Your session is about to expire
← Back to Search
Checkpoint Inhibitor
Cabozantinib +/− Atezolizumab for Advanced Kidney Cancer
Phase 2
Recruiting
Led By Benjamin L Maughan
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants with measurable disease, per RECIST version (v)1.1, must be present outside the CNS
Participants with new or progressive brain metastases (active brain metastases) must not require immediate central nervous system (CNS) specific treatment at the time of study registration or anticipated during the first cycle of therapy. Patients with leptomeningeal disease are excluded from enrolling
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing whether cabozantinib with or without atezolizumab can shrink tumors in patients with metastatic papillary kidney cancer. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, while atezolizumab may help the body's immune system attack the cancer.
Who is the study for?
Adults with advanced papillary kidney cancer that has spread, who have not had certain treatments like PD-1/PD-L1 inhibitors in the past 6 months. They must be able to swallow pills, have no major health issues affecting trial participation, and agree to use effective contraception if of reproductive potential.Check my eligibility
What is being tested?
The PAPMET2 trial is comparing cabozantinib alone versus combining it with atezolizumab in patients with metastatic papillary renal cell carcinoma. The goal is to see if adding the immunotherapy agent improves outcomes compared to just the kinase inhibitor.See study design
What are the potential side effects?
Potential side effects include high blood pressure, fatigue, diarrhea, liver enzyme changes, mouth sores, hand-foot syndrome (redness and pain on palms or soles), and possibly increased risk of infections due to immune system effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer can be measured and is not in my brain or spinal cord.
Select...
I don't need immediate treatment for brain metastases and don't have leptomeningeal disease.
Select...
My blood pressure was below 150/100 mm Hg in the last two weeks.
Select...
I have been diagnosed with a type of kidney cancer known as metastatic papillary renal cell carcinoma.
Select...
I am 18 years old or older.
Select...
I have never had bleeding in my brain or spinal cord.
Select...
I have HIV, am on effective treatment, and my viral load is undetectable.
Select...
I can take care of myself and am up and about more than 50% of my waking hours.
Select...
My recent tests show my urine protein is under control.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression free survival
Secondary outcome measures
Incidence of adverse events
Objective response rate
Overall survival
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (cabozantinib S-malate, atezolizumab)Experimental Treatment5 Interventions
Patients receive cabozantinib S-malate PO QD on days 1-21 and atezolizumab IV over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and bone scans throughout the trial. Patients may also undergo collection of blood samples throughout the trial.
Group II: Arm I (cabozantinib S-malate)Active Control4 Interventions
Patients receive cabozantinib S-malate PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and bone scans throughout the trial. Patients may also undergo collection of blood samples throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860
Biospecimen Collection
2004
Completed Phase 2
~1700
Cabozantinib S-malate
2013
Completed Phase 2
~470
Computed Tomography
2017
Completed Phase 2
~2720
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,666 Previous Clinical Trials
40,925,805 Total Patients Enrolled
Benjamin L MaughanPrincipal InvestigatorSWOG Cancer Research Network
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not need frequent procedures to remove excess fluid from my body.I am not taking, nor will I take, strong medications that affect liver enzymes while on this treatment.Your liver function test should not be more than 3 times the normal level, unless the liver is affected by the tumor, in which case it should not be more than 5 times the normal level.Your white blood cell count is at least 1.5 x 10^3 per microliter.If I can't make decisions, my legal representative can consent for me.I haven't had recent heart issues or a stroke in the last 3 months.I haven't had a heart attack or blood clot needing blood thinners in the last 3 months.I am not taking warfarin at doses meant to treat conditions. I may be on low dose aspirin or LMWH.My cancer can be measured and is not in my brain or spinal cord.My hemoglobin level is at least 9 g/dL, possibly after a transfusion.Your white blood cell count is at least 2000 cells per microliter within the last 28 days.My bilirubin levels are within the normal range, or I have Gilbert's disease with acceptable levels.I don't need immediate treatment for brain metastases and don't have leptomeningeal disease.I haven't had major surgery in the last 28 days and have recovered from any surgery effects.Your lymphocyte count is at least 0.5 x 10^3 per microliter within the last 28 days before joining the study.I had hepatitis C but am cured, or I'm being treated with undetectable levels.I finished my radiation therapy 14 days ago and have recovered from major side effects.I have had only one treatment for advanced kidney cancer, not counting certain approved drugs.I have chronic hepatitis B but it's under control with treatment.My kidney function, measured by creatinine levels or clearance, is within the required range.My liver function tests are within the required range.I am not taking, nor plan to take, strong CYP3A4 inducers.I can swallow pills and don't have major stomach or digestion issues.I haven't coughed up a noticeable amount of blood in the last 3 months.I am not on steroids for a brain condition.I haven't had PD-1/PD-L1 inhibitors in the last 6 months.My cancer has not spread to or around any major blood vessels.I had a full physical exam and medical history review within the last 28 days.My cancer has not spread to my digestive system or airways in the last 28 days.I haven't had specific brain treatments in the last month before starting the study.My blood pressure was below 150/100 mm Hg in the last two weeks.I have never been treated with cabozantinib.You should not have a major autoimmune disease, but some exceptions like diabetes, eczema, and vitiligo are okay. If you have other autoimmune diseases, it's okay if the doctor running the study says it's okay.I haven't had serious stomach or intestine bleeding in the last 3 months and don't have a high-risk GI disorder.I have been diagnosed with a type of kidney cancer known as metastatic papillary renal cell carcinoma.My cancer can be measured by scans and has been checked within the last month.I am on a stable dose of medication for seizures.I am 18 years old or older.I have never had bleeding in my brain or spinal cord.I have HIV, am on effective treatment, and my viral load is undetectable.I do not have holes in my lung tissue.I do not have severe heart failure.I can take care of myself and am up and about more than 50% of my waking hours.Your platelet count is at least 100,000 per microliter of blood within the last 28 days before joining the study.I have another cancer, but it won't affect this trial's treatment.I am not taking more than 10 mg of steroids daily, except for specific medical exceptions.My recent tests show my urine protein is under control.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (cabozantinib S-malate)
- Group 2: Arm II (cabozantinib S-malate, atezolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there different research hospitals testing this procedure within the state?
"Patients can enroll at multiple locations across the United States, including Carle Physician Group-Effingham in Effingham, Illinois, Carle Physician Group-Mattoon/Charleston in Mattoon, Oregon, and Miami Valley Hospital South in Centerville, Iowa."
Answered by AI
How many individuals are being given this experimental medication?
"That is accurate. The clinicaltrials.gov website contains information indicating that this research project, which was first announced on September 19th, 2022, is actively looking for 200 patients at 8 different locations."
Answered by AI
Are there any unfilled vacancies in this study for new participants?
"The latest information available on clinicaltrials.gov suggests that this study is still recruiting patients. The trial was originally posted on September 19th, 2020 and the listing was last updated on November 2nd, 2020."
Answered by AI
Has the FDA approved of the use of Arm (I (cabozantinib S-malate, atezolizumab))?
"Arm (I (cabozantinib S-malate, atezolizumab) has only been studied in a Phase 2 trial, so there is not much data to support its efficacy. However, it did receive a score of 2 for safety."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger