Phase I of UV1 Vaccine With Pembrolizumab



Status:Recruiting
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/3/2019
Start Date:July 9, 2018
End Date:May 2021

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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

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.


Key Inclusion Criteria:

1. Stage IIIB, IIIC or IV melanoma

2. 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:

1. Uveal or ocular malignant melanoma

2. 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

3. 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.

4. Prior therapy with an anti-CTLA4, anti-PD-1, anti-PD-L1, anti-PD-L2 agent or oncolytic
virus.

5. Known hypersensitivity to GM-CSF

6. Women who are breastfeeding, pregnant or expect to be pregnant during the study
through 6 months after the last dose

7. Men who plan to become a father during the study through 4 months after the last dose
of study medication

8. Known history of, or any evidence of active, non-infectious pneumonitis

9. History of cardiac disease
We found this trial at
4
sites
Santa Monica, California 90404
Principal Investigator: Steven J O'Day, MD
Phone: 310-449-5224
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Santa Monica, CA
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Easton, Pennsylvania 18045
Principal Investigator: Sanjay Agarwala, MD
Phone: 484-503-4152
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Easton, PA
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Iowa City, Iowa 52245
Principal Investigator: Mohammed M Milhem, MD
Phone: 319-467-5830
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Iowa City, IA
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Salt Lake City, Utah 84112
Principal Investigator: Benjamin Voorhies, MD
Phone: 801-213-4299
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Salt Lake City, UT
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