The recruitment of patients with melanoma has been completed in the phase 2 INITIUM clinical trial. Topline results from the study are expected to be reported in early 2023.
Trial Name: Efficacy and Safety of UV1 Vaccination in Combination With Nivolumab and Ipilimumab as First Line Treatment of Patients With Unresectable or Metastatic Melanoma (INITIUM Study)
ClinicalTrials.gov Indentifier: NCT04382664
Completion Date: August 15, 2022
Recruitment Status: Recruiting
Sponsor: Ultimovacs ASA
Recruitment Contact: oivind.foss@ultimovacs.com
The phase 2 INITIUM clinical trial exploring the UV1 vaccination in combination with nivolumab (Opdivo) plus ipilimumab (Yervoy) in patients with malignant melanoma is now fully enrolled, according to an announcement by Ultimovacs ASA.
A total of 154 patients with melanoma will be treated in the study. Patients in the experimental arm will receive either the UV1 vaccination 300 μg with sargramostim 75 μg as a vaccine adjuvant plus nivolumab and ipilimumab dosed according to the label or nivolumab/ipilimumab alone. In the comparator arm, patients will receive nivolumab and ipilimumab dosed according to the label.
“It is a remarkable achievement that Ultimovacs and its clinical partners have completed recruitment to INITIUM largely on schedule despite challenges caused by the pandemic,” said Carlos de Sousa, chief executive officer of Ultimovacs, in a press release.
INITIUM follows a randomized, open-label design in order to determine the efficacy and safety of the experimental combination. The study’s primary end point is progression-free survival per RECIST v1.1. The secondary end points of the study include overall survival, objective response rate per RECIST v1.1, duration of response per RECIST v1.1, and safety determined by adverse events, vital signs, laboratory assessment and ECOG performance status. Immunological mechanisms will be investigated as an exploratory study outcome.
Patients were eligible to enroll in the study given they were at least 18 years of age or older with histologically confirmed unresectable stage IIIB D, or unresectable stage IV malignant melanoma. Patients were required to be eligible to receive nivolumab and ipilimumab, have an ECOG performance status of 0 or 1, and have adequate organ function. Male patients were required to agree to use contraception and women must have had a negative pregnancy test at the time of screening.
Patients excluded from the study were those certain medical history or comorbidities like, previous nonmelanoma malignancies, know brain metastases, uveal or ocular melanoma, congestive heart failure, active infection, immunodeficiency, human immunodeficiency virus, and hepatitis B or C. Treatment with prior systemic agents, systemic corticosteroids, live vaccine, and investigational treatment within specific time periods before study treatment were also ground for exclusion form the study.
“INITIUM has been designed as a robust comparative study to demonstrate that UV1 substantially enhances outcomes for patients over and above those that can be achieved with checkpoint inhibitors alone. The results will provide a rational basis for the design and implementation of future pivotal clinical studies, together with the positive data that we have seen from our phase I studies in malignant melanoma.”
In the phase 1 study of UV1 with pembrolizumab (Keytruda; NCT03538314), the combination achieved a 73% 24-month overall survival rate. Also, the treatment led to an objective response rate of 57% and a complete response rate of 33%. Topline results from the phase 2 INITIUM study are expected to be reported in early 2023.
REFERENCES:
1. Ultimovacs completes patient recruitment in INITIUM phase ii trial of UV1 in malignant melanoma. News release. June 30, 2022. https://bit.ly/3OONhNU
2. UV1 vaccination plus nivolumab and ipilimumab in treatment of melanoma. Clinicaltrials.gov. June 28, 2022. Accessed July 6, 2022. https://bit.ly/3IlmRAX
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