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Pembrolizumab + Other Agents for Melanoma

Phase 1 & 2
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has histologically or cytologically confirmed melanoma
Female participants are not pregnant or breastfeeding and are either not a woman of child-bearing potential (WOCBP) OR use a contraceptive method that is highly effective or are abstinent from heterosexual intercourse during the intervention period and for at least 120 days after the last dose of pembrolizumab, vibostolimab, gebasaxturev, or MK-4830, favezelimab + pembrolizumab, or 30 days after the last dose of ATRA, whichever occurs last
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~60 months
Awards & highlights

Study Summary

This trial is testing new treatments for melanoma, specifically to see if they are safe and more effective than current options.

Who is the study for?
This trial is for adults with Stage III melanoma suitable for pre-surgery (neoadjuvant) therapy. They must not be pregnant, breastfeeding, or planning to conceive; agree to use contraception; have good organ function; and no recent immunosuppressive treatments or active infections. Prior treatment for melanoma is limited to surgery or radiotherapy on the primary tumor.Check my eligibility
What is being tested?
The study tests Pembrolizumab alone or combined with other agents (Vibostolimab, Gebasaxturev, MK-4830, Favezelimab, ATRA) in different groups of participants. The aim is to find which combination works better than current treatments by comparing safety and effectiveness before surgery.See study design
What are the potential side effects?
Potential side effects include immune reactions that can affect organs like the liver and lungs, infusion-related reactions such as fever and chills, fatigue, skin rash, hormonal gland issues like thyroid dysfunction, and 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 am not pregnant or breastfeeding, and if I can have children, I use effective birth control or practice abstinence.
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My organs are functioning well.
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My melanoma is at a stage where surgery is possible.
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I have had radiation therapy for my melanoma.
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I am a male willing to use contraception or abstain from sex while taking gebasaxturev and for 120 days after.
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My side effects from previous treatments are mild, except for hair loss.
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I am a male willing to use contraception or abstain from sex while on ATRA and for 7 days after.
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I have not received treatment for my Stage IIIB, IIIC, or IIID melanoma.
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I had surgery to remove my melanoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~60 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
Pathological complete response (pCR) rate
Percentage of participants who discontinue study treatment due to an AE
Percentage of participants who experience an adverse event (AE)
Secondary outcome measures
Near pathological complete response (near pCR) rate
Pathological partial response (pPR) rate
Recurrence-free survival (RFS)

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

6Treatment groups
Experimental Treatment
Group I: Pembrolizumab + all-trans retinoic acid (ATRA)Experimental Treatment2 Interventions
Prior to tumor resection surgery, in the neoadjuvant phase, participants will receive pembrolizumab IV plus ATRA orally at specified doses on specified days. After surgery, in the adjuvant phase, participants will receive pembrolizumab IV at a specified dose on specified days. Participants will receive treatments in the neoadjuvant and adjuvant phase for a total treatment duration of up to approximately 1 year.
Group II: Pembrolizumab + VibostolimabExperimental Treatment2 Interventions
Prior to tumor resection surgery, in the neoadjuvant phase, participants will receive pembrolizumab intravenously (IV) plus vibostolimab IV at specified doses on specified days. After surgery, in the adjuvant phase, participants will receive pembrolizumab IV at a specified dose on specified days. Participants will receive treatments in the neoadjuvant and adjuvant phase for a total treatment duration of up to approximately 1 year.
Group III: Pembrolizumab + MK-4830Experimental Treatment2 Interventions
Prior to tumor resection surgery, in the neoadjuvant phase, participants will receive pembrolizumab IV plus MK-4830 IV at specified doses on specified days. After surgery, in the adjuvant phase, participants will receive pembrolizumab IV at a specified dose on specified days. Participants will receive treatments in the neoadjuvant and adjuvant phase for a total treatment duration of up to approximately 1 year.
Group IV: Pembrolizumab + GebasaxturevExperimental Treatment2 Interventions
Prior to tumor resection surgery, in the neoadjuvant phase, participants will receive pembrolizumab IV plus gebasaxturev (V937) intratumorally (IT) at specified doses on specified days. After surgery, in the adjuvant phase, participants will receive pembrolizumab IV at a specified dose on specified days. Participants will receive treatments in the neoadjuvant and adjuvant phase for a total treatment duration of up to approximately 1 year.
Group V: PembrolizumabExperimental Treatment1 Intervention
Prior to tumor resection surgery, in the neoadjuvant phase, participants will receive pembrolizumab IV at a specified dose on specified days. After surgery, in the adjuvant phase, participants will receive pembrolizumab IV at a specified dose on specified days. Participants will receive treatments in the neoadjuvant and adjuvant phase for a total treatment duration of up to approximately 1 year.
Group VI: Favezelimab + PembrolizumabExperimental Treatment1 Intervention
Prior to tumor resection surgery, in the neoadjuvant phase, participants will receive MK-4280A (favezelimab and pembrolizumab administered as a co-formulation) IV at specified doses on specified days. After surgery, in the adjuvant phase, participants will receive pembrolizumab IV at a specified dose on specified days. Participants will receive treatments in the neoadjuvant and adjuvant phase for a total treatment duration of up to approximately 1 year.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gebasaxturev
2020
Completed Phase 2
~80
ATRA
1993
Completed Phase 4
~1250
Pembrolizumab
2017
Completed Phase 2
~1950

