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UV1 Vaccine With Pembrolizumab for Patients With Unresectable or Metastatic Melanoma

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 : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Ultimovacs ASA

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.

Condition or disease Intervention/treatment Phase
Malignant Melanoma Drug: UV1 Drug: GM-CSF Phase 1

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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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: Experimental Treatment
UV1/GM-CSF
Drug: UV1
UV1 (300 microgram)

Drug: GM-CSF
GM-CSF (37,5 or 75 microgram)




Primary Outcome Measures :
  1. Number of patients with treatment-related adverse events [ Time Frame: Up to week 29 ]
    Frequency and severity of adverse events


Secondary Outcome Measures :
  1. Tumor response [ Time Frame: Up to week 52 ]
    RECIST and irRECIST

  2. The length of time from the start of treatment that patients are still alive. [ Time Frame: up to 2 years ]
    Overall survival



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Ultimovacs ASA
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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: February 21, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas