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Tyrosine Kinase Inhibitor
Pembrolizumab Combinations 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
Female participants agree to abstain from breastfeeding during the study intervention period
Has American Joint Committee on Cancer (AJCC) Stage IV, M1D melanoma
Must not have
Has untreated or unresolved intracranial hemorrhage from central nervous system (CNS) metastasis
Has a history of (noninfectious) pneumonitis that required steroids or current pneumonitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~30 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing experimental treatments for melanoma, a type of skin cancer. The goal is to find treatments that are safe and more effective than what is currently available.
Who is the study for?
This trial is for adults with Stage IV melanoma that has spread to the brain, who haven't used steroids recently and aren't pregnant or breastfeeding. They must have good organ function and agree to use contraception. People with weakened immune systems, recent surgeries or therapies, active infections, other cancers within 2 years, or certain viral diseases can't join.
What is being tested?
The study tests Pembrolizumab alone or combined with Quavonlimab in treating melanoma in the brain. The combination of Pembrolizumab and Lenvatinib was part of the study but is no longer being tested as of December 2022.
What are the potential side effects?
Pembrolizumab may cause immune system reactions affecting organs, fatigue, skin issues, flu-like symptoms; Quavonlimab's side effects are under investigation but could be similar due to its nature as an immunotherapy agent.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree not to breastfeed during the study.
Select...
My melanoma is at the most advanced stage, having spread to distant parts of my body.
Select...
I am not pregnant or breastfeeding and follow the required contraceptive guidelines.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have untreated bleeding in my brain from cancer spread.
Select...
I have had pneumonitis treated with steroids or have it now.
Select...
I have been treated for an autoimmune disease in the last 2 years.
Select...
My cancer has spread to the lining of my brain and spinal cord.
Select...
I have undergone whole brain irradiation.
Select...
I have another cancer that is getting worse or needed treatment in the last 2 years.
Select...
I have a known history of HIV.
Select...
I have a history of hepatitis B or C.
Select...
I have been diagnosed with eye melanoma.
Select...
I have not had major surgery in the last 3 weeks.
Select...
I have not received a live vaccine in the last 30 days.
Select...
I have received a transplant from another person.
Select...
I am currently being treated for an infection.
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
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)
Therapeutic procedure
Percentage of participants who experience an adverse event (AE)
Secondary study objectives
Brain
Brain
Duration of Response (DOR) per RECIST 1.1
+1 moreSide effects data
From 2024 Phase 3 trial • 804 Patients • NCT0304099964%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Systemic infection
1%
Clostridium difficile colitis
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab + CRT Followed by Pembrolizumab
Placebo + CRT Followed by Placebo
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Pembrolizumab + LenvatinibExperimental Treatment2 Interventions
Participants will receive pembrolizumab IV plus lenvatinib orally 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 pembrolizumab/quavonlimab (coformulation of pembrolizumab and quavonlimab) intravenously (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 3
~3130
Pembrolizumab/Quavonlimab
2017
Completed Phase 2
~420
Lenvatinib
2017
Completed Phase 4
~2070
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,305 Total Patients Enrolled
31 Trials studying Melanoma
9,224 Patients Enrolled for Melanoma
Merck Sharp & Dohme LLCLead Sponsor
4,032 Previous Clinical Trials
5,189,501 Total Patients Enrolled
126 Trials studying Melanoma
22,912 Patients Enrolled for Melanoma
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,905 Previous Clinical Trials
8,091,169 Total Patients Enrolled
35 Trials studying Melanoma
11,100 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs are functioning well.I have untreated bleeding in my brain from cancer spread.I have had pneumonitis treated with steroids or have it now.I agree not to breastfeed during the study.My melanoma is at the most advanced stage, having spread to distant parts of my body.I have been treated for an autoimmune disease in the last 2 years.I had targeted radiotherapy within the last 2 weeks.I am not pregnant or breastfeeding and follow the required contraceptive guidelines.I have not had significant coughing up of blood or tumor bleeding in the last 2 weeks.My cancer has spread to the lining of my brain and spinal cord.I have undergone whole brain irradiation.I had radiotherapy less than 2 weeks before starting the study treatment.I haven't had brain-related symptoms or taken steroids in the last 10 days.I have another cancer that is getting worse or needed treatment in the last 2 years.I have a known history of HIV.I have a history of hepatitis B or C.I have not had cancer treatment in the last 4 weeks.I have been diagnosed with eye melanoma.I have an immune system disorder or have been on immune-weakening medication recently.I have not had major surgery in the last 3 weeks.I have not received a live vaccine in the last 30 days.I have received a transplant from another person.I am currently being treated for an infection.
Research Study Groups:
This trial has the following groups:- Group 1: Coformulation Pembrolizumab/Quavonlimab + Lenvatinib
- Group 2: Pembrolizumab + Lenvatinib
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.