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Pembrolizumab + Lenvatinib for Melanoma
Study Summary
This trial will compare the safety and efficacy of pembrolizumab and lenvatinib to pembrolizumab and placebo as first-line treatment in adults with no prior systemic therapy for their advanced melanoma.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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- I have received treatment after my primary cancer treatment.I have been treated for an autoimmune disease in the last 2 years.I have a severe fistula.I had radiotherapy less than 2 weeks before starting the study treatment.I have not coughed up blood in the last 3 weeks.I had major surgery less than 3 weeks ago.I have records of my BRAF V600 mutation status or agree to testing.I am currently being treated for an infection.I have received an organ or tissue transplant from another person.My melanoma diagnosis was confirmed through lab tests.I have or had hepatitis B or C.I am fully active or can carry out light work.I haven't had any cancer treatment or been part of a study in the last 4 weeks or longer.You have at least one detectable tumor or abnormality that can be seen on a CT scan or MRI.My blood pressure is ≤150/90 mmHg, and my medication hasn't changed recently.My organs are functioning well.I have not received a live vaccine in the last 30 days.I have not been treated for my advanced or metastatic disease.I have had active tuberculosis in the past.I have had serious heart problems in the last year.I have had treatment for melanoma that cannot be removed by surgery, but not targeted therapy.I have a known history of HIV.I do not have conditions affecting medication absorption.I have another cancer that is getting worse or needs treatment.You are allergic to the main ingredients of the treatment or had a bad reaction to a similar treatment before.My side effects from previous treatments are mild, except for hair loss.You have more than 1 gram of protein in your urine over a 24-hour period.I have cancer that has spread to my brain or surrounding membranes.I have been diagnosed with eye melanoma.My scans show my tumor is affecting major blood vessels or has hollow areas.I have an immune system disorder or am on long-term steroids.My cancer did not return during or within 6 months after my last targeted or immune therapy.I agree to use birth control and not donate sperm during and for 7 days after treatment.I am not pregnant, not breastfeeding, and meet one of the required conditions.Your heart's QTcF interval is longer than 480 milliseconds.I have or had lung inflammation that needed steroids.My melanoma cannot be surgically removed and is in stage III or IV.You need to have a sample of your tumor taken for testing.Your heart's pumping ability is below the normal range.
- Group 1: Pembrolizumab+Placebo
- Group 2: Pembrolizumab+Lenvatinib
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
What are the goals that this medical study hopes to achieve?
"The primary objective of this study, which will be measured over a period of Up to approximately 36 months, is Overall Survival (OS). Additionally, this study will be assessing secondary outcomes including Time to True Deterioration (TTD) Based on Change from Baseline in European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire-Core 30 [QLQ-C30] in Global Health Status (GHS) Score and Time to True Deterioration (TTD) Based on Change from Baseline in European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire-"
How many different hospitals are administering this trial?
"There are a total of 22 sites enrolling patients for this trial, including Lions Gate Hospital (Site 0662) in North Vancouver, OHSU Center for Health & Healing (Site 0731) in Portland, and Centre Hospitalier de l Universite de Montreal - CHUM (Site 0652) in Montreal."
Are we still looking for candidates to enroll in this experiment?
"This research is not actively recruiting patients at this current moment. The listing was first posted on March 12th, 2019 and was updated on August 22nd, 2020. There are 781 clinical trials recruiting patients with melanoma and 1077 studies recruiting patients that have been treated with Pembrolizumab."
Pembrolizumab is usually given to patients for what purpose?
"Pembrolizumab is an immunotherapy drug used to treat patients with unresectable melanoma, malignant neoplasms, and microsatellite instability high."
Could you explain the possible risks associated with Pembrolizumab?
"Pembrolizumab has been studied in Phase 3 clinical trials, meaning that there is evidence of both efficacy and safety. Consequently, our team at Power has rated Pembrolizumab as a 3 on our safety scale."
Could you please give me a rundown of other Pembrolizumab investigations?
"Pembrolizumab was first trialed a decade ago, in 2010, at City of Hope. Since then, there have been 298 completed clinical trials worldwide. As of now, 1077 clinical trials are ongoing, with a significant portion based in North Vancouver, British Columbia."
How many guinea pigs are enrolling in this human experiment?
"This study is not recruiting at the moment, according to the latest update from August 22nd, 2022. The study was first posted on March 12th, 2019. There are 781 other trials actively recruiting patients with melanoma and 1077 trials for Pembrolizumab if you are interested in participating in other clinical studies."
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