50 Participants Needed

PV-10 + Pembrolizumab for Melanoma

Recruiting at 4 trial locations
EW
Overseen ByEric Wachter, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Provectus Biopharmaceuticals, Inc.
Must be taking: Checkpoint inhibitors
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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?

EW

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

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.
See 3 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.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

12 weeks for PV-10, up to 24 months for pembrolizumab
Every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and changes in laboratory values

4 weeks after final administration of PV-10

Long-term follow-up

Participants are monitored for overall survival and progression-free survival

Up to 24 months from initiation of study treatment

What Are the Treatments Tested in This Trial?

Interventions

  • Pembrolizumab
  • PV-10
Trial Overview 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.
How Is the Trial Designed?
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:
  • 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
🇪🇺
Approved in European Union as KEYTRUDA for:
  • 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
🇬🇧
Approved in United Kingdom as KEYTRUDA for:
  • 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

Trials
5
Recruited
160+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
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