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

NCT05298592 | Completed Phase 1 FDA Drug

• 3 other identifiers: CA111-0012021-006872-17U1111-1270-3670
• Study Type: interventional
• Target: 77
• Locations: 6 countries
• Sites: 29

Brief Summary

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.

Conditions

Advanced Cancer

Keywords

Opdivo®; Immunotherapy

Outcome Measures

Primary Outcomes (5)

• Number of participants with adverse events (AEs)

  Up to 100 days

• Number of participants with serious adverse events (SAEs)

  Up to 100 days

• Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria

  Up to 28 days

• Number of participants with AEs leading to discontinuation

  Up to 100 days

• Number of participants with death

  Up to 100 days

Secondary Outcomes (9)

• Maximum observed plasma concentration (Cmax)

  Up to 14 days

• Time of maximum observed plasma concentration (Tmax)

  Up to 14 days

• Trough observed plasma concentration (Ctrough)

  Up to 14 days

• Incidence of anti-drug antibody (ADAs)

  Up to 14 days

• Objective response rate (ORR)

  Up to 24 months

Study Arms (5)

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

EXPERIMENTAL

Biological: BMS-986406

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

EXPERIMENTAL

Biological: BMS-986406; Biological: Nivolumab

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

EXPERIMENTAL

Biological: BMS-986406; Biological: Nivolumab

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

EXPERIMENTAL

Biological: BMS-986406; Biological: Nivolumab

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

EXPERIMENTAL

Biological: BMS-986406; Biological: Nivolumab; Drug: Carboplatin; Drug: Pemetrexed; Drug: Paclitaxel

Interventions

BMS-986406 BIOLOGICAL

Specified dose on specified days

Part 1A: BMS-986406 (Monotherapy Dose Escalation); Part 1B: BMS-986406 + Nivolumab (Combination Dose Escalation); Part 1C: BMS-986406 + Nivolumab (Indication-Specific Dose Expansion); Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or Paclitaxel; Part 2: BMS-986406 + Nivolumab (Expansion Cohorts)

Nivolumab BIOLOGICAL

Specified dose on specified days

Also known as: BMS-936558, Opdivo

Part 1B: BMS-986406 + Nivolumab (Combination Dose Escalation); Part 1C: BMS-986406 + Nivolumab (Indication-Specific Dose Expansion); Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or Paclitaxel; Part 2: BMS-986406 + Nivolumab (Expansion Cohorts)

Carboplatin DRUG

Specified dose on specified days

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

Pemetrexed DRUG

Specified dose on specified days

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

Paclitaxel DRUG

Specified dose on specified days

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior organ or tissue allograft
• Leptomeningeal metastases
• Untreated CNS metastases
• Serious or uncontrolled medical disorders

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (29)

Local Institution - 0021

Birmingham, Alabama, 35213, United States

Location

University California San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

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

Los Angeles, California, 90025, United States

Location

UCLA Health

Los Angeles, California, 90404, United States

Location

Local Institution - 0001

Hackensack, New Jersey, 07601, United States

Location

Carolina BioOncology Institute, PLLC

Huntersville, North Carolina, 28078, United States

Location

Sanford Cancer Center

Sioux Falls, South Dakota, 57104, United States

Location

Mary Crowley Cancer Research - Medical City Hospital

Dallas, Texas, 75230, United States

Location

Local Institution - 0006

Richmond, Virginia, 23298, United States

Location

Local Institution - 0029

Viedma, Río Negro Province, 8500, Argentina

Location

Local Institution - 0023

Rosario, Santa Fe Province, 2000, Argentina

Location

Local Institution - 0028

Buenos Aires, C1280, Argentina

Location

Local Institution - 0032

Córdoba, 5002, Argentina

Location

Local Institution - 0018

Jette, Brussels Capital, 1090, Belgium

Location

Local Institution - 0015

Edegem, MA, 2650, Belgium

Location

Local Institution - 0012

Brussels, 1200, Belgium

Location

Local Institution - 0031

Kashiwa-shi, Chiba, 2778577, Japan

Location

Local Institution - 0026

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Local Institution - 0024

Seoul, 3080, South Korea

Location

Local Institution - 0027

Seoul, 3722, South Korea

Location

Local Institution - 0025

Seoul, 6351, South Korea

Location

Local Institution - 0008

Málaga, Andaluca, 29010, Spain

Location

Local Institution - 0030

Barcelona, 08023, Spain

Location

Local Institution - 0017

Barcelona, 08035, Spain

Location

Institut Catala dOncologia ICO - Hospital Duran i Reynals Location

Barcelona, 08908, Spain

Location

Local Institution - 0014

Madrid, 28027, Spain

Location

Local Institution - 0009

Madrid, 28041, Spain

Location

Local Institution - 0016

Madrid, 28050, Spain

Location

Local Institution - 0033

Pamplona, 31008, Spain

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

Nivolumab; Carboplatin; Pemetrexed; Paclitaxel

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: March 28, 2022
• Study Start: March 31, 2022
• Primary Completion: August 16, 2024
• Study Completion: August 16, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-09

Locations

US (9); KR (4); AR (4); BE (3); ES (8); JP (1)