43 Participants Needed

Talimogene Laherparepvec + Pembrolizumab for Skin Cancer

Recruiting at 20 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: National Cancer Institute (NCI)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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

SH

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.
See 9 more

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.
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive talimogene laherparepvec intralesionally and pembrolizumab intravenously every 21 days for up to 36 cycles

Approximately 2 years
Every 21 days

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

5 years
Every 6 months for 1 year, then annually

Treatment Details

Interventions

  • Pembrolizumab
  • Talimogene Laherparepvec
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
1Treatment groups
Experimental Treatment
Group I: Treatment (talimogene laherparepvec, pembrolizumab)Experimental Treatment2 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.

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸
Approved in United States as KEYTRUDA for:
  • 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
🇪🇺
Approved in European Union as KEYTRUDA for:
  • 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
🇬🇧
Approved in United Kingdom as KEYTRUDA for:
  • 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

Trials
14,080
Recruited
41,180,000+

Findings from Research

In a phase III study involving 692 patients with advanced melanoma, the combination of talimogene laherparepvec (T-VEC) and pembrolizumab did not significantly improve progression-free survival (PFS) or overall survival (OS) compared to pembrolizumab alone.
The combination therapy showed a higher objective response rate (48.6% vs. 41.3%) and a similar safety profile to the placebo group, with grade ≥ 3 treatment-related adverse events occurring in about 20% of patients in both treatment arms.
Randomized, Double-Blind, Placebo-Controlled, Global Phase III Trial of Talimogene Laherparepvec Combined With Pembrolizumab for Advanced Melanoma.Chesney, JA., Ribas, A., Long, GV., et al.[2023]
Pembrolizumab is a monoclonal antibody that effectively blocks the PD-1 receptor on T cells, enhancing their ability to attack cancer cells, particularly in melanoma patients.
In a Phase I study involving 411 patients, pembrolizumab demonstrated high durable response rates with minimal toxicity, indicating its potential as a safe and effective treatment option for melanoma.
Pembrolizumab joins the anti-PD-1 armamentarium in the treatment of melanoma.Hersey, P., Gowrishankar, K.[2017]
Pembrolizumab (PEM) significantly improved short-term treatment effectiveness and long-term survival rates in patients with advanced cutaneous malignant melanoma compared to chemotherapy with Temozolomide, with a notable increase in one-year survival rates (53.85% vs. 40.00%).
The use of PEM did not lead to a higher incidence of adverse reactions compared to the control group, indicating that it is a relatively safe treatment option for patients with this type of melanoma.
Clinical application effect of Pembrolizumab in the treatment of advanced cutaneous malignant melanoma.Fu, L., Zhang, H., Jiang, J., et al.[2021]

References

Randomized, Double-Blind, Placebo-Controlled, Global Phase III Trial of Talimogene Laherparepvec Combined With Pembrolizumab for Advanced Melanoma. [2023]
Efficacy and safety of talimogene laherparepvec versus granulocyte-macrophage colony-stimulating factor in patients with stage IIIB/C and IVM1a melanoma: subanalysis of the Phase III OPTiM trial. [2021]
Real-World Use of Talimogene Laherparepvec in German Patients with Stage IIIB to IVM1a Melanoma: A Retrospective Chart Review and Physician Survey. [2022]
Combining talimogene laherparepvec with immunotherapies in melanoma and other solid tumors. [2022]
Final analyses of OPTiM: a randomized phase III trial of talimogene laherparepvec versus granulocyte-macrophage colony-stimulating factor in unresectable stage III-IV melanoma. [2020]
Potential clinical and immunotherapeutic utility of talimogene laherparepvec for patients with melanoma after disease progression on immune checkpoint inhibitors and BRAF inhibitors. [2019]
Pembrolizumab joins the anti-PD-1 armamentarium in the treatment of melanoma. [2017]
Clinical application effect of Pembrolizumab in the treatment of advanced cutaneous malignant melanoma. [2021]
Pembrolizumab in the management of metastatic melanoma. [2020]
Pembrolizumab: A Review in Advanced Melanoma. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Biophysical and Immunological Characterization and In Vivo Pharmacokinetics and Toxicology in Nonhuman Primates of the Anti-PD-1 Antibody Pembrolizumab. [2021]
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