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Immune and Targeted Combination Therapies for Kidney Cancer
Study Summary
This trial is studying new combinations of drugs to treat renal cell carcinoma. The goal is to find new ways to treat this disease that are more effective and have fewer side effects than current treatments.
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?
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- My organs are functioning well.Side effects from my last treatment are mild or gone.I have received an organ or tissue transplant from another person.My kidney cancer has spread and is confirmed by tissue analysis.I have had serious heart problems in the last year.My blood pressure is under control and stable for the last week.You have been diagnosed with HIV.I have nutrient absorption issues due to past stomach or intestine surgery or disease.I am not pregnant, not breastfeeding, and if able to have children, I am using birth control.I am a man who will not have sex or will use birth control during and for 7 days after my treatment.I have high protein in my urine and either low oxygen levels, need oxygen support, or had recent severe coughing with blood.I have a history of lung disease.I have a preexisting abnormal connection between two parts inside my body.I have undergone more than 4 cancer treatment plans.I have a history of Hepatitis B.I am currently being treated for an infection.I have an immune system disorder or have been on immune-weakening medication recently.I have an autoimmune disease but haven't needed systemic treatment in the last 2 years.I have a history of inflammatory bowel disease.I have another cancer that is getting worse or was treated in the last 3 years.I have not received a live vaccine within the last 30 days.I have not had major surgery in the last 3 weeks.I had radiotherapy less than 2 weeks before starting the study treatment.I can take pills by mouth.I started treatment for bone loss at least 2 weeks before joining the study.I haven't had systemic therapy for advanced kidney cancer, but may have had treatment over a year ago if it was before cancer advanced.I have cancer that has spread to my brain or spinal cord.
- Group 1: Coformulation Favezelimab/Pembrolizumab+ Lenvatinib
- Group 2: Pembrolizumab + Lenvatinib
- Group 3: Pembrolizumab + Belzutifan + Lenvatinib
- Group 4: Coformulation Vibostolimab/Pembrolizumab+Belzutifan
- Group 5: Coformulation Pembrolizumab/Quavonlimab + 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
In what capacity is Pembrolizumab typically prescribed?
"Pembrolizumab is a commonly used treatment for unresectable melanoma, but it can also be taken to help patients with microsatellite instability high and those at risk of recurrent disease."
What precedent has been set by prior research with Pembrolizumab?
"Pembrolizumab was first investigated at City of Hope in 2010, and since then 303 trials have been concluded. Currently 1042 clinical studies are active, with a considerable number originating from Iowa City, Iowa."
What objectives is this experiment attempting to accomplish?
"Merck Sharp & Dohme LLC, the trial's sponsor, has determined that its primary outcome will be assessed over a period of around 21 days. It involves tracking adverse events among participants in the study population. Additionally, secondary outcomes such as duration of response (defined by RECIST 1.1), overall survival rate and Clinical Benefit Rate (CBR) are being evaluated during this clinical trial too."
For whom is this research opportunity available?
"This trial is seeking a total of 400 individuals with carcinoma, renal cell that are aged between 18 and 120 years. Necessary entry criteria includes: no prior systemic therapy for advanced RCC; able to consume oral medication; sufficient organ functions; non-pregnant females abstaining from heterosexual intercourse or using contraception during the study intervention period and at least 120 days after the last dose of pembrolizumab, etc.; histologically confirmed diagnosis of locally advanced/metastatic ccRCC; resolution of toxic effects ≤Grade 1; male participants must abide by certain contraceptive regulations depending on which drugs they receive (lenv"
Is there still space available for participants in this research endeavor?
"Indeed, the clinical trial is actively recruiting. According to information hosted on clinicaltrials.gov, it was first posted on December 16th 2020 and updated November 18th 2022. 400 individuals are needed for participation between 11 different medical sites."
Are individuals younger than 45 years of age admissible to this medical study?
"Patients aged 18-120 are eligible for this trial, as specified by its inclusion criteria. Furthermore, there are 116 trials available to those underage and 3590 studies specifically targeting the elderly population."
How many healthcare facilities are currently conducting this research?
"11 medical centres have been identified as possible recruitment sites, including University of Iowa (Site 1012) in Iowa City, Duke Cancer Institute ( Site 1015) in Durham and Jewish General Hospital ( Site 1100) in Montreal."
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