A Phase 1 Study to Compare Bempegaldesleukin Combined With Nivolumab and Tyrosine Kinase Inhibitor (TKI) to Nivolumab and TKI Alone in Participants With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (mRCC) (PIVOT IO 011)
Overview
- Phase
- Phase 1
- Intervention
- Nivolumab
- Conditions
- Renal Cell Carcinoma
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 30
- Locations
- 37
- Primary Endpoint
- Incidence of changes in clinical laboratory results by severity: Hematology tests (Part 1)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is in Part 1, to determine the safety of nivolumab, bempegaldesleukin (BEMPEG: NKTR-214), and Tyrosine Kinase Inhibitor (TKI) combination.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histological confirmation of renal cell carcinoma (RCC) with clear cell component including participants who may also have sarcomatoid features
- •Advanced (not amenable to curative surgery or radiation therapy) or metastatic (American Joint Committee on Cancer (AJCC) Stage 4) RCC
- •No prior systemic therapy, including prior PD-L1 therapy, for RCC is allowed with the following exception:
- •i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC is allowed. Therapy must have included an agent that targets vascular endothelial growth factor (VEGF) pathway or VEGF receptors and recurrence must have occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy
- •Life Expectancy ≥ 12 weeks
- •Karnofsky Performance Status (KPS) of at least 70%
- •Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 criteria
- •Males and females must agree to follow specific methods of contraception, if applicable
Exclusion Criteria
- •Active CNS brain metastases or leptomeningeal metastases
- •Active, known or suspected autoimmune disease
- •Inadequately treated adrenal insufficiency
- •History of pulmonary embolism (PE), deep vein thrombosis (DVT), or prior clinically significant venous or non-CVA/TIA arterial thromboembolic event (eg, internal jugular vein thrombosis) within 3 months prior to treatment assignment (Part 1) and randomization (Part 2)
- •Other protocol-defined inclusion/exclusion criteria apply
Arms & Interventions
Part 1A (Part 1): Nivolumab + Axitinib
Intervention: Nivolumab
Part 1A (Part 1): Nivolumab + Axitinib
Intervention: Axitinib
Part 1B (Part 1): Nivolumab + Cabozantinib
Intervention: Nivolumab
Part 1B (Part 1): Nivolumab + Cabozantinib
Intervention: Cabozantinib
Outcomes
Primary Outcomes
Incidence of changes in clinical laboratory results by severity: Hematology tests (Part 1)
Time Frame: Up to 2.5 years
Incidence of serious adverse events (SAEs) (Part 1)
Time Frame: Up to 2.5 years
Incidence of AEs leading to discontinuation (Part 1)
Time Frame: Up to 5 years
Incidence of adverse events (AEs) by severity (Part 1)
Time Frame: Up to 2.5 years
Incidence of changes in clinical laboratory results by severity: Clinical Chemistry tests (Part 1)
Time Frame: Up to 2.5 years
Incidence of dose-limiting toxicities (DLTs) (Part 1)
Time Frame: Up to 2.5 years
Incidence of immune-mediated adverse events (imAEs) (Part 1)
Time Frame: Up to 5 years
Incidence of changes in clinical laboratory results by severity: Urinalysis tests (Part 1)
Time Frame: Up to 2.5 years