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Monoclonal Antibodies

BMS-986442 + Nivolumab for Lung Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6 months and 12 months

Awards & highlights

Study Summary

This trial is testing a new cancer drug, BMS-986442, in combination with nivolumab, with or without chemotherapy. They want to see if it is effective against tumors and if it has any benefits for participants.

Who is the study for?

This trial is for adults with certain types of lung or solid tumors who are in fairly good physical condition (able to carry out daily activities with ease or minor limitations) and expected to live at least 3 more months. They must have measurable tumor growth that can be tracked over time. People with untreated brain metastases, another cancer needing treatment, or active autoimmune diseases cannot join.Check my eligibility

What is being tested?

The study tests BMS-986442 combined with Nivolumab, a type of immunotherapy, and may include chemotherapy drugs like Pemexetred, Paclitaxel, Docetaxel, or Carboplatin. The goal is to see if this combination helps shrink the tumors better than current treatments.See study design

What are the potential side effects?

Possible side effects might include immune-related reactions affecting different organs which could cause symptoms like fatigue, skin rash or digestive issues; infusion reactions during drug administration; and typical chemotherapy side effects such as nausea and hair loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6 months and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6 months and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of AEs leading to death

Incidence of AEs leading to discontinuation

Incidence of AEs meeting protocol-defined Dose Limiting Toxicity (DLT) criteria

+2 more

Secondary outcome measures

Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])

Disease Control Rate (DCR)

Duration of Response (DOR)

+5 more

Trial Design

6Treatment groups

Experimental Treatment

Group I: Part E: BMS-986442 + Nivolumab + Carboplatin + PaclitaxelExperimental Treatment4 Interventions

Group II: Part D: BMS-986442 + Nivolumab + Carboplatin + PemetrexedExperimental Treatment4 Interventions

Group III: Part C: BMS-986442 + Nivolumab + DocetaxelExperimental Treatment3 Interventions

Group IV: Part B2: BMS-986442 + NivolumabExperimental Treatment2 Interventions

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

Group V: Part B1: BMS-986442 + NivolumabExperimental Treatment2 Interventions

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

Group VI: Part A: BMS-986442 + NivolumabExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5380

Nivolumab

2014

Completed Phase 3

~4750

Docetaxel

1995

Completed Phase 4

~5620

Carboplatin

2014

Completed Phase 3

~6670

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,635 Previous Clinical Trials

4,126,654 Total Patients Enrolled

Media Library

BMS-986442 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05543629 — Phase 1 & 2

Non-Small Cell Lung Cancer Research Study Groups: Part A: BMS-986442 + Nivolumab, Part E: BMS-986442 + Nivolumab + Carboplatin + Paclitaxel, Part B1: BMS-986442 + Nivolumab, Part B2: BMS-986442 + Nivolumab, Part C: BMS-986442 + Nivolumab + Docetaxel, Part D: BMS-986442 + Nivolumab + Carboplatin + Pemetrexed

Non-Small Cell Lung Cancer Clinical Trial 2023: BMS-986442 Highlights & Side Effects. Trial Name: NCT05543629 — Phase 1 & 2

BMS-986442 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05543629 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this trial still open?

"Data taken from clinicaltrials.gov indicates that this trial, first posted on October 4th 2022 and recently updated on November 21st 2022, is still recruiting participants."

Answered by AI

What is the scope of this trial in terms of participants?

"The study necessitates the inclusion of 225 eligible participants, recruitable from two distinct sites: Carolina BioOncology Institute in Huntersville, North carolina and John Theurer Cancer Center at Hackensack University Medical Center located in Hackensack, New jersey."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "A Study of BMS-986442 With Nivolumab With or Without Chemotherapy in Solid Tumors and Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05543629.

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