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Pembrolizumab Combinations for Melanoma

Phase 1 & 2
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 been untreated for advanced disease
Has been untreated for advanced disease.
Must not have
Has had major surgery <3 weeks prior to first dose of study intervention
Has history of Hepatitis B or known Hepatitis C virus infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~30 months
Awards & highlights

Summary

This trial is testing new treatments for melanoma, a type of skin cancer, to see if they are safe and effective. The goal is to find treatments that are better than the current options.

Who is the study for?
This trial is for adults with advanced melanoma (Stage III or IV) that can't be removed by surgery and haven't been treated yet. They must have good organ function, not be pregnant or breastfeeding, agree to use contraception if applicable, and have recovered from previous treatments' side effects. People with immune deficiencies, other active cancers, brain metastases, hepatitis B/C, recent major surgeries or vaccines, certain mental disorders or infections are excluded.
What is being tested?
The study tests the safety and effectiveness of Pembrolizumab alone or combined with experimental drugs like Vibostolimab and Lenvatinib in treating first-line advanced melanoma. Participants are divided into different groups receiving various combinations of these medications to find the best treatment option.
What are the potential side effects?
Potential side effects may include immune-related reactions affecting organs; infusion-related symptoms; fatigue; skin changes; hormonal gland issues leading to hormone imbalances; liver inflammation; digestive problems such as colitis; lung issues like pneumonitis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not received treatment for my advanced disease.
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I have not received treatment for my advanced disease.
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My melanoma diagnosis was confirmed through lab tests.
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My melanoma cannot be removed by surgery and is in stage 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 not had major surgery in the last 3 weeks.
Select...
I have had Hepatitis B or have Hepatitis C.
Select...
I had radiotherapy less than 2 weeks before starting the study treatment.
Select...
I am currently being treated for an infection.
Select...
My melanoma is in the eye or on mucous membranes.
Select...
I have been treated for an autoimmune disease in the last 2 years.
Select...
I have had lung inflammation not caused by an infection.
Select...
My cancer has spread to my brain or the membranes around my brain.
Select...
I have received a transplant from another person.
Select...
I have had active tuberculosis in the past.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~30 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
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)
Percentage of participants who discontinue study treatment due to an AE
Percentage of participants who discontinue study treatment due to an AE: Safety lead-in
+3 more
Secondary study objectives
Duration of Response (DOR) per RECIST 1.1

Side effects data

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

Trial Design

7Treatment groups
Experimental Treatment
Active Control
Group I: Pembrolizumab + VibostolimabExperimental Treatment2 Interventions
Participants will receive pembrolizumab intravenously (IV) plus vibostolimab IV at specified doses on specified days for a total treatment duration of up to approximately 2 years.
Group II: Coformulation Pembrolizumab/Quavonlimab + LenvatinibExperimental Treatment3 Interventions
Participants will receive coformulation of pembrolizumab and quavonlimab IV plus lenvatinib orally at specified doses on specified days for a total treatment duration of up to approximately 2 years.
Group III: Coformulation Pembrolizumab/QuavonlimabExperimental Treatment2 Interventions
Participants will receive coformulation of pembrolizumab and quavonlimab (MK-1308A) IV at a specified dose on specified days for a total treatment duration of up to approximately 2 years.
Group IV: Coformulation Favezelimab/Pembrolizumab + VibostolimabExperimental Treatment2 Interventions
Participants will receive coformulation of favezelimab and pembrolizumab (MK-4280A) IV and vibostolimab IV at specified doses on specified days for a total treatment duration of up to approximately 2 years.
Group V: Coformulation Favezelimab/Pembrolizumab + All-trans Retinoic Acid (ATRA)Experimental Treatment1 Intervention
Participants will receive coformulation of favezelimab and pembrolizumab IV Q3W for up to 35 cycles, plus ATRA orally (for 3 days surrounding each infusion of MK-4280A, including Days 1, 2, and 3 of Cycle 1 and on Days -1, 1, and 2 of all subsequent cycles).
Group VI: Coformulation Favezelimab/PembrolizumabExperimental Treatment1 Intervention
Participants will receive cofomulation of favezelimab + pembrolizumab (MK-4280A) IV at specified dose on specified days every 3 weeks (Q3W) for up to approximately 2 years
Group VII: PembrolizumabActive Control1 Intervention
Participants will receive pembrolizumab IV at a specified dose on specified days for a total treatment duration of up to approximately 2 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Favezelimab/Pembrolizumab
2016
Completed Phase 1
~490
ATRA
1993
Completed Phase 4
~1250
Lenvatinib
2017
Completed Phase 4
~2040
Pembrolizumab
2017
Completed Phase 2
~2070
Pembrolizumab/Quavonlimab
2017
Completed Phase 2
~420

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,950 Previous Clinical Trials
5,174,668 Total Patients Enrolled
121 Trials studying Melanoma
21,808 Patients Enrolled for Melanoma
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,264 Total Patients Enrolled
31 Trials studying Melanoma
9,209 Patients Enrolled for Melanoma
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,834 Previous Clinical Trials
8,079,465 Total Patients Enrolled
35 Trials studying Melanoma
11,085 Patients Enrolled for Melanoma

Media Library

ATRA (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04305054 — Phase 1 & 2
Melanoma Research Study Groups: Coformulation Pembrolizumab/Quavonlimab, Coformulation Favezelimab/Pembrolizumab, Coformulation Favezelimab/Pembrolizumab + All-trans Retinoic Acid (ATRA), Coformulation Favezelimab/Pembrolizumab + Vibostolimab, Coformulation Pembrolizumab/Quavonlimab + Lenvatinib, Pembrolizumab, Pembrolizumab + Vibostolimab
Melanoma Clinical Trial 2023: ATRA Highlights & Side Effects. Trial Name: NCT04305054 — Phase 1 & 2
ATRA (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04305054 — Phase 1 & 2
~178 spots leftby Apr 2030
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