UV1 Vaccine With Pembrolizumab for Patients With Unresectable or Metastatic Melanoma

NCT03538314 | Completed Phase 1 FDA Drug

• 1 other identifier: UV1/hTERT-MM-103
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Number of patients with treatment-related adverse events

  Frequency and severity of adverse events

  Up to week 29

Secondary Outcomes (2)

• Tumor response

  Up to week 52

• The length of time from the start of treatment that patients are still alive.

  up to 2 years

Study Arms (1)

Experimental Treatment

EXPERIMENTAL

UV1/GM-CSF

Drug: UV1; Drug: GM-CSF

Interventions

UV1 DRUG

UV1 (300 microgram)

Experimental Treatment

GM-CSF DRUG

GM-CSF (37,5 or 75 microgram)

Experimental Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage IIIB, IIIC or IV melanoma
• 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

You may not qualify if:

• Uveal or ocular malignant melanoma
• 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
• 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.
• Prior therapy with an anti-CTLA4, anti-PD-1, anti-PD-L1, anti-PD-L2 agent or oncolytic virus.
• Known hypersensitivity to GM-CSF
• Women who are breastfeeding, pregnant or expect to be pregnant during the study through 6 months after the last dose
• Men who plan to become a father during the study through 4 months after the last dose of study medication
• Known history of, or any evidence of active, non-infectious pneumonitis
• History of cardiac disease

Sponsors & Collaborators

• Ultimovacs ASA: lead

Study Sites (4)

John Wayne Cancer Center

Santa Monica, California, 90404, United States

Location

University of Iowa Carver College of Medicine

Iowa City, Iowa, 52242, United States

Location

St. Luke's University Health Network

Easton, Pennsylvania, 18045, United States

Location

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: UV1/GM-CSF

Study Record Dates

• First Submitted: April 22, 2018
• First Posted: May 29, 2018
• Study Start: July 9, 2018
• Primary Completion: October 1, 2022
• Study Completion: June 15, 2024
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

US (4)