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Lenvatinib + Pembrolizumab for Skin Cancer
Phase 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am 18 or older with a confirmed diagnosis of Merkel cell carcinoma.
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I am not pregnant, not breastfeeding, and follow the contraceptive guidelines.
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My cancer is at stage II, III, or IV according to the AJCC 8th edition.
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My disease can be completely removed with surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
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
Secondary outcome measures
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 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
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 2
~2010
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
543 Previous Clinical Trials
135,456 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,061,120 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What other scientific papers have been published on Pembrolizumab?
"Pembrolizumab is currently being studied in 1076 ongoing clinical trials, 134 of which are Phase 3. The majority of these research studies are based in Sacramento, California; however, there are 37371 locations worldwide where Pembrolizumab clinical trials are taking place."
Answered by AI
What risks does Pembrolizumab present to patients?
"Pembrolizumab's safety is supported by some data, but not to the same extent as a Phase 3 medication. We've rated it a 2."
Answered by AI
How many people will be participating in this clinical trial?
"Yes, this trial is still open for recruitment and information on clinicaltrials.gov reflects this. The study was posted on 5/28/2021 with the most recent edit being on 7/27/2022. They are looking to recruit 26 individuals from 1 site."
Answered by AI
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