Advanced Renal Cell Carcinoma (RCC)Phase 1/2NCT07293351
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)
A Phase 1/2 study testing Pumitamig, Ipilimumab and Cabozantinib in people with Advanced Renal Cell Carcinoma (RCC), run by Bristol-Myers Squibb at 95 sites in 20 countries.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Renal Cell Carcinoma (RCC)
- What is being tested?
- Pumitamig, Ipilimumab and Cabozantinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 474 participants
- Where
- 95 sitesin 20 countries
- Study dates
- 26 Mar 2026to 26 Nov 2031
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
- 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).
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- For Part 1B participants: Prior systemic therapy in the metastatic setting is allowed if the participant has not received prior treatment with cabozantinib.
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
95 sites in 20 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
95 sites in 20 countries
United States17 sites, 16 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Yasser Ged, Site 0123, 410-570-9410
- Not yet recruiting
Local Institution - 0176
Big Rapids, Michigan, 49307
Site 0176
- Recruiting
MUSC Hollings Cancer Center
Charleston, South Carolina, 29425
Thai Ho, Site 0165, 843-792-9300
- Not yet recruiting
Local Institution - 0135
Cincinnati, Ohio, 45219
Site 0135
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Moshe Ornstein, Site 0127, 216-445-6592
- Not yet recruiting
Local Institution - 0170
Fort Wayne, Indiana, 46825
Site 0170
- Recruiting
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, 52242
Fernando Maciel Barbosa, Site 0124
- Not yet recruiting
Local Institution - 0177
Miami, Florida, 33136
Site 0177
- Recruiting
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, 29572
Neal Shore, Site 0114, 843-449-1010
- Not yet recruiting
Local Institution - 0117
New Haven, Connecticut, 06510
Site 0117
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Sahil Doshi, Site 0096
- Not yet recruiting
Local Institution - 0126
Orlando, Florida, 32803
Site 0126
- Not yet recruiting
Local Institution - 0178
Palo Alto, California, 94305
Site 0178
- Withdrawn
Local Institution - 0158
Salt Lake City, Utah, 84112
- Not yet recruiting
Local Institution - 0095
Seattle, Washington, 98109-1023
Site 0095
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Melissa Reimers, Site 0094, 314-362-5740
- Recruiting
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
Yasser Ged, Site 0134, 410-570-9410
China9 sites, 9 recruiting
- Not yet recruiting
Local Institution - 0143
Beijing, Beijing Municipality, 100142
Site 0143
- Not yet recruiting
Local Institution - 0157
Beijing, Beijing Municipality, 102200
Site 0157
- Not yet recruiting
Local Institution - 0144
Beijing, 100034
Site 0144
- Not yet recruiting
Local Institution - 0183
Changsha Shi, Hunan, 410013
Site 0183
- Not yet recruiting
Local Institution - 0182
Guangzhou, Guangdong, 510555
Site 0182
- Not yet recruiting
Local Institution - 0187
Harbin, Heilongjiang, 150081
Site 0187
- Not yet recruiting
Local Institution - 0184
Nanjing, Jiangsu, 210008
Site 0184
- Not yet recruiting
Local Institution - 0188
Shanghai Shi, Shanghai Municipality, 200032
Site 0188
- Not yet recruiting
Local Institution - 0145
Tianjin, Hebei, 300060
Site 0145
United Kingdom8 sites, 8 recruiting
- Recruiting
Addenbrooke's Hospital
Cambridge, CB2 2QQ
Will Ince, Site 0022
- Recruiting
Velindre Cancer Centre
Cardiff, CF14 2TL
Satish Kumar, Site 0057, 442920615888
- Not yet recruiting
Local Institution - 0061
Edinburgh, EH4 2XU
Site 0061
- Recruiting
Royal Marsden Hospital (Chelsea)
London, Kensington and Chelsea, SW3 6JJ
James Larkin, Site 0063, 442078082132
- Recruiting
St Bartholomew's Hospital
London, London, City of, EC1A 7BE
Thomas Powles, Site 0019, 02078228498
- Recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BX
Tom Waddell, Site 0020, +441619187217
- Not yet recruiting
Local Institution - 0186
Preston, North West, PR29HT
Site 0186
- Recruiting
Royal Marsden Hospital Sutton
Sulton, Surrey, SM25PT
James Larkin, Site 0171, 442078082132
Australia6 sites, 6 recruiting
- Recruiting
Mater Misericordiae Limited
Brisbane, Queensland, 4101
Niara Oliveira, Site 0074, +61731636166
- Not yet recruiting
Local Institution - 0004
Heidelberg, Victoria, 3084
Site 0004
- Not yet recruiting
Local Institution - 0011
Herston, Queensland, 4029
Site 0011
- Recruiting
Cabrini Hospital - Malvern
Malvern, Victoria, 3144
David Pook, Site 0003, 61412191080
- Recruiting
Macquarie University
North Ryde, New South Wales, 2109
Howard Gurney, Site 0076, +61298123526
- Recruiting
GenesisCare St Leonards
St Leonards, New South Wales, 2065
Laurence Krieger, Site 0111, 61294631172
Japan6 sites, 6 recruiting
- Recruiting
Kyushu University Hospital
Fukuoka, 812-8582
Tokiyoshi Tanegashima, Site 0172, 0926425615
- Not yet recruiting
Local Institution - 0180
Kobe, Hyōgo, 650-0017
Site 0180
- Recruiting
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, 135-8550
Yuji Miura, Site 0097, 81335200111
- Not yet recruiting
Local Institution - 0181
Niigata, 951-8520
Site 0181
- Not yet recruiting
Local Institution - 0179
Shiwa-gun Yahaba-cho, Iwate, 028-3695
Site 0179
- Recruiting
Toyama University Hospital
Toyoma, Toyama, 930-0194
Hiroshi Kitamura, Site 0078, 81764347372
Mexico6 sites, 6 recruiting
- Not yet recruiting
Local Institution - 0046
Monterrey, Nuevo León, 64040
Site 0046
- Not yet recruiting
Local Institution - 0048
Oaxaca City, 68020
Site 0048
- Not yet recruiting
Local Institution - 0122
Puebla City, 72424
Site 0122
- Not yet recruiting
Local Institution - 0049
Tlalpan, 14080
Site 0049
- Not yet recruiting
Local Institution - 0108
Tlalpan, 14080
Site 0108
- Not yet recruiting
Local Institution - 0118
Tlalpan, 14080
Site 0118
Canada5 sites, 4 recruiting
- Not yet recruiting
Local Institution - 0007
Calgary, Alberta, T2N 5G2
Site 0007
- Not yet recruiting
Local Institution - 0189
Edmonton, Alberta, T5M 0V9
Site 0189
- Withdrawn
Local Institution - 0109
Montreal, Quebec, H2X 3E4
- Not yet recruiting
Local Institution - 0009
Montreal, Quebec, H3T 1E2
Site 0009
- Not yet recruiting
Local Institution - 0006
Québec, Quebec, G1R 2J6
Site 0006
Germany4 sites, 4 recruiting
- Not yet recruiting
Local Institution - 0026
Hamburg, 20251
Site 0026
- Not yet recruiting
Local Institution - 0014
Herne, 44649
Site 0014
- Not yet recruiting
Local Institution - 0025
Jena, Thuringia, 07747
Site 0025
- Recruiting
Klinikum Rechts der Isar der Technischen Universitaet Muenchen
München, 81675
Margitta Retz, Site 0027, 498941402522
Romania4 sites, 4 recruiting
- Not yet recruiting
Local Institution - 0103
Cluj-Napoca, 400015
Site 0103
- Recruiting
Centrul de Oncologie Sf. Nectarie SRL
Craiova, 200347
Michael Schenker, Site 0161, 40727774974
- Not yet recruiting
Local Institution - 0100
Iași, 700483
Site 0100
- Not yet recruiting
Local Institution - 0101
Sibiu, 550082
Site 0101
Argentina3 sites, 3 recruiting
- Recruiting
Instituto Medico Especializado Alexander Fleming
Buenos Aires, 1426
Juan Pablo Sade, Site 0154, 5432218900
- Not yet recruiting
Local Institution - 0156
Buenos Aires, C1199ABB
Site 0156
- Recruiting
