NCT03538314CompletedPhase 1
UV1 Vaccine With Pembrolizumab for Patients With Unresectable or Metastatic Melanoma
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
Source: ClinicalTrials.gov · Last updated 22 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 22 Apr 2018
- Start date
- 9 Jul 2018
- Primary completion date
- 1 Oct 2022
- Lead sponsor
- Ultimovacs ASA
- Diseases
- Melanoma
- NCT number
- NCT03538314
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 30
- From 9 Jul 2018 to the primary completion date, 1 Oct 2022
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Men who plan to become a father during the study through 4 months after the last dose of study medication
Other illness
- 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
- Known hypersensitivity to GM-CSF
- Known history of, or any evidence of active, non-infectious pneumonitis
- History of cardiac disease
Other
- Women who are breastfeeding, pregnant or expect to be pregnant during the study through 6 months after the last dose
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Luke's University Health Network Coordinator of this site? Confirm its status | Easton | United States | Unknown status |
| University of Iowa Carver College of Medicine Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| University of Utah - Huntsman Cancer Institute Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| John Wayne Cancer Center Coordinator of this site? Confirm its status | Santa Monica | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.