Table 2.
Clinical trials including checkpoint inhibitors for treatment of Merkel Cell Carcinoma - as of September 26, 2017
| Study Sponsor Collaborator | Phase | Official Title | Status | Tumor | Interventions | ClinicalTrials.gov Identifier Date of first submitted |
|---|---|---|---|---|---|---|
| National Cancer Institute (NCI) | II | Phase II Open-Label Trial of Ipilimumab for Metastatic Merkel Cell Carcinoma | Study withdrawn prior to enrolment | MCC | Ipilimumab | NCT01913691 July 28, 2013 |
| JAVELIN Merkel 200 EMD Serono | II | A Phase II, Open-Label, Multicenter Trial to Investigate the Clinical Activity and Safety of Avelumab (MSB0010718C) in Subjects With Merkel Cell Carcinoma | Recruiting | MCC | Avelumab | NCT02155647 June 2, 2014 |
| ADMEC Prof. Schadendorf University Hospital Essen BMS | II | Prospective Randomized Trial of an Adjuvant Therapy of Completely Resected Merkel Cell Carcinoma (MCC) With Immune Checkpoint Blocking Antibodies (Nivolumab, Opdivo®; Ipilimumab (Yervoy®) Every 3 Weeks for 12 Weeks Versus Observation | Recruiting | MCC | Ipilimumab Nivolumab | NCT02196961 June 20, 2014 |
| National Cancer Institute (NCI) | II | A Phase II Study of MK-3475 in Patients With Advanced Merkel Cell Carcinoma (MCC) | Ongoing, but not recruiting | MCC | Pembrolizumab | NCT02267603 October 14, 2014 |
| Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) EMD Serono | I / II | Study to Evaluate Cellular Adoptive Immunotherapy Using Polyclonal Autologous CD8+ Antigen-Specific T Cells for Metastatic Merkel Cell Carcinoma in Combination With MHC Class I Up-Regulation and the Anti-PD-L1 Antibody Avelumab | Recruiting | MCC | Avelumab, Laboratory Biomarker Analysis MCPyV Tag-specific polyclonal Autologous CD8-positive T-cells, Radiation Therapy Recombinant IFN Beta | NCT02584829 October 21, 2015 |
| Ludwig Institute for Cancer Research MedImmune LLC Cancer Research Institute, New York City | I / II | A Phase 1/2 Study of In Situ Vaccination With Tremelimumab and IV Durvalumab (MEDI4736) Plus the Toll-like Receptor Agonist PolyICLC in Subjects With Advanced, Measurable, Biopsy-accessible Cancers | Recruiting | MCC among other tumors | Durvalumab, Tremelimumab, Poly ICLC | NCT02643303 December 18, 2015 |
| National Cancer Institute (NCI) | II | A Phase II Study of T-VEC Followed by T-VEC + Nivolumab in Refractory T Cell and NK Cell Lymphomas, Cutaneous Squamous Cell Carcinoma, Merkel Cell Carcinoma, and Other Rare Skin Tumors | Not yet recruiting | MCC among other tumors | Nivolumab Talimogene Laherparepvec | NCT02978625 November 30, 2016 |
| AbbVie | I | A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-181, a Monoclonal Antibody, as Monotherapy and in Combination With Another Anti-Cancer Therapy in Subjects With Advanced Solid Tumors | Recrutiting | MCC among other tumors | ABBV-181 (anti-PD1) Rovalpituzumab Tesirine | NCT03000257 December 15, 2016 |
| H. Lee Moffitt Cancer Center and Research Institute BMS | II | A Phase 2, Randomized, Multi-institutional Study of Nivolumab and Ipilimumab Versus Nivolumab, Ipilimumab and Stereotactic Body Radiation Therapy for Metastatic Merkel Cell Carcinoma | Recruiting | MCC Skin Cancer | Nivolumab, ipilimumab, stereotactic body radiation therapy (SBRT) | NCT03071406 March 1, 2017 |
| AbbVie | I | A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors | Recruiting | MCC among other tumors | Nivolumab ABBV-368 (anti-c-Met) | NCT03071757 March 2, 2017 |
| Merck KGaA Pfizer | Temporary Authorization for Use (ATU) to Avelumab for Treatment of Adult Patients With Metastatic Merkel Cell Carcinoma (mMCC) with progress after at least one prior chemotherapy | Expanded access | MCC | Avelumab | NCT03089658 March 20, 2017 | |
| Incyte Biiosciences International Sàrl | I / II | A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies | Recruiting | MCC among other tumors | NCAGN01876 (anti-GITR) Nivolumab, Ipilimumab | NCT03126110 April 19, 2017 |
| NantCell, Inc. | IB / II | NANT Merkel Cell Carcinoma (MCC) Vaccine: Combination Immunotherapy in Subjects With MCC Who Have Progressed on or After Anti-programmed Death-ligand 1 (PD-L1) Therapy | Not yet recruiting | MCC | Avelumab Bevacizumab Capecitabine Cisplatin Cyclophosphamide 5-fluorouracil Leucovorin nab-Paclitaxel omega-3-acid ethyl esters Stereotactic Body Radiation Therapy ALT-803 ETBX-051 ETBX-061 GI-6301 haNK | NCT03167164 May 23, 2017 |
| Checkpoint Therapeutics, Inc. Novotech (Australia) Pty Limited | I | A Phase 1, Open-label, Multicenter, Dose-escalation Study of CK-301 Administered Intravenously as a Single Agent to Subjects With Advanced Cancers | Recruiting | MCC among other tumors | CK-301 (anti-PD-L1) | NCT03212404 July 6, 2017 |
| Incyte Biosciences International Sàrl | I / II | A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01949 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies | Not yet recruiting | MCC among other tumors | INCAGN01949 (OX40 agonist) Nivolumab Ipilimumab | NCT03241173 August 2, 2017 |
| Incyte Biosciences International Sàrl | I / II | A Phase 1/2 Safety and Efficacy Study of INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies | Recruiting | MCC among other tumors | INCAGN01876 (anti-GITR) Epacadostat Pembrolizumab | NCT03277352 August 14, 2017 |
| University of Washington National Cancer Institute | III | A Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Phase 3 Trial of Adjuvant Avelumab (Anti-PDL-1 Antibody) in Merkel Cell Carcinoma Patients With Clinically Detected Lymph Node Metastases | Not yet recruiting | MCC | Avelumab | NCT03271372 August 31, 2017 |
IgG: immunoglobulin G; MCC: merkel cell carcinoma; PD-1: programmed cell death protein 1; PD-L1: programmed cell death protein 1 ligand