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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 (PIVOT IO 011)

Primary Purpose

Renal Cell Carcinoma

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Nivolumab
Axitinib
Cabozantinib
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring NKTR-214, nivolumab, bempeg

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Local Institution - 0005
  • Local Institution
  • Local Institution - 0001
  • Local Institution - 0009
  • Local Institution
  • Local Institution
  • Local Institution - 0014
  • Local Institution - 0007
  • Local Institution - 0025
  • Local Institution - 0075
  • Local Institution - 0026
  • Local Institution - 0024
  • Local Institution - 0030
  • Local Institution - 0035
  • Local Institution - 0028
  • Local Institution - 0036
  • Local Institution - 0032
  • Local Institution
  • Local Institution - 0015
  • Local Institution - 0008
  • Local Institution - 0079
  • Local Institution - 0045
  • Local Institution - 0040
  • Local Institution - 0041
  • Local Institution - 0046
  • Local Institution - 0048
  • Local Institution - 0050
  • Local Institution - 0049
  • Local Institution - 0055
  • Local Institution - 0059
  • Local Institution - 0052
  • Local Institution - 0087
  • Local Institution - 0051
  • Local Institution - 0085
  • Local Institution - 0058

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Part 1A (Part 1): Nivolumab + Axitinib

Part 1B (Part 1): Nivolumab + Cabozantinib

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 3, 2020
Last Updated
July 24, 2023
Sponsor
Bristol-Myers Squibb
Collaborators
Nektar Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT04540705
Brief Title
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
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 11, 2020 (Actual)
Primary Completion Date
February 5, 2024 (Anticipated)
Study Completion Date
February 5, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Nektar Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
NKTR-214, nivolumab, bempeg

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1A (Part 1): Nivolumab + Axitinib
Arm Type
Experimental
Arm Title
Part 1B (Part 1): Nivolumab + Cabozantinib
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
OPDIVO
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Axitinib
Other Intervention Name(s)
INLYTA
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Cabozantinib
Other Intervention Name(s)
Cabometyx
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Incidence of adverse events (AEs) by severity (Part 1)
Time Frame
Up to 2.5 years
Title
Incidence of serious adverse events (SAEs) (Part 1)
Time Frame
Up to 2.5 years
Title
Incidence of dose-limiting toxicities (DLTs) (Part 1)
Time Frame
Up to 2.5 years
Title
Incidence of AEs leading to discontinuation (Part 1)
Time Frame
Up to 5 years
Title
Incidence of immune-mediated adverse events (imAEs) (Part 1)
Time Frame
Up to 5 years
Title
Incidence of changes in clinical laboratory results by severity: Hematology tests (Part 1)
Time Frame
Up to 2.5 years
Title
Incidence of changes in clinical laboratory results by severity: Clinical Chemistry tests (Part 1)
Time Frame
Up to 2.5 years
Title
Incidence of changes in clinical laboratory results by severity: Urinalysis tests (Part 1)
Time Frame
Up to 2.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0005
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
Facility Name
Local Institution
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Local Institution - 0001
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Local Institution - 0009
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Local Institution
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Local Institution
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Local Institution - 0014
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-3721
Country
United States
Facility Name
Local Institution - 0007
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Local Institution - 0025
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
7600
Country
Argentina
Facility Name
Local Institution - 0075
City
Río Cuarto
State/Province
Córdoba
ZIP/Postal Code
X5800ALB
Country
Argentina
Facility Name
Local Institution - 0026
City
Buenos Aires
ZIP/Postal Code
1419
Country
Argentina
Facility Name
Local Institution - 0024
City
San Juan
ZIP/Postal Code
5400
Country
Argentina
Facility Name
Local Institution - 0030
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-090
Country
Brazil
Facility Name
Local Institution - 0035
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80730-150
Country
Brazil
Facility Name
Local Institution - 0028
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Local Institution - 0036
City
Santa Cruz do Sul
State/Province
RIO Grande DO SUL
ZIP/Postal Code
96830-180
Country
Brazil
Facility Name
Local Institution - 0032
City
Barretos
State/Province
SAO Paulo
ZIP/Postal Code
14784400
Country
Brazil
Facility Name
Local Institution
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Local Institution - 0015
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Local Institution - 0008
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z5
Country
Canada
Facility Name
Local Institution - 0079
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Local Institution - 0045
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Local Institution - 0040
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Local Institution - 0041
City
Nürnberg
ZIP/Postal Code
90419
Country
Germany
Facility Name
Local Institution - 0046
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Local Institution - 0048
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Local Institution - 0050
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45070
Country
Mexico
Facility Name
Local Institution - 0049
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
66460
Country
Mexico
Facility Name
Local Institution - 0055
City
Queretaro
ZIP/Postal Code
76000
Country
Mexico
Facility Name
Local Institution - 0059
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Local Institution - 0052
City
Moscow
ZIP/Postal Code
121205
Country
Russian Federation
Facility Name
Local Institution - 0087
City
Moscow
ZIP/Postal Code
121359
Country
Russian Federation
Facility Name
Local Institution - 0051
City
Novosibirsk
ZIP/Postal Code
630099
Country
Russian Federation
Facility Name
Local Institution - 0085
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
Local Institution - 0058
City
Saint Petersburg
ZIP/Postal Code
197758
Country
Russian Federation

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
http://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting
URL
http://www.fda.gov/safety/medwatch/safetyinformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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