Asociación de Beneficencia Hospital Sirio Libanés
Ciudad Autonoma de Buenos Aires, Buenos Aires, 1419
Hernan Cutuli, Site 0093, 5491157654803
Chile3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 0105
Santiago, Santiago Metropolitan, 7510032
Site 0105
- Recruiting
Bradfordhill
Santiago, Santiago Metropolitan, 8420383
Carlos Rojas, Site 0005, +56998744662
- Recruiting
Pontificia Universidad Catolica de Chile (PUC)
Santiago, 8330023
Carolina Ibanez, Site 0163, 56223547919
Czechia3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 0149
Brno, 656 53
Site 0149
- Not yet recruiting
Local Institution - 0150
Hradec Králové, 500 05
Site 0150
- Not yet recruiting
Local Institution - 0147
Prague, Praha 5, 150 06
Site 0147
Finland3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 0044
Helsinki, Etelä-Suomen Lääni, 00290
Site 0044
- Not yet recruiting
Local Institution - 0029
Turku, 20521
Site 0029
- Not yet recruiting
Local Institution - 0060
Vantaa, 01640
Site 0060
France3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 0080
Boredeaux, 33076
Site 0080
- Not yet recruiting
Local Institution - 0083
Lille, Nord, 59020
Site 0083
- Recruiting
Gustave Roussy
Villejuif, Val-de-Marne, 94800
Laurence Albiges, Site 0028, 33142114211
Italy3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 0073
Milan, 20133
Site 0073
- Not yet recruiting
Local Institution - 0087
Napoli Campania, 80131
Site 0087
- Not yet recruiting
Local Institution - 0139
Verona, Veneto, 37126
Site 0139
South Korea3 sites, 3 recruiting
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [Seoul], 03722
Sang Joon Shin, Site 0167, 82222288138
- Recruiting
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 05505
Jae Lyun Lee, Site 0017, 82230105977
- Recruiting
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 06351
Se Hoon Park, Site 0112
Spain3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 0013
Madrid, 28041
Site 0013
- Not yet recruiting
Local Institution - 0091
Madrid, 28050
Site 0091
- Not yet recruiting
Local Institution - 0043
Seville, 41013
Site 0043
Switzerland3 sites, 3 recruiting
- Recruiting
Kantonsspital Graubünden
Chur, 7000
Richard Cathomas, Site 0054, 41812566646
- Recruiting
HOCH Health Ostschweiz
Sankt Gallen, 9007
Tobias Peres, Site 0055, 0767931903
- Recruiting
UniversitätsSpital Zürich
Zurich, 8091
Anja Lorch, Site 0056, 492118108776
Ireland2 sites, 2 recruiting
- Not yet recruiting
Local Institution - 0059
Dublin, D07 R2WY
Site 0059
- Not yet recruiting
Local Institution - 0062
Dublin, D24 NR0A
Site 0062
Colombia1 site, 1 recruiting
- Not yet recruiting
Local Institution - 0052
Cali, 760032
Site 0052
About this study
Official title: 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)
- Conditions
- Advanced Renal Cell Carcinoma (RCC)
- Being tested
- Pumitamig, Ipilimumab, Cabozantinib, Casdatifan
- Keywords
- Renal Cell Carcinoma, Cabozantinib, Pumitamig, Ipilmumab, Casdatifan
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PumitamigDrug
Also called BMS-986545, BNT327, PM8002
Specified dose on specified days
IpilimumabDrug
Also called Yervoy, BMS-734016
Specified dose on specified days
CabozantinibDrug
Specified dose on specified days
CasdatifanDrug
Also called AB521
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1A: 1A-1 Pumitamig + Ipilimumab | Experimental | Not described Receives: Drug: Pumitamig; Drug: Ipilimumab |
| Part 1A: 1A-2 Pumitamig + Ipilimumab | Experimental | Not described Receives: Drug: Pumitamig; Drug: Ipilimumab |
| Part 1B: 1B-1 Pumitamig + Cabozantinib | Experimental | Not described Receives: Drug: Pumitamig; Drug: Cabozantinib |
