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

Advanced Cancer Clinical Trial

Official title:

Phase 1/2 Study of BMS-986310 Administered Alone and in Combination With Nivolumab in Participants With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03661632
• Other study ID #: CA044-001
• Secondary ID: 2018-002108-15
• Status: Completed
• Phase: Phase 1
• Start date: September 11, 2018
• Est. completion date: December 29, 2020

Study information

• Verified date: October 2021
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 29, 2020
• Est. primary completion date: November 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer

Intervention

Drug:
• BMS-986310
Specified dose on specified days

Biological:
• Nivolumab
Specified dose on specified days

Locations

Country	Name	City	State
Belgium	Local Institution	Bruxelles
Belgium	Local Institution	Gent
Canada	Local Institution	Toronto	Ontario
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	MD Anderson Cancer Center	Houston	Texas
United States	UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Belgium,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (AE)		up to 3 years
Primary	Incidence of Serious Adverse Events (SAE)		up to 3 years
Primary	Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria		up to 3 years
Primary	Incidence of AEs leading to dose delays and discontinuation or delay in radical cystectomy (RC)		up to 3 years
Primary	Incidence of Laboratory abnormalities		up to 3 years
Primary	Incidence of death		up to 3 years
Secondary	Objective response rate (ORR)		up to 3 years
Secondary	Median duration of response (mDOR)		up to 3 years
Secondary	Progression free survival rate (PFSR)		up to 24 months
Secondary	Maximum observed serum concentration (Cmax)		up to 3 years
Secondary	Observed serum concentration at the end of a dosing interval (Ctau)		up to 3 years
Secondary	Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]		up to 3 years
Secondary	Apparent total body clearance (CLT/F)		up to 3 years
Secondary	Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]		up to 3 years
Secondary	AUC accumulation index (AI_AUC)		up to 3 years
Secondary	Cmax accumulation index (AI_Cmax)		up to 3 years
Secondary	Summary changes of prostaglandin E metabolite (PGEM) in urine		up to 3 years
Secondary	Summary changes of tumor necrosis factor (TNFa) in blood		up to 3 years
Secondary	Summary of PK parameters at T-HALF		up to 3 years
Secondary	Summary of PK parameter AUC(INF) after single dose		up to 3 years

External Links

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