Advanced Renal Cell Carcinoma (RCC)
Conditions
Keywords
Renal Cell Carcinoma, Cabozantinib, Pumitamig, Ipilmumab, Nivolumab
Brief summary
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)
Interventions
DRUGPumitamig
Specified dose on specified days
DRUGIpilimumab
Specified dose on specified days
DRUGCabozantinib
Specified dose on specified days
DRUGNivolumab
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
BioNTech SE
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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. \- 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to approximately 2 years from end of treatment | Phase 1 |
| Number of participants with serious adverse events (SAEs) (as per Common Terminology Criteria for Adverse Events v5 (CTCAE v5)) | Up to approximately 2 years from end of treatment | Phase 1 |
| Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria | Up to day 21 from first dose | Phase 1 |
| Number of participants with AEs leading to discontinuation | Up to approximately 2 years from end of treatment | Phase 1 |
| Number of participants with AEs leading to death | Up to approximately 2 years from end of treatment | Phase 1 |
| Objective response rate (ORR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment | Up to approximately 2 years from end of treatment | Phase 2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with AEs | Up to approximately 2 years from end of treatment | Phase 2 |
| Number of participants with SAEs (as per CTCAE v5) | Up to approximately 2 years from end of treatment | Phase 2 |
| Number of participants with treatment-related adverse events (TRAEs) | Up to approximately 2 years from end of treatment | Phase 2 |
| Number of participants with AEs leading to discontinuation | Up to approximately 2 years from end of treatment | Phase 2 |
| Number of participants with AEs leading to death | Up to approximately 2 years from end of treatment | Phase 2 |
| Progression-free survival (PFS) by RECIST v1.1 per investigator assessment | Up to 4 years from randomization | Phase 2 |
| Duration of response (DOR) (PR or CR) by RECIST v1.1 per investigator assessment | Up to approximately 2 years from end of treatment | Phase 2 |
Countries
Argentina, Australia, Brazil, Canada, Chile, Colombia, Czechia, Finland, France, Germany, Ireland, Italy, Japan, Mexico, Romania, South Korea, Spain, Switzerland, United Kingdom, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed