MedTrace Logo

F16IL2 Plus Paclitaxel in Metastatic Merkel Cell Carcinoma

NCT02054884 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2018-05-18

No results posted yet for this study

Summary

There is no standard treatment for Merkel cell carcinoma(MCC), as no randomized trials have been conducted to establish standard of care. Despite a sizable number of objective responses induced by combination cyototoxic chemotherapy, a prolongation of patients overall survival has never been demonstrated.

This open-label, randomized, double-arm, multi-centre, phase II study of F16IL2 in combination with paclitaxel versus paclitaxel monotherapy, proposes to test the therapeutic efficacy of F16IL2 plus paclitaxel in patients with metastatic Merkel cell carcinoma, who are not amenable to surgery.

A total of 90 patients with Merkel cell carcinoma will be enrolled and treated during the study; 45 patients will receive the combination treatment of F16IL2 and paclitaxel (Arm A), and 45 patients will receive paclitaxel monotherapy (Arm B).

Conditions

Interventions

DRUG

Arm A: F16IL2 in combination with paclitaxel

Intravenous (i.v.) 1 hour infusions of paclitaxel 90 mg/m\^2 followed, after 30 min pause, by 3 hour i.v. infusions of F16IL2 35 Mio IU on days 1, 8, 15 of each 28 day cycle. Patients will receive 4 week cycles of study therapy for a maximum of 24 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent.

DRUG

Arm B: Paclitaxel

Intravenous (i.v.) 1 hour infusions of Paclitaxel 90 mg/m\^2 on days 1, 8, 15 of each 28 day cycle. Patients will receive 4 week cycles of study therapy for a maximum of 24 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent.

Sponsors & Collaborators

  • Immatics Biotechnologies GmbH

    collaborator INDUSTRY

  • Philogen S.p.A.

    lead INDUSTRY

Principal Investigators

  • Jürgen C. Becker, Prof. · Medical University of Graz, Austria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-25
Primary Completion
2016-12-31
Completion
2017-12-15

Countries

  • Austria
  • Denmark
  • France
  • Germany
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT02054884 on ClinicalTrials.gov