Although significant progress has been made in the treatment of melanoma, many important clinical questions still need to be answered. We continue to explore the frontiers of discovery in the treatment of melanoma thanks in part to the many patients who willingly to participate in new treatment trials. Participation in a new treatment trial can be a rewarding option for the appropriate patient. Clinical trial availability changes frequently. If you are a melanoma patient at Johns Hopkins Kimmel Cancer, please ask your health team about clinical trial participation. If you are not a Johns Hopkins patient but would be interested in participating in a trial, please contact us at 410-955-8804.

Cancer Clinical Trials at Johns Hopkin Kimmel Cancer Center
(Kimmel Cancer Center searchable database.)

Summary of Current Melanoma Trials

Hopkins Melanoma Program: Clinical trials for patients with advanced skin cancer

1. J1866 - Nivolumab Alone or Plus Ipilimumab for Patients with Locally-Advanced Unresectable or Metastatic Basal Cell Carcinoma. This study tests nivolumab, alone or combined with ipilimumab in patients with advanced basal cell carcinoma. Patients must have disease that is not curable with surgery, or for whom surgery would be intolerable. Patients may be naïve to therapy, or have already received a hedgehog inhibitor (e.g., Erivedge, Odomzo) and/or anti-PD-1.
2. J1814 - J1814 - A Phase 1/2a Study of BMS-986253 in Combination with Nivolumab in Advanced Cancers (CA027-002). This study tests nivolumab plus anti-interleukin-8 in patients with unresectable or metastatic cancers, including melanoma.
3. EA6174: A Phase 3 Randomized Trial Comparing Adjuvant MK-3475 (Pembrolizumab) to Standard of Care Observation in Completely Resected Merkel Cell Carcinoma (MCC). This study will evaluate the effectiveness of pembrolizumab compared to standard of care observation to assess recurrence in patients with Merkel cell carcinoma that has been removed by surgery.
4. J21102 – MONETTE: A Randomized, Open-Label, Phase 2 Study of ATR inhibitor (Ceralasertib) Monotherapy and Ceralasertib plus Durvalumab (anti-PD-1) in Patients with Unresectable or Advanced Melanoma and Primary or Secondary Resistance to PD-(L)1 Inhibition. Patients who had disease progression on prior anti-PD-(L)1 immunotherapy will be randomized to receive either an ATR inhibitor (ceralasertib) alone, or an ATR inhibitor in combination with anti-PD-1 therapy. This study is pending activation and enrollment.
5. J20124 - A Phase 1b, Open-Label, Multicenter Study To Evaluate The Safety, Pharmacokinetics, And Activity Of Belvarafenib (pan-RAF inhibitor) As A Single Agent And In Combination With Either Cobimetinib (MEK inihbitor) Or Cobimetinib Plus Atezolizumab (anti-PD-L1) In Patients With NRAS-Mutant Advanced Melanoma Who Have Received Anti-PD-1/PD-L1 Therapy. This study is enrolling patients with NRAS-mutant advanced melanoma who have received anti-PD-(L)1 immunotherapy before. Patients will receive a pan-RAF inhibitor (Belvarafenib) either alone, in combination with Cobimetinib (MEK inhibitor), or in combination with both Cobimetinib and atezolizumab (anti-PD-L1). This study is actively enrolling patients.
6. J2108 - A Phase 1/2 Open-Label, Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants with Melanoma (KEYNOTE-U02). This study is enrolling patients to receive pembrolizumab (anti-PD-1) in combination with a variety of study drugs, to include MK 7684 (anti-Tigit), MK 1308 (anti-CTLA-4), lenvatinib (tyrosine kinase inhibitor), and V9373 (Talimogene laherparepvec) intratumorally. There are multiple arms to this study dependent on the patient’s stage of disease. This study is pending activation and enrollment.