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IMCgp100-201

AcronymISRCTNEudraCTClinicaltrials.govDRKS
2015-002971-12

A Phase II/b Open-Label, Multi-Center Study of the Safety and Efficacy of IMCgp100 in Combination with Durvalumab (MEDI4736) or Tremelimumab or the Combination of Durvalumab and Tremelimumab Compared with IMCgp100 Alone in Patients with Advanced Melanoma.

Status: Active

Purpose / Objectives

Primary Outcome

Phase Ib: To characterize the safety and tolerability, and subsequently identify the Maximum tolerated dose (MTD) or recommended Phase II dose (RP2D), of the combination of durvalumab or tremelimumab with IMCgp100 (Arms 1 and 2) and tremelimumab + durvalumab with IMCgp100 (Arm 3).

 

Phase II: To evaluate the objective Response rate (ORR) of IMCgp100 using Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria as a single Agent (Arm 4) and in combination with checkpoint Inhibition with durvalumab (Arm 1), tremelimumab (Arm 2) or the combination of durvalumab and tremelimumab (Arm 3).

Secondary Outcomes

To characterize the safety and tolerability of single-Agent IMCgp100 (given alone in Arm 4) and in combination with durvalumab and/or tremelimumab

To characterize the PK Profile of single Agent IMCgp100 (given alone in Arm 4) and in combination with durvalumab and/or tremelimumab in Arms 1, 2 and 3.


To assess potential predictors of efficacy of gp100 and/or PD-L1 Expression or baseline lactate Dehydrogenase (LDH) Level with IMCgp100 in combination with durvalumab and/or tremelimumab in Arms 1,2 and 3 and IMCgp100 alone in Arm 4.

To assess the preliminary antitumor efficacy of IMCgp100 alone and in combination with durvalumab and /or tremelimumab.

To evaluate the incidence of anti-IMCgp100, anti-durvalumab and anti-tremelimumab antibody Formation following multiple infusions of IMCgp100 alone and in combination with durvalumab and/or tremelimumab.

Diagnosis

Patient attributes

Stage

III to IV

Age

18-99

Inclusion criteria

1. Age ≥ 18

2, Written informed consent must be obtained from all patients Prior to any study procedures.

3. Patients with advanced cutaneous melanoma defined als unresectable III or metastatic Stage IV disease.

Trial design

  • Phase I/II
  • Multicenter
  • Four-arm
  • Open Label

Documents (password protected)

Responsibilities in overall trial

Immunocore

    National Coordinating Investigator

    Prof Dirk Schadendorf

    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

    Contact at Site