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Trial record 1 of 1 for:    NCT03729245
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A Study of Bempegaldesleukin (NKTR-214: BEMPEG) in Combination With Nivolumab Compared With the Investigator's Choice of a Tyrosine Kinase Inhibitor (TKI) Therapy (Either Sunitinib or Cabozantinib Monotherapy) for Advanced Metastatic Renal Cell Carcinoma (RCC)

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ClinicalTrials.gov Identifier: NCT03729245
Recruitment Status : Active, not recruiting
First Posted : November 2, 2018
Last Update Posted : April 4, 2022
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Nektar Therapeutics

Brief Summary:
The main purpose of this study is to compare the objective response rate (ORR) and overall survival (OS) of bempegaldesleukin (NKTR-214: BEMPEG) combined with nivolumab to that of tyrosine kinase inhibitor (TKI) monotherapy (sunitinib or cabozantinib) in IMDC intermediate- or poor-risk patients and IMDC all-risk patients with previously untreated advanced renal cell carcinoma (RCC).

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Metastatic Renal Cell Carcinoma Biological: bempegaldesleukin Drug: sunitinib Biological: nivolumab Drug: cabozantinib Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 623 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized Open Label Study to Compare NKTR-214 Combined With Nivolumab to the Investigator's Choice of Sunitinib or Cabozantinib in Patients With Previously Untreated Advanced Renal Cell Carcinoma
Actual Study Start Date : December 18, 2018
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2024


Arm Intervention/treatment
Experimental: Combination of bempegaldesleukin + nivolumab
Patients in Arm A will receive bempegaldesleukin in combination with nivolumab.
Biological: bempegaldesleukin
Specified dose on specified days
Other Names:
  • BEMPEG
  • BMS-986321

Biological: nivolumab
Specified dose on specified days
Other Names:
  • Opdivo®
  • BMS-936558

Active Comparator: sunitinib or cabozantinib
Patients in Arm B will receive the Investigator's choice of either one of two treatment options.
Drug: sunitinib
Specified dose on specified days
Other Name: Sutent®

Drug: cabozantinib
Specified dose on specified days
Other Name: Cabometyx®




Primary Outcome Measures :
  1. ORR using mRECIST 1.1 by BICR in IMDC intermediate- or poor-risk patients with previously untreated advanced RCC [ Time Frame: Approximately 32 months ]
    ORR using modified Response Evaluation Criteria in Solid Tumors (mRECIST) 1.1 by Blinded Independent Central Review (BICR) in International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) intermediate- or poor-risk patients. ORR is defined as the proportion of enrolled participants who achieved a Best Overall Response (BOR) of CR or PR. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR is calculated as the sum of CR and PR.

  2. ORR per mRECIST 1.1 by BICR in IMDC all-risk patients with previously untreated advanced RCC [ Time Frame: Approximately 32 months ]
    ORR is defined as the proportion of enrolled participants who achieved a Best Overall Response (BOR) of CR or PR. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR is calculated as the sum of CR and PR.

  3. Overall survival (OS) in IMDC intermediate- or poor-risk patients with previously untreated advanced RCC [ Time Frame: 32-59 months ]
    OS is defined as the time from date of first dose to the date of death.

  4. OS in IMDC all-risk patients with previously untreated advanced RCC [ Time Frame: 32-59 months ]
    OS is defined as the time from date of first dose to the date of death.


Secondary Outcome Measures :
  1. Progression-free survival (PFS) per mRECIST 1.1 by BICR in IMDC intermediate- or poor-risk patients with previously untreated advanced RCC [ Time Frame: 32-59 months ]
    PFS is defined as the time from date of first dose to the date of the first objectively documented tumor progression or death due to any cause.

  2. PFS per mRECIST 1.1 by BICR in IMDC all risk-patients with previously untreated advanced RCC [ Time Frame: 32-59 months ]
    PFS is defined as the time from date of first dose to the date of the first objectively documented tumor progression or death due to any cause.

  3. Incidence of treatment-related Adverse Events (AEs) of Bempegaldesleukin combined with Nivolumab versus TKI monotherapy (sunitinib or cabozantinib) in patients with previously untreated advanced RCC [ Time Frame: Up to 5 years ]
  4. Changes in cancer-related symptoms and quality-of-life in patients using the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy (NCCN/FACT) Symptom Index for Kidney Cancer (FKSI-19) [ Time Frame: 32-59 months ]
    Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-P domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to 12 questions ("I have a lack of energy," "I feel pain," for example) by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 48). A negative change from baseline indicates a worsening of condition.

  5. PD-L1 expression on tumor cells (< 1% vs ≥ 1%) using the PD-L1 immunohistochemistry (IHC) 28-8 pharmDx assay as a predictive biomarker for ORR, PFS, and OS in patients with previously untreated advanced RCC [ Time Frame: 32-59 months ]


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

Key Inclusion Criteria:

  • Provide written, informed consent to participate in the study and follow the study procedures
  • Karnofsky Performance Status (KPS) of at least 70%
  • Measurable disease per mRECIST 1.1 criteria
  • Histologically confirmed RCC with a clear-cell component (may have sarcomatoid features); advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC
  • Patients with any International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) score (favorable-, intermediate-, or poor-risk) are eligible. At least one IMDC prognostic factor must be present to qualify as either intermediate- or poor-risk renal cell carcinoma.
  • No prior systemic therapy (including neoadjuvant, adjuvant, or vaccine therapy) for RCC

Key Exclusion Criteria:

  • An active, known or suspected autoimmune disease that has required systemic treatment within the past 3 months (exceptions exist)
  • Patients who have a known additional malignancy that is progressing or requires active treatment (exceptions exist)
  • Any tumor invading the wall of a major blood vessels
  • Any tumor invading the gastrointestinal (GI) tract or any evidence of endotracheal or endobronchial tumor within 28 days prior to randomization
  • Need for >2 medications for management of hypertension (including diuretics)
  • History of pulmonary embolism, deep vein thrombosis (not including tumor thrombus), or clinically significant thromboembolic event within 3 months of randomization

Additional protocol defined inclusion/exclusion criteria and exceptions 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): NCT03729245


Locations
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Sponsors and Collaborators
Nektar Therapeutics
Bristol-Myers Squibb
Investigators
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Study Director: Study Director Nektar Therapeutics
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Responsible Party: Nektar Therapeutics
ClinicalTrials.gov Identifier: NCT03729245    
Other Study ID Numbers: 17-214-09
CA045002 ( Other Identifier: Bristol-Myers Squibb Protocol ID )
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: April 4, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Nektar Therapeutics:
Kidney Cancer
Kidney Neoplasms
Renal Cancer
Renal Neoplasms
CD122
CD122-Biased Agonist
CD122-Biased Cytokine
IL-2 receptor agonist
Immuno-oncology therapy
NKTR-214
Nivolumab
Opdivo®
PD-L1
PD-1
Bempegaldesleukin
IL-2
BEMPEG
CD122-Preferential
IL-2 pathway agonist
Checkpoint inhibition
Immune checkpoint inhibitor
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
Sunitinib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors