An investigational immunotherapy study of BMS-986310 administered alone and in combination with Nivolumab inpatients with advanced solid tumors

Phase 1

• Conditions: Advanced Solid Tumors; MedDRA version: 20.0Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-002108-15-BE
• 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: 2018-08-01
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

- Patients with measurable disease per RECIST v1.1 and have at least one lesion accessible for biopsy.
- ECOG performance status less than or equal to 1

Part 1 and Sub-study B:
i) Part 1 participants must have advanced or metastatic disease where no other standard of care treatment option is possible.
ii) Sub-study B participants must have advanced or metastatic disease where no other standard of care treatment is possible, and they must have had disease progression on an anti-PD-(L)1 based regimen as their most recent prior therapy;
Tumor size equal to or greater than 1 cm
Sub-study A:
i) Males and females with histologically confirmed TNBC with no prior treatment for TNBC

Part 2
i) Patients with NSCLC
ii) Patients with Pancreatic Cancer
iii) Patients with TNBC
iiii) Patients with CRC
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 168
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 112

Exclusion Criteria

- History of severe adverse drug reactions to nonsteroidal anti-inflammatory drugs (NSAIDs), or those with adverse reactions to an NSAID that is currently prescribed
- Participants with an active, known or suspected autoimmune disease.

Study & Design

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