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Checkpoint Inhibitor
Pembrolizumab/Vibostolimab vs. Pembrolizumab for Melanoma
Phase 3
Recruiting
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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 96 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 96 months
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 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
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%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
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
3,892 Previous Clinical Trials
5,059,586 Total Patients Enrolled
120 Trials studying Melanoma
20,123 Patients Enrolled for Melanoma
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,062,659 Total Patients Enrolled
35 Trials studying Melanoma
9,744 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My HIV is well controlled with medication.I have been treated for an autoimmune disease in the last 2 years.I have received an organ or tissue transplant from another person.I have only had surgery for my melanoma, no other treatments.I am HBsAg positive but have been on HBV therapy for 4 weeks with an undetectable viral load.I have not had radiotherapy in the last 2 weeks or suffered from radiation pneumonitis.I have or had lung inflammation that needed steroids.I am currently being treated for an infection.I have active brain metastases or cancer in my brain's lining.My melanoma was surgically removed and confirmed to be stage IIB, IIC, III, or IV.I had hepatitis C but my current tests show no virus.I am still recovering from a major surgery or have ongoing complications.I have not received a live vaccine within the last 30 days.I have another cancer that is getting worse or was treated in the last 3 years.It has been less than 12 weeks since my last cancer surgery.My melanoma is in the eye, mucous membranes, or conjunctiva.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab/Vibostolimab
- Group 2: Pembrolizumab
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor presently seeking participants?
"According to data hosted on clinicaltrials.gov, this research trial is actively searching for candidates. Initially posted in January 19th 2023 and recently edited in May 5th 2023."
Answered by AI
Has the FDA sanctioned Pembrolizumab/Vibostolimab for medical use?
"The safety of Pembrolizumab/Vibostolimab has been rated a 3, as there is ample clinical evidence to support efficacy and multiple rounds of data attesting to its security."
Answered by AI
How many research facilities are currently conducting this experiment?
"Patients can receive this medication at Comprehensive Cancer Centers of Nevada in Las Vegas, Centro de Educación Médica e Investigaciones Clínicas (CEMIC) in Buenos Aires and Instituto de Oncología de Rosario in Rosario. There are also 35 other recruiting medical centres dispersed across the globe."
Answered by AI
How many participants are currently taking part in this clinical experiment?
"Affirmative, clinicaltrials.gov displays evidence that this trial is presently recruiting patients. It was originally posted on January 19th 2023 and has since been updated on May 5th of the same year. 1,560 participants must be located across 35 different medical centres to complete the study's requirements."
Answered by AI
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