Bristol-Myers Squibb

ROSETTA RCC-208: A Phase 1/2 Open-label, Multi-center, Randomized Study of Pumitamig Alone or in Combination With Other Agents in Participants With Advanced Renal Cell Carcinoma (RCC)

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
474

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1426
        • Recruiting
        • Instituto Medico Especializado Alexander Fleming
        • Contact:
          • Juan Pablo Sade, Site 0154
          • Phone Number: 5432218900
      • Buenos Aires, Argentina, C1199ABB
        • Not yet recruiting
        • Local Institution - 0156
        • Contact:
          • Site 0156
  • Australia
      • Malvern, Australia, 3144
        • Not yet recruiting
        • Local Institution - 0003
        • Contact:
          • Site 0003
    • New South Wales
      • North Ryde, New South Wales, Australia, 2109
        • Recruiting
        • Macquarie University
        • Contact:
          • Howard Gurney, Site 0076
          • Phone Number: +61298123526
      • St Leonards, New South Wales, Australia, 2065
        • Recruiting
        • GenesisCare St Leonards
        • Contact:
          • Laurence Krieger, Site 0111
          • Phone Number: 61294631172
    • Queensland
      • Brisbane, Queensland, Australia, 4101
        • Recruiting
        • Mater Misericordiae Limited
        • Contact:
          • Niara Oliveira, Site 0074
          • Phone Number: +61731636166
      • Herston, Queensland, Australia, 4029
        • Not yet recruiting
        • Local Institution - 0011
        • Contact:
          • Site 0011
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Not yet recruiting
        • Local Institution - 0004
        • Contact:
          • Site 0004
  • Brazil
    • Federal District
      • Brasília, Federal District, Brazil, 70200-730
        • Recruiting
        • Hospital Sírio Libanês
        • Contact:
          • Hernan Cutuli, Site 0093
          • Phone Number: 5491157654803
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Not yet recruiting
        • Local Institution - 0007
        • Contact:
          • Site 0007
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • Not yet recruiting
        • Local Institution - 0109
        • Contact:
          • Site 0109
      • Montreal, Quebec, Canada, H3T 1E2
        • Not yet recruiting
        • Local Institution - 0009
        • Contact:
          • Site 0009
  • Chile
      • Santiago, Chile, 8330023
        • Not yet recruiting
        • Local Institution - 0163
        • Contact:
          • Site 0163
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 8420383
        • Recruiting
        • Bradfordhill
        • Contact:
          • Carlos Rojas, Site 0005
          • Phone Number: +56998744662
      • Santiago, Santiago Metropolitan, Chile, 7510032
        • Not yet recruiting
        • Local Institution - 0105
        • Contact:
          • Site 0105
  • China
      • Beijing, China, 100034
        • Not yet recruiting
        • Local Institution - 0144
        • Contact:
          • Site 0144
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Not yet recruiting
        • Local Institution - 0143
        • Contact:
          • Site 0143
      • Beijing, Beijing Municipality, China, 102200
        • Not yet recruiting
        • Local Institution - 0157
        • Contact:
          • Site 0157
    • Guangdong
      • Guangzhou, Guangdong, China, 510555
        • Not yet recruiting
        • Local Institution - 0182
        • Contact:
          • Site 0182
    • Hunan
      • Changsha Shi, Hunan, China, 410013
        • Not yet recruiting
        • Local Institution - 0183
        • Contact:
          • Site 0183
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Not yet recruiting
        • Local Institution - 0184
        • Contact:
          • Site 0184
    • Shanghai Municipality
      • Shanghai Shi, Shanghai Municipality, China, 200032
        • Not yet recruiting
        • Local Institution - 0188
        • Contact:
          • Site 0188
  • Colombia
      • Cali, Colombia, 760032
        • Not yet recruiting
        • Local Institution - 0052
        • Contact:
          • Site 0052
  • Czechia
      • Brno, Czechia, 656 53
        • Not yet recruiting
        • Local Institution - 0149
        • Contact:
          • Site 0149
      • Hradec Králové, Czechia, 500 05
        • Not yet recruiting
        • Local Institution - 0150
        • Contact:
          • Site 0150
    • Praha 5
      • Prague, Praha 5, Czechia, 150 06
        • Not yet recruiting
        • Local Institution - 0147
        • Contact:
          • Site 0147
  • Finland
      • Turku, Finland, 20521
        • Not yet recruiting
        • Local Institution - 0029
        • Contact:
          • Site 0029
      • Vantaa, Finland, 01640
        • Not yet recruiting
        • Local Institution - 0060
        • Contact:
          • Site 0060
    • Etelä-Suomen Lääni
      • Helsinki, Etelä-Suomen Lääni, Finland, 00290
        • Not yet recruiting
        • Local Institution - 0044
        • Contact:
          • Site 0044
  • France
      • Boredeaux, France, 33076
        • Not yet recruiting
        • Local Institution - 0080
        • Contact:
          • Site 0080
      • Villejuif, France, 94805
        • Not yet recruiting
        • Local Institution - 0028
        • Contact:
          • Site 0028
    • Nord
      • Lille, Nord, France, 59020
        • Not yet recruiting
        • Local Institution - 0083
        • Contact:
          • Site 0083
  • Germany
      • Hamburg, Germany, 20251
        • Not yet recruiting
        • Local Institution - 0026
        • Contact:
          • Site 0026
      • Herne, Germany, 44649
        • Not yet recruiting
        • Local Institution - 0014
        • Contact:
          • Site 0014
      • München, Germany, 81675
        • Not yet recruiting
        • Local Institution - 0027
        • Contact:
          • Site 0027
    • Thuringia
      • Jena, Thuringia, Germany, 07747
        • Not yet recruiting
        • Local Institution - 0025
        • Contact:
          • Site 0025
  • Ireland
      • Dublin, Ireland, D07 R2WY
        • Not yet recruiting
        • Local Institution - 0059
        • Contact:
          • Site 0059
      • Dublin, Ireland, D24 NR0A
        • Not yet recruiting
        • Local Institution - 0062
        • Contact:
          • Site 0062
  • Italy
      • Milan, Italy, 20133
        • Not yet recruiting
        • Local Institution - 0073
        • Contact:
          • Site 0073
      • Napoli Campania, Italy, 80131
        • Not yet recruiting
        • Local Institution - 0087
        • Contact:
          • Site 0087
    • Veneto
      • Verona, Veneto, Italy, 37126
        • Not yet recruiting
        • Local Institution - 0139
        • Contact:
          • Site 0139
  • Japan
      • Fukuoka, Japan, 812-8582
        • Recruiting
        • Kyushu University Hospital
        • Contact:
          • Tokiyoshi Tanegashima, Site 0172
          • Phone Number: 0926425615
      • Niigata, Japan, 951-8520
        • Not yet recruiting
        • Local Institution - 0181
        • Contact:
          • Site 0181
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650-0017
        • Not yet recruiting
        • Local Institution - 0180
        • Contact:
          • Site 0180
    • Iwate
      • Shiwa-gun Yahaba-cho, Iwate, Japan, 028-3695
        • Not yet recruiting
        • Local Institution - 0179
        • Contact:
          • Site 0179
    • Tokyo
      • Koto-ku, Tokyo, Japan, 135-8550
        • Recruiting
        • The Cancer Institute Hospital Of JFCR
        • Contact:
          • Yuji Miura, Site 0097
          • Phone Number: 81335200111
    • Toyama
      • Toyoma, Toyama, Japan, 930-0194
        • Not yet recruiting
        • Local Institution - 0078
        • Contact:
          • Site 0078
  • Mexico
      • Oaxaca City, Mexico, 68020
        • Not yet recruiting
        • Local Institution - 0048
        • Contact:
          • Site 0048
      • Puebla City, Mexico, 72424
        • Not yet recruiting
        • Local Institution - 0122
        • Contact:
          • Site 0122
      • Tlalpan, Mexico, 14080
        • Not yet recruiting
        • Local Institution - 0049
        • Contact:
          • Site 0049
      • Tlalpan, Mexico, 14080
        • Not yet recruiting
        • Local Institution - 0108
        • Contact:
          • Site 0108
      • Tlalpan, Mexico, 14080
        • Not yet recruiting
        • Local Institution - 0118
        • Contact:
          • Site 0118
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64040
        • Not yet recruiting
        • Local Institution - 0046
        • Contact:
          • Site 0046
  • Romania
      • Cluj-Napoca, Romania, 400015
        • Not yet recruiting
        • Local Institution - 0103
        • Contact:
          • Site 0103
      • Craiova, Romania, 200347
        • Not yet recruiting
        • Local Institution - 0161
        • Contact:
          • Site 0161
      • Iași, Romania, 700483
        • Not yet recruiting
        • Local Institution - 0100
        • Contact:
          • Site 0100
      • Sibiu, Romania, 550082
        • Not yet recruiting
        • Local Institution - 0101
        • Contact:
          • Site 0101
  • South Korea
      • Seoul, South Korea, 120-752
        • Not yet recruiting
        • Local Institution - 0167
        • Contact:
          • Site 0167
    • Seoul-teukbyeolsi
      • Seoul, Seoul-teukbyeolsi, South Korea, 05505
        • Not yet recruiting
        • Local Institution - 0017
        • Contact:
          • Site 0017
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06351
        • Not yet recruiting
        • Local Institution - 0112
        • Contact:
          • Site 0112
  • Spain
      • Madrid, Spain, 28041
        • Not yet recruiting
        • Local Institution - 0013
        • Contact:
          • Site 0013
      • Madrid, Spain, 28050
        • Not yet recruiting
        • Local Institution - 0091
        • Contact:
          • Site 0091
      • Seville, Spain, 41013
