Spots Global Cancer Trial Database for Study of Adjuvant Immunotherapy With EVX-02 and Anti-PD-1

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Trial Identification

Brief Title: Study of Adjuvant Immunotherapy With EVX-02 and Anti-PD-1

Official Title: A Phase 1/2, Study of Adjuvant Immunotherapy With EVX-02 and Anti-PD-1 After Complete Resection of Stage IIIB/IIIC/IIID or Stage IV Melanoma in Patients at High Risk for Recurrence

Study ID: NCT04455503

Conditions

Melanoma Stage IV

Melanoma Stage III

Interventions

EVX-02A

EVX-02B

EVX-02A OR EVX-02B

Study Description

Brief Summary: This is a Phase 1/2, open label, multi-centre study to assess the safety, tolerability, PD, and efficacy of adjuvant immunotherapy EVX-02 vaccine and anti-PD-1 (Nivolumab) in patients who have had a complete resection of a Stage IIIB/IIIC/IIID or Stage IV melanoma who are at high risk of recurrence.

Detailed Description: This study will be conducted in two parts: a safety, efficacy and PD response part using two different drug delivery methods and an expansion cohort. All patients will be administered with anti-PD-1 once every 4 weeks for up to 1 year commencing on Day 1 and with EVX-02 vaccine as soon as it is produced. Part 1 will consist of two cohorts: Cohort A: Will receive EVX- 02A delivered by delivery methodology 1. Cohort B: Will receive EVX- 02B delivered by delivery device 2. Part 2 (Cohort C) will be an expansion cohort. In this part, only one delivery methods, either EVX-02A or EVX-02B with will be used.