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

NCT02196961 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-04-09

No results posted yet for this study

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

Conditions

Interventions

DRUG

Nivolumab

adjuvant treatment of completely resected Merkel cell carcinoma

Sponsors & Collaborators

Principal Investigators

  • Dirk Schadendorf, Prof. Dr. · University Hospital, Essen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2024-08-31
Completion
2024-08-31

Countries

  • Germany
  • Netherlands

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02196961 on ClinicalTrials.gov