An Investigational Immuno-Therapy Study of Experimental Medication BMS-986253 Given in Combination with Nivolumab in Patients with Advanced Cancers

Phase 1

• Conditions: Advanced Cancers; MedDRA version: 21.1 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-000340-26-GB
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-06
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 800

Inclusion Criteria

- Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with
measurable disease per RECIST v1.1
- At least 1 lesion accessible for biopsy
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400

Exclusion Criteria

- Participants with primary central nervous system (CNS) tumors, or with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll)
- Participants with active, known or suspected autoimmune disease
- Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
- Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)
- Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified