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Monoclonal Antibodies

Pembrolizumab Combo for Melanoma

Phase 1 & 2
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 histologically or cytologically confirmed melanoma
Has not received more than 3 lines of therapy for their advanced melanoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~30 months
Awards & highlights

Study Summary

This trial is testing experimental treatments for melanoma to see if they are more effective than the current options.

Who is the study for?
This trial is for adults with advanced melanoma that has worsened despite treatment with PD-1 inhibitors. Participants must have adequate organ function, not be pregnant or breastfeeding, and agree to use contraception if necessary. They should not have had more than three prior treatments for their melanoma and must have recovered from the major side effects of previous therapies.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of combining Pembrolizumab with other investigational drugs (Lenvatinib, ATRA, Quavonlimab, Vibostolimab) in treating melanoma resistant to standard PD-1 inhibitor therapy. It aims to find better options than current treatments by comparing different drug combinations.See study design
What are the potential side effects?
Potential side effects may include immune system reactions affecting organs, infusion-related symptoms like fever or chills, fatigue, digestive issues such as nausea or diarrhea, skin reactions at injection sites, liver problems indicated by yellowing eyes or skin (jaundice), and an increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My melanoma diagnosis was confirmed through lab tests.
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I have had 3 or fewer treatments for my advanced melanoma.
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I am a male willing to use contraception if I take lenvatinib or ATRA.
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My melanoma cannot be removed with surgery and is in stage III or IV.
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I am not pregnant or breastfeeding, and if I can have children, I use effective birth control or practice abstinence.
Select...
My side effects from the last treatment are mild, except for hair loss.
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My cancer has grown despite treatment with specific immune therapy.
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My condition worsened despite treatment with an anti-PD-1/L1 drug.
Select...
My organs are functioning well.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 experience an adverse event (AE)
Secondary outcome measures
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%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

3Treatment groups
Experimental Treatment
Group I: Pembrolizumab + all-trans retinoic acid (ATRA)Experimental Treatment1 Intervention
Participants will receive pembrolizumab IV plus ATRA orally at specified doses on specified days for a total treatment duration of up to approximately 2 years
Group II: Pembrolizumab + Quavonlimab + VibostolimabExperimental Treatment3 Interventions
Participants will receive pembrolizumab intravenously (IV) plus quavonlimab IV plus vibostolimab IV at specified doses on specified days for a total treatment duration of up to approximately 2 years.
Group III: Pembrolizumab + Quavonlimab + LenvatinibExperimental Treatment3 Interventions
Participants will receive pembrolizumab IV plus quavonlimab IV plus lenvatinib orally at specified doses 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
Pembrolizumab
2017
Completed Phase 2
~1950
Lenvatinib
2005
Completed Phase 4
~2690
ATRA
1993
Completed Phase 4
~1250

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,862 Previous Clinical Trials
5,049,500 Total Patients Enrolled
120 Trials studying Melanoma
21,442 Patients Enrolled for Melanoma
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,711 Total Patients Enrolled
31 Trials studying Melanoma
9,262 Patients Enrolled for Melanoma
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,769 Previous Clinical Trials
8,062,000 Total Patients Enrolled
35 Trials studying Melanoma
11,104 Patients Enrolled for Melanoma

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04305041 — Phase 1 & 2
Melanoma Research Study Groups: Pembrolizumab + Quavonlimab + Lenvatinib, Pembrolizumab + all-trans retinoic acid (ATRA), Pembrolizumab + Quavonlimab + Vibostolimab
Melanoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT04305041 — Phase 1 & 2
Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04305041 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are engaged in this medical experiment?

"Merck Sharp & Dohme LLC is sponsoring this clinical trial, which requires 200 qualifying patients to be recruited from two locations: the University of Texas MD Anderson Cancer Centre in Houston, TX and UCLA Hematology & Oncology in Los Angeles, CA."

Answered by AI

Do I meet the criteria to partake in this investigation?

"Patients with melanoma aged 18 to 120 years old have the opportunity to be chosen for this clinical trial. Approximately 200 participants are being recruited."

Answered by AI

Is the enrollment period still open for this research project?

"Affirmative. The information hosted on clinicaltrials.gov states that this research is currently enlisting patients; it was initially posted in June of 2020, and revised last October. 200 people are being sought to participate at 12 sites across the country."

Answered by AI

What medical conditions usually necessitate the administration of Pembrolizumab?

"Pembrolizumab is generally prescribed to patients with unresectable melanoma, yet it has also proved effective in managing microsatellite instability high, the risk of recurrence, and other diseases."

Answered by AI

What prior investigations involving Pembrolizumab have been conducted?

"At the moment, 1032 clinical trials exploring pembrolizumab exist. Of those, 134 are currently in Phase 3 of their research process. The primary study centre is located in Sacramento, California; however 37065 other locations are conducting studies using this medication."

Answered by AI

Does this research accommodate octogenarians?

"According to the established criteria for this clinical trial, individuals aged 18-120 are eligible for enrollment."

Answered by AI

Are there a substantial number of locations administering this study in North America?

"The research team at UT MD Anderson Cancer Center in Houston, Texas; UCLA Hematology & Oncology in Los Angeles, California; NYU Clinical Cancer Centre in New york City and 12 other sites are coordinating this clinical trial."

Answered by AI
~123 spots leftby Apr 2030