Ignite Creation Date:
2025-12-24 @ 12:57 PM
Ignite Modification Date:
2026-01-03 @ 8:45 PM
Study NCT ID:
NCT02196961
Status:
COMPLETED
Last Update Posted:
2025-04-09
First Post:
2014-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjuvant Therapy of Completely Resected Merkel Cell Carcinoma With Immune Checkpoint Blocking Antibodies vs Observation
Sponsor:
Prof. Dr. med. Dirk Schadendorf
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADMEC-O
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:
* Adverse events according to CTCAE, Version 4.0 criteria, that are related to the administration of nivolumab
* Disease-free survival (DFS)
* Overall survival (OS) and OS rates at 12, 24 and 48 months after randomization
Explorative Endpoints:
* Distant-metastases-free survival (DMFS) and DMFS rate at 12, 24 and 48 months after randomization
* Identification and validation of prognostic/predictive biomarkers
* Quality of life (EORTC QLQ-C30) until 24 months after randomization
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:
* Adverse events according to CTCAE, Version 4.0 criteria, that are related to the administration of nivolumab
* Disease-free survival (DFS)
* Overall survival (OS) and OS rates at 12, 24 and 48 months after randomization
Explorative Endpoints:
* Distant-metastases-free survival (DMFS) and DMFS rate at 12, 24 and 48 months after randomization
* Identification and validation of prognostic/predictive biomarkers
* Quality of life (EORTC QLQ-C30) until 24 months after randomization
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: