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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03662659
Registration number
NCT03662659
Ethics application status
Date submitted
6/09/2018
Date registered
7/09/2018
Date last updated
13/02/2024
Titles & IDs
Public title
An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers
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Scientific title
A Randomized, Open-label, Phase II Clinical Trial of Relatlimab (Anti-LAG-3) and Nivolumab in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy as First-Line Treatment in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma
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Secondary ID [1]
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2018-001069-18
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Secondary ID [2]
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CA224-060
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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:
Gastric Cancer
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Cancer of the Stomach
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Esophagogastric Junction
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Condition category
Condition code
Cancer
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0
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0
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Stomach
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - BMS-986213
Treatment: Other - Nivolumab
Treatment: Drugs - XELOX
Treatment: Drugs - FOLFOX
Treatment: Drugs - SOX
Experimental: BMS-986213 + investigator's choice chemotherapy - BMS-986213 + XELOX or BMS-986213 + FOLFOX or BMS-986213 + SOX
Experimental: Nivolumab + investigator's choice chemotherapy - Nivolumab + XELOX or Nivolumab + FOLFOX or Nivolumab + SOX
Treatment: Other: BMS-986213
Relatlimab + Nivolumab specified dose on specified days
Treatment: Other: Nivolumab
Specified dose on specified days
Treatment: Drugs: XELOX
Oxaliplatin + capecitabine
Treatment: Drugs: FOLFOX
Oxaliplatin + leucovorin + fluorouracil
Treatment: Drugs: SOX
Oxaliplatin + tegafur/gimeracil/oteracil potassium
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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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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BICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants
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Assessment method [1]
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The number of LAG-3 Positive (\>=1%) participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of randomized LAG-3 positive (\>=1%) participants in each arm; recorded between randomization date and the date of objectively documented progression \[per RECISIT 1.1\], death due to any cause, or date of subsequent anticancer therapy, whichever occurs first.
CR= Disappearance of all target lesions PR= At least a 30% decrease in the sum of diameters of target lesions
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Timepoint [1]
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Up to 25 months
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Secondary outcome [1]
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Objective Response Rate (ORR)
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Assessment method [1]
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Objective response rate (ORR) based on Blinded Independent Central Review (BICR) and Investigator assessments is defined as the number of participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of randomized participants in each arm; recorded between randomization date and the date of objectively documented progression \[per RECISIT 1.1\], death due to any cause, or date of subsequent anticancer therapy, whichever occurs first.
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Timepoint [1]
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Up to 25 months
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Secondary outcome [2]
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Duration of Response (DOR)
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Assessment method [2]
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Duration of Response (DOR) based on Blinded Independent Central Review (BICR) and investigator is defined as the time between the date of first documented response (complete response or partial response) and the date of the first disease progression, per RECIST 1.1, or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first.
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Timepoint [2]
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Up to 25 months
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Secondary outcome [3]
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Overall Survival (OS)
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Assessment method [3]
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Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. For those without documentation of death, OS will be censored on the last date the participant was known to be alive.
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Timepoint [3]
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Up to 25 months
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Secondary outcome [4]
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Progression-Free Survival (PFS)
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Assessment method [4]
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Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR) and Investigator is defined as the time between the date of randomization and the first date of documented progression, or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first. Participants who die without a reported prior progression (and die without start of subsequent therapy) will be considered to have progressed on the date of death.
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Timepoint [4]
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Up to 25 months
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Secondary outcome [5]
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Number of Participants With Adverse Events (AEs)
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Assessment method [5]
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Number of participants with any grade adverse events (AEs), serious adverse events (SAE), and adverse events leading to discontinuation using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v 5.0) to assess the overall safety and tolerability of BMS-986213 in combination with chemotherapy vs. Nivolumab in combination with chemotherapy.
