UV1 Vaccination Plus Nivolumab and Ipilimumab in Treatment of Melanoma

STATUS

Recruiting
End date

Sep 15, 2024
participants needed

154
sponsor

Ultimovacs ASA

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Updated on 4 October 2022

See if I qualify

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 Identifier	NCT04382664
Sponsor	Ultimovacs ASA
Last Modified on	4 October 2022

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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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UV1 Vaccination Plus Nivolumab and Ipilimumab in Treatment of Melanoma