Trial studying safety and effects for Melanoma Stage III
Official title The Efficacy and Safety of PRTX007-003 Combined With Pembrolizumab in Resectable Stage III Melanoma
ClinicalTrials.gov ID: NCT07565285
What this study is testing
What is PRTX007?
PRTX007 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for melanoma stage iii.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This Phase 2, multi-center, single-arm study evaluates the safety, tolerability, and activity of neoadjuvant PRTX007 in combination with pembrolizumab in participants with resectable Stage III melanoma. Neoadjuvant immunotherapy has demonstrated improved clinical outcomes compared with adjuvant-only approaches, but there remains a need to enhance pathologic response rates without significant added toxicity.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults aged 18 years or older
- Histologically confirmed, resectable Stage III cutaneous melanoma.
- Candidate for curative-intent surgical resection
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Adequate organ function
You likely can't join if
- Prior systemic therapy for melanoma, including immunotherapy
- Uveal melanoma or mucosal melanoma.
- Active autoimmune disease requiring systemic treatment
- Primary immunodeficiency or use of systemic immunosuppressive therapy
- Women who are pregnant or breastfeeding
- Recent treatment with another investigational therapy
See the full eligibility criteria
- Adults aged 18 years or older
- Histologically confirmed, resectable Stage III cutaneous melanoma.
- Candidate for curative-intent surgical resection
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Adequate organ function
- Able to provide written informed consent
- Prior systemic therapy for melanoma, including immunotherapy
- Uveal melanoma or mucosal melanoma.
- Active autoimmune disease requiring systemic treatment
- Primary immunodeficiency or use of systemic immunosuppressive therapy
- Women who are pregnant or breastfeeding
- Recent treatment with another investigational therapy
- Any condition that, in the opinion of the investigator, would interfere with study participation or safety
The study team makes the final eligibility decision.
Where it's taking place
- Waratah, New South Wales, Australia
- Cairns, Queensland, Australia
- Greenslopes, Queensland, Australia
- Woolloongabba, Queensland, Australia
- Melbourne, Victoria, Australia
- Nedlands, Western Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Waratah, New South Wales, Australia; Cairns, Queensland, Australia; Greenslopes, Queensland, Australia; Woolloongabba, Queensland, Australia; Melbourne, Victoria, Australia; Nedlands, Western Australia, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.