What is the mechanism of action of this treatment?

Common treatments for melanoma, such as immune checkpoint inhibitors, work by enhancing the immune system's ability to detect and fight cancer cells. Pembrolizumab, a PD-1 inhibitor, blocks the PD-1 protein on T cells, preventing cancer cells from evading immune detection. Vibostolimab, a TIGIT inhibitor, further modulates the immune response to improve anti-tumor activity. These mechanisms are important for melanoma patients as they can potentially improve survival by leveraging the body's natural defenses against cancer.

What side effects are associated with this type of intervention?

Common treatments for melanoma, particularly those involving immune checkpoint inhibitors like pembrolizumab (a PD-1 inhibitor) and vibostolimab (a TIGIT inhibitor), are associated with several side effects. The most prevalent side effects include pruritus (itching), rash, and vitiligo, which are generally mild (grades 1 and 2). More severe immune-related adverse events can occur, such as skin reactions, endocrine events, and gastrointestinal issues like colitis. In some cases, patients may experience autoimmune dermatologic toxicities, including bullous skin eruptions and mucous membrane pemphigoid. These treatments can also cause inflammation in various organ systems, which may require immunosuppression and supportive care.

What other types of research exist?

Promising alternatives to Pembrolizumab/Vibostolimab for melanoma patients include: 1) Nivolumab combined with Relatlimab (a LAG-3 inhibitor), which has shown efficacy in clinical trials. 2) Ipilimumab combined with Nivolumab, which remains a strong option for treatment-naïve patients. 3) Durvalumab combined with Tremelimumab, particularly for patients with high tumor mutational burden. These combinations leverage different immune pathways to enhance anti-tumor activity.

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Checkpoint Inhibitor

Pembrolizumab/Vibostolimab vs. Pembrolizumab for Melanoma

Q: What prior FDA approvals exist?

Pembrolizumab, a PD-1 inhibitor, has been FDA-approved for the treatment of melanoma, demonstrating significant efficacy in improving overall survival and reducing disease progression. Other PD-1 inhibitors, such as nivolumab, have also received FDA approval for melanoma treatment. These inhibitors work by enhancing the immune system's ability to detect and fight cancer cells. Combination therapies, such as nivolumab with ipilimumab (a CTLA-4 inhibitor), have shown improved outcomes compared to monotherapy. While vibostolimab, a TIGIT inhibitor, is still under investigation, the combination of immune checkpoint inhibitors represents a promising approach in melanoma treatment.

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

Has not received any prior systemic therapy for melanoma beyond surgical resection

Has surgically resected and histologically or pathologically confirmed diagnosis of Stage IIB and IIC (pathological or clinical), III, or IV cutaneous melanoma per the American Joint Committee on Cancer (AJCC) eighth edition guidelines

Must not have

Has had an allogenic tissue/solid organ transplant

Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 92 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing whether a combination of two drugs is better than one drug at preventing melanoma from coming back after surgery. The study focuses on patients with high-risk melanoma that has been surgically removed. One drug helps the immune system attack cancer cells, and the other drug may boost this effect.

Who is the study for?

This trial is for people with high-risk Stage IIB, IIC, III or IV melanoma that's been surgically removed. They shouldn't have had other systemic treatments for melanoma and no major surgeries or live vaccines within a month before the trial. Those with HIV must be on effective treatment, and hepatitis B or C patients need controlled viral loads.

What is being tested?

The study is testing if combining Pembrolizumab/Vibostolimab improves recurrence-free survival compared to just Pembrolizumab in participants who've had high-risk melanoma surgically removed. The goal is to see which treatment better prevents cancer from coming back.

What are the potential side effects?

Possible side effects include immune system reactions affecting organs, infusion-related symptoms like fever or chills, fatigue, skin reactions, hormonal gland problems (like thyroid), and potential worsening of pre-existing liver conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have only had surgery for my melanoma, no other treatments.

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My melanoma was surgically removed and confirmed to be stage IIB, IIC, III, or IV.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received an organ or tissue transplant from another person.

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I have active brain metastases or cancer in my brain's lining.

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I have not had radiotherapy in the last 2 weeks or suffered from radiation pneumonitis.

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I have or had lung inflammation that needed steroids.

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I have been treated for an autoimmune disease in the last 2 years.

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I am currently being treated for an infection.

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I am still recovering from a major surgery or have ongoing complications.

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I have another cancer that is getting worse or was treated in the last 3 years.

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My melanoma is in the eye, mucous membranes, or conjunctiva.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 92 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 92 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 92 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

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

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.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pembrolizumab/VibostolimabExperimental Treatment1 Intervention

Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 17 cycles (up to \~1 year).

Group II: PembrolizumabActive Control1 Intervention

Adult participants receive 200 mg and adolescent participants ≥40 kg receive 2 mg/kg (up to a max of 200 mg) pembrolizumab via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 17 cycles (up to \~1 year).

0 / 11Eligibility criteria met

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

Common treatments for melanoma, such as immune checkpoint inhibitors, work by enhancing the immune system's ability to detect and fight cancer cells. Pembrolizumab, a PD-1 inhibitor, blocks the PD-1 protein on T cells, preventing cancer cells from evading immune detection. Vibostolimab, a TIGIT inhibitor, further modulates the immune response to improve anti-tumor activity. These mechanisms are important for melanoma patients as they can potentially improve survival by leveraging the body's natural defenses against cancer.