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

NCT03661632 | Completed Phase 1 FDA Drug

• 2 other identifiers: CA044-0012018-002108-15
• Study Type: interventional
• Target: 27
• Locations: 3 countries
• Sites: 7

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.

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (6)

• Incidence of Adverse Events (AE)

  up to 3 years

• Incidence of Serious Adverse Events (SAE)

  up to 3 years

• Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria

  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

• Incidence of death

  up to 3 years

Secondary Outcomes (14)

• Objective response rate (ORR)

  up to 3 years

• Median duration of response (mDOR)

  up to 3 years

• Progression free survival rate (PFSR)

  up to 24 months

• Maximum observed serum concentration (Cmax)

  up to 3 years

• Observed serum concentration at the end of a dosing interval (Ctau)

  up to 3 years

Study Arms (2)

Dose Escalation

EXPERIMENTAL

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

Drug: BMS-986310; Biological: Nivolumab

Cohort Expansion

EXPERIMENTAL

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.

Drug: BMS-986310; Biological: Nivolumab

Interventions

BMS-986310 DRUG

Specified dose on specified days

Cohort Expansion; Dose Escalation

Nivolumab BIOLOGICAL

Specified dose on specified days

Also known as: Opdivo, BMS-936558

Cohort Expansion; Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (7)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Local Institution

Brussels, 1200, Belgium

Location

Local Institution

Ghent, 9000, Belgium

Location

Local Institution

Toronto, Ontario, M5G 1Z5, Canada

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Interventions

Nivolumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: September 7, 2018
• Study Start: September 11, 2018
• Primary Completion: November 11, 2019
• Study Completion: December 29, 2020
• Last Updated: November 8, 2021

Record last verified: 2021-10

Locations

US (4); CA (1); BE (2)