A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination with Nivolumab in Advanced Solid Tumors

Phase 1

• Conditions: Advanced Solid Tumors; MedDRA version: 21.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-000416-21-RO
• 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: 2022-04-19
• Last Update Posted: 25 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 435

Inclusion Criteria

-Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy;
-Eastern Cooperative Oncology Group Performance Status of 0 or 1;
-Some participants must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to solid tumor histologies;
-Prior anti-cancer treatments such as chemotherapy, radiotherapy, or hormonal are permitted for some patients;
-Understand and sign an IRB/IEC-approved ICF prior to any study-specific evaluation;
-Willing and able to comply with all study procedures.

Other protocol defined inclusion criteria could apply.
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 327
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 108

Exclusion Criteria

-Participants with primary CNS malignancies, tumors with CNS metastases as the only site of disease or active brain metastases will be excluded;
-Active, known, or suspected autoimmune disease;
-Participants with other active malignancy requiring concurrent intervention;
-Prior organ allograft.

Other protocol defined exclusion criteria could apply.

Study & Design

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