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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)
Timepoint [1] 0 0
Measurements at Baseline through study completion (up to 102 weeks)
Secondary outcome [1] 0 0
Change in overall response rate
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)
Timepoint [2] 0 0
Measurements at Baseline through study completion (up to 102 weeks)
Secondary outcome [3] 0 0
Change in overall survival (OS)
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)
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
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
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
NA
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
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this single arm, multi-national clinical trial in patients with metastatic or unresectable melanoma is to evaluate the BOR and compare it to historical data on patients on anti-PD1 treatment with pembrolizumab alone.
Trial website
https://clinicaltrials.gov/study/NCT05309421
Trial related presentations / publications
Long GV, Ferrucci PF, Khattak A, Meniawy TM, Ott PA, Chisamore M, Trolle T, Hyseni A, Heegaard E. KEYNOTE - D36: personalized immunotherapy with a neoepitope vaccine, EVX-01 and pembrolizumab in advanced melanoma. Future Oncol. 2022 Oct;18(31):3473-3480. doi: 10.2217/fon-2022-0694. Epub 2022 Sep 1.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 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
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05309421