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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
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

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 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

Side effects data

From 2022 Phase 1 & 2 trial • 35 Patients • NCT03003468
40%
FATIGUE
37%
INFUSION RELATED REACTION
37%
NAUSEA
23%
DIARRHEA
23%
BACK PAIN
23%
ABDOMINAL PAIN
23%
ANOREXIA
20%
ARTHRALGIA
20%
COUGH
20%
NON-CARDIAC CHEST PAIN
17%
DYSPNEA
17%
CONSTIPATION
17%
CHILLS
17%
MYALGIA
13%
DIZZINESS
13%
HEADACHE
13%
PRURITUS
13%
RASH MACULO-PAPULAR
10%
ANEMIA
10%
URTICARIA
10%
SINUS TACHYCARDIA
10%
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY
10%
EDEMA LIMBS
10%
ALLERGIC REACTION
10%
ANXIETY
10%
LUNG INFECTION
10%
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY
7%
TUMOR PAIN
7%
EAR AND LABYRINTH DISORDERS - OTHER, SPECIFY
7%
HYPERGLYCEMIA
7%
PAIN
7%
PELVIC PAIN
7%
PRODUCTIVE COUGH
7%
PLEURAL EFFUSION
7%
VOICE ALTERATION
7%
VOMITING
7%
FEVER
7%
FLATULENCE
7%
CREATININE INCREASED
7%
HYPERTHYROIDISM
7%
NECK PAIN
7%
DEPRESSION
7%
FLU LIKE SYMPTOMS
7%
LYMPHOCYTE COUNT DECREASED
7%
DYSPEPSIA
7%
FLUSHING
7%
HYPONATREMIA
7%
HYPOTHYROIDISM
7%
URINARY TRACT INFECTION
3%
MUSCLE WEAKNESS LOWER LIMB
3%
ALKALINE PHOSPHATASE INCREASED
3%
DYSPHAGIA
3%
ESOPHAGITIS
3%
GASTROESOPHAGEAL REFLUX DISEASE
3%
OSTEONECROSIS OF JAW
3%
BRONCHOSPASM
3%
PNEUMONITIS
3%
BLURRED VISION
3%
GAIT DISTURBANCE
3%
HEMORRHOIDS
3%
POSTNASAL DRIP
3%
PRESYNCOPE
3%
SORE THROAT
3%
ACUTE KIDNEY INJURY
3%
PERIPHERAL MOTOR NEUROPATHY
3%
DRY SKIN
3%
FLASHING LIGHTS
3%
HYPOMAGNESEMIA
3%
HYPERTENSION
3%
HYPOTENSION
3%
SINUSITIS
3%
SYNCOPE
3%
HEARING IMPAIRED
3%
RASH ACNEIFORM
3%
SOMNOLENCE
3%
COLITIS
3%
HOT FLASHES
3%
RESPIRATORY FAILURE
3%
CONJUNCTIVITIS
3%
MOVEMENTS INVOLUNTARY
3%
NASAL CONGESTION
3%
PARESTHESIA
3%
VAGINAL INFECTION
3%
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY
3%
NEUTROPHIL COUNT DECREASED
3%
ALLERGIC RHINITIS
3%
PAIN IN EXTREMITY
3%
SEPSIS
3%
BLOATING
3%
DEHYDRATION
3%
DRY MOUTH
3%
INSOMNIA
3%
MALAISE
3%
PAIN OF SKIN
3%
THROMBOEMBOLIC EVENT
3%
TREMOR
3%
WEIGHT GAIN
100%
80%
60%
40%
20%
0%
Study treatment Arm
Imprime PGG 4 mg/kg
Imprime PGG 2 mg/kg

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).

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.

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,950 Previous Clinical Trials
5,173,389 Total Patients Enrolled
121 Trials studying Melanoma
20,529 Patients Enrolled for Melanoma
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,834 Previous Clinical Trials
8,078,186 Total Patients Enrolled
35 Trials studying Melanoma
9,806 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
~598 spots leftby Sep 2025
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