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Clinical Trials in the UK / NCT07293351
Recruiting Phase 1/Phase 2

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)

NCT07293351 · tracked via the Priya Life Science UK tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 1/Phase 2
Started
2026-03-26
Last updated
2026-09-14

Condition(s) studied

Advanced Renal Cell Carcinoma (RCC)

Investigational drug(s) / intervention(s)

PumitamigIpilimumabCabozantinibCasdatifan

Pumitamig: Specified dose on specified days

Ipilimumab: Specified dose on specified days

Cabozantinib: Specified dose on specified days

Casdatifan: Specified dose on specified days

Study 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)

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (96)

FacilityCityRegionStatus
Local Institution - 0178 Palo Alto California Not Yet Recruiting
Local Institution - 0117 New Haven Connecticut Not Yet Recruiting
Sibley Memorial Hospital Washington D.C. District of Columbia Recruiting
Local Institution - 0177 Miami Florida Not Yet Recruiting
Local Institution - 0126 Orlando Florida Not Yet Recruiting
Local Institution - 0175 Atlanta Georgia Not Yet Recruiting
Local Institution - 0170 Fort Wayne Indiana Not Yet Recruiting
University Of Iowa Hospitals And Clinics Iowa City Iowa Recruiting
Johns Hopkins Hospital Baltimore Maryland Recruiting
Local Institution - 0176 Big Rapids Michigan Not Yet Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Local Institution - 0135 Cincinnati Ohio Not Yet Recruiting
Cleveland Clinic Cleveland Ohio Recruiting
MUSC Hollings Cancer Center Charleston South Carolina Recruiting
Carolina Urologic Research Center, LLC Myrtle Beach South Carolina Recruiting
Local Institution - 0158 Salt Lake City Utah Withdrawn
Local Institution - 0095 Seattle Washington Not Yet Recruiting
Asociación de Beneficencia Hospital Sirio Libanés Ciudad Autonoma de Buenos Aires Buenos Aires Recruiting
Instituto Medico Especializado Alexander Fleming Buenos Aires Argentina Recruiting
Local Institution - 0156 Buenos Aires Argentina Not Yet Recruiting
Macquarie University North Ryde New South Wales Recruiting
GenesisCare St Leonards St Leonards New South Wales Recruiting
Mater Misericordiae Limited Brisbane Queensland Recruiting
Local Institution - 0011 Herston Queensland Not Yet Recruiting
Local Institution - 0004 Heidelberg Victoria Not Yet Recruiting
Local Institution - 0003 Malvern Australia Not Yet Recruiting
Local Institution - 0007 Calgary Alberta Not Yet Recruiting
Local Institution - 0189 Edmonton Alberta Not Yet Recruiting
Local Institution - 0109 Montreal Quebec Withdrawn
Local Institution - 0009 Montreal Quebec Not Yet Recruiting
Local Institution - 0006 Québec Quebec Not Yet Recruiting
Local Institution - 0105 Santiago Santiago Metropolitan Not Yet Recruiting
Bradfordhill Santiago Santiago Metropolitan Recruiting
Local Institution - 0163 Santiago Chile Not Yet Recruiting
Local Institution - 0143 Beijing Beijing Municipality Not Yet Recruiting
Local Institution - 0157 Beijing Beijing Municipality Not Yet Recruiting
Local Institution - 0182 Guangzhou Guangdong Not Yet Recruiting
Local Institution - 0145 Tianjin Hebei Not Yet Recruiting
Local Institution - 0187 Harbin Heilongjiang Not Yet Recruiting

+ 56 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07293351 on ClinicalTrials.gov ↗ ← All trials in the UK