NCT05543629|TerminatedPhase 1ResultsFDA Drug

Study Stopped

Business objectives have changed

A Study of BMS-986442 With Nivolumab With or Without Chemotherapy in Solid Tumors and Non-small Cell Lung Cancer

A Phase 1b/2 Study of BMS-986442 in Combination With Nivolumab or Nivolumab and Chemotherapies in Participants With Advanced Solid Tumors and Non-small Cell Lung Cancer

Bristol-Myers Squibb ClinicalTrials.gov

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3 other identifiers

CA115-0012022-501676-26U1111-1283-1243

Study Type

interventional

Target

Locations

5 countries

Sites

Timeline

RegisteredSep 2022

StartedOct 2022

CompletionSep 2024

Brief Summary

The purpose of this study is to evaluate BMS-986442 in combination with nivolumab (with or without chemotherapy) for its antitumor efficacy and benefit to participants.

Trial Health

Monitor

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 Oct 2022

Typical duration for phase_1

Geographic Reach

5 countries

32 active sites

Status

terminated

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

1.9 years study duration

First Submitted

Initial submission to the registry

September 14, 2022

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed

18 days until next milestone

Study Start

First participant enrolled

October 4, 2022

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2024

Completed

6 months until next milestone

Results Posted

Study results publicly available

March 18, 2025

Completed

Last Updated

March 18, 2025

Status Verified

February 1, 2025

Enrollment Period

1.9 years

First QC Date

September 14, 2022

Results QC Date

January 16, 2025

Last Update Submit

February 27, 2025

Conditions

Advanced Solid Tumors Non-small Cell Lung Cancer

Keywords

BMS-986442NivolumabChemotherapy

Outcome Measures

Primary Outcomes (5)

Number of Participants With Adverse Events
Number of Participants with Adverse Events. An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. For the reporting of all AEs, including intensity or severity, on case report forms, please follow the definitions in National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).
From first dose to 100 days post last dose (Approximately 6 Months)
Number of Participants With Serious Adverse Events
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: * Results in death. * Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe). * Requires inpatient hospitalization or causes prolongation of existing hospitalization
From first dose to 100 days post last dose (Approximately 6 Months)
Number of Participants With Adverse Events Leading to Discontinuation
Number of Participants with adverse events leading to discontinuation
From first dose to 100 days post last dose (Approximately 6 Months)
Number of Participants With Dose Limiting Toxicities
DLTs will be defined based on the incidence, intensity, and duration of the AEs for which no clear alternative cause is identified and will exclude events clearly related to disease progression or intercurrent illness. in addition, the following AEs will be DLTs: * Any death that is not clearly due to the underlying disease or extraneous causes * Any Grade ≥ 3 non-hematological toxicity * Any Grade myocarditis * Any Grade myelitis, encephalitis, myasthenia gravis, or Guillain-Barre syndrome * Grade 4 neutropenia of \> 7 days duration * Grade 4 thrombocytopenia. * Grade 3 thrombocytopenia with clinically significant bleeding. * Febrile neutropenia Any AE that is not clearly due to disease progression or extraneous causes that occurs within the 28-day DLT evaluation window and meets criteria for permanent discontinuation will be considered a DLT.
From Cycle 1 day 1 to day 28 (28 Days)
Number of Participants Who Died
Number of Participants who died
From first dose to 100 days post last dose (Approximately 6 Months)

Secondary Outcomes (6)

CMax
On Cycle 1 Day 1 and on Cycle 4 Day 1 (Each cycle = 3 Weeks)
Tmax
On Cycle 1 Day 1 and on Cycle 4 Day 1 (Each cycle = 3 Weeks)
AUC (Tau)
On Cycle 1 Day 1 and on Cycle 4 Day 1 (Each cycle = 3 Weeks)
Number of Participants With BMS-986442 Anti Drug Antibody (ADA)
From first dose to 100 days post last dose (Approximately 6 Months)
Objective Response Rate (ORR) Per Recist v1.1 by Investigator
From first dose to 100 days post last dose (Approximately 6 Months)
+1 more secondary outcomes

Study Arms (6)

Part A: BMS-986442 + Nivolumab

EXPERIMENTAL

Biological: BMS-986442Biological: Nivolumab

Part B1: BMS-986442 + Nivolumab

EXPERIMENTAL

Second line (2L) + Post-immuno-oncology (IO)/Platinum-Doublet Non-small cell lung cancer (NSCLC)

Biological: BMS-986442Biological: Nivolumab

Part B2: BMS-986442 + Nivolumab

EXPERIMENTAL

Post IO Gastric Cancer/Gastroesophageal Junction and Post-IO squamous cell carcinoma of the head and neck (SCCHN)

Biological: BMS-986442Biological: Nivolumab

Part C: BMS-986442 + Nivolumab + Docetaxel

EXPERIMENTAL

Biological: BMS-986442Biological: NivolumabDrug: Docetaxel

Part D: BMS-986442 + Nivolumab + Carboplatin + Pemetrexed

EXPERIMENTAL

Biological: BMS-986442Biological: NivolumabDrug: CarboplatinDrug: Pemexetred

Part E: BMS-986442 + Nivolumab + Carboplatin + Paclitaxel

EXPERIMENTAL

Biological: BMS-986442Biological: NivolumabDrug: CarboplatinDrug: Paclitaxel