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Checkpoint Inhibitor

Pembrolizumab/Vibostolimab vs. 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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 96 months
Awards & highlights

Study Summary

This trial will compare two drugs for high-risk melanoma to see which one is better at preventing it from coming back. #melanoma

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.Check my eligibility
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.See study design
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
Select...
I have only had surgery for my melanoma, no other treatments.
Select...
My melanoma was surgically removed and confirmed to be stage IIB, IIC, III, or IV.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 96 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 96 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recurrence-Free Survival (RFS)
Secondary outcome measures
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

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

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).

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,907 Previous Clinical Trials
5,064,502 Total Patients Enrolled
120 Trials studying Melanoma
20,605 Patients Enrolled for Melanoma
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,789 Previous Clinical Trials
8,065,736 Total Patients Enrolled
35 Trials studying Melanoma
9,744 Patients Enrolled for Melanoma

Media Library

Pembrolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05665595 — Phase 3
Melanoma Research Study Groups: Pembrolizumab/Vibostolimab, Pembrolizumab
Melanoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT05665595 — Phase 3
Pembrolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05665595 — Phase 3
~683 spots leftby Jun 2025
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