Back to resultsUV1 Vaccine With Pembrolizumab for Patients With Unresectable or Metastatic Melanoma
Primary Purpose
Malignant Melanoma
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
UV1
GM-CSF
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Melanoma
Eligibility Criteria
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
Sites / Locations
- John Wayne Cancer Center
- University of Iowa Carver College of Medicine
- St. Luke's University Health Network
- University of Utah Huntsman Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental Treatment
Arm Description
UV1/GM-CSF
Outcomes
Primary Outcome Measures
Number of patients with treatment-related adverse events
Frequency and severity of adverse events
Secondary Outcome Measures
Tumor response
RECIST and iRECIST
The length of time from the start of treatment that patients are still alive.
Overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03538314
Brief Title
UV1 Vaccine With Pembrolizumab for Patients With Unresectable or Metastatic Melanoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 9, 2018 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ultimovacs ASA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
UV1/GM-CSF
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Treatment
Arm Type
Experimental
Arm Description
UV1/GM-CSF
Intervention Type
Drug
Intervention Name(s)
UV1
Intervention Description
UV1 (300 microgram)
Intervention Type
Drug
Intervention Name(s)
GM-CSF
Intervention Description
GM-CSF (37,5 or 75 microgram)
Primary Outcome Measure Information:
Title
Number of patients with treatment-related adverse events
Description
Frequency and severity of adverse events
Time Frame
Up to week 29
Secondary Outcome Measure Information:
Title
Tumor response
Description
RECIST and iRECIST
Time Frame
Up to week 52
Title
The length of time from the start of treatment that patients are still alive.
Description
Overall survival
Time Frame
up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
John Wayne Cancer Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
University of Iowa Carver College of Medicine
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
St. Luke's University Health Network
City
Easton
State/Province
Pennsylvania
ZIP/Postal Code
18045
Country
United States
Facility Name
University of Utah Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
12. IPD Sharing Statement
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UV1 Vaccine With Pembrolizumab for Patients With Unresectable or Metastatic Melanoma
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