| Part 1B: 1B-2 Pumitamig + Cabozantinib | Experimental | Not described Receives: Drug: Pumitamig; Drug: Cabozantinib |
| Part 2A: 2A-1 Pumitamig + Ipilimumab | Experimental | Not described Receives: Drug: Pumitamig; Drug: Ipilimumab |
| Part 2A: 2A-2 Pumitamig + Ipilimumab | Experimental | Not described Receives: Drug: Pumitamig; Drug: Ipilimumab |
| Part 2B: 2B-1 Pumitamig + Cabozantinib | Experimental | Not described Receives: Drug: Pumitamig; Drug: Cabozantinib |
| Part 2B: 2B-2 Pumitamig + Cabozantinib | Experimental | Not described Receives: Drug: Pumitamig; Drug: Cabozantinib |
| Part 2C: 2C-1 Pumitamig | Experimental | Not described Receives: Drug: Pumitamig |
| Part 2D: 2D-1 Pumitamig + Casdatifan | Experimental | Not described Receives: Drug: Pumitamig; Drug: Casdatifan |
| Part 2E: 2E-1 Pumitamig + Ipilimumab + Casdatifan | Experimental | Not described Receives: Drug: Pumitamig; Drug: Ipilimumab; Drug: Casdatifan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)
Phase 1
Measured: 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))
Phase 1
Measured: Up to approximately 2 years from end of treatment
Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Phase 1
Measured: Up to day 21 from first dose
Number of participants with AEs leading to discontinuation
Phase 1
Measured: Up to approximately 2 years from end of treatment
Number of participants with AEs leading to death
Phase 1
Measured: 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
Phase 2
Measured: Up to approximately 2 years from end of treatment
Secondary outcomes (7)
Number of participants with AEs
Phase 2
Measured: Up to approximately 2 years from end of treatment
Number of participants with SAEs (as per CTCAE v5)
Phase 2
Measured: Up to approximately 2 years from end of treatment
Number of participants with treatment-related adverse events (TRAEs)
Phase 2
Measured: Up to approximately 2 years from end of treatment
Number of participants with AEs leading to discontinuation
Phase 2
Measured: Up to approximately 2 years from end of treatment
Number of participants with AEs leading to death
Phase 2
Measured: Up to approximately 2 years from end of treatment
Progression-free survival (PFS) by RECIST v1.1 per investigator assessment
Phase 2
Measured: Up to 4 years from randomization
Duration of response (DOR) (PR or CR) by RECIST v1.1 per investigator assessment
Phase 2
Measured: Up to approximately 2 years from end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start26 Mar 2026
- Primary completion28 Nov 2029 (estimated)
- Study completion26 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Renal Cell Carcinoma (RCC)Studies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 474 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioNTech SE
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293351
- Sponsor's protocol ID
- CA266-0008
- Other IDs
- U1111-1327-6332, 2026-527163-15-00
- Status last verified
- Oct 2026
- First submitted
- 17 Dec 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07293351
- Acronym / sponsor ID
- CA266-0008
- Conditions
- Advanced Renal Cell Carcinoma (RCC)
- Keywords
- Renal Cell Carcinoma, Cabozantinib, Pumitamig, Ipilmumab, Casdatifan
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 474 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- BioNTech SE
- Study start
- 26 Mar 2026 (actual)
- Primary completion
- 28 Nov 2029 (estimated)
- Study completion
- 26 Nov 2031 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Part 1A: 1A-1 Pumitamig + Ipilimumab | Experimental | Drug: Pumitamig, Drug: Ipilimumab |
