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OpenTrials
Completed

NCT Number: NCT01629758

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

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Key information

Conditions

Neoplasms by Site Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Oncology Research Associates, Pllc D/B/A, Scottsdale, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Denenicokin

Biological

Other names: BMS-982470, rIL-21(recombinant interleukin 21)

Nivolumab

Biological

Other names: BMS-936558, Anti-PD-1 (Anti-Programmed-Death-1), MDX-1106

Primary outcomes

  1. Safety, as measured by the rate of adverse events and serious adverse events

    Time frame: Approximately up to 4.5 years

Secondary outcomes

  1. 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)

  2. 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 28, 2012
Registry last updated
Mar 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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