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Tyrosine Kinase Inhibitor
Lenvatinib + Pembrolizumab for Uveal Melanoma
Phase 2
Recruiting
Led By Matthew Taylor, MD
Research Sponsored by Providence Health & Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after last treatment dose
Awards & highlights
Study Summary
This trial will test whether lenvatinib and pembrolizumab are effective in treating metastatic uveal melanoma.
Who is the study for?
This trial is for adults with a confirmed diagnosis of metastatic uveal melanoma who haven't been treated with certain immune therapies before. Participants must have measurable disease, provide tissue samples, and have good organ function and performance status. They should agree to use contraception and not be pregnant or breastfeeding.Check my eligibility
What is being tested?
The study tests the effectiveness of combining lenvatinib with pembrolizumab in treating metastatic uveal melanoma. It aims to see how well these drugs work together for patients who haven't received similar treatments previously.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system, such as inflammation in various organs; skin issues; fatigue; liver problems; thyroid dysfunction; digestive disturbances; and an increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have provided a sample of my tumor that has not been treated with radiation.
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I am fully active or can carry out light work.
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I am 18 or older with a confirmed diagnosis of metastatic uveal melanoma.
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I am not pregnant, not breastfeeding, and follow the birth control guidelines.
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I can't have a biopsy due to my tumor's location or other health reasons but can still join.
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My organs are functioning well.
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I agree to follow the contraception guidelines and not donate sperm for 120 days after my last dose.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days after last treatment dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days after last treatment dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate the effect of lenvatinib plus pembrolizumab on progression free survival
Secondary outcome measures
Therapeutic procedure
Therapeutic procedure
Evaluate the safety and tolerability of treatment with lenvatinib plus pembrolizumab in patients with metastatic uveal melanoma
Side effects data
From 2019 Phase 3 trial • 392 Patients • NCT0132155470%
Diarrhoea
69%
Hypertension
57%
Decreased appetite
54%
Weight decreased
49%
Nausea
44%
Fatigue
40%
Headache
38%
Proteinuria
38%
Vomiting
38%
Stomatitis
33%
Palmar-plantar erythrodysaesthesia syndrome
33%
Arthralgia
33%
Dysphonia
32%
Constipation
30%
Cough
26%
Asthenia
25%
Oedema peripheral
21%
Rash
20%
Back pain
20%
Myalgia
19%
Abdominal pain
18%
Pain in extremity
18%
Abdominal pain upper
18%
Musculoskeletal pain
18%
Dry mouth
18%
Dyspnoea
18%
Dysgeusia
17%
Dizziness
16%
Pyrexia
16%
Oropharyngeal pain
16%
Hypokalaemia
15%
Hypocalcaemia
15%
Dyspepsia
14%
Epistaxis
13%
Dysphagia
13%
Alopecia
12%
Anaemia
12%
Musculoskeletal chest pain
12%
Dry skin
11%
Urinary tract infection
11%
Nasopharyngitis
10%
Thrombocytopenia
10%
Oral pain
10%
Blood creatinine increased
10%
Electrocardiogram QT prolonged
10%
Hypoalbuminaemia
10%
Upper respiratory tract infection
9%
Dehydration
9%
Neck pain
8%
Hypomagnesaemia
8%
Influenza like illness
8%
Muscle spasms
8%
Depression
8%
Lymphopenia
8%
Alanine aminotransferase increased
8%
Muscular weakness
7%
Hyponatraemia
7%
Ejection fraction decreased
7%
Haematuria
7%
Malaise
7%
Blood thyroid stimulating hormone increased
7%
Platelet count decreased
7%
Aspartate aminotransferase increased
7%
Toothache
7%
Glossodynia
7%
Blood alkaline phosphatase increased
7%
Hyperkeratosis
7%
Bronchitis
7%
Pruritus
6%
Influenza
6%
Anxiety
6%
Flatulence
6%
Hyperglycaemia
6%
Leukopenia
6%
Dysuria
5%
Paraesthesia
5%
Non-cardiac chest pain
5%
Productive cough
5%
Hypothyroidism
5%
Haemoptysis
5%
White blood cell count decreased
5%
Pneumonia
3%
General physical health deterioration
2%
Sepsis
2%
Cholecystitis
2%
Pulmonary embolism
2%
seizure
2%
Acute myocardial infarction
2%
Atrial fibrillation
2%
Lower respiratory tract infection
2%
Hypotension
2%
Lung infection
2%
Malignant pleural effusion
2%
Spinal cord compression
2%
Acute kidney injury
1%
Acute coronary syndrome
1%
Blood uric acid increased
