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

Renal Cell Carcinoma Clinical Trial

— PIVOT IO 011  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04540705
• Other study ID #: CA045-011
• Secondary ID: 2018-003200-3918
• Status: Completed
• Phase: Phase 1
• Start date: September 11, 2020
• Est. completion date: January 18, 2024

Study information

• Verified date: February 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 18, 2024
• Est. primary completion date: January 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Biological:
• Nivolumab
Specified dose on specified days

Drug:
• Axitinib
Specified dose on specified days
• Cabozantinib
Specified dose on specified days

Locations

Country	Name	City	State
Argentina	Local Institution - 0026	Buenos Aires
Argentina	Local Institution - 0025	Mar del Plata	Buenos Aires
Argentina	Local Institution - 0075	Río Cuarto	Córdoba
Argentina	Local Institution - 0024	San Juan
Brazil	Local Institution - 0032	Barretos	SAO Paulo
Brazil	Local Institution - 0030	Belo Horizonte	Minas Gerais
Brazil	Local Institution - 0035	Curitiba	Parana
Brazil	Local Institution - 0028	Porto Alegre	RIO Grande DO SUL
Brazil	Local Institution - 0036	Santa Cruz do Sul	RIO Grande DO SUL
Brazil	Local Institution - 0029	Sao Jose do Rio Preto	SAO Paulo
Canada	Local Institution - 0056	Edmonton	Alberta
Canada	Local Institution - 0022	St. Johns	Newfoundland and Labrador
Canada	Local Institution - 0008	Toronto	Ontario
Canada	Local Institution - 0015	Vancouver	British Columbia
France	Local Institution - 0079	Marseille
Germany	Local Institution - 0042	Essen
Germany	Local Institution - 0045	Hannover
Germany	Local Institution - 0040	Jena
Germany	Local Institution - 0044	Munich
Germany	Local Institution - 0041	Nürnberg
Germany	Local Institution - 0046	Würzburg
Mexico	Local Institution - 0048	Mexico City	Distrito Federal
Mexico	Local Institution - 0049	Monterrey	Nuevo LEON
Mexico	Local Institution - 0055	Queretaro
Mexico	Local Institution - 0050	Zapopan	Jalisco
Russian Federation	Local Institution - 0052	Moscow
Russian Federation	Local Institution - 0059	Moscow
Russian Federation	Local Institution - 0087	Moscow
Russian Federation	Local Institution - 0051	Novosibirsk
Russian Federation	Local Institution - 0085	Omsk
Russian Federation	Local Institution - 0058	Saint Petersburg
United States	Local Institution - 0014	Houston	Texas
United States	Local Institution	Louisville	Kentucky
United States	Local Institution	Nashville	Tennessee
United States	Local Institution - 0009	New York	New York
United States	Local Institution	Portland	Oregon
United States	Local Institution - 0001	Saint Louis	Missouri
United States	Local Institution - 0007	Seattle	Washington
United States	Local Institution - 0005	Springdale	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Nektar Therapeutics

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  France,  Germany,  Mexico,  Russian Federation, 

Outcome

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

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting