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Pembrolizumab + Lenvatinib for Solid Cancers
Study Summary
This trial will test a combination of two drugs to see if it is safe and effective for treating various types of cancer.
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.Trial Design
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Who is running the clinical trial?
Media Library
- I have not had major surgery in the last 3 weeks.I agree to use contraception or avoid sex for 7 days after my last dose.I am currently being treated for an infection.I haven't had any cancer treatment or experimental drugs in the last 4 weeks.I have fluid buildup needing drainage or medication, except if I have ovarian cancer.I have a serious wound or broken bone that isn't healing.I have been treated for an autoimmune disease in the last 2 years.You are allergic to lenvatinib or any of its ingredients.You have a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.I have been treated with specific cancer drugs like lenvatinib or immunotherapy before.I have not received a live vaccine in the last 30 days.You have been diagnosed with HIV in the past.I have a history of hepatitis B or currently have hepatitis C.I have had an organ or tissue transplant and need medicine to prevent rejection.I have GBM, failed my first treatment, am neurologically stable, and know my MGMT status.My scans show no major blood vessel or heart involvement by the tumor.I have had a blood clot in an artery in the past year.My advanced cancer cannot be surgically removed and standard treatments have failed.I have not had significant coughing up of blood or tumor bleeding in the last 2 weeks.I have gastric cancer and have undergone two previous treatments.I have another cancer that is getting worse or was treated in the last 3 years.My condition worsened after my last treatment.I had radiotherapy over 2 weeks ago, with no ongoing side effects.I have a condition that affects how my body absorbs medication.I have triple-negative breast cancer, treated 1-2 times, normal LDH levels, and known hormone receptor status.For participants with a type of brain cancer called GBM: You have cancer spread to the covering of the brain, a very large recurrent tumor, tumor mainly in the brainstem or spinal cord, cancer in multiple areas, bleeding around the tumor, or have used Optune® TTFields recently.I have had two treatments for my colorectal cancer.I am not pregnant, breastfeeding, and if capable of bearing children, I agree to use contraception as required.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I have biliary tract cancer, received one prior treatment, and my liver is functioning well.I haven't had biologic response modifiers therapy in the last 4 weeks.I have an active tuberculosis infection.I can perform all my usual activities without significant limitations.I haven't had major heart problems like heart failure, heart attack, or stroke in the last year.I have fully recovered from any major surgery before starting the study treatment.I have had or currently have lung inflammation treated with steroids.My cancer has spread to my brain stem.I have ovarian cancer and have undergone 3 previous treatments.My organs are functioning well.I have active brain metastases or cancer in my brain's lining.I have pancreatic cancer that has spread, and I've had 1-2 treatments including platinum or gemcitabine.I have provided a sample of my tumor for PD-L1 testing.My cancer can be measured using specific criteria.I have a severe fistula in my GI tract or elsewhere.
- Group 1: Pembrolizumab + Lenvatinib (Arm 1)
- Group 2: Lenvatinib Monotherapy (Arm 2)
- 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
What is the current scope of participation for this experiment?
"Unfortunately, this clinical trial has ceased its search for patients. It was initially advertised on February 12th 2019 and last updated August 19th 2022. If you are searching for other research opportunities, there are currently 2790 trials recruiting participants with glioblastoma and 1032 using pembrolizumab as a treatment that are actively enrolling."
Are there any precedent experiments that utilized Pembrolizumab?
"The initial pembrolizumab study was conducted in the City of Hope back in 2010. Since then, 302 studies have finished and over 1,000 are currently recruiting participants from Montreal and other locations."
Are new participants being taken on for this research endeavor?
"Unfortunately, this clinical trial is not currently accepting new participants. It was originally posted on February 12th 2019 and has since been updated for the last time on August 19th 2022. For those looking for similar studies related to glioblastoma, there are 2790 trials recruiting; 1032 of them involve Pembrolizumab as a medication or intervention."
Has the FDA provided clearance for Pembrolizumab?
"With Phase 2 data, our team at Power ranked the safety of Pembrolizumab as a 2 on a 1 to 3 scale. This is due to there being evidence in support of its safety but not yet any studies that prove efficacy."
Are there a plethora of locations in the US that are hosting this experiment?
"Participants who are interested in this clinical trial have the option of enrolling at one of 16 sites across North America, including cities such as Montreal, Sioux Falls and Fargo. To reduce travel burdens it is advised to pick a location that is closest to you."
What are the chief aims of this investigation?
"The primary aim of this research project, to be evaluated over 72 months at its maximum duration, is the percentage of participants receiving lenvatinib monotherapy who experience an adverse event. Secondary objectives include progression-free survival according to RECIST 1.1 or RANO (GBM) by BICR in expanded cohorts (combined with initial cohorts), PFS per RECIST 1.1 by BICR in lenvatinib monotherapy arm and overall response rate according to RECIST 1.1 by BICR in lenvatinib monotherapy arm.."
What medical applications is Pembrolizumab most commonly used for?
"Pembrolizumab can be used to combat malignant neoplasms, unresectable melanomas, and cases of microsatellite instability high."
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