Description:
The purpose of this study is to first, in Part 1, to determine the safety of nivolumab,
bempegaldesleukin (BEMPEG: NKTR-214), and Tyrosine Kinase Inhibitor (TKI) combination and
then, in Part 2, to evaluate the effectiveness of nivolumab, bempegaldesleukin, and
cabozantinib when compared with nivolumab and cabozantinib in participants with previously
untreated kidney cancer that has advanced or has spread.
Title
- 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
- Official Title: A Phase 1/2 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 IDs
- ORG STUDY ID:
CA045-011
- SECONDARY ID:
2018-003200-39
- SECONDARY ID:
18-214-15
- NCT ID:
NCT04540705
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Nivolumab | OPDIVO | Arm A (Part 2): Nivolumab + Bempegaldesleukin + Cabozantinib |
Bempegaldesleukin | BMS-986321, NKTR-214, bempegaldesleukin | Arm A (Part 2): Nivolumab + Bempegaldesleukin + Cabozantinib |
Axitinib | INLYTA | Part 1A (Part 1): Nivolumab + Bempegaldesleukin + Axitinib |
Cabozantinib | | Arm A (Part 2): Nivolumab + Bempegaldesleukin + Cabozantinib |
Purpose
The purpose of this study is to first, in Part 1, to determine the safety of nivolumab,
bempegaldesleukin (BEMPEG: NKTR-214), and Tyrosine Kinase Inhibitor (TKI) combination and
then, in Part 2, to evaluate the effectiveness of nivolumab, bempegaldesleukin, and
cabozantinib when compared with nivolumab and cabozantinib in participants with previously
untreated kidney cancer that has advanced or has spread.
Trial Arms
Name | Type | Description | Interventions |
---|
Part 1A (Part 1): Nivolumab + Bempegaldesleukin + Axitinib | Experimental | | - Nivolumab
- Bempegaldesleukin
- Axitinib
|
Part 1B (Part 1): Nivolumab + Bempegaldesleukin + Cabozantinib | Experimental | | - Nivolumab
- Bempegaldesleukin
- Cabozantinib
|
Arm A (Part 2): Nivolumab + Bempegaldesleukin + Cabozantinib | Experimental | | - Nivolumab
- Bempegaldesleukin
- Cabozantinib
|
Arm B (Part 2): Nivolumab + Cabozantinib | Experimental | | |
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
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)
NOTE: Other protocol defined inclusion/exclusion criteria apply
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence of adverse events (AEs) by severity (Part 1) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Progression-free survival (PFS) by RECIST 1.1 by Investigator (Part 2) |
Time Frame: | Up to 32 months from start of Part 2 |
Safety Issue: | |
Description: | |
Measure: | Overall survival (OS) (Part 2) |
Time Frame: | Up to 60 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of AEs by severity (Part 2) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of SAEs (Part 2) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of AEs leading to discontinuation (Part 2) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of imAEs (Part 2) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of changes in clinical laboratory results by severity: Hematology tests (Part 2) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of changes in clinical laboratory results by severity: Clinical Chemistry tests (Part 2) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of changes in clinical laboratory results by severity: Urinalysis tests (Part 2) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Bristol-Myers Squibb |
Trial Keywords
Last Updated
July 26, 2021