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,821 Total Patients Enrolled
31 Trials studying Melanoma
9,372 Patients Enrolled for Melanoma
Merck Sharp & Dohme LLCLead Sponsor
3,862 Previous Clinical Trials
5,049,610 Total Patients Enrolled
120 Trials studying Melanoma
21,552 Patients Enrolled for Melanoma
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,769 Previous Clinical Trials
8,062,110 Total Patients Enrolled
35 Trials studying Melanoma
11,214 Patients Enrolled for Melanoma

Media Library

ATRA (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04303169 — Phase 1 & 2
Melanoma Research Study Groups: Favezelimab + Pembrolizumab, Pembrolizumab + Vibostolimab, Pembrolizumab + Gebasaxturev, Pembrolizumab, Pembrolizumab + all-trans retinoic acid (ATRA), Pembrolizumab + MK-4830
Melanoma Clinical Trial 2023: ATRA Highlights & Side Effects. Trial Name: NCT04303169 — Phase 1 & 2
ATRA (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04303169 — Phase 1 & 2

Frequently Asked Questions

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

What is the standard dosage of Pembrolizumab for most patients?

"Pembrolizumab is most commonly used to treat malignant neoplasms, but it can also be employed to shrink tumours that are resistant to surgery, microsatellite instability high, and help patients who have seen disease progression after chemotherapy."

Answered by AI

Is Pembrolizumab a new or innovative treatment?

"Pembrolizumab was first trialled in 2010 at City of Hope. In the decade since, there have been 258 additional completed studies. There are presently 1000 active trials worldwide; a large number of these are based out of New york, New York."

Answered by AI

In how many distinct places can participants take part in this research?

"Patients are being accepted at NYU Clinical Cancer Center (Site 3002) in New york, NY; Providence Saint John's Health Center (Site 3010) in Santa Monica, CA; University of Colorado Anschutz Cancer Pavilion (3012) in Aurora, CO; and 9 other locations."

Answered by AI

Can new participants still join this research project?

"That is accurate. The clinical trial detailed on clinicaltrials.gov is looking for more participants and was originally posted on 6/26/2020. The listing was updated on 10/28/2022 and notes that 90 people are needed to participate at 9 different locations."

Answered by AI

Does this research require participants to be of a certain age?

"The age requirements to participate in this clinical trial are that you must be over 18 years old but not a day over 120 years."

Answered by AI

Who is this clinical trial meant for?

"This medical study is looking for 90 individuals who have a diagnosis of melanoma. To be eligible, participants must also meet the following requirements: histologically or cytologically confirmed Stage IIIB, IIIC, or IIID melanoma that is resectable and clinically detectable; no prior treatment for Stage IIIB, IIIC, or IIID melanoma; surgical resection of primary melanoma allowed; prior radiotherapy to the primary melanoma allowed; provided baseline tumor biopsy; male participants must use contraception during and after the intervention period if they are not abstinent from heterosexual intercourse; female participants cannot be pregnant or breastfeeding,"

Answered by AI
~55 spots leftby Apr 2030