Talimogene Laherparepvec + Pembrolizumab for Skin Cancer

Recruiting at20 trial locations

Overseen by Siwen Hu-Lieskovan

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well talimogene laherparepvec and pembrolizumab work in treating patients with stage III-IV melanoma. Biological therapies, such as talimogene laherparepvec, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop tumor cells from growing. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving talimogene laherparepvec and pembrolizumab may work better in treating patients with melanoma by shrinking the tumor.

Research Team

Siwen Hu-Lieskovan

Principal Investigator

SWOG Cancer Research Network

Eligibility Criteria

This trial is for adults with stage III-IV melanoma who've had prior treatment with anti-PD-1 or anti-PD-L1 agents and saw their disease progress. They must have measurable disease, be in good physical condition, and agree to provide tissue samples. Exclusions include recent treatments, active autoimmune diseases requiring systemic treatment, uncontrolled illnesses that could limit compliance, pregnancy or nursing women.

Inclusion Criteria

As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

I have received anti-PD-1 or anti-PD-L1 treatment and my disease progressed after this treatment.

My melanoma is at an advanced stage and cannot be removed with surgery.

Exclusion Criteria

Patients must not have evidence of any clinically significant immunosuppression

I have not had any recent surgeries or therapies.

I do not have an active autoimmune disease needing systemic treatment.

Treatment Details

Interventions

• Pembrolizumab (Monoclonal Antibodies)
• Talimogene Laherparepvec (Virus Therapy)

Trial Overview The study tests talimogene laherparepvec (a biological therapy) combined with pembrolizumab (an immunotherapy antibody), aiming to shrink tumors in advanced melanoma patients. It's a phase II trial exploring if this combination can stimulate the immune system more effectively than current treatments.

Participant Groups

Group I: Treatment (talimogene laherparepvec, pembrolizumab) Experimental Treatment 2 Interventions

Patients receive talimogene laherparepvec IL and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School