Talimogene Laherparepvec and Pembrolizumab in Treating Patients With Stage III-IV Melanoma (NCT02965716)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Patients must have pathologically confirmed stage IV or unresectable stage III melanoma; patients must not have disease that is suitable for local therapy, administered with curative intent
2. Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; contrast-enhanced computed tomography (CT) scans of the chest, abdomen and pelvis are required; a whole body positron emission tomography (PET)/CT scan with diagnostic quality images and intravenous iodinated contrast may be used in lieu of a contrast enhanced CT of the chest, abdomen and pelvis; imaging of the head and neck, or the limbs is required only if the patient has a lesion(s) in these areas; contrast may be omitted if the treating investigator believes that exposure to contrast poses an excessive risk to the patient; if skin lesions are being followed as measurable disease, photograph with a ruler included and physician's measurements, must be kept in the patients chart as source documentation; all measurable lesions must be assessed within 28 days prior to registration; tests to assess non-measurable disease must be performed within 42 days prior to registration.; all disease must be assessed and documented on the baseline tumor assessment form (RECIST 1.1)
3. Cohort A: Patients must have at least one measurable visceral lesion (per RECIST 1.1); a visceral lesion is any solid organ except for skin, lymph node, and musculoskeletal tissue; at least one of these visceral lesions must be measurable per RECIST 1.1
4. Patients must, in the opinion of the treating physician, be candidates for intralesional administration into cutaneous, subcutaneous, or nodal lesions
5. Patients may have brain metastases if all lesions have been treated with stereotactic radiation therapy, craniotomy, or gamma knife therapy and have not required steroids for at least 14 days prior to registration
6. Patient must have had prior treatment with anti-PD-1 or anti-PD-L1 agents and have documented disease progression on these agents prior to registration; patients who have progressed after adjuvant anti-PD1/L1 agents are eligible
7. Patients must be \>= 18 years of age
8. Patients must have Zubrod performance status =\< 2
9. Absolute neutrophil count (ANC) \>= 1,500/mcL (within 28 days prior to registration)
10. Hemoglobin \>= 8 g/dL (within 28 days prior to registration)
11. Platelets \>= 100,000/mcL (within 28 days prior to registration)
12. Albumin \>= 2.5 g/dL (within 28 days prior to registration)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (20 Sites)

• University of South Alabama Mitchell Cancer Institute — Mobile, Alabama
• CTCA at Western Regional Medical Center — Goodyear, Arizona
• Los Angeles General Medical Center — Los Angeles, California
• USC / Norris Comprehensive Cancer Center — Los Angeles, California
• UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California
• Keck Medical Center of USC Pasadena — Pasadena, California
• Loyola University Medical Center — Maywood, Illinois
• Indiana University/Melvin and Bren Simon Cancer Center — Indianapolis, Indiana
• University of Kansas Hospital-Westwood Cancer Center — Westwood, Kansas
• Henry Ford Cancer Institute-Downriver — Brownstown, Michigan
• Henry Ford Macomb Hospital-Clinton Township — Clinton Township, Michigan
• Henry Ford Hospital — Detroit, Michigan
• Allegiance Health — Jackson, Michigan
• Henry Ford West Bloomfield Hospital — West Bloomfield, Michigan
• Kansas City Veterans Affairs Medical Center — Kansas City, Missouri
• University of Cincinnati Cancer Center-UC Medical Center — Cincinnati, Ohio
• Ohio State University Comprehensive Cancer Center — Columbus, Ohio
• University of Cincinnati Cancer Center-West Chester — West Chester, Ohio
• Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee
• Huntsman Cancer Institute/University of Utah — Salt Lake City, Utah

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.