Study of Adjuvant Ipilimumab and Nivolumab in Subjects With High-risk Ocular Melanoma
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ClinicalTrials.gov Identifier: NCT03528408 |
Recruitment Status :
Recruiting
First Posted : May 17, 2018
Last Update Posted : January 6, 2021
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Sponsor:
Suthee Rapisuwon
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Suthee Rapisuwon, Hoosier Cancer Research Network
Tracking Information | |||||||||
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First Submitted Date ICMJE | May 7, 2018 | ||||||||
First Posted Date ICMJE | May 17, 2018 | ||||||||
Last Update Posted Date | January 6, 2021 | ||||||||
Actual Study Start Date ICMJE | July 26, 2018 | ||||||||
Estimated Primary Completion Date | July 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
3 year Relapse Free Survival (RFS) [ Time Frame: 36 months ] RFS is defined as time from registration to recurrence of disease or death from any cause.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Study of Adjuvant Ipilimumab and Nivolumab in Subjects With High-risk Ocular Melanoma | ||||||||
Official Title ICMJE | Phase II Single-arm Multi-center Study of Adjuvant Ipilimumab in Combination With Nivolumab in Subjects With High-risk Ocular Melanoma | ||||||||
Brief Summary | This is an open-label, multi-site, single-arm Phase 2 study of adjuvant nivolumab combined with ipilimumab for the treatment of adult subjects with completely treated high-risk ocular melanoma, as defined in eligibility criteria, without evidence of metastatic disease. All patients enrolled to the study will be treated with nivolumab 240 mg IV every 2 weeks plus ipilimumab 1mg/kg IV every 6 weeks. 1 cycle = 6 weeks. Treatment will continue until disease progression, unacceptable toxicity, patient request to discontinue or completion of treatment. Subjects may receive up to 25 doses of nivolumab and 8 doses of ipilimumab | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Nivolumab and Ipilimumab
All patients enrolled to the study will be treated with nivolumab 240 mg IV every 2 weeks plus ipilimumab 1mg/kg IV every 6 weeks. 1 cycle = 6 weeks.
Interventions:
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
50 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | June 2023 | ||||||||
Estimated Primary Completion Date | July 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03528408 | ||||||||
Other Study ID Numbers ICMJE | HCRN-MEL17-309 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Suthee Rapisuwon, Hoosier Cancer Research Network | ||||||||
Study Sponsor ICMJE | Suthee Rapisuwon | ||||||||
Collaborators ICMJE | Bristol-Myers Squibb | ||||||||
Investigators ICMJE |
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PRS Account | Hoosier Cancer Research Network | ||||||||
Verification Date | January 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |