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Looking for participantsPhase1/Phase2

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)

Sponsor: Bristol-Myers Squibb

NCT ID: NCT07293351

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Pumitamig (drug), Ipilimumab (drug), Cabozantinib (drug), Casdatifan (drug)
How long the study runs
Study runs about 68 months (dates as stated)
About the drug or intervention
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
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
474
Started
2026-03-26
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for advanced renal cell carcinoma (rcc)
  • • Phase1/Phase2 - 474 participants
  • • 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)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with advanced renal cell carcinoma (rcc)

Where?

  • • London - Royal Marsden Hospital (Chelsea)
  • • London - St Bartholomew's Hospital
  • • Preston - Local Institution - 0186
  • • Cambridge - Local Institution - 0022
  • • +4 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

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)

Advanced Renal Cell Carcinoma (RCC)

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ clear cell RCC (ccRCC) or non-clear cell RCC (nccRCC) may be enrolled in Part 1
  • ✓ cabozantinib
  • ✓ a HIF-2α inhibit
  • ✓ measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1

What the study is looking for

  • ✓Inclusion Criteria
  • ✓Participants must have a confirmed by a biopsy diagnosis of that has grown locally, unresectable (not amenable to...
  • ✓Participants must have clear cell RCC (ccRCC) or non-clear cell RCC (nccRCC) may be enrolled in Part 1. Note: Part 2...
  • ✓Participants may have favorable, intermediate or poor risk disease categories.
  • ✓Participants must not have received prior treatment that goes through your whole body for that has spread RCC, with the following exceptions:
See the full criteria
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.

Where Is This Study? (8 UK sites)

Royal Marsden Hospital (Chelsea)

London SW3 6JJ, United Kingdom

Recruiting
Site contact (verified)
James Larkin, Site 0063442078082132

St Bartholomew's Hospital

London EC1A 7BE, United Kingdom

Recruiting
Site contact (verified)
Thomas Powles, Site 001902078228498

Local Institution - 0186

Preston PR29HT, United Kingdom

NOT_YET_RECRUITING

Local Institution - 0022

Cambridge CB2 2QQ, United Kingdom

NOT_YET_RECRUITING

Velindre Cancer Centre

Cardiff CF14 2TL, United Kingdom

Recruiting
Site contact (verified)
Satish Kumar, Site 0057442920615888

Local Institution - 0061

Edinburgh EH4 2XU, United Kingdom

NOT_YET_RECRUITING

The Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

Recruiting
Site contact (verified)
Tom Waddell, Site 0020+441619187217

Royal Marsden Hospital Sutton

Sulton, Surrey SM25PT, United Kingdom

Recruiting
Site contact (verified)
James Larkin, Site 0171442078082132

How to Get in Touch

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Sponsor contact

CONTACT

855-907-3286 Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-09