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

Phase 1

Completed

• Conditions: Advanced Cancer
• Interventions: Drug: BMS-986310; Biological: Nivolumab

• Registration Number: NCT03661632
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-08-30
• Study First Submitted QC: 2018-09-05
• Study First Posted: 2018-09-07
• Study Start: 2018-09-11
• Primary Completion: 2019-11-11
• Study Completion: 2020-12-29
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-31
• Last Update Posted: 2021-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose Escalation	BMS-986310	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
Cohort Expansion	Nivolumab	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.
Dose Escalation	Nivolumab	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
Cohort Expansion	BMS-986310	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.

Primary Outcome Measures

Name	Time	Method
Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria	up to 3 years
Incidence of Serious Adverse Events (SAE)	up to 3 years
Incidence of death	up to 3 years
Incidence of Adverse Events (AE)	up to 3 years
Incidence of AEs leading to dose delays and discontinuation or delay in radical cystectomy (RC)	up to 3 years
Incidence of Laboratory abnormalities	up to 3 years

Secondary Outcome Measures

Name	Time	Method
Cmax accumulation index (AI_Cmax)	up to 3 years
Progression free survival rate (PFSR)	up to 24 months
Observed serum concentration at the end of a dosing interval (Ctau)	up to 3 years
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]	up to 3 years
Apparent total body clearance (CLT/F)	up to 3 years
Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]	up to 3 years
Summary changes of prostaglandin E metabolite (PGEM) in urine	up to 3 years
AUC accumulation index (AI_AUC)	up to 3 years
Summary changes of tumor necrosis factor (TNFa) in blood	up to 3 years
Objective response rate (ORR)	up to 3 years
Median duration of response (mDOR)	up to 3 years
Maximum observed serum concentration (Cmax)	up to 3 years
Summary of PK parameters at T-HALF	up to 3 years
Summary of PK parameter AUC(INF) after single dose	up to 3 years

Trial Locations

Locations (5)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

UPMC Hillman Cancer Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

Local Institution; 🇨🇦 Toronto, Ontario, Canada

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States