PV-10 + Pembrolizumab for Melanoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This is an international multicenter, open-label, sequential phase study of intralesional (IL) PV-10 in combination with immune checkpoint inhibition. Metastatic melanoma patients (Stage IV or Stage III unresectable, in-transit or satellite disease) with at least one injectable lesion who are candidates for pembrolizumab (both treatment naïve patients and treatment refractory patients who have failed to achieve a complete or partial response to or previously progressed on one or more checkpoint inhibitor) will be eligible for study participation. In the Phase 1b portion of the study, all participants will receive the combination of IL PV-10 and pembrolizumab (i.e., PV-10 + standard of care). In the subsequent Phase 2 portion of the study participants will be randomized 1:1 to receive either the combination of IL PV-10 and pembrolizumab or pembrolizumab alone (i.e., PV-10 + standard of care vs. standard of care).
Who Is on the Research Team?
Eric Wachter, Ph.D.
Principal Investigator
Provectus Pharmaceuticals, Inc.
Are You a Good Fit for This Trial?
Adults with confirmed melanoma, either Stage IV or unresectable Stage III, who have at least one lesion that can be treated with an injection and are fit for pembrolizumab therapy. They must not be pregnant, should use effective contraception if of childbearing potential, and cannot have untreated brain metastases or a history of severe autoimmune disease.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive IL PV-10 and pembrolizumab, with PV-10 administered every 3 weeks for up to 12 weeks and pembrolizumab every 3 weeks for up to 24 months
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and changes in laboratory values
Long-term follow-up
Participants are monitored for overall survival and progression-free survival
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
- PV-10
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
Find a Clinic Near You
Who Is Running the Clinical Trial?
Provectus Biopharmaceuticals, Inc.
Lead Sponsor