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Lenvatinib + Pembrolizumab for Skin Cancer
Phase 2
Waitlist Available
Led By Andrew Brohl, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
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 or 1
Must not have
History of (non-infectious) pneumonitis that required steroids or has current pneumonitis
Known active CNS metastases and/or carcinomatous meningitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new cancer treatment combining two drugs.
Who is the study for?
Adults diagnosed with Merkel cell carcinoma, stages II-IV, who can provide a tumor sample and are able to monitor their blood pressure at home. They must not be pregnant or breastfeeding and agree to use contraception. Excluded are those with active autoimmune diseases, certain infections like HIV or hepatitis, severe allergies to trial drugs, recent other cancer treatments or vaccinations, uncontrolled high blood pressure, or any condition that could affect study results.
What is being tested?
The trial is testing the combination of two drugs: Lenvatinib (oral) and Pembrolizumab (injection), in patients with Merkel cell carcinoma. It's a single-arm study where all participants receive the same treatment regimen before surgery to remove detectable cancer.
What are the potential side effects?
Possible side effects include high blood pressure; fatigue; nausea; kidney problems; liver issues; heart complications such as irregular heartbeat; increased risk of infection due to immune system effects; rash or skin reactions.
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.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I am 18 or older with a confirmed diagnosis of Merkel cell carcinoma.
Select...
I am not pregnant, not breastfeeding, and follow the contraceptive guidelines.
Select...
My cancer is at stage II, III, or IV according to the AJCC 8th edition.
Select...
My disease can be completely removed with surgery.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had pneumonitis treated with steroids or currently have it.
Select...
I have active brain metastases or cancer in the lining of my brain.
Select...
I am currently on medication for an infection.
Select...
I have previously received therapy targeting my immune system.
Select...
I have been diagnosed with HIV.
Select...
I have a bleeding or clotting disorder, or I'm at high risk for severe bleeding.
Select...
I have serious heart problems or a history of heart events.
Select...
I have a history of Hepatitis B or an active Hepatitis C infection.
Select...
I have another cancer that is getting worse or was treated in the last 3 years.
Select...
I have been treated with a drug targeting blood vessel growth in cancer.
Select...
My blood pressure is high despite taking medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pathological Complete Response
Secondary study objectives
Percentage of patients able to complete both neoadjuvant cycles of trial therapy and able to complete planned surgical resection.
Progression Free Survival
Side 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
1Treatment groups
Experimental Treatment
Group I: Lenvatinib plus PembrolizumabExperimental Treatment2 Interventions
Participants with Merkel cell carcinoma amenable to complete resection will receive two cycles (6 weeks) of therapy with the combination of lenvatinib plus pembrolizumab and then proceed to planned resection within 2-4 weeks following completion of cycle 2. Following surgical recovery and completion of adjuvant radiation therapy (if indicated), treatment will resume with pembrolizumab monotherapy with intent to complete 17 cycles total of pembrolizumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~3150
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
564 Previous Clinical Trials
144,857 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,027 Previous Clinical Trials
5,188,777 Total Patients Enrolled
Andrew Brohl, MDPrincipal InvestigatorMoffitt Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had pneumonitis treated with steroids or currently have it.I have provided a sample of my tumor that has not been treated with radiation.I have active brain metastases or cancer in the lining of my brain.My organs are functioning well.I am fully active or restricted in physically strenuous activity but can do light work.I am 18 or older with a confirmed diagnosis of Merkel cell carcinoma.I am not pregnant, not breastfeeding, and follow the contraceptive guidelines.I am currently on medication for an infection.I don't have any health issues that could affect the study's results.I have previously received therapy targeting my immune system.You have an ongoing autoimmune disease that needed medication in the past 2 years.I have been diagnosed with HIV.My urine protein levels are low based on a 24-hour test.I agree to use birth control and not donate sperm during and for 6 days after treatment.I have a bleeding or clotting disorder, or I'm at high risk for severe bleeding.I have serious heart problems or a history of heart events.I had radiotherapy less than 2 weeks before starting the study treatment.I have had cancer treatment or been in a trial recently.I have not received a live vaccine in the last 30 days.I have a history of Hepatitis B or an active Hepatitis C infection.My cancer is at stage II, III, or IV according to the AJCC 8th edition.I have another cancer that is getting worse or was treated in the last 3 years.You have a very strong allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.I have an immune system disorder or I'm on long-term steroids or other drugs that weaken my immune system.My disease can be completely removed with surgery.I have been treated with a drug targeting blood vessel growth in cancer.My blood pressure is high despite taking medication.
Research Study Groups:
This trial has the following groups:- Group 1: Lenvatinib plus Pembrolizumab
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.