UV1 Vaccine With Pembrolizumab for Patients With Unresectable or Metastatic Melanoma

Malignant Melanoma Clinical Trial

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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03538314
• Other study ID #: UV1/hTERT-MM-103
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 9, 2018
• Est. completion date: October 2025

Study information

• Verified date: November 2022
• Source: Ultimovacs ASA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: October 2025
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Intervention

Drug:
• UV1
UV1 (300 microgram)
• GM-CSF
GM-CSF (37,5 or 75 microgram)

Locations

Country	Name	City	State
United States	St. Luke's University Health Network	Easton	Pennsylvania
United States	University of Iowa Carver College of Medicine	Iowa City	Iowa
United States	University of Utah Huntsman Cancer Institute	Salt Lake City	Utah
United States	John Wayne Cancer Center	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Ultimovacs ASA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with treatment-related adverse events	Frequency and severity of adverse events	Up to week 29
Secondary	Tumor response	RECIST and iRECIST	Up to week 52
Secondary	The length of time from the start of treatment that patients are still alive.	Overall survival	up to 2 years