NCT07293351Recruiting
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)
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)
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.
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 1 · Phase 2
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Italy, United States, Argentina, Australia, Canada, Chile, China, Colombia, Czechia, Finland, Ireland, Japan, Mexico, Romania, South Korea, Spain, United Kingdom
- Sponsor
- Bristol-Myers Squibb(Industry)
- Protocol no.
- CA266-0008
- Conditions
- Advanced Renal Cell Carcinoma (RCC)
- Interventions
- Drug
Treatments studied
- Pumitamig
- Ipilimumab
- Cabozantinib
- Casdatifan
Collaborators
BioNTech SE
Locations · 34
- Chur, SwitzerlandKantonsspital GraubündenRecruiting at this site
- Sankt Gallen, SwitzerlandHOCH Health OstschweizRecruiting at this site
- Zurich, SwitzerlandUniversitätsSpital ZürichRecruiting at this site
- Villejuif, FranceGustave RoussyRecruiting at this site
- München, GermanyKlinikum Rechts der Isar der Technischen Universitaet MuenchenRecruiting at this site
- Washington D.C., United StatesSibley Memorial HospitalRecruiting at this site
- Iowa City, United StatesUniversity Of Iowa Hospitals And ClinicsRecruiting at this site
- Baltimore, United StatesJohns Hopkins HospitalRecruiting at this site
- St Louis, United StatesWashington University School of MedicineRecruiting at this site
- New York, United StatesMemorial Sloan Kettering Cancer CenterRecruiting at this site
- Cleveland, United StatesCleveland ClinicRecruiting at this site
- Charleston, United StatesMUSC Hollings Cancer CenterRecruiting at this site
- Myrtle Beach, United StatesCarolina Urologic Research Center, LLCRecruiting at this site
- Ciudad Autonoma de Buenos Aires, ArgentinaAsociación de Beneficencia Hospital Sirio LibanésRecruiting at this site
- Buenos Aires, ArgentinaInstituto Medico Especializado Alexander FlemingRecruiting at this site
- North Ryde, AustraliaMacquarie UniversityRecruiting at this site
- St Leonards, AustraliaGenesisCare St LeonardsRecruiting at this site
- Brisbane, AustraliaMater Misericordiae LimitedRecruiting at this site
- Malvern, AustraliaCabrini Hospital - MalvernRecruiting at this site
- Santiago, ChileBradfordhillRecruiting at this site
- Santiago, ChilePontificia Universidad Catolica de Chile (PUC)Recruiting at this site
- Koto-ku, JapanThe Cancer Institute Hospital of JFCRRecruiting at this site
- Toyoma, JapanToyama University HospitalRecruiting at this site
- Fukuoka, JapanKyushu University HospitalRecruiting at this site
- Craiova, RomaniaCentrul de Oncologie Sf. Nectarie SRLRecruiting at this site
- Seoul, South KoreaSeverance Hospital, Yonsei University Health SystemRecruiting at this site
- Seoul, South KoreaAsan Medical CenterRecruiting at this site
- Seoul, South KoreaSamsung Medical CenterRecruiting at this site
- London, United KingdomRoyal Marsden Hospital (Chelsea)Recruiting at this site
- London, United KingdomSt Bartholomew's HospitalRecruiting at this site
In total, worldwide, 34 of the 95 sites listed in the registry are recruiting; the other 61 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: October 23, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 4 more locations
Other identifiers
- U1111-1327-6332 · other identifier
- 2026-527163-15-00 · other identifier
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.