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
A
Amikar Sehdev, MD
Primary Investigator
Recruiting
18-100 years
All
Phase
N/A
2 Locations
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).
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: melanoma
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Age: Between 18 Years - 100 Years
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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.
Additional Information:Participants will not be paid for their participation.
Updated on
01 Aug 2024.
Study ID: 1809367652 (S1607)
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