UV1 Vaccination Plus Nivolumab and Ipilimumab in Treatment of Melanoma

  • STATUS
    Recruiting
  • End date
    Sep 15, 2024
  • participants needed
    154
  • sponsor
    Ultimovacs ASA
Updated on 26 April 2022
platelet count
metastatic melanoma
cancer
direct bilirubin
lung cancer
vaccination
metastasis
neutrophil count
liver metastasis
pembrolizumab
nivolumab
ipilimumab
immunologic adjuvant

Summary

UV1 is a therapeutic cancer vaccine that has been explored in prostate, lung cancer, in combination with ipilimumab in malignant melanoma and in combination with pembrolizumab in metastatic melanoma. This study will explore the Efficacy and Safety of UV1 administered with GM-CSF in combination with nivolumab and ipilimumab.

Description

This is a randomized, open label study to investigate efficacy and safety of UV1 vaccination in combination with nivolumab and ipilimumab as first line treatment of adult patients with histologically confirmed unresectable metastatic melanoma.

Patients in the experimental arm will receive 8 UV1 vaccinations over 4 cycles of nivolumab and ipilimumab. Patients in the control arm will receive 4 cycles of nivolumab and ipilimumab. Patients in both arms will start maintenance therapy 6 weeks after the last dose of induction therapy, nivolumab at a dose of 480 mg every 4 weeks.

All patients will be followed up until death or until the end of the study.

Details
Condition Malignant Melanoma
Treatment Ipilimumab, Nivolumab, sargramostim, UV1
Clinical Study IdentifierNCT04382664
SponsorUltimovacs ASA
Last Modified on26 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female patients at least 18 years of age at the time of signing the ICF
Histologically confirmed diagnosis of unresectable stage IIIB D, or unresectable stage IV malignant melanoma
Eligible for combination treatment with nivolumab and ipilimumab
An ECOG performance status of 0 or 1
Adequate organ function as indicated by the following laboratory values
Hematological
Absolute neutrophil count ≥1,500/µL
Platelet count ≥100 x 103/µL
Hemoglobin ≥9 g/dL or ≥5.6 mmol/L Renal
Creatinine ≤1.5 x upper limit of normal (ULN) Hepatic
Total bilirubin ≤1.5 x ULN or direct bilirubin ≤ ULN for patients with total bilirubin levels >1.5 ULN
Aspartate aminotransferase/serum glutamic oxaloacetic transaminase and alanine aminotransferase/serum glutamic pyruvic transaminase ≤2.5 x ULN for patients without liver metastasis or ≤5 x ULN for patients with liver metastasis
Male patients who are sexually active with a female of childbearing potential must
Women of childbearing potential (WOCBP) must have a negative urine or serum/plasma pregnancy test
agree to use an adequate method of contraception
WOCBP must use adequate contraception

Exclusion Criteria

Previous non melanoma malignancies unless curatively treated and complete remission was achieved at least 2 years prior to randomization. Patients with prior curatively treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the breast, or other in situ cancers are allowed irrespective of time passed since curative treatment. Patients with prior completely resected malignant melanoma are also allowed
Known brain metastases or leptomeningeal metastases. If a patient experiences neurological symptoms indicative of brain metastases, a brain MRI should be performed
Diagnosis of uveal or ocular melanoma
Known history or any evidence of active, non-infectious pneumonitis
History of New York Heart Association class 3-4 congestive heart failure or history of myocardial infarction within 6 months of starting induction therapy
Active infection requiring systemic treatment
Diagnosis of immunodeficiency
Known history of severe hypersensitivity reactions to nivolumab, ipilimumab, sargramostim, or their excipients
Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
History of or active hepatitis B (hepatitis B surface antigen reactive) or active hepatitis C (hepatitis C virus antibody)
Women who are breastfeeding
Prior systemic treatment for unresectable stage IIIB D or unresectable stage IV malignant melanoma
Systemic corticosteroid treatment (doses exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive treatment within 7 days prior to the first dose of induction therapy
Receipt of a live vaccine within 30 days prior to start of induction therapy
Receipt of any other investigational treatment within 4 weeks of the first dose of induction therapy
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