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Trial record 1 of 1 for:    PIVOT-IO-011
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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04540705
Recruitment Status : Active, not recruiting
First Posted : September 7, 2020
Last Update Posted : August 29, 2022
Sponsor:
Collaborator:
Nektar Therapeutics
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

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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


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 :
  1. Incidence of adverse events (AEs) by severity (Part 1) [ Time Frame: Up to 2.5 years ]
  2. Incidence of serious adverse events (SAEs) (Part 1) [ Time Frame: Up to 2.5 years ]
  3. Incidence of dose-limiting toxicities (DLTs) (Part 1) [ Time Frame: Up to 2.5 years ]
  4. Incidence of AEs leading to discontinuation (Part 1) [ Time Frame: Up to 5 years ]
  5. Incidence of immune-mediated adverse events (imAEs) (Part 1) [ Time Frame: Up to 5 years ]
  6. Incidence of changes in clinical laboratory results by severity: Hematology tests (Part 1) [ Time Frame: Up to 2.5 years ]
  7. Incidence of changes in clinical laboratory results by severity: Clinical Chemistry tests (Part 1) [ Time Frame: Up to 2.5 years ]
  8. 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
  • 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 Show 35 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Nektar Therapeutics
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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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: August 29, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
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