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

A Phase 1 First-in-human Study of BMS-986406 as Monotherapy and Combination Therapies in Participants With Advanced Malignant Tumors

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Cancer
• Intervention / Treatment: Biological: Nivolumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Pemetrexed; Biological: BMS-986406

• Study Type: Interventional
• Enrollment (Estimated): 154
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: BMS Study Connect Contact Center www.BMSStudyConnect.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com
• Study Contact Backup: Name: First line of email MUST contain NCT # and Site #.

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1280
    • Not yet recruiting
    • Local Institution - 0028
    • Contact: Site 0028
  • Cordoba, Argentina, 5002
    • Not yet recruiting
    • Local Institution - 0032
    • Contact: Site 0032
  • Rio Negro
    • Viedma, Rio Negro, Argentina, 8500
      • Not yet recruiting
      • Local Institution - 0029
      • Contact: Site 0029
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • Not yet recruiting
      • Local Institution - 0023
      • Contact: Site 0023
• Belgium
  • Brussels, Belgium, 1200
    • Recruiting
    • Cliniques Universitaires Saint Luc
    • Contact: Jean-Pascal Machiels, Site 0012; Phone Number: 3227645457
  • Leuven, Belgium, 3000
    • Withdrawn
    • Local Institution - 0011
  • Brussel
    • Brussel (Jette), Brussel, Belgium, 1090
      • Not yet recruiting
      • Local Institution - 0018
      • Contact: Site 0018
  • MA
    • Edegem, MA, Belgium, 2650
      • Not yet recruiting
      • Local Institution - 0015
      • Contact: Site 0015
• Japan
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 2778577
      • Recruiting
      • National Cancer Center Hospital East
      • Contact: Shigehiro Koganemaru, Site 0031; Phone Number: 81471331111
• Korea, Republic of
  • Seoul, Korea, Republic of, 3080
    • Not yet recruiting
    • Local Institution - 0024
    • Contact: Site 0024
  • Seoul, Korea, Republic of, 3722
    • Not yet recruiting
    • Local Institution - 0027
    • Contact: Site 0027
  • Seoul, Korea, Republic of, 6351
    • Not yet recruiting
    • Local Institution - 0025
    • Contact: Site 0025
  • Gyeonggi-do
    • Seongnam, Gyeonggi-do, Korea, Republic of, 13620
      • Not yet recruiting
      • Local Institution - 0026
      • Contact: Site 0026
• Spain
  • Barcelona, Spain, 08908
    • Recruiting
    • Institut Catala Doncologia Ico - Hospital Duran I Reynals Location
    • Contact: Marta Gil Martin, Site 0007; Phone Number: 34932607294932607744
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitario Vall Dhebron
    • Contact: Elena Garralda Cabanas, Site 0017; Phone Number: 349327460004910
  • Barcelona, Spain, 08023
    • Not yet recruiting
    • Local Institution - 0022
    • Contact: Site 0022
  • Barcelona, Spain, 08023
    • Recruiting
    • Hospital Hm Nou Delfos
    • Contact: Tatiana Hernandez, Site 0030
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital 12 de Octubre
    • Contact: Rocio Garcia Carbonero, Site 0009; Phone Number: 34913908003
  • Madrid, Spain, 28027
    • Recruiting
    • Local Institution - 0014
    • Contact: Site 0014
  • Madrid, Spain, 28023
    • Recruiting
    • START madrid-CIOCC Hospital Universitario HM Sanchinarro
    • Contact: Emiliano Calvo Aller, Site 0016; Phone Number: +34620423957
  • Pamplona, Spain, 31008
    • Recruiting
    • Local Institution - 0033
    • Contact: Site 0033
  • Andaluca
    • Malaga, Andaluca, Spain, 29010
      • Recruiting
      • Local Institution - 0008
      • Contact: Site 0008
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35213
      • Not yet recruiting
      • The Kirklin Clinic of UAB Hospital, Birmingham, AL
      • Contact: Mehmet Akce, Site 0021; Phone Number: +19343411
  • California
    • La Jolla, California, United States, 92093
      • Recruiting
      • University California San Diego Moores Cancer Center
      • Contact: Sandip Patel, Site 0010; Phone Number: 858-822-1962
    • Los Angeles, California, United States, 90025
      • Recruiting
      • The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate
      • Contact: Omid Hamid, Site 0004; Phone Number: 310-231-2121
    • Los Angeles, California, United States, 90404
      • Not yet recruiting
      • UCLA Health
      • Contact: Zev Wainberg, Site 0020; Phone Number: 310-829-5471
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Not yet recruiting
      • Yale Cancer Center
      • Contact: So Yeon Kim, Site 0034
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Recruiting
      • Hackensack University Medical Center
      • Contact: Martin Gutierrez, Site 0001; Phone Number: 551-996-5863
  • New York
    • New York, New York, United States, 10016
      • Withdrawn
      • NYU Langone Medical Center
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Recruiting
      • Carolina BioOncology Institute, PLLC
      • Contact: John Powderly, Site 0002; Phone Number: 704-654-0485
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111-2497
      • Withdrawn
      • Fox Chase Cancer Center
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Recruiting
      • Sanford Cancer Center
      • Contact: Steven Powell, Site 0013; Phone Number: 605-328-8000
  • Texas
    • Dallas, Texas, United States, 75230
      • Recruiting
      • Mary Crowley Cancer Research - Medical City Hospital
      • Contact: Minal Barve, Site 0005; Phone Number: 972-566-3000
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Recruiting
      • VCU Massey Cancer Center
      • Contact: Andrew Poklepovic, Site 0006; Phone Number: 804-628-2321

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1A: BMS-986406 (Monotherapy Dose Escalation)	Biological: BMS-986406; Specified dose on specified days
Experimental: Part 1B: BMS-986406 + Nivolumab (Combination Dose Escalation)	Biological: Nivolumab; Specified dose on specified days; Other Names: BMS-936558; Opdivo; Biological: BMS-986406; Specified dose on specified days
Experimental: Part 1C: BMS-986406 + Nivolumab (Indication-Specific Dose Expansion)	Biological: Nivolumab; Specified dose on specified days; Other Names: BMS-936558; Opdivo; Biological: BMS-986406; Specified dose on specified days
Experimental: Part 2: BMS-986406 + Nivolumab (Expansion Cohorts)	Biological: Nivolumab; Specified dose on specified days; Other Names: BMS-936558; Opdivo; Biological: BMS-986406; Specified dose on specified days
Experimental: Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or Paclitaxel	Biological: Nivolumab; Specified dose on specified days; Other Names: BMS-936558; Opdivo; Drug: Carboplatin; Specified dose on specified days; Drug: Paclitaxel; Specified dose on specified days; Drug: Pemetrexed; Specified dose on specified days; Biological: BMS-986406; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Disease control rate (DCR)	Up to 24 months
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
Duration of response (DOR) per tumor appropriate criteria: Modified Response Evaluation Criteria in Solid Tumors (mRECIST) for mesothelioma	Up to 24 months
DOR per tumor appropriate criteria: Prostate Cancer Working Group 3 (PCWG3) for prostate cancer	Up to 24 months
DOR per tumor appropriate criteria: Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) for other solid tumor types	Up to 24 months

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2022
• Primary Completion (Estimated): April 9, 2026
• Study Completion (Estimated): July 8, 2026

Study Registration Dates

• First Submitted: March 17, 2022
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (Actual): March 28, 2022

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Immunotherapy; Opdivo®
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Folic Acid Antagonists; Carboplatin; Paclitaxel; Nivolumab; Pemetrexed
• Other Study ID Numbers: CA111-001; 2021-006872-17 (EudraCT Number); U1111-1270-3670 (Registry Identifier: WHO)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No