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

Neoplasms by Site Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01629758
• Other study ID #: CA220-008
• Status: Completed
• Phase: Phase 1
• First received: June 26, 2012
• Last updated: March 5, 2015
• Start date: June 2012
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms by Site

Intervention

Biological:
• Denenicokin

• Nivolumab

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins	Baltimore	Maryland
United States	Yale University School Of Medicine	New Haven	Connecticut
United States	Oncology Research Associates, Pllc D/B/A	Scottsdale	Arizona
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety, as measured by the rate of adverse events and serious adverse events		Approximately up to 4.5 years	Yes
Secondary	Efficacy as measured by tumor assessment (RECIST)	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)	No
Secondary	Immunogenicity as measured by incidence of specific antidrug antibodies (ADA) to BMS-98470 and BMS-936558		Up to 2 years + 100 days post-treatment follow-up	No

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form