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.
Melanoma Clinical Trials Available at Johns Hopkins (Kimmel Cancer Center searchable database.)
Summary of Current Melanoma Trials
Hopkins Melanoma Program: Open and Accruing Clinical Trials
Hopkins Melanoma Program: Clinical trials for patients with advanced skin cancer
- 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.
- J1860 - A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined with Nivolumab versus Nivolumab in Participants with Previously Untreated Metastatic or Unresectable Melanoma. This study tests BMS-986016 (Anti-LAG-3) and BMS-936558 (nivolumab, anti-PD-1) in patients with unresectable or metastatic melanoma who have never received prior treatment.
- J1825 – A Phase 1/2 Study of Relatlimab (anti-LAG-3 Monoclonal Antibody) Administered in Combination with Both Nivolumab (anti-PD-1 Monoclonal Antibody) and BMS- 986205 (IDO1 inhibitor) or in Combination with Both Nivolumab and Ipilimumab (anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors (CA224-048). This study tests a combination of 3 therapies in patients with unresectable or metastatic melanoma.
- J13101: A Phase 1/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination with Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors. This study tests BMS-986016 (Anti-LAG-3) and BMS-936558 (nivolumab, anti-PD-1) in patients with advanced melanoma. Anti-LAG-3 and nivolumab are drugs that help to activate the immune system. Patients may have received prior treatment with anti-PD-1 and must:
- have unresectable or metastatic melanoma
- provide a baseline tumor biopsy and be willing to undergo an on-treatment tumor biopsy
- J15117: Non-Comparative, Open-Label, Multiple Cohort, Phase 1/2 Study of Nivolumab and Nivolumab plus Ipilimumab in Subjects with Virus-Positive and Virus-Negative Solid Tumors. This study tests nivolumab and ipilimumab in several dose combinations, in patients with advanced virus-associated tumors including Merkel cell carcinoma. Therapy is administered prior to surgery to remove stage III Merkel cell carcinoma. Requirements:
- Patients 18 years or older with resectable Stage III Merkel cell carcinoma
- Prior anti-PD-1 treatment is not permitted
- J15214 - A Pilot Study of Stereotactic Radiosurgery combined with Nivolumab in Patients with Newly Diagnosed Melanoma Metastases in the Brain and Spine. This study is being done to look at the safety of using stereotactic radiosurgery (SRS) and nivolumab (anti-PD-1) together to treat melanoma that has spread to the brain or spine. Both nivolumab and SRS are used separately for the treatment of advanced melanoma. We are testing these therapies together because there is laboratory evidence that suggests that the combination may be more powerful than either treatment by itself. Nivolumab is approved by the U.S. Food and Drug Administration (FDA) for the treatment of melanoma that has spread throughout the body. It works by activating your immune system to fight off cancer. Stereotactic radiosurgery uses radiation to treat tumors without needing to cut or use stitches, and is approved by the FDA for the treatment of melanoma in the brain or spine. Requirements:
- Patients with melanoma that has spread to the brain or spine
- Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PDL-2 antibody is not permitted
- Prior whole brain radiation or conventional radiation to the spine at the site of new lesion is not permitted
- 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.
- J18109 - Adjuvant Therapy with Pembrolizumab versus Placebo in Resected High-risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study. This study will examine whether the benefits achieved with pembrolizumab adjuvant therapy seen in Stage III and IV melanoma translates to the adult (≥18 years of age) and pediatric (age 12 and older) High Risk Stage II melanoma populations, while identifying biomarker correlates. Requirements:
- Newly diagnosed, pathologically confirmed, completely resected Stage IIB and IIC melanoma with negative margins and had a negative sentinel lymph node biopsy
- Participants cannot have received prior systemic therapy for Stage II melanoma.
- E10214 – Tacrolimus, Nivolumab, and Ipilimumab in Treating Kidney Transplant Recipients With Selected Unresectable or Metastatic Cancers. This study will examine how well tacrolimus, nivolumab, and ipilimumab work in treating kidney transplant recipients with cancer that cannot be removed by surgery or has spread to other places in the body. Requirements:
- Patients must be kidney transplant recipients with a functioning allograft who do not currently require dialysis
- Patients must have histologically or cytologically confirmed melanoma, basal cell carcinoma, Merkel cell carcinoma, cutaneous squamous cell carcinoma, or microsatellite instability (MSI)-high cancers for which standard non-immunological medical, surgical, or radiation therapy would be insufficient
- 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.
- J1980: A Randomized, Placebo-Controlled, Double-Blind Study of Adjuvant Cemiplimab versus Placebo after Surgery and Radiation Therapy in Patients with High Risk Cutaneous Squamous Cell Carcinoma CSCC. This phase 3 study compares the rates of cancer relapse in patients with squamous cell carcinoma of the skin who undergo surgery, radiation treatment and then receive either cemiplimab (anti-PD-1) versus placebo.
- J19103: A Phase 2 Study of Neoadjuvant Cemiplimab for Stage II to IV (MO) Cutaneous Squamous Cell Carcinoma (cSCC). This study evaluates the effectiveness of cemiplimab administered prior to surgery for squamous cell carcinoma of the skin. After surgery, patients will have the option to continue cemiplimab for about a year. For stage II patients, the longest diameter of the tumor must at least 3 cm.