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)
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| ClinicalTrials.gov Identifier: NCT04540705 |
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Recruitment Status :
Active, not recruiting
First Posted : September 7, 2020
Last Update Posted : March 14, 2023
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Sponsor:
Bristol-Myers Squibb
Collaborator:
Nektar Therapeutics
Information provided by (Responsible Party):
Bristol-Myers Squibb
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Renal Cell Carcinoma | Biological: Nivolumab Drug: Axitinib Drug: Cabozantinib | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 30 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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) |
| Actual Study Start Date : | September 11, 2020 |
| Estimated Primary Completion Date : | February 5, 2024 |
| Estimated Study Completion Date : | February 5, 2024 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Experimental: Part 1A (Part 1): Nivolumab + Axitinib |
Biological: Nivolumab
Specified dose on specified days
Other Name: OPDIVO Drug: Axitinib Specified dose on specified days
Other Name: INLYTA |
| Experimental: Part 1B (Part 1): Nivolumab + Cabozantinib |
Biological: Nivolumab
Specified dose on specified days
Other Name: OPDIVO Drug: Cabozantinib Specified dose on specified days
Other Name: Cabometyx |
Primary Outcome Measures :
- Incidence of adverse events (AEs) by severity (Part 1) [ Time Frame: Up to 2.5 years ]
- Incidence of serious adverse events (SAEs) (Part 1) [ Time Frame: Up to 2.5 years ]
- Incidence of dose-limiting toxicities (DLTs) (Part 1) [ Time Frame: Up to 2.5 years ]
- Incidence of AEs leading to discontinuation (Part 1) [ Time Frame: Up to 5 years ]
- Incidence of immune-mediated adverse events (imAEs) (Part 1) [ Time Frame: Up to 5 years ]
- Incidence of changes in clinical laboratory results by severity: Hematology tests (Part 1) [ Time Frame: Up to 2.5 years ]
- Incidence of changes in clinical laboratory results by severity: Clinical Chemistry tests (Part 1) [ Time Frame: Up to 2.5 years ]
- Incidence of changes in clinical laboratory results by severity: Urinalysis tests (Part 1) [ Time Frame: Up to 2.5 years ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04540705
Locations
Show 34 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Nektar Therapeutics
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT04540705 |
| Other Study ID Numbers: |
CA045-011 2018-003200-39 ( EudraCT Number ) 18-214-15 ( Other Identifier: Nektar Therapeutics ) |
| First Posted: | September 7, 2020 Key Record Dates |
| Last Update Posted: | March 14, 2023 |
| Last Verified: | March 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Bristol-Myers Squibb:
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NKTR-214 nivolumab bempeg |
Additional relevant MeSH terms:
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Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Kidney Diseases Urologic Diseases Nivolumab Axitinib Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action Protein Kinase Inhibitors Enzyme Inhibitors |