        • Not yet recruiting
        • Local Institution - 0043
        • Contact:
          • Site 0043
  • Switzerland
      • Chur, Switzerland, 7000
        • Recruiting
        • Kantonsspital Graubünden
        • Contact:
          • Richard Cathomas, Site 0054
          • Phone Number: 41812566646
      • Sankt Gallen, Switzerland, 9007
        • Recruiting
        • HOCH Health Ostschweiz
        • Contact:
          • Tobias Peres, Site 0055
          • Phone Number: 0767931903
      • Zurich, Switzerland, 8091
        • Recruiting
        • Universitätsspital Zürich
        • Contact:
          • Anja Lorch, Site 0056
          • Phone Number: 492118108776
  • United Kingdom
      • Cambridge, United Kingdom, CB2 2QQ
        • Not yet recruiting
        • Local Institution - 0022
        • Contact:
          • Site 0022
      • Cardiff, United Kingdom, CF14 2TL
        • Recruiting
        • Velindre Cancer Centre
        • Contact:
          • Satish Kumar, Site 0057
          • Phone Number: 442920615888
      • Edinburgh, United Kingdom, EH4 2XU
        • Not yet recruiting
        • Local Institution - 0061
        • Contact:
          • Site 0061
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • The Christie NHS Foundation Trust
        • Contact:
          • Tom Waddell, Site 0020
          • Phone Number: +441619187217
      • Sulton, Surrey, United Kingdom, SM25PT
        • Recruiting
        • Royal Marsden Hospital Sutton
        • Contact:
          • James Larkin, Site 0171
          • Phone Number: 442078082132
    • Kensington and Chelsea
      • London, Kensington and Chelsea, United Kingdom, SW3 6JJ
        • Recruiting
        • Royal Marsden Hospital (Chelsea)
        • Contact:
          • James Larkin, Site 0063
          • Phone Number: 442078082132
    • London, City of
      • London, London, City of, United Kingdom, EC1A 7BE
        • Recruiting
        • St Bartholomew's Hospital
        • Contact:
          • Thomas Powles, Site 0019
          • Phone Number: 02078228498
    • North West
      • Preston, North West, United Kingdom, PR29HT
        • Not yet recruiting
        • Local Institution - 0186
        • Contact:
          • Site 0186
  • United States
    • California
      • Palo Alto, California, United States, 94305
        • Not yet recruiting
        • Local Institution - 0178
        • Contact:
          • Site 0178
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Not yet recruiting
        • Local Institution - 0117
        • Contact:
          • Site 0117
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20016
        • Recruiting
        • Sibley Memorial Hospital
        • Contact:
          • Yasser Ged, Site 0134
          • Phone Number: 410-570-9410
    • Florida
      • Miami, Florida, United States, 33136
        • Not yet recruiting
        • Local Institution - 0177
        • Contact:
          • Site 0177
      • Orlando, Florida, United States, 32803
        • Not yet recruiting
        • Local Institution - 0126
        • Contact:
          • Site 0126
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Not yet recruiting
        • Local Institution - 0175
        • Contact:
          • Site 0175
    • Indiana
      • Fort Wayne, Indiana, United States, 46825
        • Not yet recruiting
        • Local Institution - 0170
        • Contact:
          • Site 0170
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Hospitals and Clinics
        • Contact:
          • Fernando Maciel Barbosa, Site 0124
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Hospital
        • Contact:
          • Yasser Ged, Site 0123
          • Phone Number: 410-570-9410
    • Michigan
      • Big Rapids, Michigan, United States, 49307
        • Not yet recruiting
        • Local Institution - 0176
        • Contact:
          • Site 0176
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
          • Melissa Reimers, Site 0094
          • Phone Number: 314-362-5740
    • New York
      • Hauppauge, New York, United States, 11788
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Sahil Doshi, Site 0096
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Not yet recruiting
        • Local Institution - 0135
        • Contact:
          • Site 0135
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
          • Moshe Ornstein, Site 0127
          • Phone Number: 216-445-6592
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • MUSC Hollings Cancer Center
        • Contact:
          • Thai Ho, Site 0165
          • Phone Number: 843-792-9300
      • Myrtle Beach, South Carolina, United States, 29572
        • Recruiting
        • Carolina Urologic Research Center, LLC
        • Contact:
          • Neal Shore, Site 0114
          • Phone Number: 843-449-1010
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Withdrawn
        • Local Institution - 0158
    • Washington
      • Seattle, Washington, United States, 98109-1023
        • Not yet recruiting
        • Local Institution - 0095
        • Contact:
          • Site 0095

