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Pembrolizumab + Lenvatinib for Kidney Cancer (KEYNOTE-B61 Trial)
KEYNOTE-B61 Trial Summary
This trial is testing a new cancer treatment on people who haven't been treated before to see if it's effective.
KEYNOTE-B61 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowKEYNOTE-B61 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.KEYNOTE-B61 Trial Design
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Who is running the clinical trial?
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- My heart's pumping ability is below the normal range.My organs are functioning well.I have coughed up bright red blood recently.My kidney cancer is of a type called collecting duct.I have not had a live vaccine in the last 30 days.I have received an organ or tissue transplant from another person.I have not had cancer treatment or been in a drug trial in the last 4 weeks.I have another cancer that is getting worse or was treated in the last 3 years.My cancer can be measured and has grown in areas previously treated with radiation.I have an active tuberculosis infection.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.My cancer is affecting a major blood vessel or has caused a cavity within the tumor.I have had serious heart problems in the last year.I have been treated with specific immune therapy for cancer.I had radiotherapy over 2 weeks ago, with no ongoing side effects and didn't need steroids.You have a serious allergic reaction to pembrolizumab or lenvatinib.My cancer is at stage IV.I have provided a recent or past sample of my tumor for testing.I have a history of Hepatitis B or active Hepatitis C.I am not pregnant, breastfeeding, and if capable of bearing children, I agree to use contraception during and after treatment.I have or had lung inflammation that needed steroids.My kidney cancer is not of the clear cell type.I agree to use contraception or avoid heterosexual intercourse for 7 days after my last dose.I have active brain metastases or cancer in the lining of my brain.I have a condition that affects how my body absorbs medication.I have not had major surgery in the last 3 weeks.I haven't had systemic therapy for advanced kidney cancer, but treatments over a year ago are okay.My blood pressure is under control, with or without medication.I am currently being treated for an infection.I am mostly able to care for myself and carry out daily activities.You have been diagnosed with HIV.I have been treated for an autoimmune disease in the last 2 years.
- Group 1: 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
How many participants are actively involved in this clinical experiment?
"This medical trial has since ceased recruitment of new patients; it was initially posted on the 23rd February 2021 and edited for the final time on 31st January 2022. Alternatively, there are 2,582 studies recruiting participants with carcinoma renal cell and 1,032 seeking individuals to participate in pembrolizumab trials."
Has the FDA authorized Pembrolizumab as a viable treatment option?
"Pembrolizumab is classified as a "2" on the safety scale due to its Phase 2 status. This denotes that there are some data points affirming safety, but none yet verifying efficacy."
How many locales are overseeing this experiment?
"A dozen sites are recruiting for this medical trial, including Memorial Sloan Kettering Cancer Center (Site 0015) in New york, Comprehensive Cancer Centers of Nevada (Site 0010) in Las Vegas, and BC Cancer Vancouver-Clinical Trials Unit ( Site 1500) in Vancouver."
What maladies have been remedied through the use of Pembrolizumab?
"Pembrolizumab is frequently administered to combat malignant neoplasms, as well as unresectable melanoma, microsatellite instability high cases and chemotherapy-resistant progessions."
Is the elderly population being considered for participation in this trial?
"This clinical trial only includes individuals aged 18 to 120. For those under the age of consent, there are 116 studies available and 3581 for elderly patients above 65 years old."
Could you inform me of any prior research studies involving Pembrolizumab?
"Back in 2010, City of Hope was the first to explore pembrolizumab. Since then, 302 trials have been concluded and an additional 1032 studies are underway. With a concentration of these ongoing experiments based out of New york City."
Who meets the criteria to be admitted into this research trial?
"This medical trial is seeking 152 individuals with renal cell carcinoma aged between 18 and 120. To be eligible, they must fulfill the following criteria: Present a histologically-confirmed diagnosis of non-clear cell RCC., Exhibit advanced/metastasized disease (i.e. Stage IV per AJC guidelines), Demonstrate adequately regulated blood pressure with or without antihypertensive medication, Have no prior systemic therapy for nccRCC within 12 months before recruitment (exception made in case of neoadjuvant/adjuvant treatment). Furthermore, male participants must agree to use contraception for at least 7 days after the last"
Are there any opportunities currently available to join this experiment?
"According to the information hosted on clinicaltrials.gov, this research endeavour is not currently open for participant recruitment. This trial was initially made available February 23rd 2021 and last updated January 31st 2022; however, there are 3,614 other studies that presently seeking participants."
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