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Immune + Targeted Therapies for Renal Cell Carcinoma
Study Summary
This trial is a substudy of a larger study that is testing experimental treatments for renal cell carcinoma. The goal of this substudy is to see if the combination of investigational agents is safe and effective in people with advanced ccRCC.
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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- I have an autoimmune disease but haven't needed systemic treatment in the last 2 years.I have been treated with belzutifan before.I have a preexisting abnormal connection between two parts inside my body.I have an immune system disorder or have been on immune-weakening medication recently.I have another cancer that is getting worse or was treated in the last 3 years.I had radiotherapy less than 2 weeks before starting the study treatment.I have not received a live vaccine within the last 30 days.I have high protein in my urine and either low oxygen levels, need oxygen, or had recent severe coughing with blood.I am not pregnant, breastfeeding, and if able to bear children, I am using contraception or abstaining from sex.My kidney cancer worsened after treatment with specific immune or targeted therapies.I can take pills by mouth.I have nutrient absorption issues due to past stomach or intestine surgery or disease.I am a male willing to use contraception or abstain from sex while on treatment and for 7 days after.I have a history of Hepatitis B.I have received an organ or tissue transplant from another person.I have been treated with pembrolizumab and lenvatinib together.I have not had major surgery in the last 3 weeks.I have undergone more than 4 cancer treatment plans.You have been diagnosed with HIV.I have had serious heart problems in the last year.I have a history of inflammatory bowel disease.I started treatment for bone loss at least 2 weeks before joining the study.I am currently being treated for an infection with medication.My organs are functioning well.I have a history of lung disease.Side effects from my previous treatments are mild or gone.My blood pressure is under control and stable for the last week.My kidney cancer has spread and is confirmed by tissue analysis.My cancer has spread to my brain or spinal cord.
- Group 1: Coformulation Pembrolizumab/Quavonlimab
- Group 2: Coformulation Favezelimab/Pembrolizumab
- Group 3: Pembrolizumab + MK-4830
- Group 4: Pembrolizumab + Belzutifan
- Group 5: Belzutifan + Lenvatinib
- Group 6: 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
What other investigations have been conducted utilizing Pembrolizumab?
"As of now, 1042 clinical trials for Pembrolizumab are running with 135 at Phase 3. In the vicinity of Sacramento, California there are several locations offering this trial whereas globally 37368 medical centres are enrolling patients in the study."
What pathologies is Pembrolizumab most frequently employed to remedy?
"Pembrolizumab can be utilized to combat unresectable melanoma, microsatellite instability high conditions, and those with a heightened risk of recurrence."
Is it still possible to volunteer for this experimental protocol?
"Affirmative. According to clinicaltrials.gov, this research trial is actively seeking participants for recruitment; the initial post was on December 17th 2020 and it has been updated as recently as November 18th 2022. In total, 370 individuals must be sourced from 12 different medical centres."
How can I qualify to join this clinical trial?
"For this clinical trial, patients with a diagnosis of carcinoma or renal cell are eligible and must fall into the age range of 18 to 120. In total, 370 individuals will be accepted for participation."
What is the current participation rate for this research endeavor?
"Yes, the information hosted on clinicaltrials.gov confirms that this study is currently recruiting volunteers. It has been posted since December 17th 2020 and last updated on November 18th 2022 with a requirement for 370 participants to be recruited from 12 separate sites."
How many medical facilities are actively participating in this research endeavor?
"This clinical trial has locations in Iowa City, New york and Nashville respectively, as well as 12 other sites. University of Iowa ( Site 3012), Laura and Isaac Perlmutter Cancer Center (Site 3016)and Vanderbilt University Medical Center ( Site 3004) are among the participating facilities."
What goals is the research team hoping to accomplish by conducting this trial?
"The key metric that will be tracked over a maximum of 37 months is the number of participants who experience adverse events (AEs). Secondary outcomes include duration of response, progression-free survival, and overall survival. These measures are determined by assessing responses according to Response Evaluation Criteria In Solid Tumors version 1.1 via Blinded Independent Central Review."
Is this clinical experiment open to people younger than 65 years old?
"This research is enrolling individuals over the age of 18 and below 120 years old."
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