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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~30 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have not received treatment for my advanced disease.
Select...
I have not received treatment for my advanced disease.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to ~30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~30 months
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 discontinue study treatment due to an AE: Safety lead-in
+3 moreSecondary outcome measures
Duration of Response (DOR) per RECIST 1.1
Side 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
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
2005
Completed Phase 4
~2690
Pembrolizumab
2017
Completed Phase 2
~2010
Pembrolizumab/Quavonlimab
2017
Completed Phase 2
~420
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
3,891 Previous Clinical Trials
5,060,106 Total Patients Enrolled
120 Trials studying Melanoma
21,368 Patients Enrolled for Melanoma
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,820 Total Patients Enrolled
31 Trials studying Melanoma
9,147 Patients Enrolled for Melanoma
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,425 Total Patients Enrolled
35 Trials studying Melanoma
10,989 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had major surgery in the last 3 weeks.My side effects from previous treatments are mild, except for possible hair loss or moderate nerve pain.You have been diagnosed with HIV.I have had Hepatitis B or have Hepatitis C.I had radiotherapy less than 2 weeks before starting the study treatment.I am currently being treated for an infection.I have not received a live vaccine in the last 30 days.I am not pregnant or breastfeeding and follow the required contraceptive guidelines.I have not received treatment for my advanced disease.My organs are functioning well.My melanoma is in the eye or on mucous membranes.I have not received treatment for my advanced disease.I have been treated for an autoimmune disease in the last 2 years.You have given a sample of your tumor for testing.My melanoma diagnosis was confirmed through lab tests.I have had lung inflammation not caused by an infection.My melanoma cannot be removed by surgery and is in stage III or IV.My cancer has spread to my brain or the membranes around my brain.I have received a transplant from another person.I have had cancer treatment within the last 4 weeks.I have an immune system disorder or have been on immune-weakening medication recently.I have another cancer that is getting worse or needed treatment in the last 2 years.I am taking lenvatinib, which has its own set of rules for joining.I have had active tuberculosis in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Coformulation Pembrolizumab/Quavonlimab
- Group 2: Coformulation Favezelimab/Pembrolizumab
- Group 3: Coformulation Favezelimab/Pembrolizumab + All-trans Retinoic Acid (ATRA)
- Group 4: Coformulation Favezelimab/Pembrolizumab + Vibostolimab
- Group 5: Coformulation Pembrolizumab/Quavonlimab + Lenvatinib
- Group 6: Pembrolizumab
- Group 7: Pembrolizumab + Vibostolimab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Has Pembrolizumab been the subject of past experiments?
"Pembrolizumab was initially studied in 2010 at City of Hope, and since then 302 studies have been completed. Currently, 1032 live trials are being conducted with a considerable number operating from Los Angeles."
Answered by AI
Are there any opportunities for individuals to participate in this clinical experiment?
"Clinicaltrials.gov confirms that enrolment into this medical trial is currently in progress. This study was first made public on July 1st 2020 and latest update occurred October 13th 2022."
Answered by AI
Could I be a participant in this experiment?
"To meet the criteria of inclusion, potential participants must have a diagnosis of melanoma and be in between 18-120 years old. The total number of people being recruited is 315."
Answered by AI
In what geographic locations is this research being conducted?
"The Angeles Clinic and Research Institute (Site 2009) in Los Angeles, the University of Colorado Anschutz Cancer Pavilion (Site 2012), Inova Schar Cancer Institute ( Site 2011 )in Fairfax, are only a few of the 10 clinical trial sites that are registering patients."
Answered by AI
Does this clinical trial admit individuals above the age of forty-five?
"The eligibility parameters for this clinical trial require that patients are 18-120 years of age. There are 85 trials recruiting participants younger than 18 and 1764 studies accepting seniors 65 or older."
Answered by AI
Could you provide the upper limit to participant numbers in this experiment?
"315 patients, that meet the defined requirements of this trial, are necessary to partake in its execution. Those interested can attend one of two sites - The Angeles Clinic and Research Institute (Site 2009) located in Los Angeles or University of Colorado's Anschutz Cancer Pavilion( Site 2012) which is situated in Aurora."
Answered by AI
What ailments is Pembrolizumab employed to address?
"Pembrolizumab is a medication applied to treat unresectable melanoma, as well as conditions related to microsatellite instability high, heightened risk of relapse and disease."
Answered by AI
Who else is applying?
What state do they live in?
Virginia
What site did they apply to?
Inova Schar Cancer Institute ( Site 2011)
What portion of applicants met pre-screening criteria?
Did not meet criteria
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