1%
Hypercalcaemia
1%
Monoparesis
1%
Death
1%
Small intestinal obstruction
1%
Intestinal obstruction
1%
Osteoarthritis
1%
Colitis
1%
Transient ischaemic attack
1%
Acute respiratory failure
1%
Pancreatitis
1%
Atrial flutter
1%
Cardio-respiratory arrest
1%
Uterine prolapse
1%
Coronary artery stenosis
1%
Pneumatosis intestinalis
1%
Cerebrovascular accident
1%
Confusional state
1%
Hepatic failure
1%
Liver injury
1%
Diverticulitis
1%
Appendicitis
1%
Bacteraemia
1%
Gastroenteritis
1%
Perineal abscess
1%
Wound infection
1%
Intracranial tumour haemorrhage
1%
Malignant neoplasm progression
1%
Bone pain
1%
Cancer pain
1%
Syncope
1%
Vocal cord paralysis
1%
Respiratory failure
1%
Nephrotic syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Randomization Phase: Lenvatinib 24 mg
Randomization Phase: Placebo
OOL, Treatment Period: Lenvatinib 20 mg
OOL, Treatment Period: Lenvatinib 24 mg
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab + LenvatinibExperimental Treatment2 Interventions
Lenvatinib 20 mg daily plus pembrolizumab 200 mg IV every 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Lenvatinib
FDA approved
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,887 Previous Clinical Trials
5,054,627 Total Patients Enrolled
Providence Health & ServicesLead Sponsor
117 Previous Clinical Trials
822,505 Total Patients Enrolled
Eisai Inc.Industry Sponsor
515 Previous Clinical Trials
153,990 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have provided a sample of my tumor that has not been treated with radiation.You have uncorrected problems with the minerals in your body.I have no health issues that could affect the study's results.I am fully active or can carry out light work.You have high levels of protein in your urine.You have a severe allergic reaction to pembrolizumab or any of its ingredients.You have had a severe allergic reaction (Grade 3 or higher) to lenvatinib or any of its ingredients.I am currently being treated for an infection.I am 18 or older with a confirmed diagnosis of metastatic uveal melanoma.I am not pregnant, not breastfeeding, and follow the birth control guidelines.I am willing to use effective birth control during the study and for 4 months after.I can't have a biopsy due to my tumor's location or other health reasons but can still join.I have a serious heart condition.You have been diagnosed with mental health or substance abuse issues.I have received an organ or tissue transplant from another person.My blood pressure is not well-controlled.I have a bleeding or clotting disorder, or I'm at high risk for severe bleeding.I am not pregnant or breastfeeding.My organs are functioning well.I agree to follow the contraception guidelines and not donate sperm for 120 days after my last dose.You have a disease that can be measured according to specific criteria.I have recovered from side effects of previous cancer treatments or major surgeries.I have been treated with specific immune therapy for cancer.I have not received a live vaccine in the last 30 days.I have an immune system disorder or am on long-term steroids.I have recovered from all side effects of my previous radiation therapy and do not need steroids.I have an autoimmune disease treated with medication in the last 2 years.I have or had lung inflammation that needed steroids.I have active brain metastases or cancer in the lining of my brain.I have another cancer that has gotten worse or needed treatment in the last 3 years.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab + Lenvatinib
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Is this research effort currently enrolling new participants?
"That is correct. According to clinicaltrials.gov, this medical trial was initially published on August 2nd 2022 and the listing has been updated recently too. 30 participants are currently being sought out from 1 site for participation in the study."
Answered by AI
What is the current enrollment capacity for this clinical research endeavor?
"Affirmative. Clinicaltrials.gov has information confirming that this medical research is currently enrolling volunteers, which was initially posted on August 2nd 2022 and amended recently the same day. This trial requires 30 individuals from a single site to participate in their study."
Answered by AI
Has Lenvatinib acquired the sanction of federal regulators?
"Lenvatinib's safety has been partially demonstrated via clinical data, landing it a score of 2. There is no existing evidence that this drug may be efficacious in treating cancer."
Answered by AI
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