What side effects are associated with this type of intervention?

The most common treatments for melanoma, such as pembrolizumab (a PD-1 inhibitor), are associated with a range of immune-related adverse events. These can include skin reactions (e.g., rash, pruritus), endocrine disorders (e.g., hypothyroidism, adrenal insufficiency), and gastrointestinal issues (e.g., colitis, diarrhea). More severe but less common side effects include pneumonitis, hepatitis, and nephritis. Individualized neoantigen therapies like V940 may also cause similar immune-related side effects, given their mechanism of action in stimulating the immune system. Patients should discuss these potential risks with their healthcare provider to manage and mitigate adverse effects effectively.

What prior FDA approvals exist?

Pembrolizumab, a PD-1 inhibitor, has been approved by the FDA for the treatment of melanoma, both as a monotherapy and in combination with other agents. For instance, pembrolizumab has been approved for use in combination with ipilimumab, another immune checkpoint inhibitor, for patients with advanced melanoma. Additionally, nivolumab, another PD-1 inhibitor, has been approved for similar indications, often in combination with ipilimumab. These approvals are based on clinical trials demonstrating improved outcomes in terms of overall survival and response rates compared to traditional chemotherapy.

What other types of research exist?

Promising alternatives to V940 with pembrolizumab for melanoma patients include: 1) Nivolumab plus Ipilimumab, which has shown robust antitumor activity in advanced melanoma. 2) Pembrolizumab combined with alternative-dose Ipilimumab, as evaluated in the KEYNOTE-029 study, demonstrating tolerability and efficacy. 3) Novel biomarkers and combination therapies involving PD-1/PD-L1 inhibitors and other agents, which are under ongoing investigation to optimize therapeutic outcomes.

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Checkpoint Inhibitor

V940 Vaccine + Pembrolizumab for Melanoma

Phase 3

Waitlist Available

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 85 months

Awards & highlights

Pivotal Trial

Summary

This trial tests a personalized cancer vaccine (V940) combined with an existing drug (pembrolizumab) in people with high-risk melanoma to see if it can better prevent cancer from returning compared to the drug alone. Pembrolizumab has been shown to improve relapse-free survival in high-risk melanoma patients in previous trials.

Who is the study for?

This trial is for individuals with high-risk melanoma who have had surgery but no other systemic therapy. Participants must be disease-free post-surgery, not more than 13 weeks from their last resection, and if HIV-positive, well-controlled on ART. It excludes those with ocular/mucosal melanoma, active heart failure within 6 months, prior cancer therapies or vaccines, another recent or active spreadable cancer.

What is being tested?

The study tests V940 (an individualized neoantigen therapy) combined with pembrolizumab against pembrolizumab alone to see which is better at preventing the return of melanoma after surgical removal. The safety of this combination and its effectiveness in keeping patients cancer-free are being evaluated.

What are the potential side effects?

Potential side effects include reactions related to immune system activation such as fatigue, skin issues, flu-like symptoms and possible organ inflammation due to pembrolizumab; specific side effects of V940 are not detailed but may involve similar immune-related responses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 85 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 85 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 85 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Recurrence-Free Survival (RFS)

Secondary study objectives

Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30

Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30

Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score

+4 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: V940 + PembrolizumabExperimental Treatment2 Interventions

Participants receive up to 9 doses of V940 via an intramuscular (IM) injection (every 3 weeks) plus up to 9 doses of pembrolizumab via an intravenous (IV) infusion (once every 6 weeks) until disease recurrence or unacceptable toxicity, or for a total treatment duration of up to approximately 56 weeks, whichever is sooner.

Group II: Placebo + PembrolizumabActive Control2 Interventions

Participants receive up to 9 doses of dose matched placebo to V940 via an IM injection (every 3 weeks) plus up to 9 doses of pembrolizumab via an IV infusion (once every 6 weeks) until disease recurrence or unacceptable toxicity, or for a total treatment duration of up to approximately 56 weeks, whichever is sooner.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3130

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Melanoma treatments often involve immunotherapies that harness the body's immune system to target and destroy cancer cells. Pembrolizumab, a PD-1 inhibitor, works by blocking the PD-1 pathway, which cancer cells exploit to evade immune detection. By inhibiting this pathway, Pembrolizumab reactivates T-cells to recognize and attack melanoma cells. Individualized Neoantigen Therapy (INT) like V940 involves creating a personalized vaccine based on the unique mutations in a patient's tumor, stimulating a targeted immune response against those specific cancer cells. These therapies are significant for melanoma patients as they offer a tailored approach to treatment, potentially improving efficacy and reducing the likelihood of cancer recurrence.