| Part 1A: 1A-2 Pumitamig + Ipilimumab | Experimental | Drug: Pumitamig, Drug: Ipilimumab |
| Part 1B: 1B-1 Pumitamig + Cabozantinib | Experimental | Drug: Pumitamig, Drug: Cabozantinib |
| Part 1B: 1B-2 Pumitamig + Cabozantinib | Experimental | Drug: Pumitamig, Drug: Cabozantinib |
| Part 2A: 2A-1 Pumitamig + Ipilimumab | Experimental | Drug: Pumitamig, Drug: Ipilimumab |
| Part 2A: 2A-2 Pumitamig + Ipilimumab | Experimental | Drug: Pumitamig, Drug: Ipilimumab |
| Part 2B: 2B-1 Pumitamig + Cabozantinib | Experimental | Drug: Pumitamig, Drug: Cabozantinib |
| Part 2B: 2B-2 Pumitamig + Cabozantinib | Experimental | Drug: Pumitamig, Drug: Cabozantinib |
| Part 2C: 2C-1 Pumitamig | Experimental | Drug: Pumitamig |
| Part 2D: 2D-1 Pumitamig + Casdatifan | Experimental | Drug: Pumitamig, Drug: Casdatifan |
| Part 2E: 2E-1 Pumitamig + Ipilimumab + Casdatifan | Experimental | Drug: Pumitamig, Drug: Ipilimumab, Drug: Casdatifan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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).
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PumitamigAlso: BMS-986545, BNT327, PM8002Specified dose on specified days | Drug | Part 1A: 1A-1 Pumitamig + Ipilimumab, Part 1A: 1A-2 Pumitamig + Ipilimumab, Part 1B: 1B-1 Pumitamig + Cabozantinib, Part 1B: 1B-2 Pumitamig + Cabozantinib, Part 2A: 2A-1 Pumitamig + Ipilimumab, Part 2A: 2A-2 Pumitamig + Ipilimumab, Part 2B: 2B-1 Pumitamig + Cabozantinib, Part 2B: 2B-2 Pumitamig + Cabozantinib, Part 2C: 2C-1 Pumitamig, Part 2D: 2D-1 Pumitamig + Casdatifan, Part 2E: 2E-1 Pumitamig + Ipilimumab + Casdatifan |
| IpilimumabAlso: Yervoy, BMS-734016Specified dose on specified days | Drug | Part 1A: 1A-1 Pumitamig + Ipilimumab, Part 1A: 1A-2 Pumitamig + Ipilimumab, Part 2A: 2A-1 Pumitamig + Ipilimumab, Part 2A: 2A-2 Pumitamig + Ipilimumab, Part 2E: 2E-1 Pumitamig + Ipilimumab + Casdatifan |
| CabozantinibSpecified dose on specified days | Drug | Part 1B: 1B-1 Pumitamig + Cabozantinib, Part 1B: 1B-2 Pumitamig + Cabozantinib, Part 2B: 2B-1 Pumitamig + Cabozantinib, Part 2B: 2B-2 Pumitamig + Cabozantinib |
| CasdatifanAlso: AB521Specified dose on specified days | Drug | Part 2D: 2D-1 Pumitamig + Casdatifan, Part 2E: 2E-1 Pumitamig + Ipilimumab + Casdatifan |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: Up to approximately 2 years from end of treatment
Phase 1
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
Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Time frame: Up to day 21 from first dose
Phase 1
Number of participants with AEs leading to discontinuation
Time frame: Up to approximately 2 years from end of treatment
Phase 1
Number of participants with AEs leading to death
Time frame: Up to approximately 2 years from end of treatment
Phase 1
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
7 secondary outcomes
Number of participants with AEs
Time frame: 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
Number of participants with treatment-related adverse events (TRAEs)
Time frame: 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
Number of participants with AEs leading to death
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
95 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pumitamig, Ipilimumab and Cabozantinib in people with Advanced Renal Cell Carcinoma (RCC), run by Bristol-Myers Squibb at 95 sites in 20 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 95 sites in United States, China, United Kingdom, Australia, Japan and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (AEs) (time frame: Up to approximately 2 years from end of treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.