A Study to Evaluate the Safety and Tolerability of Monoclonal Antibody BMS-986207 Alone and in Combination With Nivolumab in Advanced (Solid Tumor) Cancers

Phase 1

Completed

• Conditions: Broad Solid Tumor

• Registration Number: JPRN-jRCT2080223478
• Lead Sponsor: Bristol-Myers Squibb K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-14
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Must have received and progressed on or failed one standard/approved treatment for cancer type, if available
At least 4 weeks since any previous treatment for cancer
Subject must consent to pretreatment and on treatment tumor biopsies
At least one lesion with measurable disease at baseline

Exclusion Criteria

Patients with primary brain tumors or primary tumors with central nervous system metastases as only location of disease. Controlled brain metastases are permitted
Prior organ transplant
Participants with second/other active cancers requiring current treatment
Uncontrolled/significant heart disease
History of chronic hepatitis, Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except participants with liver cancer) or Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome(HIV/AIDS)
Active/uncontrolled autoimmune disease
Active infection

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety<br>Incidence of adverse events of BMS-986207 [ Time Frame: Up to 15 months ]<br>Incidence of adverse events of nivolumab (BMS-936558) and BMS-986207 when given in combination [ Time Frame: Up to 15 months ]<br>Incidence of clinically significant abnormalities in general laboratory tests of BMS-986207 [ Time Frame: Up to 15 months ]<br>Incidence of clinically significant abnormalities in general laboratory tests of nivolumab(BMS-936558) and BMS-986207 when given in combination [ Time Frame: Up to 15 months ]