A Study to Compare Bempegaldesleukin (BEMPEG: NKTR-214) Combined With Nivolumab and Tyrosine Kinase Inhibitor (TKI) to Nivolumab and TKI Alone in Participants With Previously Untreated Kidney Cancer That is Advanced or Has Spread

Phase 1

Completed

• Conditions: Renal Cell Carcinoma
• Interventions: Biological: Nivolumab; Drug: Cabozantinib; Drug: Axitinib

• Registration Number: NCT04540705
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-03
• Study First Submitted QC: 2020-09-03
• Study First Posted: 2020-09-07
• Study Start: 2020-09-11
• Primary Completion: 2024-01-18
• Study Completion: 2024-01-18
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 1B (Part 1): Nivolumab + Cabozantinib	Nivolumab	-
Part 1A (Part 1): Nivolumab + Axitinib	Nivolumab	-
Part 1B (Part 1): Nivolumab + Cabozantinib	Cabozantinib	-
Part 1A (Part 1): Nivolumab + Axitinib	Axitinib	-

Primary Outcome Measures

Name	Time	Method
Incidence of serious adverse events (SAEs) (Part 1)	Up to 2.5 years
Incidence of dose-limiting toxicities (DLTs) (Part 1)	Up to 2.5 years
Incidence of immune-mediated adverse events (imAEs) (Part 1)	Up to 5 years
Incidence of changes in clinical laboratory results by severity: Urinalysis tests (Part 1)	Up to 2.5 years
Incidence of changes in clinical laboratory results by severity: Hematology tests (Part 1)	Up to 2.5 years
Incidence of AEs leading to discontinuation (Part 1)	Up to 5 years
Incidence of adverse events (AEs) by severity (Part 1)	Up to 2.5 years
Incidence of changes in clinical laboratory results by severity: Clinical Chemistry tests (Part 1)	Up to 2.5 years

Trial Locations

Locations (37)

Local Institution - 0044; 🇩🇪 Munich, Germany

Local Institution - 0001; 🇺🇸 Saint Louis, Missouri, United States

Local Institution - 0040; 🇩🇪 Jena, Germany

Local Institution - 0042; 🇩🇪 Essen, Germany

Local Institution - 0046; 🇩🇪 Würzburg, Germany

Local Institution - 0079; 🇫🇷 Marseille, France

Local Institution - 0035; 🇧🇷 Curitiba, Parana, Brazil

Local Institution - 0029; 🇧🇷 Sao Jose do Rio Preto, SAO Paulo, Brazil

Local Institution - 0041; 🇩🇪 Nürnberg, Germany

Local Institution - 0032; 🇧🇷 Barretos, SAO Paulo, Brazil

Local Institution - 0045; 🇩🇪 Hannover, Germany

Local Institution - 0050; 🇲🇽 Zapopan, Jalisco, Mexico

Local Institution - 0007; 🇺🇸 Seattle, Washington, United States

Local Institution - 0008; 🇨🇦 Toronto, Ontario, Canada

Local Institution - 0009; 🇺🇸 New York, New York, United States

Local Institution - 0014; 🇺🇸 Houston, Texas, United States

Local Institution - 0036; 🇧🇷 Santa Cruz do Sul, RIO Grande DO SUL, Brazil

Local Institution - 0028; 🇧🇷 Porto Alegre, RIO Grande DO SUL, Brazil

Local Institution - 0030; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil

Local Institution; 🇺🇸 Nashville, Tennessee, United States

Local Institution - 0052; 🇷🇺 Moscow, Russian Federation

Local Institution - 0022; 🇨🇦 St. Johns, Newfoundland and Labrador, Canada

Local Institution - 0055; 🇲🇽 Queretaro, Mexico

Local Institution - 0049; 🇲🇽 Monterrey, Nuevo LEON, Mexico

Local Institution - 0051; 🇷🇺 Novosibirsk, Russian Federation

Local Institution - 0085; 🇷🇺 Omsk, Russian Federation

Local Institution - 0005; 🇺🇸 Springdale, Arkansas, United States

Local Institution - 0075; 🇦🇷 Río Cuarto, Córdoba, Argentina

Local Institution - 0026; 🇦🇷 Buenos Aires, Argentina

Local Institution - 0087; 🇷🇺 Moscow, Russian Federation

Local Institution - 0025; 🇦🇷 Mar del Plata, Buenos Aires, Argentina

Local Institution - 0024; 🇦🇷 San Juan, Argentina

Local Institution - 0015; 🇨🇦 Vancouver, British Columbia, Canada

Local Institution - 0059; 🇷🇺 Moscow, Russian Federation

Local Institution - 0048; 🇲🇽 Mexico City, Distrito Federal, Mexico

Local Institution - 0058; 🇷🇺 Saint Petersburg, Russian Federation

Local Institution - 0056; 🇨🇦 Edmonton, Alberta, Canada