A Study of BMS-986406 as Monotherapy and Combination Therapies in Participants With Advanced Tumors

NCT ID: NCT05298592

Last Updated: 2024-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-31

Study Completion Date

2024-08-16

Brief Summary

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The purpose of this study is to assess the safety and tolerability of BMS-986406 administered alone, in combination with nivolumab, or in combination with nivolumab and platinum-doublet chemotherapy (PDCT) in participants with advanced tumors.

Detailed Description

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Conditions

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Advanced Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1A: BMS-986406 (Monotherapy Dose Escalation)

Group Type EXPERIMENTAL

BMS-986406

Intervention Type BIOLOGICAL

Specified dose on specified days

Part 1B: BMS-986406 + Nivolumab (Combination Dose Escalation)

Group Type EXPERIMENTAL

BMS-986406

Intervention Type BIOLOGICAL

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Part 1C: BMS-986406 + Nivolumab (Indication-Specific Dose Expansion)

Group Type EXPERIMENTAL

BMS-986406

Intervention Type BIOLOGICAL

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Part 2: BMS-986406 + Nivolumab (Expansion Cohorts)

Group Type EXPERIMENTAL

BMS-986406

Intervention Type BIOLOGICAL

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or Paclitaxel

Group Type EXPERIMENTAL

BMS-986406

Intervention Type BIOLOGICAL

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Carboplatin

Intervention Type DRUG

Specified dose on specified days

Pemetrexed

Intervention Type DRUG

Specified dose on specified days

Paclitaxel

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986406

Specified dose on specified days

Intervention Type BIOLOGICAL

Nivolumab

Specified dose on specified days

Intervention Type BIOLOGICAL

Carboplatin

Specified dose on specified days

Intervention Type DRUG

Pemetrexed

Specified dose on specified days

Intervention Type DRUG

Paclitaxel

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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BMS-936558 Opdivo

Eligibility Criteria

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Inclusion Criteria

Parts 1A, 1B, 1C:

* Histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent malignant tumor. Eligible tumor types are non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction, castration-resistant prostate cancer (CRPC), ovarian, squamous cell carcinoma of the head and neck (SCCHN), bladder, melanoma, mesothelioma, triple negative breast cancer (TNBC), and soft tissue sarcoma, except for participants with tumors with central nervous system (CNS) metastases as the only site of active disease

Part 1D:

* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of non-squamous or squamous histology with Stage IV A/B (as defined by the 8th International Association for the Study of Lung Cancer Classification) or recurrent disease following multi-modal therapy for locally advanced disease, who have not had systemic therapy for metastatic or recurrent disease.

All Parts:

* Measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), Prostate Cancer Working Group 3 (PCWG3) (for prostate cancer), or modified Response Evaluation Criteria in Solid tumors (mRECIST) (for mesothelioma)
* Eastern Cooperative Oncology Group Performance Status of 0 or 1
* Adequate organ function

Exclusion Criteria

* Prior organ or tissue allograft
* Leptomeningeal metastases
* Untreated CNS metastases
* Serious or uncontrolled medical disorders
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0021

Birmingham, Alabama, United States

Site Status

University California San Diego Moores Cancer Center

La Jolla, California, United States

Site Status

The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate

Los Angeles, California, United States

Site Status

UCLA Health

Los Angeles, California, United States

Site Status

Local Institution - 0001

Hackensack, New Jersey, United States

Site Status

Carolina BioOncology Institute, PLLC

Huntersville, North Carolina, United States

Site Status

Sanford Cancer Center

Sioux Falls, South Dakota, United States

Site Status

Mary Crowley Cancer Research - Medical City Hospital

Dallas, Texas, United States

Site Status

Local Institution - 0006

Richmond, Virginia, United States

Site Status

Local Institution - 0029

Viedma, Río Negro Province, Argentina

Site Status

Local Institution - 0023

Rosario, Santa Fe Province, Argentina

Site Status

Local Institution - 0028

Buenos Aires, , Argentina

Site Status

Local Institution - 0032

Córdoba, , Argentina

Site Status

Local Institution - 0018

Jette, Brussels Capital, Belgium

Site Status

Local Institution - 0015

Edegem, MA, Belgium

Site Status

Local Institution - 0012

Brussels, , Belgium

Site Status

Local Institution - 0031

Kashiwa-shi, Chiba, Japan

Site Status

Local Institution - 0026

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Local Institution - 0024

Seoul, , South Korea

Site Status

Local Institution - 0027

Seoul, , South Korea

Site Status

Local Institution - 0025

Seoul, , South Korea

Site Status

Local Institution - 0008

Málaga, Andaluca, Spain

Site Status

Local Institution - 0030

Barcelona, , Spain

Site Status

Local Institution - 0017

Barcelona, , Spain

Site Status

Institut Catala dOncologia ICO - Hospital Duran i Reynals Location

Barcelona, , Spain

Site Status

Local Institution - 0014

Madrid, , Spain

Site Status

Local Institution - 0009

Madrid, , Spain

Site Status

Local Institution - 0016

Madrid, , Spain

Site Status

Local Institution - 0033

Pamplona, , Spain

Site Status

Countries

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United States Argentina Belgium Japan South Korea Spain

Related Links

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Other Identifiers

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2021-006872-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1270-3670

Identifier Type: REGISTRY

Identifier Source: secondary_id

CA111-001

Identifier Type: -

Identifier Source: org_study_id

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