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • 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.

  • Participants must not have received prior systemic therapy for metastatic RCC, with the following exceptions:

    i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC is allowed if such therapy did not include an agent that targets vascular endothelial growth factor (VEGF) or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy.

ii) For Part 1A participants: Prior systemic therapy in the metastatic setting is allowed if the participant has not received any therapy targeting cytotoxic T-lymphocyte antigen 4 (CTLA-4) (e.g., ipilimumab).

iii) For Part 1B participants: Prior systemic therapy in the metastatic setting is allowed if the participant has not received prior treatment with cabozantinib.

iv) For Parts 2D and 2E: Prior treatment with a HIF-2α inhibitor or other agent that targets the HIF-2α pathway is not allowed.

- Participants must have measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Exclusion Criteria

  • 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.
  • Participants must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis, cerebrovascular accident within 6 months prior to C1D1, uncontrolled hypertension (≥ 150 systolic, ≥ 90 diastolic mm Hg) despite optimal medical management, left ventricular ejection fraction (LVEF) <50% (for Part 2D and 2E) or congenital long QT syndrome.
  • Participants must not have a urine protein ≥ 2+ on dipstick or urinalysis at baseline and confirmed proteinuria ≥ 1 g/24 hours or urine protein-creatinine ratio (UPCR) > 1000 mg/g.
  • Participants must not have evidence of major coagulation disorders.
  • Participants must not have a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism within 6 months prior to C1D1.
  • Participants must not have a history of abdominal fistula or gastrointestinal (GI) perforation within 6 months.
  • Participants must not have had a major surgery or trauma within 28 days prior to C1D1.
  • For Part 2D and 2E: Receiving ongoing concomitant treatment with sensitive substrates of CYP3A4, CYP2C8, CYP2C9, or CYP2C19 with narrow therapeutic indices within 5 half-lives of the concomitant treatment or up to 28 days, whichever is shorter, prior to randomization.
  • For Part 2D and 2E: Receiving ongoing concomitant treatment with moderate or strong CYP3A4 inducers, or moderate or strong CYP3A4 inhibitors within 5 half-lives of the concomitant treatment, or up to 28 days, whichever is shorter, prior to randomization.
  • For Part 2D and 2E: Has hypoxia defined by a pulse oximeter reading < 92% at rest or requires intermittent or chronic supplemental oxygen.
  • For Part 2D and 2E: Exercise-induced desaturation on a 6-minute walk test, defined as a blood oxygen saturation by pulse oximetry ≤ 88%.
  • For Part 2D and 2E: Presence of significant pulmonary disease/condition (eg, chronic obstructive pulmonary disease, pleural effusion, etc) that, in the opinion of the Investigator, could put participant at increased risk from study intervention or impact interpretation of safety data.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1A: 1A-1 Pumitamig + Ipilimumab
Drug: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BNT327
  • PM8002
  • BMS-986545
Experimental: Part 1A: 1A-2 Pumitamig + Ipilimumab
Drug: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BNT327
  • PM8002
  • BMS-986545
Experimental: Part 1B: 1B-1 Pumitamig + Cabozantinib
Drug: Cabozantinib
Specified dose on specified days
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BNT327
  • PM8002
  • BMS-986545
Experimental: Part 1B: 1B-2 Pumitamig + Cabozantinib
Drug: Cabozantinib
Specified dose on specified days
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BNT327
  • PM8002
  • BMS-986545
Experimental: Part 2A: 2A-1 Pumitamig + Ipilimumab
Drug: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BNT327
