Table 2.
Ongoing active clinical trials for MCC.
(source: https://www.clinicaltrials.gov)
| NCT | Title | Phase | Intervention |
|---|---|---|---|
| NCT02196961 | Adjuvant Therapy of Completely Resected Merkel Cell Carcinoma With Immune Checkpoint Blocking Antibodies versus Observation (ADMEC-O) | II |
Ipilimumab Nivolumab |
| NCT02488759 | Non-Comparative, Open-Label, Multiple Cohort, Phase 1/2 Study of Nivolumab Monotherapy and Nivolumab Combination Therapy in Subjects With Virus-Positive and Virus-Negative Solid Tumors |
I II |
Nivolumab Ipilimumab BMS-986016 Daratumumab |
| NCT03167164 | 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 |
I II |
Avelumab Bevacizumab Capecitabine Cisplatin Cyclophosphamide 5-fluorouracil Leucovorin Nab-Paclitaxel Omega-3-acid ethyl esters Stereotactic Body Radiation Therapy + 5 biological |
| NCT02465957 | Phase II Study of aNK (Activated NK-92 Natural Killer Cells) Infusions in Combination With ALT-803 (IL-15) in Patients With Stage III (IIIB) or Stage IV Merkel Cell Carcinoma (MCC) | II | aNK (NK-92) |
| NCT02036476 | Cabozantinib in Recurrent/Metastatic Merkel Cell Carcinoma | II | Cabozantinib |
| NCT03071406 | A Phase II, Randomized, Multi-institutional Study of Nivolumab and Ipilimumab versus Nivolumab, Ipilimumab and Stereotactic Body Radiation Therapy for Metastatic Merkel Cell Carcinoma | II |
Nivolumab Ipilimumab Stereotactic Body Radiation Therapy |
| NCT03271372 | A Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Phase III Trial of Adjuvant Avelumab (Anti-PDL-1 Antibody) in Merkel Cell Carcinoma Patients With Clinically Detected Lymph Node Metastases | III |
Avelumab Placebo |
| NCT02155647 | A Phase II, Open-Label, Multicenter Trial to Investigate the Clinical Activity and Safety of Avelumab (MSB0010718C) in Subjects With Merkel Cell Carcinoma | II | Avelumab |
| NCT01013779 | A Phase II Efficacy Study of Chemo-Radiotherapy in PET Stage II and III Merkel Cell Carcinoma of the Skin | II | Carboplatin Etoposide Radiotherapy |
| NCT02584829 | 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 |
I II |
Avelumab MCPyV TAg-specific Polyclonal Autologous CD8-positive T Cells Radiation Therapy Recombinant Interferon Beta |
| NCT02819843 | A Phase II Randomized Trial of Intralesional Talimogene Laherparepvec (TALIMOGENE LAHERPAREPVEC) With or Without Radiotherapy for Cutaneous Melanoma, Merkel Cell Carcinoma, or Other Solid Tumors | II | TALIMOGENE LAHERPAREPVEC (TVEC) Hypofractionated Radiotherapy |
| NCT03304639 | A Randomized Phase II Study of Anti-PD1 Antibody [MK-3475 (Pembrolizumab)] Alone versus Anti-PD1 Antibody Plus Stereotactic Body Radiation Therapy in Advanced Merkel Cell Carcinoma | II | Pembrolizumab Stereotactic Body Radiation Therapy |
| NCT02267603 | A Phase II Study of MK-3475 in Patients With Advanced Merkel Cell Carcinoma (MCC) | II | Pembrolizumab |
| NCT02978625 | A Phase II Study of Talimogene Laherparepvec Followed by Talimogene Laherparepvec + Nivolumab in Refractory T Cell and NK Cell Lymphomas, Cutaneous Squamous Cell Carcinoma, Merkel Cell Carcinoma, and Other Rare Skin Tumors | II | Nivolumab Talimogene Laherparepvec |
| NCT03458117 | A Phase I, Open Label, Single Arm, Single Centre Study to Evaluate Mechanism of Action of Talimogene Laherparepvec (T-VEC) in Locally Advanced Non-melanoma Skin Cancer | I | Talimogene Laherparepvec (T-VEC) |
| NCT03435640 | A Phase 1/2, Open-label, Multicenter, Dose Escalation and Dose Expansion Study of NKTR-262 in Combination With NKTR-214 and in Combination With NKTR-214 Plus Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumor Malignancies |
I II |
NKTR-262 NKTR-214 Nivolumab |
| NCT02890368 | A Phase 1 Dose Escalation Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Percutaneously-Accessible Solid Tumors and Mycosis Fungoides | I |
TTI-621 TTI-621 + PD-1/PD-L1 inhibitor TTI-621 + pegylated interferon-α2a TTI-621 + T-Vec TTI-621 + radiation |
| NCT02643303 | 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 |
I II |
Durvalumab Tremelimumab Poly ICLC |
| NCT03212404 | A Phase 1, Open-label, Multicenter, Dose-escalation Study of CK-301 Administered Intravenously as a Single Agent to Subjects With Advanced Cancers | I | CK-301 |
| NCT03241173 | 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 |
I II |
INCAGN01949 Nivolumab Ipilimumab |
| NCT03071757 | 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 | I | ABBV-368 Nivolumab |
| NCT03000257 | 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 | I |
Rovalpituzumab Tesirine ABBV-181 |