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EMR 100070-003, Part B

AcronymISRCTNEudraCTClinicaltrials.govDRKS
2014-000445-79

A Phase II, open-Label, multicenter Trial to investigate the clinical activity and safety of avelumab (MSB0010718C) in subjects with Merkel cell carcinoma.

Status: Active

Purpose / Objectives

Primary Outcome

Part B: to evaluate the clinical activity of avelumab as first-line treatment for metastaticordistally recurrent MCC as determined by the durable response rate (DRR) according to RECIST 1.1 by an Independent Endpoint Review Committee (IERC).

 

 

Diagnosis

Confirmation of the diagnosis by immuno-histochemistry detection of CK20 (or other appropriate cytokeratin Expression such as pancytokeratin, AE1/AE3, or Cam5.2, local laboratary testingIn in the Tumor cell is mandatory. Subjects must have metastativ disease; subjects with non-metastatic MCC that is only recurrent or unresectable are not eligible; for Part B, M1 Status muss be confirmed at entry. For Part B: Subjects must not have received any Prior systemic Treatment for metastatic MCC. Prior chemotherapy Treatment in the adjuvant Setting (no clinically detectable disease; no metastatic disease) is allowable if the end of Treatment occurred at least 6 months Prior to study start. Estimated life expectancy of more than 12 weeks.

Patient attributes

Age

18-99

Inclusion criteria

ŸFor Part B: Subjects must not have received any prior systemic treatment for metastatic MCC. ŸPart B, M1 status must be confirmed at entry Ÿ

For Part B: A recently obtained formalin-fixed, paraffin-embedded (FFPE) block containing tumor tissue (preferably within 6 months)

For Part B: Highly effective contraception° for both male and female subjects if the risk of conception exists.

Contraception must be used 28 days (Part B) prior to first study treatment administration, for the duration of study treatment, and at least for 60 days after stopping study Treatment.

Exclusion criteria

Prior T-cell targeted therapy: consult with the Medical Monitor and consider other co-regulatory targets such as 4-1BB

Trial design

  • Phase II
  • Multicenter
  • Open Label

Documents (password protected)

Responsibilities in overall trial

Merck KGaA, Darmstadt, Germany

    National Coordinating Investigator

    Dr. med. Felix Kiecker

    Study Sites

    Klinik & Poliklinik für Dermatologie & Venerologie Köln

    Study office

    Status

    Active

    Principal Investigator

    Univ.-Prof. Dr. med. Dr. Cornelia Mauch

    Deputy of Principal Investigator

    • Dr. Nicole Kreuzberg

    Subinvestigator

    • Bodo Bühler
    • Dr. Nicole Kreuzberg
    • Sarah Ramesh

    Contact at Site