Adjuvant Therapy of Completely Resected Merkel Cell Carcinoma With Immune Checkpoint Blocking Antibodies vs Observation (ADMEC-O)
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ClinicalTrials.gov Identifier: NCT02196961 |
Recruitment Status :
Active, not recruiting
First Posted : July 22, 2014
Last Update Posted : November 28, 2023
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Tracking Information | ||||
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First Submitted Date ICMJE | June 20, 2014 | |||
First Posted Date ICMJE | July 22, 2014 | |||
Last Update Posted Date | November 28, 2023 | |||
Actual Study Start Date ICMJE | June 2014 | |||
Estimated Primary Completion Date | August 31, 2024 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Disease-free survival (DFS) rate at 12 months [ Time Frame: 1 year post last patient first treatment/randomization ] The number of patients alive and free of disease at 12 months after randomization divided by the total number of patients randomized.
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Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures |
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Descriptive Information | ||||
Brief Title ICMJE | Adjuvant Therapy of Completely Resected Merkel Cell Carcinoma With Immune Checkpoint Blocking Antibodies vs Observation | |||
Official Title ICMJE | Prospective Randomized Trial of an Adjuvant Therapy of Completely Resected Merkel Cell Carcinoma (MCC) With Immune Checkpoint Blocking Antibodies (Nivolumab, Opdivo®; Ipilimumab (Yervoy®) Every 3 Weeks for 12 Weeks Versus Observation | |||
Brief Summary | Primary objective: To estimate the efficacy of adjuvant nivolumab monotherapy in completely resected MCC patients Primary endpoint: Disease-free survival (DFS) rate evaluated at 12, 24 and 48 months after date of randomization Secondary Objectives: To describe the safety profile and additional efficacy parameters of the nivolumab treatment in MCC Secondary endpoints:
Explorative Endpoints:
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Detailed Description | This is an international, open-label, randomized, multicenter phase II study to assess the efficacy of adjuvant nivolumab therapy in completely resected MCC patients. In the initial trial design, the immune modulating treatment was based on CTLA-4 blockade by ipilimumab; however, the advent of PD-1/PD-L1 blockade in the palliative treatment of MCC (presented at AACR, ASCO and ESMO) dramatically changed the treatment environment to an extent that applying treatments other than by PD-1/PD-L1 blockade had become very difficult. Moreover, the side effects of PD-1/PD-L1 blocking are far less frequent than side effects of ipilimumab. Consequently, randomization into the previous Ipilimumab treatment arm A was stopped. New patients will be randomized to nivolumab treatment instead. Patients randomized already into the Ipilimumab-arm will be evaluated descriptively for efficacy and safety. Patients already randomized into the observation arm (arm B) will be evaluated together with the newly randomized arm B-patients. A total of 177 patients with completely resected MCC will be enrolled over a recruitment period of 36 months into this trial, and randomized 2:1 as mentioned above. Patients will be stratified by sex, age, and stage of disease. Examinations and Follow-up Phase: The disease will be assessed at baseline, and thereafter every 12 weeks according to the current German guidelines for the management of MCC patients for 24 months after randomization, or until withdrawal of informed consent, lost to follow-up, or death, whichever occurs first. In addition, the patient's quality of life will be evaluated at baseline (pretreatment visit) and every 3 months until 24 months after randomization using a standard questionnaire (EORTC QLQC30). After 24 months, additional FU visits (or phone calls) will be conducted 6-monthly recording survival and tumor status including subsequent therapies until withdrawal of informed consent, lost to follow-up, death or end of study, whichever occurs first. End of study is defined as 48 months post LPFV (last patient first visit = date of randomization). Same methods of assessment (e.g. ultrasonography, CT or MRI scans) used at baseline will be used during follow-up. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Merkel Cell Carcinoma | |||
Intervention ICMJE | Drug: Nivolumab
adjuvant treatment of completely resected Merkel cell carcinoma
Other Name: Opdivo
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Study Arms ICMJE |
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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 | Active, not recruiting | |||
Actual Enrollment ICMJE |
180 | |||
Original Estimated Enrollment ICMJE |
222 | |||
Estimated Study Completion Date ICMJE | August 31, 2024 | |||
Estimated Primary Completion Date | August 31, 2024 (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 | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Germany, Netherlands | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02196961 | |||
Other Study ID Numbers ICMJE | CA184-205 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Current Responsible Party | Prof. Dr. med. Dirk Schadendorf, University Hospital, Essen | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Prof. Dr. med. Dirk Schadendorf | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Bristol-Myers Squibb | |||
Investigators ICMJE |
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PRS Account | University Hospital, Essen | |||
Verification Date | November 2023 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |