A Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid Tumors
NCT ID: NCT05625412
Last Updated: 2025-06-13
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
70 participants
INTERVENTIONAL
2022-12-09
2025-05-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BMS-986360
BMS-986360
Specified dose on specified days
BMS-986360 + Docetaxel
BMS-986360
Specified dose on specified days
Docetaxel
Specified dose on specified days
BMS-986360 + Nivolumab
BMS-986360
Specified dose on specified days
Nivolumab
Specified dose on specified days
BMS-986360 + Capecitabine
BMS-986360
Specified dose on specified days
Capecitabine
Specified dose on specified days
Interventions
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BMS-986360
Specified dose on specified days
Docetaxel
Specified dose on specified days
Nivolumab
Specified dose on specified days
Capecitabine
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* In Part 2, archival biopsy collected within 3 months of screening with no intervening therapy (formalin-fixed, paraffin embedded \[FFPE\] blocks or a minimum of 20 freshly cut unstained FFPE slides with an associated pathological report) or fresh biopsy collection at Screening and fresh biopsy collection at cycle 3 day 1 (C3D1) (± 5 days) are mandatory, while it is strongly encouraged but optional at progression. Therefore, the participant in Part 2 must have a suitable tumor lesion for the biopsy procedure, as judged by the investigator, in order to be eligible for the study.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Participants resistant/refractory to or intolerant of existing standard therapies known to provide clinical benefit (in addition, participants with NSCLC must be resistant or refractory to anti-PD-(L)1-based immunotherapy)
Exclusion Criteria
* Participants with a condition requiring systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalent) within 14 days or other immunosuppressive medications within 30 days of randomization. Inhaled or topical steroids and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease.
* Participants with concurrent malignancy or history of prior malignancy active within 2 years (except history of early-stage basal/squamous cell skin cancer or non-invasive or in situ cancers who have undergone definitive treatment) are excluded unless treatment was completed at least 2 years before randomization and the participant has no evidence of disease.
* Participants with NSCLC with known or not tested for epidermal growth factor receptor (EGFR) or V-raf murine sarcoma viral oncogene homolog B1 (BRAF) V600E mutations, or anaplastic lymphoma kinase (ALK) or receptor tyrosine kinase (ROS1) translocations sensitive to available targeted inhibitor therapy
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 - 0029
Los Angeles, California, United States
Local Institution - 0051
Los Angeles, California, United States
Local Institution - 0026
New Orleans, Louisiana, United States
Local Institution - 0001
Hackensack, New Jersey, United States
Local Institution - 0018
Huntersville, North Carolina, United States
Local Institution - 0028
Nashville, Tennessee, United States
Local Institution - 0027
San Antonio, Texas, United States
Local Institution - 0046
West Valley City, Utah, United States
Local Institution - 0033
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0030
CABA, Buenos Aires F.D., Argentina
Local Institution - 0031
Buenos Aires, , Argentina
Local Institution - 0010
Darlinghurst, New South Wales, Australia
Local Institution - 0061
St Leonards, New South Wales, Australia
Local Institution - 0008
Brisbane, Queensland, Australia
Local Institution - 0063
Frankston, Victoria, Australia
Local Institution - 0003
Ottawa, Ontario, Canada
Local Institution - 0005
Toronto, Ontario, Canada
Local Institution - 0047
Santiago, Santiago Metropolitan, Chile
Local Institution - 0035
Santiago, Santiago Metropolitan, Chile
Local Institution - 0034
Santiago, Santiago Metropolitan, Chile
Local Institution - 0049
Marseille, Provence-Alpes-Côte d'Azur Region, France
Local Institution - 0052
Villejuif, Val-de-Marne, France
Local Institution - 0048
Paris, , France
Local Institution - 0050
Toulouse, , France
Local Institution - 0057
Rozzano, Milano, Italy
Local Institution - 0059
Candiolo, Torino, Italy
Local Institution - 0065
Padua, , Italy
Local Institution - 0041
Zapopan, Jalisco, Mexico
Local Institution - 0038
Mexico City, Mexico City, Mexico
Local Institution - 0039
Monterrey, Nuevo León, Mexico
Local Institution - 0037
Puebla City, , Mexico
Local Institution - 0053
Barcelona, Catalunya [Cataluña], Spain
Local Institution - 0055
Madrid, Madrid, Comunidad de, Spain
Local Institution - 0056
Madrid, Madrid, Comunidad de, Spain
Local Institution - 0064
Seville, , 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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2022-500930-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IM043-004
Identifier Type: -
Identifier Source: org_study_id
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