NCT03956680|CompletedPhase 1FDA Drug

An Investigational Immunotherapy Study of BMS-986301 Alone or in Combination With Nivolumab, and Ipilimumab in Participants With Advanced Solid Cancers

A Phase I Study of BMS-986301 Monotherapy and Combination Therapy With Nivolumab and Ipilimumab in Participants With Advanced Solid Cancers

Bristol-Myers Squibb ClinicalTrials.gov

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2 other identifiers

CA046-0062018-003610-41

Study Type

interventional

Target

Locations

2 countries

Sites

Timeline

RegisteredMay 2019

StartedMar 2019

CompletionApr 2024

Brief Summary

The main purpose of this study is to characterize the safety, tolerability, dose limiting toxicities, best route of administration, maximum tolerated dose, maximum administered dose, or alternative dose of BMS-986301 alone or in combination with nivolumab and ipilimumab in participants with cancers that have failed to respond to T cell checkpoint inhibiting antibodies.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_1

Timeline

Completed

Started Mar 2019

Longer than P75 for phase_1

Geographic Reach

2 countries

5 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.1 years study duration

Study Start

First participant enrolled

March 26, 2019

Completed

28 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2019

Completed

28 days until next milestone

First Posted

Study publicly available on registry

May 21, 2019

Completed

4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2024

Completed

7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2024

Completed

Last Updated

February 19, 2025

Status Verified

February 1, 2025

Enrollment Period

5.1 years

First QC Date

April 23, 2019

Last Update Submit

February 18, 2025

Conditions

Advanced Solid Cancers

Outcome Measures

Primary Outcomes (8)

Incidence of dose-limiting toxicity (DLTs)
Cycle 1 (28 days)
Incidence of adverse events (AEs)
From Baseline until study exit (up to approximately 2 years)
Incidence of serious adverse events (SAEs)
From Baseline until study exit (up to approximately 2 years)
Incidence of AEs leading to discontinuation
From Baseline until study exit (up to approximately 2 years)
Incidence of deaths
From Baseline until study exit (up to approximately 2 years)
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
From Baseline until disease progression (approximately 2 years)
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
From Baseline until disease progression (approximately 2 years)
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
From Baseline until disease progression (approximately 2 years)