UV1 Vaccine With Pembrolizumab for Patients With Unresectable or Metastatic Melanoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03538314
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Ultimovacs ASA
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Malignant Melanoma

Arms & Interventions

Arms

Experimental: Experimental Treatment

UV1/GM-CSF

Interventions

Drug: - UV1/GM-CSF

UV1 (300 microgram) GM-CSF (37.5 microgram)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

John Wayne Cancer Center, Santa Monica, California

Status

Recruiting

Address

John Wayne Cancer Center

Santa Monica, California, 90404

Site Contact

Hunter Cole

310-449-5224

Iowa City, Iowa

Status

Recruiting

Address

University of Iowa Carver College of Medicine

Iowa City, Iowa, 52242

Site Contact

Kristina Smith

319-467-5830

St. Luke's University Health Network, Easton, Pennsylvania

Status

Recruiting

Address

St. Luke's University Health Network

Easton, Pennsylvania, 18045

Site Contact

Robyn Rex, RN

robyn.rex@sluhn.org

484-503-4152

Salt Lake City, Utah

Status

Recruiting

Address

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, 84112

Site Contact

Carolyn Hunter

801-213-4299

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