An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT03994601 Recruiting June 21, 2019 November 23, 2021

study description
Brief Summary

The purpose of this study is to determine whether BMS-986288 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of select advanced solid tumors.

Condition or Disease: Advanced Cancer
Intervention/treatment: Drug: BMS-986288
Drug: Nivolumab
Phase: Phase 1/Phase 2
Detailed Description

N/A


study design
Study Type: Interventional
Estimated Enrollment : 344 participants
Intervention Model : Parallel Assignment
Masking: None (Open Label) ()
Primary Purpose: Treatment
Official Title: A Phase 1/2 First-in-human Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Malignant Tumors
Actual Study Start Date: September 2019
Estimated Primary Completion Date: September 2023
Estimated Study Completion Date: April 2024

Arms and interventions
Arm Intervention/treatment
Experimental: Arm A BMS-986288
Drug: BMS-986288
Specified dose on specified days
Experimental: Arm B BMS-986288 in combination with Nivolumab
Drug: BMS-986288
Specified dose on specified days

Drug: Nivolumab
Specified dose on specified days
outcome measures
Primary Outcome Measures: 1. Incidence of Adverse Events (AEs) [ Time Frame: Up to 2 years ]
2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 2 years ]
3. Incidence of AEs meeting protocol-defined Dose Limiting Toxicities (DLT) criteria [ Time Frame: Up to 2 years ]
4. Incidence of AEs leading to discontinuation [ Time Frame: Up to 2 years ]
5. Incidence of AEs leading to death [ Time Frame: Up to 2 years ]
6. Incidence of AEs leading to laboratory abnormalities [ Time Frame: Up to 2 years ]
Secondary Outcome Measures: 1. Maximum Observed Concentration (Cmax) of BMS-986288 [ Time Frame: Up to 2 years ]
2. Time of Maximum Observed Concentration (Tmax) of BMS-986288 [ Time Frame: Up to 2 years ]
3. Area Under the Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration AUC(0-T) of BMS-986288 [ Time Frame: Up to 2 years ]
4. Area Under the Concentration-Time Curve in one Dosing Interval AUC(TAU) of BMS-986288 [ Time Frame: Up to 2 years ]
5. Observed Concentration at the end of a Dosing Interval (Ctau) of BMS-986288 [ Time Frame: Up to 2 years ]
6. Trough Observed Concentrations (Ctrough) of BMS-986288 [ Time Frame: Up to 2 years ]
7. Total Body Clearance (CLT) of BMS-986288 [ Time Frame: Up to 4 months ]
8. Average Concentration Over a Dosing Interval at Steady State (Cavgss) of BMS-986288 [ Time Frame: Up to 4 months ]
9. Accumulation Index (AI) of BMS-986288 [ Time Frame: Up to 4 months ]
10. Terminal Half-Life (T-HALF) of BMS-986288 [ Time Frame: Up to 4 months ]
11. Incidence of Anti-Drug Antibodies (ADAs) to BMS-986288 [ Time Frame: Up to 2 years ]
12. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator assessment [ Time Frame: Up to 4 years ]
13. Duration of Response (DOR) by RECIST v1.1 by Investigator Assessment [ Time Frame: Up to 4 years ]
14. Progression-Free Survival (PFS) by RECIST v1.1 by Investigator Assessment [ Time Frame: Up to 4 years ]
15. Time to Response (TTR) by RECIST v1.1 by Investigator Assessment [ Time Frame: Up to 4 years ]
16. Percentage of change from baseline in T-regulatory cells (Tregs) [ Time Frame: Up to 2 years ]

Eligibility Criteria
Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

Histologic or cytologic confirmation of select solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy Eastern Cooperative Oncology Group Performance Status of 0 or 1 Received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to select solid tumor histologies

Exclusion Criteria:

Active, known or suspected autoimmune disease Active malignancy requiring concurrent intervention Primary Central Nervous System (CNS) malignancies or tumors with CNS metastasis as the only site of disease, will be excluded

Other protocol-defined inclusion/exclusion criteria apply


Contacts and Locations
Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations
United States, Colorado University Of Colorado Aurora
United States, Maryland Johns Hopkins University Baltimore
United States, Missouri Washington University Saint Louis
United States, New Jersey Hackensack University Medical Center Hackensack
Argentina, Buenos Aires Local Institution Caba
Argentina, Buenos Aires Local Institution Ciudad Autónoma De Buenos Aires
Argentina, Cordoba Local Institution Río Cuarto
Argentina, Distrito Federal Local Institution ABB
Argentina, Distrito Federal Local Institution Buenos Aires
Argentina, Distrito Federal Local Institution Capital
Argentina Local Institution Cordoba
Canada, Ontario Local Institution Toronto
Chile, Metropolitana Local Institution Recoleta
Chile, Metropolitana Local Institution Santiago
Chile, Valparaiso Local Institution Viña del Mar
France Local Institution Bron
France Local Institution Lyon
France Local Institution Marseille
France Local Institution Paris
Italy Local Institution Ancona
Italy Local Institution Milano
Italy Local Institution Milano
Italy Local Institution Monza
Spain Local Institution Madrid
Spain Local Institution Majadahonda
Spain Local Institution Valencia
Sponsors and Collaborators
Bristol-Myers Squibb
Investigator
Study Director : Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Responsible Party : Bristol-Myers Squibb
ClinicalTrials.gov Identifier : NCT03994601     
Other Study ID Numbers : CA043-001
First Posted : June 21, 2019
Last Update Posted : November 23, 2021
Last Verified : November 2021
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No