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: (MK3475-U02/KEYNOTE U02)

The U02 study is a 3-part research study that is testing experimental treatments for melanoma, a type of skin cancer. This larger study is known as an umbrella study. The sub-studies are: 02A, 02B, 02C, and 02D.

This study is testing drugs that have not been approved for treatment of advanced melanoma when they are given with pembrolizumab. Pembrolizumab (MK-3475) is a drug that has been approved in the United States by the U.S. Food and Drug Administration (FDA), and other countries for treatment of advanced melanoma. It is a PD-1 treatment. It is also known as KEYTRUDA®. Some treatment groups in this study will test if combining pembrolizumab with other drugs helps to treat PD-1 refractory melanoma. Various study drugs will be tested in combination with pembrolizumab in this study. These combinations are considered experimental. "Experimental" means that the combinations are not approved by the U.S. Food and Drug Administration (FDA) to treat melanoma. Other experimental treatments included in this study are: MK-7684, V937, MK-1308, and lenvatinib.

Inova Schar Cancer Institute
8081 Innovation Park Dr.
Fairfax, VA 22031

A department of Inova Fairfax Hospital

• Adults (18 years of age and older)
• Histologically or cytologically confirmed melanoma
• Has unresectable Stage III or Stage IV melanoma, per AJCC 8th Edition Staging Criteria, not amenable to local therapy
• Has the presence of at least 1 measurable lesion by CT or MRI per RECIST 1.1 as confirmed by BICR
• Adequate organ function
• Additional eligibility in protocol and may vary by sub-study

• Has received more than 3 lines of therapy for their advanced melanoma
• Pregnant or breastfeeding
• A diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study intervention
• Has a known additional malignancy that is progressing or requires active treatment within the past 2 years. Exceptions to the secondary malignancy exclusion include: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, new nonulcerated primary melanoma <1 mm in depth with no nodal involvement, Grade 1 follicular lymphoma or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy
• Has an active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs)
• Additional ineligibility in protocol and may vary by sub-study

Additional information can be found at:

https://clinicaltrials.gov/ct2/show/NCT04305054

https://clinicaltrials.gov/ct2/show/NCT04305041

https://clinicaltrials.gov/ct2/show/NCT04303169

https://clinicaltrials.gov/ct2/show/NCT04700072