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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03068455
Registration number
NCT03068455
Ethics application status
Date submitted
27/02/2017
Date registered
1/03/2017
Date last updated
20/09/2021
Titles & IDs
Public title
An Investigational Immuno-therapy Study of Nivolumab Combined With Ipilimumab Compared to Nivolumab by Itself After Complete Surgical Removal of Stage IIIb/c/d or Stage IV Melanoma
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Scientific title
A Phase 3, Randomized Study of Adjuvant Immunotherapy With Nivolumab Combined With Ipilimumab Versus Nivolumab Monotherapy After Complete Resection of Stage IIIb/c/d or Stage IV Melanoma
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Secondary ID [1]
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0
2016-003729-41
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Secondary ID [2]
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CA209-915
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Universal Trial Number (UTN)
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Trial acronym
CheckMate 915
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Melanoma
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0
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Condition category
Condition code
Cancer
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0
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0
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - nivolumab
Treatment: Other - ipilimumab
Experimental: nivolumab + ipilimumab - Specified Dose on Specified Days
Experimental: nivolumab - Specified Dose on Specified Days
Treatment: Other: nivolumab
Specified Dose on Specified Days
Treatment: Other: ipilimumab
Specified Dose on Specified Days
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Intervention code [1]
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Treatment: Other
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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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Recurrence-free Survival (RFS) - All Randomized Participants
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Assessment method [1]
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RFS was defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma (including melanoma in situ), or death (from any cause), whichever occurred first.
Median values based on Kaplan-Meier Estimates.
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Timepoint [1]
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From randomization to Primary Completion Date (up to approximately 3 years)
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Primary outcome [2]
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Recurrence-free Survival (RFS) - All Randomized Participants With PD-L1 Expression Level < 1%
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Assessment method [2]
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RFS was defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma (including melanoma in situ), or death (from any cause), whichever occurred first.
Median based on Kaplan-Meier Estimates.
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Timepoint [2]
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From randomization to Primary Completion Date (up to approximately 3 years)
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Secondary outcome [1]
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Overall Survival (OS) - All Randomized Participants
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Assessment method [1]
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OS is defined as the time between the date of randomization and the date of death. Median based on Kaplan-Meier Estimates.
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Timepoint [1]
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From randomization to date of death (up to approximately 45 months)
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Secondary outcome [2]
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Overall Survival (OS) - All Randomized Participants With PD-L1 Expression Level < 1%
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Assessment method [2]
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OS is defined as the time between the date of randomization and the date of death. Median based on Kaplan-Meier Estimates.
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Timepoint [2]
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From randomization to date of death (up to approximately 45 months)
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Secondary outcome [3]
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Recurrence-free Survival (RFS) by Baseline Tumor PD-L1 Expression
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Assessment method [3]
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RFS was defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma (including melanoma in situ), or death (from any cause), whichever occurred first.
Median based on Kaplan-Meier Estimates.
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Timepoint [3]
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From randomization to Study Completion Date (up to approximately 45 months)
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Secondary outcome [4]
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Time to Next-Line Therapies - All Randomized Participants
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Assessment method [4]
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Time to next therapy was defined as the time from the date of randomization to the start date of next systemic therapy. Participants who did not receive next treatment were censored at the last known alive date.
Time to second next therapy was defined as the time from the date of randomization to the start date of second next systemic therapy. Participants who did not receive second next treatment were censored at the last known alive date.
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Timepoint [4]
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From randomization to start of next therapy or second next therapy (up to approximately 45 months)
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Secondary outcome [5]
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Time to Next-Line Therapies - All Randomized Participants With PD-L1 Expression Level < 1%
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Assessment method [5]
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Time to next therapy was defined as the time from the date of randomization to the start date of next systemic therapy. Participants who did not receive next treatment were censored at the last known alive date.
Time to second next therapy was defined as the time from the date of randomization to the start date of second next systemic therapy. Participants who did not receive second next treatment were censored at the last known alive date
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Timepoint [5]
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From randomization to start of next therapy or second next therapy (up to approximately 45 months)
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Secondary outcome [6]
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Time From Next Therapy to Second Next Therapy - All Randomized Participants
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Assessment method [6]
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Time from next treatment to second next treatment was defined as the time from the start date of next systemic therapy to start date of second next systemic therapy. No censoring rules were applied here as analysis was only performed for the subset of participants who received second next treatment.
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Timepoint [6]
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From start of first next systemic therapy to start of second next systemic therapy (up to approximately 28 months)
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Secondary outcome [7]
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Time From Next Therapy to Second Next Therapy - All Randomized Participants With PD-L1 Expression Level < 1%
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Assessment method [7]
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Time from next treatment to second next treatment was defined as the time from the start date of next systemic therapy to start date of second next systemic therapy. No censoring rules were applied here as analysis was only performed for the subset of participants who received second next treatment.
