Safety Study of IL-21/Anti-PD-1 Combination in the Treatment of Solid Tumors

March 5, 2015 updated by: Bristol-Myers Squibb

A Phase 1 Dose Escalation Study of BMS-982470 (Recombinant Interleukin-21, rIL-21) in Combination With BMS-936558 (Anti-PD-1) in Subjects With Advanced or Metastatic Solid Tumors

The purpose of this study is to determine whether the combination of the 2 drugs being investigated (IL-21 and anti-PD-1) is safe, and provide preliminary information on the clinical benefits of two different schedules of the combination.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Oncology Research Associates, Pllc D/B/A
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University School of Medicine
    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • All subjects will have locally advanced or metastatic solid tumors

  • For Part 2 (Cohort Expansion):

    • Tumor types will be restricted to clear cell renal cell carcinoma (ccRCC), non-small cell lung cancer (NSCLC), and melanoma
  • At least 1 lesion with measurable disease
  • Only subjects with tumor samples that are PD-L1 positive or negative are eligible

Exclusion Criteria:

  • Uncontrolled central nervous system (CNS) or leptomeningeal metastasis
  • Inadequate liver or kidney function
  • History of autoimmune Disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Part 1-Arm A: BMS-982470 (weekly x 4) + BMS-936558
Dose Escalation BMS-982470 10, 30, 50, 75 or 100 µg/kg Solution, Intravenous, During each 6 week cycle: weekly x 4 (i.e during weeks 1 through 4), Up to 2 years + BMS-936558 3 mg/kg Solution, Intravenous, During each 6 week cycle: every other week (i.e during weeks 1, 3, and 5), Up to 2 years
Biological: Nivolumab
Other Names:
  • BMS-936558
  • MDX-1106
  • Anti-PD-1 (Anti-Programmed-Death-1)
Biological: Denenicokin
Other Names:
  • BMS-982470
  • rIL-21(recombinant interleukin 21)
EXPERIMENTAL: Part 1-Arm B: BMS-982470 (3 times/week) + BMS-936558
Dose Escalation BMS-982470 10, 30, 50, 75 or 100 µg/kg Solution, Intravenous, During each 6 week cycle: 3 times/week during weeks 1 and 3, Up to 2 years + BMS-936558 3 mg/kg Solution, Intravenous, During each 6 week cycle: every other week (i.e during weeks 1, 3, and 5), Up to 2 years
Biological: Nivolumab
Other Names:
  • BMS-936558
  • MDX-1106
  • Anti-PD-1 (Anti-Programmed-Death-1)
Biological: Denenicokin
Other Names:
  • BMS-982470
  • rIL-21(recombinant interleukin 21)
EXPERIMENTAL: Part 2-Arm A: BMS-982470 (weekly x 4) + BMS-936558
Cohort Expansion BMS-982470 (dose selected in Part 1) Solution, Intravenous, During each 6 week cycle: weekly x 4 (i.e during weeks 1 through 4), Up to 2 years + BMS-936558 3 mg/kg Solution, Intravenous, During each 6 week cycle: every other week (i.e during weeks 1, 3, and 5), Up to 2 years
Biological: Nivolumab
Other Names:
  • BMS-936558
  • MDX-1106
  • Anti-PD-1 (Anti-Programmed-Death-1)
Biological: Denenicokin
Other Names:
  • BMS-982470
  • rIL-21(recombinant interleukin 21)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety, as measured by the rate of adverse events and serious adverse events
Time Frame: Approximately up to 4.5 years
Approximately up to 4.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy as measured by tumor assessment (RECIST)
Time Frame: Week 6 of for the first 4 cycles, Week 6 of alternate cycle starting with cycle 6, End of Treatment (2 years) and approximately every 12 weeks during follow-up (approximately 1 year)
Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 using Best overall response (BOR), Objective response rate (ORR), Duration of Response (DOR), Progression-Free Survival Rate (PFSR)
Week 6 of for the first 4 cycles, Week 6 of alternate cycle starting with cycle 6, End of Treatment (2 years) and approximately every 12 weeks during follow-up (approximately 1 year)
Immunogenicity as measured by incidence of specific antidrug antibodies (ADA) to BMS-98470 and BMS-936558
Time Frame: Up to 2 years + 100 days post-treatment follow-up
Up to 2 years + 100 days post-treatment follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

June 26, 2012

First Submitted That Met QC Criteria

June 26, 2012

First Posted (ESTIMATE)

June 28, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 6, 2015

Last Update Submitted That Met QC Criteria

March 5, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA220-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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