Pumitamig
DrugSpecified dose on specified days
Other names: BMS-986545, BNT327, PM8002
NCT Number: NCT07293351
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)
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Instituto Medico Especializado Alexander Fleming, Buenos Aires, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Exclusion criteria
Specified dose on specified days
Other names: BMS-986545, BNT327, PM8002
Specified dose on specified days
Other names: Yervoy, BMS-734016
Specified dose on specified days
Time frame: Up to approximately 2 years from end of treatment
Phase 1
Time frame: Up to approximately 2 years from end of treatment
Phase 1
Time frame: Up to day 21 from first dose
Phase 1
Time frame: Up to approximately 2 years from end of treatment
Phase 1
Time frame: Up to approximately 2 years from end of treatment
Phase 1
Time frame: Up to approximately 2 years from end of treatment
Phase 2
Time frame: Up to approximately 2 years from end of treatment
Phase 2
Time frame: Up to approximately 2 years from end of treatment
Phase 2
Time frame: Up to approximately 2 years from end of treatment
Phase 2
Time frame: Up to approximately 2 years from end of treatment
Phase 2
Time frame: Up to approximately 2 years from end of treatment
Phase 2
Time frame: Up to 4 years from randomization
Phase 2
Time frame: Up to approximately 2 years from end of treatment
Phase 2
Contact information is provided by the study sponsor or research team.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
First line of the email MUST contain NCT # and Site #.
CONTACT
Bristol-Myers Squibb
Industry
ROSETTA RCC-208: A Phase 1/2 Open-label, Multi-center, Randomized Study of Pumitamig Alone or in Combination With Ipilimumab or Cabozantinib in Participants With Advanced Renal Cell Carcinoma (RCC)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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