The Efficacy and Safety of PRTX007-003 Combined With Pembrolizumab in Resectable Stage III Melanoma
Recruiting
Phase 2
Interventional Study
Melanoma Stage III
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 48 (estimated)
- Sponsor
- Primmune Therapeutics, Inc. · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion 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 infor…
Contacts