Talimogene Laherparepvec + Pembrolizumab for Skin Cancer
Trial Summary
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you must not have had surgery, biologic therapy, hormonal therapy, chemotherapy, targeted small molecule therapy, or radiation therapy within 14 days before joining the trial. It's best to discuss your specific medications with the study team.
What data supports the effectiveness of the treatment Talimogene Laherparepvec combined with Pembrolizumab for skin cancer?
Research shows that the combination of Talimogene Laherparepvec and Pembrolizumab has shown promising results in treating advanced melanoma, a type of skin cancer, with a good safety profile and encouraging response rates. Studies indicate that this combination may work better than using either treatment alone, without adding extra safety concerns.12345
Is the combination of Talimogene Laherparepvec and Pembrolizumab safe for humans?
The combination of Talimogene Laherparepvec (T-VEC) and Pembrolizumab has shown an acceptable safety profile in patients with advanced melanoma, with most side effects being mild to moderate. Early results indicate that combining T-VEC with Pembrolizumab does not introduce additional safety concerns beyond those expected for each treatment alone.13456
What makes the drug combination of Talimogene Laherparepvec and Pembrolizumab unique for treating skin cancer?
This treatment combines Talimogene Laherparepvec, a virus-based therapy that directly attacks cancer cells, with Pembrolizumab, an immune checkpoint inhibitor that boosts the immune system's ability to fight cancer. This combination is unique because it uses two different mechanisms to enhance the body's natural defenses against skin cancer.7891011
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive talimogene laherparepvec intralesionally and pembrolizumab intravenously every 21 days for up to 36 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
Treatment Details
Interventions
- Pembrolizumab
- Talimogene Laherparepvec
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor