UV1 Vaccine With Pembrolizumab for Patients With Unresectable or Metastatic Melanoma

Phase 1

Completed

• Conditions: Malignant Melanoma
• Interventions: Drug: UV1; Drug: GM-CSF

• Registration Number: NCT03538314
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-22
• Study First Submitted QC: 2018-05-15
• Study First Posted: 2018-05-29
• Study Start: 2018-07-09
• Primary Completion: 2022-10-01
• Study Completion: 2024-06-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Treatment	GM-CSF	UV1/GM-CSF
Experimental Treatment	UV1	UV1/GM-CSF

Primary Outcome Measures

Name	Time	Method
Number of patients with treatment-related adverse events	Up to week 29	Frequency and severity of adverse events

Secondary Outcome Measures

Name	Time	Method
Tumor response	Up to week 52	RECIST and iRECIST
The length of time from the start of treatment that patients are still alive.	up to 2 years	Overall survival

Trial Locations

Locations (4)

John Wayne Cancer Center; 🇺🇸 Santa Monica, California, 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