PV-10 + Pembrolizumab for Melanoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination treatment for people with advanced melanoma, a type of skin cancer. Researchers are examining how well a drug called PV-10, injected directly into the tumor, works with pembrolizumab (KEYTRUDA), a standard treatment that boosts the immune system to fight cancer. In the first phase, all participants receive both treatments. In the second phase, some will receive only pembrolizumab for comparison. People with advanced melanoma that cannot be surgically removed, who have at least one tumor suitable for injection, and who qualify for pembrolizumab treatment may be suitable for this study. As a Phase 1/Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking cancer research.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not have had other cancer therapies or vaccines within a certain time before starting the trial. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of PV-10 and pembrolizumab is generally well-tolerated by patients. In a study involving 21 patients who had not previously received immune checkpoint inhibitors, the most common side effects were mild to moderate, including manageable reactions at the injection site. Most side effects were mild, classified as grade 1 or 2, indicating they were not severe.
PV-10 is injected directly into tumors and aids the immune system in recognizing and attacking cancer by causing cancer cells to die. Pembrolizumab, already approved for treating some cancers, enhances the immune system's ability to fight cancer cells.
Overall, the safety data so far suggests that these treatments can be tolerated without severe side effects, making them a promising option for patients with melanoma. However, as with any treatment, individual risks and side effects may still occur.12345Why are researchers excited about this trial's treatments?
Researchers are excited about PV-10 combined with pembrolizumab for treating melanoma because it offers a novel approach compared to standard treatments. PV-10 works by directly injecting a substance into melanoma lesions, which can prompt a strong immune response against the cancer cells. Unlike typical therapies that may rely solely on systemic immune modulators, this dual approach leverages local and systemic immune activation. Additionally, pembrolizumab, a well-known immunotherapy, enhances the body's ability to fight cancer by blocking a specific pathway that tumors use to avoid immune detection. This combination has the potential to improve outcomes by tackling melanoma from multiple angles.
What evidence suggests that this trial's treatments could be effective for melanoma?
Research shows that using PV-10 with pembrolizumab may help treat advanced melanoma. In this trial, some participants will receive the combination of PV-10 and pembrolizumab, while others will receive pembrolizumab alone. Studies have found that injecting PV-10 directly into tumors can shrink them by breaking down cancer cells and boosting the body's immune response. Pembrolizumab helps the immune system recognize and attack cancer cells. Together, these treatments might work better than when used alone, offering hope for patients with hard-to-treat melanoma. Initial results suggest this combination could be more effective than using each treatment by itself.13456
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