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A Single Arm Trial Evaluating the Efficacy and Safety of EVX-01 in Combination With Pembrolizumab in Adults With Unresectable or Metastatic Melanoma

PHASE2RECRUITING

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.

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Study details:

Patients will initiate treatment with pembrolizumab at the start of the trial and receive up to 18 treatment cycles (approximately 2 years). Immunization with the EVX-01 will be initiated at Week 12. In total, 10 doses of EVX-01 will be administered intramuscularly, with 6 doses given two weeks apart and 4 booster doses at later time points.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

Patient may not have a diagnosis of uveal or ocular melanoma.

Patients must be treatment naïve to checkpoint inhibitor (CPI) therapy

Patients must have testing for a BRAF mutation prior to study entry.

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.

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-08-30

Primary completion: 2025-06-28

Study completion finish: 2025-07-25

Study type

TREATMENT

Phase

PHASE2

Trial ID

NCT05309421

Intervention or treatment

DRUG: EVX-01

DRUG: Pembrolizumab 25 MG/ML

Conditions

• Melanoma Stage III
• Melanoma Stage IV

Condition: Melanoma Stage III, Melanoma Stage IV
DRUG: EVX-01 and other drugs
Wollstonecraft, New South Wales, Australia and more
Sponsor: Evaxion Biotech A/S

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Melanoma Institute Australia

Research sites nearby

Select from list below to view details:

Melanoma Institute Australia
Wollstonecraft, New South Wales, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Ballarat Health Services (Grampians Health)
Ballarat Central, Victoria, Australia
One Clinical Research
Nedlands, Western Australia, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: EVX-01 in combination with pembrolizumab EVX-01 is administered im. Pembrolizumab is administered according to label	DRUG: EVX-01 Investigational drug given in combination with standard of care

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Change in the best overall response (BOR)	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	Measurements at Baseline through study completion (up to 102 weeks)

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Change in overall response rate	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	Measurements at Baseline through study completion (up to 102 weeks)
Change in progression free survival (PFS)	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	Measurements at Baseline through study completion (up to 102 weeks)
Change in overall survival (OS)	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	Measurements at Baseline through study completion (up to 102 weeks)
Number, type and severity of adverse events (AEs) and serious adverse events (SAEs)	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	Measurements at Baseline through study completion (up to 102 weeks)
Immunologic response induced by EVX-01	Activation and level of neoepitope specific CD4+ and CD8+ T-cells before, during and after EVX-01 immunization	Measurements at Baseline through study completion (up to 102 weeks)
Percentage of patients in which EVX-01 is generated, produced, and administered	Percentage of patients in which EVX-01 is generated, produced, and administered to evaluate the manufacturing feasibility of EVX-01	From tumor biopsy sampling to first dose of EVX-01 (up to 16 weeks)

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: A Single Arm Trial Evaluating the Efficacy and Safety of EVX-01 in Combination With Pembrolizumab in Adults With Unresectable or Metastatic Melanoma