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Timepoint [5]
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From first dose to 30 days post last dose (Up to 23 months)
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Secondary outcome [6]
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Number of Deaths
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Assessment method [6]
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Number of deaths in each arm to assess the overall safety and tolerability of BMS-986213 in combination with chemotherapy vs. Nivolumab in combination with chemotherapy.
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Timepoint [6]
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Up to 25 months
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Secondary outcome [7]
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Number of Participants With Laboratory Abnormalities in Specific Liver Tests
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Assessment method [7]
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Number of participants with laboratory abnormalities in specific liver tests based on US conventional units to assess the overall safety and tolerability of BMS-986213 in combination with chemotherapy vs. Nivolumab in combination with chemotherapy. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:
* ALT or AST \> 3 x ULN, \> 5 x ULN, \> 10 x ULN and \> 20 x ULN
* Total bilirubin \> 2 x ULN
* ALP \> 1.5 x ULN
* Concurrent (within 1 day) ALT or AST \> 3 x ULN and total bilirubin \> 1.5 x ULN
* Concurrent (within 30 days) ALT or AST \> 3 x ULN and total bilirubin \> 1.5 x ULN
* Concurrent (within 1 day) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN
* Concurrent (within 30 days) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN
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Timepoint [7]
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From first dose to up to 30 days post last dose (Up to 23 months)
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Secondary outcome [8]
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Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
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Assessment method [8]
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Number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:
* TSH value \> ULN and
* with baseline TSH value \<= ULN
* with at least one FT3/FT4 test value \< LLN within 2-week window after the abnormal TSH test
* with all FT3/FT4 test values \>= LLN within 2-week window after the abnormal TSH test
* with FT3/FT4 missing within 2-week window after the abnormal TSH test.
* TSH \< LLN and
* with baseline TSH value \>= LLN
* with at least one FT3/FT4 test value \> ULN within 2-week window after the abnormal TSH test
* with all FT3/FT4 test values \<= ULN within 2-week window after the abnormal TSH test
* with FT3/FT4 missing within 2-week window after the abnormal TSH test
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Timepoint [8]
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From first dose to up to 30 days post last dose (Up to 23 months)
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Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Histologically- or cytologically-confirmed diagnosis of unresectable and either locally advanced, or metastatic gastric cancer or GEJ adenocarcinoma
* No prior treatment with systemic treatment (including HER 2 inhibitors) given as primary therapy for unresectable and either locally advanced, or metastatic GC or GEJ adenocarcinoma
* Tumor tissue must be provided for biomarker analyses
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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 HER2 positive status
* Participants with known untreated central nervous system (CNS) metastases
* Uncontrolled or significant cardiovascular disease
Other protocol defined inclusion/exclusion criteria could 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 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
16/10/2018
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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
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Actual
18/01/2024
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Sample size
Target
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Accrual to date
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Final
274
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Local Institution - 0027 - Westmead
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Recruitment hospital [2]
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Local Institution - 0007 - Herston
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Recruitment hospital [3]
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Local Institution - 0003 - Heidelberg
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Recruitment hospital [4]
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Local Institution - 0029 - Malvern
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Local Institution - 0008 - Shepparton
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Recruitment hospital [6]
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Local Institution - 0005 - Murdoch
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Recruitment hospital [7]
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Local Institution - 0028 - Bedford Park
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Recruitment postcode(s) [1]
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2145 - Westmead
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4029 - Herston
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3084 - Heidelberg
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3144 - Malvern
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3630 - Shepparton
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Recruitment postcode(s) [6]
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6150 - Murdoch
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Recruitment postcode(s) [7]
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5024 - Bedford Park
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Recruitment outside Australia
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California
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Northwood
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Southampton
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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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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine the efficacy and safety of investigational drug relatlimab plus nivolumab in combination with chemotherapy in participants with unresectable, untreated, locally advanced or metastatic gastric or GEJ cancer.
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Trial website
https://clinicaltrials.gov/study/NCT03662659
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Trial related presentations / publications
Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.
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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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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/59/NCT03662659/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/59/NCT03662659/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03662659
Download to PDF