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Timepoint [7]
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From start of first next systemic therapy to start of second next systemic therapy (up to approximately 28 months)
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Secondary outcome [8]
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Progression-free Survival (PFS) on Next-line Therapy - All Randomized Participants
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Assessment method [8]
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PFS2 was defined as the time from randomization to the progression date on next-line systemic therapy or the end date of next-line systemic therapy (if progression date not available) or death from any cause (if both progression date and end date not available), and to last known alive date in case of no event (ie, censoring), meaning either (1) no subsequent systemic therapy and no death OR (2) subsequent systemic therapy but no progression date nor end date available and no death.
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Timepoint [8]
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From randomization to progression event (up to approximately 45 months)
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Secondary outcome [9]
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Progression-free Survival (PFS) on Next-line Therapy - All Randomized Participants With PD-L1 Expression Level < 1%
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Assessment method [9]
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PFS2 was defined as the time from randomization to the progression date on next-line systemic therapy or the end date of next-line systemic therapy (if progression date not available) or death from any cause (if both progression date and end date not available), and to last known alive date in case of no event (ie, censoring), meaning either (1) no subsequent systemic therapy and no death OR (2) subsequent systemic therapy but no progression date nor end date available and no death.
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Timepoint [9]
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From randomization to progression event (up to approximately 45 months)
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Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
* Completely surgically resected stage IIIb/c/d or stage IV melanoma within 12 weeks of participation in study.
* Must have full activity or, if limited, must be able to walk and carry out activities such as light house work or office work
* No prior anti-cancer treatment for melanoma (except surgery for the melanoma lesion(s) and/or except for adjuvant radiation therapy (RT) after neurosurgical resection for central nervous system (CNS) lesions)
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Minimum age
12
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
* History of uveal melanoma
* Patients with active, known or suspected autoimmune disease
* Prior treatment with interferon (if complete < 6 months prior to participation in study), anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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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
11/04/2017
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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
2/02/2021
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Sample size
Target
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Accrual to date
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Final
1844
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Local Institution - North Sydney
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2060 - North Sydney
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2298 - Waratah
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2145 - Westmead
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4120 - Greenslopes
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4215 - Southport
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4120 - Woolloongabba
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Recruitment postcode(s) [7]
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5000 - Adelaide
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3128 - Box Hill
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3000 - Melbourne
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Recruitment postcode(s) [10]
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3004 - Melbourne
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Recruitment postcode(s) [11]
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6009 - Nedlands
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Recruitment postcode(s) [12]
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6008 - Subiaco
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Recruitment outside Australia
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Sutton.
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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 whether an investigational immunotherapy Nivolumab, when combined with Ipilimumab, is more effective than Nivolumab by itself, in delaying the return of cancer in patients who have had a complete surgical removal of stage IIIb/c/d or stage IV Melanoma
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Trial website
https://clinicaltrials.gov/study/NCT03068455
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Trial related presentations / publications
Weber JS, Schadendorf D, Del Vecchio M, Larkin J, Atkinson V, Schenker M, Pigozzo J, Gogas H, Dalle S, Meyer N, Ascierto PA, Sandhu S, Eigentler T, Gutzmer R, Hassel JC, Robert C, Carlino MS, Di Giacomo AM, Butler MO, Munoz-Couselo E, Brown MP, Rutkowski P, Haydon A, Grob JJ, Schachter J, Queirolo P, de la Cruz-Merino L, van der Westhuizen A, Menzies AM, Re S, Bas T, de Pril V, Braverman J, Tenney DJ, Tang H, Long GV. Adjuvant Therapy of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Patients With Resected Stage IIIB-D or Stage IV Melanoma (CheckMate 915). J Clin Oncol. 2023 Jan 20;41(3):517-527. doi: 10.1200/JCO.22.00533. Epub 2022 Sep 26. Yoshino T, Oki E, Misumi T, Kotaka M, Manaka D, Eto T, Hasegawa J, Takagane A, Nakamura M, Kato T, Munemoto Y, Nakamura F, Bando H, Taniguchi H, Sakamoto Y, Shiozawa M, Nishi M, Horiuchi T, Yamagishi H, Sakamoto J, Mizushima T, Ohtsu A, Mori M. Final Analysis of 3 Versus 6 Months of Adjuvant Oxaliplatin and Fluoropyrimidine-Based Therapy in Patients With Stage III Colon Cancer: The Randomized Phase III ACHIEVE Trial. J Clin Oncol. 2022 Oct 10;40(29):3419-3429. doi: 10.1200/JCO.21.02628. Epub 2022 May 5.
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Study protocol
https://cdn.clinicaltrials.gov/large-docs/55/NCT03068455/Prot_002.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/55/NCT03068455/SAP_003.pdf
Results publications and other study-related documents
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Results not provided in
https://clinicaltrials.gov/study/NCT03068455
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