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Recruiting Phase 1/2 NCT07293351

A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Ipilimumab or Cabozantinib in Participants With Advanced Renal Cell Carcinoma (RCC) (ROSETTA RCC-208)

Phase 1/2 – combined early trial
Conditions: Advanced Renal Cell Carcinoma (RCC)

Sponsor: Bristol-Myers Squibb

trial.available_in: БГ
Overview
The purpose of this study is to evaluate the safety, tolerability, and efficacy of Pumitamig alone or in combination with Ipilimumab or Cabozantinib in participants with advanced Renal Cell Carcinoma (RCC)
Who can participate
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. \- 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, or congenital long QT syndrome. * Participants must not have a urine protein ≥ 2+ and 24 hour urine protein ≥ 1 g at baseline. * 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. * Other protocol-defined Inclusion/Exclusion criteria apply.
Locations 20
Argentina (1)
Local Institution - 0154
Buenos Aires
NOT_YET_RECRUITING
Australia (1)
Local Institution - 0076
North Ryde , New South Wales
NOT_YET_RECRUITING
Brazil (1)
Local Institution - 0093
Brasília , Federal District
NOT_YET_RECRUITING
Canada (1)
Local Institution - 0007
Calgary , Alberta
NOT_YET_RECRUITING
Chile (1)
Local Institution - 0105
Santiago , Santiago Metropolitan
NOT_YET_RECRUITING
Colombia (1)
Local Institution - 0052
Cali
NOT_YET_RECRUITING
Czech Republic (1)
Local Institution - 0147
Prague , Praha 5
NOT_YET_RECRUITING
Finland (1)
Local Institution - 0044
Helsinki , Etelä-Suomen Lääni
NOT_YET_RECRUITING
France (1)
Local Institution - 0083
Lille , Nord
NOT_YET_RECRUITING
Germany (1)
Local Institution - 0025
Jena , Thuringia
NOT_YET_RECRUITING
Ireland (1)
Local Institution - 0059
Dublin
NOT_YET_RECRUITING
Italy (1)
Local Institution - 0139
Verona , Veneto
NOT_YET_RECRUITING
Japan (1)
Local Institution - 0097
Koto-ku , Tokyo
NOT_YET_RECRUITING
Mexico (1)
Local Institution - 0046
Monterrey , Nuevo León
NOT_YET_RECRUITING
Romania (1)
Local Institution - 0103
Cluj-Napoca
NOT_YET_RECRUITING
South Korea (1)
Local Institution - 0112
Seoul , Seoul-teukbyeolsi [Seoul]
NOT_YET_RECRUITING
Spain (1)
Local Institution - 0013
Madrid
NOT_YET_RECRUITING
Switzerland (1)
Local Institution - 0054
Chur
NOT_YET_RECRUITING
United Kingdom (1)
Royal Marsden Hospital (Chelsea)
London , Kensington and Chelsea
James Larkin, Site 0063
United States (1)
Local Institution - 0117
New Haven , Connecticut
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
30.04.2026
Completion date
26.11.2031
Registry ID
NCT07293351
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.