PV-10 + Pembrolizumab for Melanoma

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Provectus Biopharmaceuticals, Inc.

No Placebo Group

Breakthrough Therapy

Trial Summary

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).

Eligibility Criteria

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

You need to have at least one tumor that can be accurately measured using a ruler, CT scan, or MRI.

Your blood counts, kidney function, liver function, and thyroid function are within certain healthy levels.

My melanoma is at an advanced stage and cannot be surgically removed.

+4 more

Exclusion Criteria

I do not have severe autoimmune diseases, uncontrolled illnesses, or recent other cancers.

Known sensitivity to any of the products or components to be administered during dosing

I have not been treated with PV-10 or checkpoint inhibitors without meeting certain conditions.

+4 more

Participant Groups

The trial is testing PV-10 in combination with Pembrolizumab versus Pembrolizumab alone for treating metastatic melanoma. Initially, all participants will receive both treatments; later on, they'll be randomly assigned to continue this combo or just get Pembrolizumab.

3Treatment groups

Experimental Treatment

Active Control

Group I: Phase 2 (Arm 1)Experimental Treatment2 Interventions

PV-10 (intralesional) and pembrolizumab (2 mg/kg every 3 weeks)

Group II: Phase 1bExperimental Treatment2 Interventions

PV-10 (intralesional) and pembrolizumab (2 mg/kg every 3 weeks)

Group III: Phase 2 (Arm 2)Active Control1 Intervention

Pembrolizumab (2 mg/kg every 3 weeks)

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸 Approved in United States as KEYTRUDA for: