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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05309421




Registration number
NCT05309421
Ethics application status
Date submitted
22/03/2022
Date registered
4/04/2022
Date last updated
28/09/2023

Titles & IDs
Public title
A Single Arm Trial Evaluating the Efficacy and Safety of EVX-01 in Combination With Pembrolizumab in Adults With Unresectable or Metastatic Melanoma
Scientific title
An Open Label, Single Arm Trial Evaluating the Efficacy and Safety of EVX-01 in Combination With Pembrolizumab in Checkpoint Inhibitor Treatment naïve Adults With Unresectable or Metastatic Melanoma
Secondary ID [1] 0 0
KEYNOTE-D36
Secondary ID [2] 0 0
EVX-01-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma Stage III 0 0
Melanoma Stage IV 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - EVX-01
Treatment: Drugs - Pembrolizumab 25 MG/ML

Experimental: EVX-01 in combination with pembrolizumab - EVX-01 is administered im. Pembrolizumab is administered according to label


Treatment: Drugs: EVX-01
Investigational drug given in combination with standard of care

Treatment: Drugs: Pembrolizumab 25 MG/ML
Standard of care
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in the best overall response (BOR)
Assessment method [1] 0 0
Composite of a BOR of complete response (CR) or PR for patients with SD at the time of first EVX-01 administration and a BOR of CR for patients with PR at the time of first EVX-01 administration, within 2 years of treatment with pembrolizumab, as per RECIST 1.1 criteria
Timepoint [1] 0 0
Measurements at Baseline through study completion (up to 102 weeks)
Secondary outcome [1] 0 0
Change in overall response rate
Assessment method [1] 0 0
Overall response rate, defined as the proportion of the patients who have best response as CR or PR assessed 2 years after initiation of treatment with pembrolizumab, as per RECIST 1.1 criteria
Timepoint [1] 0 0
Measurements at Baseline through study completion (up to 102 weeks)
Secondary outcome [2] 0 0
Change in progression free survival (PFS)
Assessment method [2] 0 0
PFS in patients with an assessment of SD, PR, or CR at the time of first EVX-01 administration, assessed 2 years after initiation of treatment with pembrolizumab and defined as the time from the first EVX-01 administration to the first documented disease progression per RECIST 1.1. criteria or death due to any causes, whichever occurs first
Timepoint [2] 0 0
Measurements at Baseline through study completion (up to 102 weeks)
Secondary outcome [3] 0 0
Change in overall survival (OS)
Assessment method [3] 0 0
OS assessed 2 years after initiation of treatment with pembrolizumab and defined as the time from initiation of treatment of pembrolizumab to death due to any cause
Timepoint [3] 0 0
Measurements at Baseline through study completion (up to 102 weeks)
Secondary outcome [4] 0 0
Number, type and severity of adverse events (AEs) and serious adverse events (SAEs)
Assessment method [4] 0 0
Number, type and severity of adverse events (AEs) and serious adverse events (SAEs) to evaluate the safety of EVX-01 in patients with metastatic or unresectable melanoma on pembrolizumab treatment
Timepoint [4] 0 0
Measurements at Baseline through study completion (up to 102 weeks)
Secondary outcome [5] 0 0
Immunologic response induced by EVX-01
Assessment method [5] 0 0
Activation and level of neoepitope specific CD4+ and CD8+ T-cells before, during and after EVX-01 immunization
Timepoint [5] 0 0
Measurements at Baseline through study completion (up to 102 weeks)
Secondary outcome [6] 0 0
Percentage of patients in which EVX-01 is generated, produced, and administered
Assessment method [6] 0 0
Percentage of patients in which EVX-01 is generated, produced, and administered to evaluate the manufacturing feasibility of EVX-01
Timepoint [6] 0 0
From tumor biopsy sampling to first dose of EVX-01 (up to 16 weeks)

Eligibility
Key inclusion criteria
* Be at least 18 years of age on day of signing informed consent.
* Histologically confirmed, and not amenable to local therapy, metastatic or unresectable melanoma Stage III or Stage IV, as per AJCC 8th ed. staging system.

1. Patient may not have a diagnosis of uveal or ocular melanoma.
2. Patients must be treatment naïve to checkpoint inhibitor (CPI) therapy
3. Patients must have testing for a BRAF mutation prior to study entry.

Note: Patients with BRAF V600E mutant melanoma may have received prior BRAF inhibitor therapy as first-line systemic therapy and be eligible for this study as second line treatment. At the discretion of the investigator, patients with BRAF V600E mutant melanoma who have NOT received a BRAF inhibitor are also eligible for this study as first line treatment if they meet the following additional criteria:

i. LDH < local ULN, ii. No clinically significant tumor related symptoms in the judgment of the investigator, and iii. Absence of rapidly progressing metastatic melanoma in the judgment of the investigator

* Have measurable disease per RECIST 1.1 as assessed by the local site investigator within 4 weeks prior to the first visit. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
* Patients must be willing and able to provide fresh or frozen tumor tissue from an unresectable or metastatic site of disease for neoepitope and biomarker analyses. If a sufficient amount of tumor tissue from an unresectable or metastatic site is not available prior to the start of the screening phase, subjects must consent to allow the acquisition of additional tumor tissue. In addition, participants may provide additional biopsy at the time of discontinuation due to progression.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).
* Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment.
* Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=2 weeks of radiotherapy) to non-CNS disease.
* Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Note: Administration of killed vaccines are allowed.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/07/2025
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Melanoma Institute Australia - Wollstonecraft
Recruitment hospital [2] 0 0
Ballarat Health Services (Grampians Health) - Ballarat Central
Recruitment hospital [3] 0 0
One Clinical Research - Nedlands
Recruitment hospital [4] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2065 - Wollstonecraft
Recruitment postcode(s) [2] 0 0
3350 - Ballarat Central
Recruitment postcode(s) [3] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Evaxion Biotech A/S
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Anders Jespersen, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
+45 28 93 12 38
Email 0 0
clinicaltrials@evaxion-biotech.com
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05309421