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Pembrolizumab Combinations for Melanoma
Study 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.
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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Who is running the clinical trial?
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- 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.
- Group 1: Coformulation Pembrolizumab/Quavonlimab + Lenvatinib
- Group 2: Pembrolizumab + Lenvatinib
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is there an upper age limit for eligibility to participate in this investigation?
"This medical study is open to all individuals aged 18 or older and younger than 120 years."
Are there any precedential studies of Pembrolizumab?
"Currently there are 1032 studies exploring the effectiveness of Pembrolizumab, with 134 trials in their third phase. Most Pembrolizumab research is conducted out of Sacramento, though 37001 other medical centres have active clinical trials involving this drug."
What is the upper limit for enrollment in this research trial?
"All told, 300 eligible participants are necessary to successfully run this trial. Merck Sharp & Dohme LLC is overseeing the experiment from numerous locations; two of which being NYU Clinical Cancer Center (Site 4002) located in New york City and Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins School of Medicine ( Site 4022) based out of Baltimore, Maryland."
Does this experiment still accept new participants?
"According to clinicaltrials.gov, the trial is currently recruiting and was first launched on May 3rd 2021. The latest update occurred on September 15th 2022."
Is the clinical trial being conducted in North America at more than one site?
"Currently, 8 medical sites are hosting this trial. These include centres in New york, Baltimore and Durham amongst several other areas. It is important for patients to select the nearest location to reduce travel requirements if they do decide to take part."
What conditions does Pembrolizumab typically treat?
"Pembrolizumab is an effective treatment for malignant neoplasms, inoperable melanoma, and microsatellite instability high."
What is the intended outcome of this clinical investigation?
"This medical trial's primary endpoint is to calculate the percentage of participants who endure any adverse events (AE) over a period of 24 months. Secondary endpoints include Brain Metastasis Duration Of Response, RECIST 1.1-derived Duration Of Response and Progression Free Survival under the same criteria as described in RECIST 1.1."
Would I meet the criteria to join this experiment?
"This research project plans to enrol 300 individuals with melanoma who are between 18 and 120 years of age. For successful application, female participants should not be pregnant or breastfeeding, must either have no child-bearing potential (WOCBP) OR employ a highly effective contraceptive method during the intervention period before ceasing for at least 120 days after their last dose of pembrolizumab/quavonlimab or 30 days post lenvatinib intake; male applicants will need to abstain from heterosexual intercourse or use contraception throughout the trial duration. Additionally, patients must demonstrate neurological symptomlessness from brain metastases and possess healthy organ function"
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