A Phase 1/2 First-in-Human Study of BMS-986249 Alone and inCombination 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-IT
• Lead Sponsor: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-17
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

_Participants must be at least 18 years old;
_have histologic or cytologic confirmation of a solid tumor that is
advanced (metastatic, recurrent, and/or unresectable) with measurable
disease
_Have at least 1 lesion accessible for biopsy;
_Eastern Cooperative Oncology Group Performance Status of 0 or 1;
_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.
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 338
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 112

Exclusion Criteria

-Participants with primary CNS malignancies, tumors with CNS
metastases as the only site of disease, active brain metastases, or
leptomeningeal metastasis 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