An Investigational Immunotherapy Study of BMS-986310 Administered Alone and in Combination With Nivolumab in Patients With Advanced Solid Tumors

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Advanced Cancer

Treatments: Drug: BMS-986310; Biological: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03661632

2018-002108-15 (EudraCT Number)

CA044-001

Details and patient eligibility

About

The purpose of this study is to determine if BMS-986310 administered in combination with nivolumab, will demonstrate adequate safety and tolerability, as well as a favorable risk/benefit profile, to support further clinical testing.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

• History of severe adverse drug reactions to nonsteroidal anti-inflammatory drugs (NSAIDs) or Cyclooxygenase-2 (COX-2) inhibitors.
• Participants with an active, known or suspected autoimmune disease.
• Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Dose Escalation

Experimental group

Description:

Part 1: BMS-986310 + Nivolumab Combination Dose Escalation Sub-Study A: A cohort of Cisplatin Ineligible Muscle Invasive Bladder Cancer patients will receive either monotherapy BMS-986310, or BMS-986310 + Nivolumab, or Nivolumab monotherapy. Sub-Study B: A cohort of PD\[L\]1 relapsed / refractory tumor cancer patients will be treated with monotherapy BMS-986310 followed by BMS-986310 + nivolumab

Treatment:

Drug: BMS-986310

Biological: Nivolumab

Cohort Expansion

Experimental group

Description:

Part 2: Cohort Expansion will initiate upon consideration of the totality of data from Part 1. BMS-986310 + Nivolumab combination will be administered in specific patient populations.

Treatment:

Drug: BMS-986310

Biological: Nivolumab