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Completed

NCT Number: NCT05298592

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0029, Viedma, Río Negro Province, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986406

Biological

Specified dose on specified days

Nivolumab

Biological

Specified dose on specified days

Other names: BMS-936558, Opdivo

carboplatin

Drug

Specified dose on specified days

Pemetrexed

Drug

Specified dose on specified days

paclitaxel

Drug

Specified dose on specified days

Primary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to 100 days

  2. Number of participants with serious adverse events (SAEs)

    Time frame: Up to 100 days

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

    Time frame: Up to 28 days

  4. Number of participants with AEs leading to discontinuation

    Time frame: Up to 100 days

  5. Number of participants with death

    Time frame: Up to 100 days

Secondary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to 14 days

  2. Time of maximum observed plasma concentration (Tmax)

    Time frame: Up to 14 days

  3. Trough observed plasma concentration (Ctrough)

    Time frame: Up to 14 days

  4. Incidence of anti-drug antibody (ADAs)

    Time frame: Up to 14 days

  5. Objective response rate (ORR)

    Time frame: Up to 24 months

  6. Disease control rate (DCR)

    Time frame: Up to 24 months

  7. Duration of response (DOR) per tumor appropriate criteria: Modified Response Evaluation Criteria in Solid Tumors (mRECIST) for mesothelioma

    Time frame: Up to 24 months

  8. DOR per tumor appropriate criteria: Prostate Cancer Working Group 3 (PCWG3) for prostate cancer

    Time frame: Up to 24 months

  9. DOR per tumor appropriate criteria: Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) for other solid tumor types

    Time frame: Up to 24 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 28, 2022
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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