A Phase II Study of Combining Talimogene Laherparepvec T-VEC (NSC-785349) and MK-3475 (Pembrolizumab) (NSC-776864) in Patients With Advanced Melanoma Who Have Progressed on Anti-PD1/L1 Based Therapy

Study on the Effects of an Investigational Medication Combination in Skin Cancer (Melanoma) Patients

Recruiting
18 years - 100 years
All
Phase N/A
1 Location

Brief description of study.

The purpose of this study is to test any good and bad effects of the combination of study drugs called MK-3475 (pembrolizumab) and talimogene laherparepvec (T-VEC) in melanoma patients.

Detailed description of study

The purpose of this study is to evaluate the durable response rate of treatment with talimogene laherparepvec (T-VEC) in combination with MK-3475 (pembrolizumab) following progression on prior anti-PD-1 or anti-PD-L1 therapy alone or in combination with other agents different from talimogene laherparepvec (T-VEC).
Participants will not be paid for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: melanoma
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria

In order to be eligible to take part in this trial, patients must meet the following criteria:

  • 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.
  • Patients may have brain metastases if all lesions have been treated with stereotactic radiation therapy, craniotomy, or gamma knife therapy with no evidence of progression (demonstrated by identical imaging modality for 2 consecutive assessments/scans [magnetic resonance imaging (MRI) or CT scans], at least 4 weeks apart) and have not required steroids for at least 14 days prior to registration.

For a full list of participation criteria, please visit clinicaltrials.gov.

Updated on 19 Feb 2024. Study ID: 1809367652 (S1607)

This study investigates the effects of a combination of investigational medications in patients with melanoma. Melanoma is a type of skin cancer that can spread to other parts of the body. The purpose of this study is to evaluate how well this combination works in patients who have already tried other treatments.

Participants in the study will receive a combination of two investigational medications. These medications will be given to see if they can provide a durable response in treating melanoma. The study will involve regular monitoring to assess the effects of the treatment.

  • Who can participate: Adults with stage IV or unresectable stage III melanoma can participate. Patients must not have disease suitable for local therapy, and those with treated brain metastases may join if there is no disease progression and no steroid use for 14 days prior.
  • Study details: Participants will receive a combination of investigational medications and be monitored to evaluate the response to the treatment. No payment will be provided for participation.

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