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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02935634
Registration number
NCT02935634
Ethics application status
Date submitted
14/10/2016
Date registered
17/10/2016
Date last updated
9/06/2023
Titles & IDs
Public title
A Study to Test Combination Treatments in Participants With Advanced Gastric Cancer
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Scientific title
A Phase 2, Fast Real-time Assessment of Combination Therapies in Immuno-ONcology Study in Participants With Advanced Gastric Cancer (FRACTION-Gastric Cancer)
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Secondary ID [1]
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2016-002807-24
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Secondary ID [2]
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CA018-003
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Universal Trial Number (UTN)
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Trial acronym
FRACTION-GC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Gastric Cancer
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Condition category
Condition code
Cancer
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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 - Nivolumab
Treatment: Other - Ipilimumab
Treatment: Other - Relatlimab
Treatment: Other - BMS-986205
Treatment: Drugs - Rucaparib
Active comparator: Nivolumab + Ipilimumab -
Experimental: Nivolumab + Relatlimab -
Experimental: Nivolumab + BMS-986205 -
Experimental: Nivolumab + Rucaparib -
Experimental: Ipilimumab + Rucaparib -
Experimental: Nivolumab + Ipilimumab + Rucaparib -
Treatment: Other: Nivolumab
Specified dose on specified days
Treatment: Other: Ipilimumab
Specified dose on specified days
Treatment: Other: Relatlimab
Specified dose on specified days
Treatment: Other: BMS-986205
Specified dose on specified days
Treatment: Drugs: Rucaparib
Specified dose on specified days
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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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Objective Response Rate (ORR) by Investigator
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Assessment method [1]
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ORR is the percent of participants whose best overall response (BOR) is complete response (CR) or partial response (PR). BOR is the best response from the start of the study treatment until objectively documented progression per RECIST v1.1 or subsequent anticancer therapy, whichever occurs first. CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have reduction in short axis to \<10 mm. PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The Response Evaluation Criteria in Solid Tumors (RECIST) is a standard way to measure the response of a tumor to treatment. CR+PR, confidence interval based on Clopper and Pearson method.
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Timepoint [1]
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From first dose of study treatment until progression or subsequent anticancer therapy, whichever occurs first (up to approximately 65 months)
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Primary outcome [2]
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Median Duration of Response (DOR)
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Assessment method [2]
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Duration of Response (DOR) is the time between the date of first response and the date of first documented disease progression as determined by RECIST 1.1 or death due to any cause, whichever occurred first. Complete Response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Median computed using Kaplan -Meier method.
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Timepoint [2]
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From first dose to date of first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 65 months)
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Primary outcome [3]
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Kaplan-Meier Analysis of Progression Free Survival Rate (PFSR) at 24 Weeks
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Assessment method [3]
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The PFSR at 24 weeks is defined as the proportion of treated participants remaining progression free and surviving at 24 weeks since the first dosing date. Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Point estimates are derived from Kaplan-Meier analyses, the 95% CIs are derived from Greenwood formula.
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Timepoint [3]
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24 weeks after first dose
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Secondary outcome [1]
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Number of Participants With AEs, SAEs, AEs Leading to Discontinuation, and Death
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Assessment method [1]
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An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization.
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Timepoint [1]
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From first dose to 100 days after last dose of study therapy (assessed up to approximately 30 months)
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Secondary outcome [2]
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Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
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Assessment method [2]
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The number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal.
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Timepoint [2]
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From first dose to 100 days after last dose of study therapy (approximately 30 months)
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Secondary outcome [3]
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Number of Participants With Laboratory Abnormalities in Specific Liver Tests
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Assessment method [3]
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The number of participants with laboratory abnormalities in specific liver tests based on US conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal
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Timepoint [3]
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From first dose to 100 days after last dose of study therapy (approximately 30 months)
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Eligibility
Key inclusion criteria
* Inoperable, advanced or metastatic esophageal cancer (EC), gastric cancer (GC) or gastroesophageal junction (GEJ) carcinoma and have histologically confirmed predominant adenocarcinoma and/or squamous carcinoma
* Eastern Cooperative Oncology Group (ECOG) performance status = 1
* At least 1 lesion with measurable disease
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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
* HER2-positive tumor and previously untreated with trastuzumab
* Suspected, known or progressive central nervous system metastases
* Other active malignancy requiring concurrent intervention
* Active, known or suspected autoimmune disease
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 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
29/11/2016
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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
11/05/2022
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Sample size
Target
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Accrual to date
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Final
190
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Local Institution - 0035 - Westmead
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Recruitment hospital [2]
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Local Institution - 0033 - Heidelberg
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Recruitment hospital [3]
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Local Institution - Randwick
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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3084 - Heidelberg
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Recruitment postcode(s) [3]
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2031 - Randwick
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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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Arizona
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Connecticut
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District of Columbia
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United States of America
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Florida
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United States of America
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Maryland
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Minnesota
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Missouri
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New Jersey
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New York
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Oregon
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Pennsylvania
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United States of America
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Washington
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Germany
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Heidelberg
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Germany
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Leipzig
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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Lombardia
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Italy
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Milano
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Netherlands
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Amsterdam
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Netherlands
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Utrecht
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Singapore
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Singapore
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Switzerland
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Graubünden (de)
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Switzerland
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Zuerich
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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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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Clovis Oncology, Inc.
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the preliminary efficacy, safety, and tolerability of Nivolumab in combination with Ipilimumab or other treatment therapies in participants with advanced gastric cancer.
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Trial website
https://clinicaltrials.gov/study/NCT02935634
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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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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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Address
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Fax
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Email
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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
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/34/NCT02935634/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/34/NCT02935634/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02935634
Download to PDF