UV1 Vaccine With Pembrolizumab for Patients With Unresectable or Metastatic Melanoma

Study Overview
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Brief Summary
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UV1 is a therapeutic cancer vaccine that has been explored in prostate and lung cancers, and in combination with ipilimumab in malignant melanoma. This study will explore the safety, tolerability and efficacy of UV1 administered with GM-CSF in melanoma patients who are also receiving pembrolizumab.

Official Title
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A Phase I, Open-label, Multicenter Study Investigating the Tolerability and Efficacy of UV1 Vaccine in First-line Malignant Melanoma Patients Planned for Treatment With Pembrolizumab

Conditions
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Malignant Melanoma

Intervention / Treatment
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* Drug: UV1
* Drug: GM-CSF


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Stage IIIB, IIIC or IV melanoma Previously untreated and eligible for pembrolizumab treatment (prior treatment with BRAF and MEK inhibitors permitted) 3) Adequate blood, liver and kidney function 4) Consent to undergo tumor biopsies during the study Exclusion Criteria: Uveal or ocular malignant melanoma History of hematologic or primary solid tumor malignancy with the exception of patients in remission for at least 5 years, as judged by the investigator are allowed Prior systemic treatment for unresectable or metastatic melanoma. Exception: Prior treatment with BRAF and MEK inhibitors permitted. A washout period of at least 3-half-lives (median terminal half-life) prior to the first dose of trial treatment must have elapsed. Prior therapy with an anti-CTLA4, anti-PD-1, anti-PD-L1, anti-PD-L2 agent or oncolytic virus. Known hypersensitivity to GM-CSF Women who are breastfeeding, pregnant or expect to be pregnant during the study through 6 months after the last dose Men who plan to become a father during the study through 4 months after the last dose of study medication Known history of, or any evidence of active, non-infectious pneumonitis History of cardiac disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: UV1/GM-CSF
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Treatment<br>UV1/GM-CSF | Drug: UV1<br>* UV1 (300 microgram)<br>Drug: GM-CSF<br>* GM-CSF (37,5 or 75 microgram)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with treatment-related adverse events | Frequency and severity of adverse events | Up to week 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response | RECIST and iRECIST | Up to week 52 | 
| The length of time from the start of treatment that patients are still alive. | Overall survival | up to 2 years |