Adjuvant Therapy of Completely Resected Merkel Cell Carcinoma With Immune Checkpoint Blocking Antibodies vs Observation

Sponsor
Prof. Dr. med. Dirk Schadendorf
Study ID
NCT02196961
Phase
PHASE2
Status
Completed

Conditions

  • Merkel Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    adjuvant treatment of completely resected Merkel cell carcinoma

Study Details

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

Key Dates

Start date
Jun 30, 2014
Status verified
Nov 2024
Primary completion
Aug 31, 2024
Completion
Aug 31, 2024

Study Design

Enrollment
180 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Observation
    After complete resection of Merkel cell carcinoma, patients randomized to the observational arm will be observed only
  • Experimental: Nivolumab
    After complete resection of Merkel cell carcinoma, patients randomized to the treatment arm will receive nivolumab at a fixed dose of 480 mg by IV infusion every 4 weeks for up to one year (i.e.13 doses).

Primary Outcome Measure

Disease-free survival (DFS) rate at 12 months [ Time Frame: 1 years post last patient first treatment/randomization ]

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