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.
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
Interventions
Drug | Synonyms | Arms |
---|
UV1 | | Experimental Treatment |
GM-CSF | | Experimental 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
Name | Type | Description | Interventions |
---|
Experimental Treatment | Experimental | 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 iRECIST |
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: | Active, not recruiting |
Lead Sponsor: | Ultimovacs ASA |
Last Updated
May 25, 2021