UV1 Vaccine With Pembrolizumab for Patients With Unresectable or Metastatic Melanoma

Conditions

Malignant Melanoma

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.

Haakensen VD, Nowak AK, Ellingsen EB, Farooqi SJ, Bjaanæs MM, Horndalsveen H, Mcculloch T, Grundberg O, Cedres SM, Helland Å.

2021-05-3123 citations

10.1186/s12967-021-02905-3

A phase I clinical trial investigating the telomerase vaccine UV1 in combination with pembrolizumab in patients with advanced melanoma.

Yousef Zakharia, Steven O’Day, Wenche Rasch, Mohammed Milhem

Journal of Clinical Oncology2021-05-204 citations

10.1200/jco.2021.39.15_suppl.2620

Combining a Universal Telomerase Based Cancer Vaccine With Ipilimumab in Patients With Metastatic Melanoma - Five-Year Follow Up of a Phase I/IIa Trial

Elin Aamdal, Else Marit Inderberg, Espen B. Ellingsen, Wenche Rasch, Paal Brunsvig et al. (13 authors)

Frontiers in Immunology2021-05-1140 citations

10.3389/fimmu.2021.663865

Interventions

DRUGUV1

UV1 (300 microgram)

DRUGGM-CSF

GM-CSF (37,5 or 75 microgram)

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

UV1/GM-CSF

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Number of patients with treatment-related adverse events	Up to week 29	Frequency and severity of adverse events

Secondary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed