UV1 Vaccine With Pembrolizumab for Patients With Unresectable or Metastatic Melanoma
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03538314 |
Recruitment Status :
Active, not recruiting
First Posted : May 29, 2018
Last Update Posted : May 25, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Malignant Melanoma | Drug: UV1 Drug: GM-CSF | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | UV1/GM-CSF |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | July 9, 2018 |
Estimated Primary Completion Date : | October 2022 |
Estimated Study Completion Date : | October 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Experimental Treatment
UV1/GM-CSF
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Drug: UV1
UV1 (300 microgram) Drug: GM-CSF GM-CSF (37,5 or 75 microgram) |
- Number of patients with treatment-related adverse events [ Time Frame: Up to week 29 ]Frequency and severity of adverse events
- Tumor response [ Time Frame: Up to week 52 ]RECIST and iRECIST
- The length of time from the start of treatment that patients are still alive. [ Time Frame: up to 2 years ]Overall survival

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03538314
United States, California | |
John Wayne Cancer Center | |
Santa Monica, California, United States, 90404 | |
United States, Iowa | |
University of Iowa Carver College of Medicine | |
Iowa City, Iowa, United States, 52242 | |
United States, Pennsylvania | |
St. Luke's University Health Network | |
Easton, Pennsylvania, United States, 18045 | |
United States, Utah | |
University of Utah Huntsman Cancer Institute | |
Salt Lake City, Utah, United States, 84112 |
Responsible Party: | Ultimovacs ASA |
ClinicalTrials.gov Identifier: | NCT03538314 |
Other Study ID Numbers: |
UV1/hTERT-MM-103 |
First Posted: | May 29, 2018 Key Record Dates |
Last Update Posted: | May 25, 2021 |
Last Verified: | May 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |