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

NCT04540705 | Completed Phase 1 DMC FDA Drug

• 3 other identifiers: CA045-0112018-003200-3918-214-15
• Study Type: interventional
• Target: 30
• Locations: 8 countries
• Sites: 39

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.

Conditions

Renal Cell Carcinoma

Keywords

NKTR-214; nivolumab; bempeg

Outcome Measures

Primary Outcomes (8)

• Incidence of adverse events (AEs) by severity (Part 1)

  Up to 2.5 years

• 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 AEs leading to discontinuation (Part 1)

  Up to 5 years

• Incidence of immune-mediated adverse events (imAEs) (Part 1)

  Up to 5 years

• Incidence of changes in clinical laboratory results by severity: Hematology tests (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

• Incidence of changes in clinical laboratory results by severity: Urinalysis tests (Part 1)

  Up to 2.5 years

Study Arms (2)

Part 1A (Part 1): Nivolumab + Axitinib

EXPERIMENTAL

Biological: Nivolumab; Drug: Axitinib

Part 1B (Part 1): Nivolumab + Cabozantinib

EXPERIMENTAL

Biological: Nivolumab; Drug: Cabozantinib

Interventions

Nivolumab BIOLOGICAL

Specified dose on specified days

Also known as: OPDIVO

Part 1A (Part 1): Nivolumab + Axitinib; Part 1B (Part 1): Nivolumab + Cabozantinib

Axitinib DRUG

Specified dose on specified days

Also known as: INLYTA

Part 1A (Part 1): Nivolumab + Axitinib

Cabozantinib DRUG

Specified dose on specified days

Also known as: Cabometyx

Part 1B (Part 1): Nivolumab + Cabozantinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Nektar Therapeutics: collaborator

Study Sites (39)

Local Institution - 0005

Springdale, Arkansas, 72762, United States

Location

Local Institution

Louisville, Kentucky, 40202, United States

Location

Local Institution - 0001

St Louis, Missouri, 63110, United States

Location

Local Institution - 0009

New York, New York, 10065, United States

Location

Local Institution

Portland, Oregon, 97213, United States

Location

Local Institution

Nashville, Tennessee, 37232, United States

Location

Local Institution - 0014

Houston, Texas, 77030-3721, United States

Location

Local Institution - 0007

Seattle, Washington, 98109, United States

Location

Local Institution - 0025

Mar del Plata, Buenos Aires, 7600, Argentina

Location

Local Institution - 0075

Río Cuarto, Córdoba Province, X5800ALB, Argentina

Location

Local Institution - 0026

Buenos Aires, 1419, Argentina

Location

Local Institution - 0024

San Juan, 5400, Argentina

Location

Local Institution - 0030

Belo Horizonte, Minas Gerais, 30130-090, Brazil

Location

Local Institution - 0035

Curitiba, Paraná, 80730-150, Brazil

Location

Local Institution - 0028

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Local Institution - 0036

Santa Cruz do Sul, Rio Grande do Sul, 96830-180, Brazil

Location

Local Institution - 0032

Barretos, São Paulo, 14784400, Brazil

Location

Local Institution - 0029

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Local Institution - 0056

Edmonton, Alberta, T6G 1Z2, Canada

Location

Local Institution - 0015

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Local Institution - 0022

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Local Institution - 0008

Toronto, Ontario, M5G 1Z5, Canada

Location

Local Institution - 0079

Marseille, 13273, France

Location

Local Institution - 0042

Essen, 45147, Germany

Location

Local Institution - 0045

Hanover, 30625, Germany

Location

Local Institution - 0040

Jena, 07747, Germany

Location

Local Institution - 0044

Munich, 81675, Germany

Location

Local Institution - 0041

Nuremberg, 90419, Germany

Location

Local Institution - 0046

Würzburg, 97080, Germany

Location

Local Institution - 0050

Zapopan, Jalisco, 45070, Mexico

Location

Local Institution - 0048

Mexico City, Mexico City, 14080, Mexico

Location

Local Institution - 0049

Monterrey, Nuevo León, 66460, Mexico

Location

Local Institution - 0055

Querétaro, 76000, Mexico

Location

Local Institution - 0059

Moscow, 115478, Russia

Location

Local Institution - 0052

Moscow, 121205, Russia

Location

Local Institution - 0087

Moscow, 121359, Russia

Location

Local Institution - 0051

Novosibirsk, 630099, Russia

Location

Local Institution - 0085

Omsk, 644013, Russia

Location

Local Institution - 0058

Saint Petersburg, 197758, Russia

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Nivolumab; Axitinib; cabozantinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 7, 2020
• Study Start: September 11, 2020
• Primary Completion: January 18, 2024
• Study Completion: January 18, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

CA (4); AR (4); BR (6); US (8); FR (1); DE (6); ME (4); RU (6)