Trial record 1 of 1 for:    CA220-008
Previous Study | Return to List | Next Study

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01629758
First received: June 26, 2012
Last updated: July 9, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Neoplasms by Site
Biological: Denenicokin
Biological: Nivolumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Safety, as measured by the rate of adverse events and serious adverse events [ Time Frame: Approximately up to 4.5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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)

  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 165
Study Start Date: June 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Denenicokin
Other Names:
  • BMS-982470
  • rIL-21(recombinant interleukin 21)
Biological: Nivolumab
Other Names:
  • BMS-936558
  • Anti-PD-1 (Anti-Programmed-Death-1)
  • MDX-1106
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: Denenicokin
Other Names:
  • BMS-982470
  • rIL-21(recombinant interleukin 21)
Biological: Nivolumab
Other Names:
  • BMS-936558
  • Anti-PD-1 (Anti-Programmed-Death-1)
  • MDX-1106
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: Denenicokin
Other Names:
  • BMS-982470
  • rIL-21(recombinant interleukin 21)
Biological: Nivolumab
Other Names:
  • BMS-936558
  • Anti-PD-1 (Anti-Programmed-Death-1)
  • MDX-1106

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01629758

Locations
United States, Arizona
Oncology Research Associates, Pllc D/B/A
Scottsdale, Arizona, United States, 85258
United States, Connecticut
Yale University School Of Medicine
New Haven, Connecticut, United States, 06520
United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, United States, 21231
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01629758     History of Changes
Other Study ID Numbers: CA220-008
Study First Received: June 26, 2012
Last Updated: July 9, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on July 29, 2014