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
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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COMPLETED
PHASE1
77 participants
INTERVENTIONAL
2022-03-31
2024-08-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1A: BMS-986406 (Monotherapy Dose Escalation)
BMS-986406
Specified dose on specified days
Part 1B: BMS-986406 + Nivolumab (Combination Dose Escalation)
BMS-986406
Specified dose on specified days
Nivolumab
Specified dose on specified days
Part 1C: BMS-986406 + Nivolumab (Indication-Specific Dose Expansion)
BMS-986406
Specified dose on specified days
Nivolumab
Specified dose on specified days
Part 2: BMS-986406 + Nivolumab (Expansion Cohorts)
BMS-986406
Specified dose on specified days
Nivolumab
Specified dose on specified days
Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or Paclitaxel
BMS-986406
Specified dose on specified days
Nivolumab
Specified dose on specified days
Carboplatin
Specified dose on specified days
Pemetrexed
Specified dose on specified days
Paclitaxel
Specified dose on specified days
Interventions
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BMS-986406
Specified dose on specified days
Nivolumab
Specified dose on specified days
Carboplatin
Specified dose on specified days
Pemetrexed
Specified dose on specified days
Paclitaxel
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Leptomeningeal metastases
* Untreated CNS metastases
* Serious or uncontrolled medical disorders
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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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
University California San Diego Moores Cancer Center
La Jolla, California, United States
The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate
Los Angeles, California, United States
UCLA Health
Los Angeles, California, United States
Local Institution - 0001
Hackensack, New Jersey, United States
Carolina BioOncology Institute, PLLC
Huntersville, North Carolina, United States
Sanford Cancer Center
Sioux Falls, South Dakota, United States
Mary Crowley Cancer Research - Medical City Hospital
Dallas, Texas, United States
Local Institution - 0006
Richmond, Virginia, United States
Local Institution - 0029
Viedma, Río Negro Province, Argentina
Local Institution - 0023
Rosario, Santa Fe Province, Argentina
Local Institution - 0028
Buenos Aires, , Argentina
Local Institution - 0032
Córdoba, , Argentina
Local Institution - 0018
Jette, Brussels Capital, Belgium
Local Institution - 0015
Edegem, MA, Belgium
Local Institution - 0012
Brussels, , Belgium
Local Institution - 0031
Kashiwa-shi, Chiba, Japan
Local Institution - 0026
Seongnam-si, Gyeonggi-do, South Korea
Local Institution - 0024
Seoul, , South Korea
Local Institution - 0027
Seoul, , South Korea
Local Institution - 0025
Seoul, , South Korea
Local Institution - 0008
Málaga, Andaluca, Spain
Local Institution - 0030
Barcelona, , Spain
Local Institution - 0017
Barcelona, , Spain
Institut Catala dOncologia ICO - Hospital Duran i Reynals Location
Barcelona, , Spain
Local Institution - 0014
Madrid, , Spain
Local Institution - 0009
Madrid, , Spain
Local Institution - 0016
Madrid, , Spain
Local Institution - 0033
Pamplona, , Spain
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
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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