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Combination Immunotherapy for Stage III Melanoma

This study is testing a combination of two immunotherapy drugs, Pembrolizumab and Talimogene Laherparepvec (T-VEC), before surgery for people with stage III melanoma that has spread to the lymph nodes. Immunotherapy helps your body's immune system fight cancer. Researchers want to see how safe and effective this combination is. You might be able to join if you are 18 or older, have stage III melanoma that can be removed by surgery, and meet other health requirements. The main goal is to see if the treatment completely removes the cancer before surgery, which will be checked at 6 months. The current status of this study is unclear, and it plans to enroll 28 participants.

Study design
This is a single-arm Phase 2 study, meaning all 28 participants will receive the same treatment. It is designed to evaluate the safety and effectiveness of the combined therapy.
What's involved
You would receive Pembrolizumab infusions and T-VEC injections before having surgery to remove lymph nodes. This treatment would be given for 6 months.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, pathologic complete response, is measured at 6 months after treatment.

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NCT03842943

Neoadjuvant Combination Immunotherapy for Stage III Melanoma

Recruiting
PHASE2Ages 18+Interventional
University of Louisville
~28 participants
Updated 2024-05-02 on ClinicalTrials.gov
What's tested:PembrolizumabTalimogene Laherparepvec

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pathologic Complete Response
Measured over 6 months

Conditions

Cutaneous Melanoma

Explore related trials

Cutaneous Melanoma

Where it's being run

1 sites across 1 states
Kentucky1

Study leadership

  • Michael Egger, MD · PRINCIPAL_INVESTIGATOR · University of Louisville

Who to contact

Michael Egger, MD
[email protected]
502-629-6950
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

18 years of age, any race or sex, who have pathologically confirmed cutaneous melanoma
ECOG performance status of 0 or 1
Adequate hematologic, hepatic, renal and coagulation function
Must have measurable disease and have an injectable target lymph node for intralesional therapy administration
Primary melanoma has been resected
Pathologically confirmed resectable stage III disease, clinically apparent. Resectability is at the discretion of the treating surgeon who is a melanoma specialist.
Stage III disease can be at time of diagnosis of primary melanoma or a recurrence after initial treatment of stage I-II disease.
BRAF mutant or wild type allowed (mutations status not necessary for enrollment)
Signed, written informed consent

Exclusion

Cannot have metastatic (AJCC M1) disease
No primary mucosal or uveal melanoma
No evidence of melanoma associated with immunodeficiency state or history or other malignancies (other than non-melanoma skin cancer) within the past 3 years
May not have been previously treated with T-VEC, any other oncolytic virus, pembrolizumab, or any other PD-1, PD-L1, or PD-L2 inhibitor
Must not have a history or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other symptomatic autoimmune disease, document history of autoimmune disease or syndrome requiring systemic treatment in the past two years (i.e. use of disease modifying agents, steroids, or immunosuppressive agents) except vitiligo or resolved childhood asthma/atopy, or evidence of clinically significant immunosuppression
Must not have active herpetic skin lesions or prior complications of herpetic infection and must not require intermittent or chronic treatment with an anti-herpetic drug (e.g. acyclovir) other than intermittent topical use

What this trial measures

  • Pathologic Complete Response6 months

    Pathologic response rate in the regional nodal basin assessed after complete lymph node dissection