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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05625412
Registration number
NCT05625412
Ethics application status
Date submitted
15/11/2022
Date registered
22/11/2022
Date last updated
9/05/2024
Titles & IDs
Public title
A Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid Tumors
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Scientific title
A Phase 1, Open-label, Multicenter Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid Tumors
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Secondary ID [1]
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2022-500930-27
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Secondary ID [2]
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IM043-004
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BMS-986360
Treatment: Drugs - Docetaxel
Treatment: Drugs - Nivolumab
Treatment: Drugs - Capecitabine
Experimental: BMS-986360 -
Experimental: BMS-986360 + Docetaxel -
Experimental: BMS-986360 + Nivolumab -
Experimental: BMS-986360 + Capecitabine -
Treatment: Drugs: BMS-986360
Specified dose on specified days
Treatment: Drugs: Docetaxel
Specified dose on specified days
Treatment: Drugs: Nivolumab
Specified dose on specified days
Treatment: Drugs: Capecitabine
Specified dose on specified days
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of participants with Adverse Events (AEs)
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Assessment method [1]
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Timepoint [1]
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Up to approximately 2 years
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Primary outcome [2]
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Number of participants with Serious Adverse Events (SAEs)
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Assessment method [2]
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Timepoint [2]
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Up to approximately 2 years
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Primary outcome [3]
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Number of participants with Dose-Limiting Toxicities (DLTs)
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Assessment method [3]
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Timepoint [3]
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Up to approximately 2 years
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Primary outcome [4]
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Number of participants with AEs leading to discontinuation
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Assessment method [4]
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Timepoint [4]
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Up to approximately 2 years
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Primary outcome [5]
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Number of deaths
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Assessment method [5]
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Timepoint [5]
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Up to approximately 2 years
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Secondary outcome [1]
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Maximum observed plasma concentration (Cmax)
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Assessment method [1]
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Timepoint [1]
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Up to approximately 2 years
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Secondary outcome [2]
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Time of maximum observed plasma concentration (Tmax)
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Assessment method [2]
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Timepoint [2]
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Up to approximately 2 years
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Secondary outcome [3]
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Area under the plasma concentration-time curve (AUC)
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Assessment method [3]
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Timepoint [3]
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Up to approximately 2 years
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Secondary outcome [4]
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Part 1: Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST v1.1) by investigator
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Assessment method [4]
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Timepoint [4]
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Up to approximately 2 years
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Secondary outcome [5]
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Part 2: ORR based on RECIST v1.1 by blinded independent central review (BICR) assessment
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Assessment method [5]
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Timepoint [5]
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Up to approximately 2 years
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Secondary outcome [6]
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Part 1: Duration of Response (DOR) based on RECIST v1.1 by investigator
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Assessment method [6]
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Timepoint [6]
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Up to approximately 2 years
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Secondary outcome [7]
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Part 2: DOR based on RECIST v1.1 by BICR assessment
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Assessment method [7]
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Timepoint [7]
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Up to approximately 2 years
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Eligibility
Key inclusion criteria
- Participants in Part 1 must have histologic or cytologic confirmation of non-small
cell lung cancer (NSCLC), metastatic triple negative breast cancer (mTNBC), squamous
cell carcinoma of head and neck (SCCHN), pancreatic adenocarcinoma (PAAD), renal cell
carcinoma (RCC), microsatellite-stable colorectal carcinoma (MSS CRC), or sarcoma,
that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease
per RECIST v1.1. In Part 2, only participants with histologic confirmation of advanced
NSCLC or mTNBC with measurable disease per RECIST v1.1 are eligible.
- 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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Participants with primary central nervous system (CNS) disease, or tumors with CNS
metastases as the only disease site, will be excluded. Participants with controlled
brain metastases, however, will be allowed to enroll. Controlled brain metastases are
defined as no radiographic progression for at least 4 weeks following radiation and/or
surgical treatment (or 4 weeks of observation if no intervention is clinically
indicated), no longer taking steroids for at least 2 weeks prior to first dose of
study intervention, and with no new or progressive neurological signs and symptoms.
- 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
Other protocol-defined inclusion/exclusion criteria apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/12/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/07/2027
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Actual
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Sample size
Target
220
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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St Vincent's Hospital - The Kinghorn Cancer Center - Darlinghurst
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Recruitment hospital [2]
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GenesisCare North Shore - St Leonards
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Recruitment hospital [3]
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Gallipoli Medical Research Ltd - Brisbane
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Recruitment hospital [4]
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Frankston Hospital - Frankston
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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2065 - St Leonards
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Recruitment postcode(s) [3]
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4120 - Brisbane
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Recruitment postcode(s) [4]
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3199 - Frankston
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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Hawaii
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United States of America
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Louisiana
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United States of America
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New Jersey
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Country [5]
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United States of America
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State/province [5]
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North Carolina
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Country [6]
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United States of America
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State/province [6]
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Tennessee
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Country [7]
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United States of America
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State/province [7]
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Texas
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Country [8]
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United States of America
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State/province [8]
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Utah
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Country [9]
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Argentina
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State/province [9]
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Buenos Aires
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Country [10]
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Argentina
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State/province [10]
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Ciudad Autónoma De Buenos Aires
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Country [11]
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Argentina
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State/province [11]
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Ciudad Autónoma de Buenos Aires
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Country [12]
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Canada
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State/province [12]
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Ontario
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Country [13]
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Chile
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State/province [13]
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Región Metropolitana De Santiago
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Country [14]
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France
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State/province [14]
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Provence-Alpes-Côte-d'Azur
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Country [15]
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France
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State/province [15]
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Val-de-Marne
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France
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Paris
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France
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Toulouse
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Italy
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Milano
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Italy
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Torino
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Italy
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Padova
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Mexico
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Distrito Federal
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Mexico
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Jalisco
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Country [23]
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Mexico
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State/province [23]
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Nuevo León
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Mexico
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State/province [24]
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Puebla
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Spain
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Catalunya [Cataluña]
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Country [26]
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Spain
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State/province [26]
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Madrid, Comunidad De
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Country [27]
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Spain
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State/province [27]
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Sevilla
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The aim of this study is to assess the safety and tolerability of BMS-986360 as monotherapy
and in combination with chemotherapy or nivolumab in participants with advanced solid tumors.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05625412
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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BMS Study Connect Contact Center www.BMSStudyConnect.com
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Address
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Country
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Phone
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855-907-3286
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05625412
Download to PDF