An investigational immunotherapy study of BMS-986310 administered alone and in combination with Nivolumab in patients with 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: EUCTR2018-002108-15-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: 2020-11-10
• Last Update Posted: 11 January 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, in one of the
following tumor types: Renal cell carcinoma, Melanoma, colorectal
cancer (CRC) microsatellite instability (MSI)-High (determined by
Clinical Laboratory Improvement Amendments (CLIA) validated assay,
testing methodology must be provided), Bladder cancer, Squamous Cell
Carcinoma of the Head and Neck (SCCHN), and they must have had
disease progression on an anti-PD-(L)1 based regimen as their most
recent prior therapy
Sub-study A:
i) Participants must be newly diagnosed, no prior history of treatment
for bladder cancer
ii) Participants must not meet criteria for standard of care neoadjuvant
therapy and must be candidates for SOC surgical resection of primary
tumor.
iii) Histologically confirmed muscle-Invasive bladder cancer (MIBC) pure
or mixed histology urothelial carcinoma
Part 2 - Patients with relapsed / refractory solid tumors where no other
standard of care treatment option is available
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