Ignite Creation Date:
2024-05-06 @ 3:04 AM
Last Modification Date:
2024-10-26 @ 11:27 AM
Study NCT ID:
NCT02196961
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-28
First Post:
2014-06-20
Brief Title:
Adjuvant Therapy of Completely Resected Merkel Cell Carcinoma With Immune Checkpoint Blocking Antibodies vs Observation
Sponsor:
Prof Dr med Dirk Schadendorf
Organization:
University Hospital Essen
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:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
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 40 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 prognosticpredictive 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 40 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 prognosticpredictive 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-1PD-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-1PD-L1 blockade had become very difficult Moreover the side effects of PD-1PD-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 21 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 patients 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 eg 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 patients 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 eg ultrasonography CT or MRI scans used at baseline will be used during follow-up
Study Oversight
Has Oversight DMC:
None
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?:
None