UV1 Vaccine With Pembrolizumab for Patients With Unresectable or Metastatic Melanoma

NCT ID: NCT03538314

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-09
• Study Completion Date: 2024-06-15

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.

Conditions

Malignant Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Treatment

UV1/GM-CSF

Group Type: EXPERIMENTAL

UV1

Intervention Type: DRUG

UV1 (300 microgram)

GM-CSF

Intervention Type: DRUG

GM-CSF (37,5 or 75 microgram)

Interventions

UV1

UV1 (300 microgram)

Intervention Type: DRUG

GM-CSF

GM-CSF (37,5 or 75 microgram)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ultimovacs ASA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

John Wayne Cancer Center

Santa Monica, California, United States

University of Iowa Carver College of Medicine

Iowa City, Iowa, United States

St. Luke's University Health Network

Easton, Pennsylvania, United States

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

UV1/hTERT-MM-103

Identifier Type: -

Identifier Source: org_study_id