  • PM8002
  • BMS-986545
Experimental: Part 2A: 2A-2 Pumitamig + Ipilimumab
Drug: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BNT327
  • PM8002
  • BMS-986545
Experimental: Part 2B: 2B-1 Pumitamig + Cabozantinib
Drug: Cabozantinib
Specified dose on specified days
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BNT327
  • PM8002
  • BMS-986545
Experimental: Part 2B: 2B-2 Pumitamig + Cabozantinib
Drug: Cabozantinib
Specified dose on specified days
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BNT327
  • PM8002
  • BMS-986545
Experimental: Part 2C: 2C-1 Pumitamig
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BNT327
  • PM8002
  • BMS-986545
Experimental: Part 2D: 2D-1 Pumitamig + Casdatifan
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BNT327
  • PM8002
  • BMS-986545
Drug: Casdatifan
Specified dose on specified days
Other Names:
  • AB521
Experimental: Part 2E: 2E-1 Pumitamig + Ipilimumab + Casdatifan
Drug: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BNT327
  • PM8002
  • BMS-986545
Drug: Casdatifan
Specified dose on specified days
Other Names:
  • AB521

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events (AEs)
Time Frame: Up to approximately 2 years from end of treatment
Phase 1
Up to approximately 2 years from end of treatment
Number of participants with serious adverse events (SAEs) (as per Common Terminology Criteria for Adverse Events v5 (CTCAE v5))
Time Frame: Up to approximately 2 years from end of treatment
Phase 1
Up to approximately 2 years from end of treatment
Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Time Frame: Up to day 21 from first dose
Phase 1
Up to day 21 from first dose
Number of participants with AEs leading to discontinuation
Time Frame: Up to approximately 2 years from end of treatment
Phase 1
Up to approximately 2 years from end of treatment
Number of participants with AEs leading to death
Time Frame: Up to approximately 2 years from end of treatment
Phase 1
Up to approximately 2 years from end of treatment
Objective response rate (ORR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment
Time Frame: Up to approximately 2 years from end of treatment
Phase 2
Up to approximately 2 years from end of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants with AEs
Time Frame: Up to approximately 2 years from end of treatment
Phase 2
Up to approximately 2 years from end of treatment
Number of participants with SAEs (as per CTCAE v5)
Time Frame: Up to approximately 2 years from end of treatment
Phase 2
Up to approximately 2 years from end of treatment
Number of participants with treatment-related adverse events (TRAEs)
Time Frame: Up to approximately 2 years from end of treatment
Phase 2
Up to approximately 2 years from end of treatment
Number of participants with AEs leading to discontinuation
Time Frame: Up to approximately 2 years from end of treatment
Phase 2
Up to approximately 2 years from end of treatment
Number of participants with AEs leading to death
Time Frame: Up to approximately 2 years from end of treatment
Phase 2
Up to approximately 2 years from end of treatment
Progression-free survival (PFS) by RECIST v1.1 per investigator assessment
Time Frame: Up to 4 years from randomization
Phase 2
Up to 4 years from randomization
Duration of response (DOR) (PR or CR) by RECIST v1.1 per investigator assessment
Time Frame: Up to approximately 2 years from end of treatment
Phase 2
Up to approximately 2 years from end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
BioNTech SE

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 26, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 28, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 26, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA266-0008
  • U1111-1327-6332 (Other Identifier: WHO)
  • 2026-527163-15-00 (Other Identifier: EU CTR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings