Clinical Trials /

UV1 Vaccine With Pembrolizumab for Patients With Unresectable or Metastatic Melanoma

NCT03538314

Description:

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.

Related Conditions:
  • Melanoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: UV1/hTERT-MM-103
  • NCT ID: NCT03538314

Conditions

  • Malignant Melanoma

Interventions

DrugSynonymsArms
UV1/GM-CSFExperimental Treatment

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.

Trial Arms

NameTypeDescriptionInterventions
Experimental TreatmentExperimentalUV1/GM-CSF
  • UV1/GM-CSF

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of patients with treatment-related adverse events
Time Frame:Up to week 29
Safety Issue:
Description:Frequency and severity of adverse events

Secondary Outcome Measures

Measure:Tumor response
Time Frame:Up to week 52
Safety Issue:
Description:RECIST and irRECIST
Measure:The length of time from the start of treatment that patients are still alive.
Time Frame:up to 2 years
Safety Issue:
Description:Overall survival

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Ultimovacs AS

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