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Tyrosine Kinase Inhibitor
Nivolumab + Cabozantinib for Kidney Cancer
Phase 2
Waitlist Available
Led By Chung-Han Lee, MD, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Availability of a representative formalin fixed, paraffin embedded tumor specimen or fresh frozen tissue specimen that enables the definitive diagnosis of RCC, accompanied by an associated pathology report. Specimens can be collected by surgical resection or biopsy of the primary tumor or biopsy or resection of a metastatic lesion
Pathologic or histologically confirmed unresectable advanced or metastatic nccRCC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will compare the effects of a combination of two drugs, nivolumab and cabozantinib, to standard treatment in people with metastatic kidney cancer.
Who is the study for?
This trial is for adults (18+) with advanced or metastatic non-clear cell renal cell carcinoma who've had 0 or 1 prior treatments. They must be able to understand the study, consent to it, and agree to use contraception if fertile. Excluded are those on certain medications, with severe allergies, HIV/hepatitis B/C infections, uncontrolled conditions like hypertension or thyroid issues, recent major surgery, brain/spinal cancer history or significant cardiovascular disease.Check my eligibility
What is being tested?
The study tests a combination of two drugs: Nivolumab (Opdivo®) and Cabozantinib (Cabometyx®), in patients with metastatic kidney cancer. It aims to assess the benefits and adverse effects compared to current standard treatments.See study design
What are the potential side effects?
Potential side effects include immune-related reactions such as inflammation in organs; high blood pressure; fatigue; liver issues; digestive disturbances like nausea and diarrhea; increased protein in urine; mouth sores; hand-foot syndrome.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can provide a tissue sample from my cancer for testing.
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My kidney cancer cannot be removed by surgery and has spread.
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I am mostly able to care for myself.
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I am 18 years old or older.
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I have had one or no previous systemic treatments for my condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
objective response rate
Trial Design
4Treatment groups
Experimental Treatment
Group I: Cohort 4: Unclassified, papillary, and HL RCCExperimental Treatment2 Interventions
Cohort 4 is an expansion of Cohorts 1+3, which will accure an additional 40 patients
Group II: Cohort 3: Unclassified, papillary, and HL RCCExperimental Treatment2 Interventions
Cohort 3 is designed as an expansion cohort of Cohort 1 with 20 additional patients to obtain a more precise estimate of the ORR and clinical outcomes
Group III: Cohort 2: Chromophobe RCCExperimental Treatment2 Interventions
Cohort 2 is designed as a Simon's optimal two-stage design with a total possible sample size of 17. This design discriminates between ORR rates of 5 and 25%.
Group IV: Cohort 1: Unclassified, papillary, and HL RCCExperimental Treatment2 Interventions
Cohort 1 is designed as a single stage study with a total sample size of 20. This design discriminates between ORR rates of 10 and 35%.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
cabozantinib
2011
Completed Phase 3
~1240
nivolumab
2016
Completed Phase 3
~4960
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,562 Total Patients Enrolled
Chung-Han Lee, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Darren Feldman, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
8 Previous Clinical Trials
1,740 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a serious wound, ulcer, or bone fracture that is not healing.My heart's electrical activity (QTcF) is not over 500 ms.I have lung lesions or disease in my airways.I can provide a tissue sample from my cancer for testing.My recent blood and organ tests meet the study's requirements.I have been treated with cabozantinib for a type of kidney cancer that is not clear cell.I haven't received any cancer treatment or experimental drugs in the last 4 weeks.I have previously been treated with immunotherapy.You have had serious allergic reactions to certain types of medications in the past.I frequently need procedures to remove excess fluid from my chest or abdomen.I haven't had any cancer besides skin cancer or low-grade tumors in the past 2 years.I haven't taken steroids or immunosuppressants in the last 14 days.I have a history of HIV infection.I have a serious heart condition.My high blood pressure is not under control.My kidney cancer cannot be removed by surgery and has spread.My side effects from previous treatments are mild or back to normal.I need IV fluids, nutrition, or tube feeding due to stomach or intestine problems.My tumor is growing into or around major blood vessels.My cancer has spread to my digestive system or airways recently.I agree to use birth control during and after the study.I am mostly able to care for myself.I have high calcium levels that need ongoing treatment.My pain medication dose has been stable before joining the study.I am 18 years old or older.I have had one or no previous systemic treatments for my condition.I cannot swallow pills or capsules.You have a condition that causes frequent or severe bleeding, or problems with blood clotting.I have not had significant blood in my urine, vomit, or coughed up blood in the last 3 months.I do not have cancer in my brain, spinal cord, or its coverings.You have a disease that can be measured using a specific set of guidelines.I am currently taking blood thinners.The ratio of protein to creatinine in your urine is less than or equal to 1 mg/mg.I haven't had major blood vessel problems in the last 6 months.I haven't taken any targeted cancer drugs in the last 2 weeks.I have symptoms of underactive thyroid that aren't treated.I haven't had radiation for bone metastasis in the last 2 weeks or any other radiation in the last 4 weeks.I have an active or chronic hepatitis B or C infection.My liver is not working well.I have not had major surgery in the last 8 weeks.I have not had a stroke or mini-stroke in the last 6 months.You have other health issues that could make it unsafe for you to take part in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2: Chromophobe RCC
- Group 2: Cohort 4: Unclassified, papillary, and HL RCC
- Group 3: Cohort 1: Unclassified, papillary, and HL RCC
- Group 4: Cohort 3: Unclassified, papillary, and HL RCC
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.
Has there ever been a comparable research project undertaken before?
"Since 2012, cabozantinib has been under intense clinical scrutiny. Exelixis initiated the first trial with 86 participants in that same year, leading to its Phase 2 drug approval status. Currently there are 793 active trials for this medication spanning 53 different nations and 2553 cities."
Answered by AI
Are there multiple research centers conducting this experiment in the metropolis?
"Patients may enroll in this clinical trial at seven different medical centres, like Memorial Sloan Kettering Commack in Commack, Montvale's Memorial Sloan Kettering Bergen or the Uniondale-based Memorial Sloan Kettering Nassau."
Answered by AI
What medical applications does cabozantinib typically treat?
"Cabozantinib is frequently used to battle malignant tumors, and can be helpful in addressing unresectable melanoma, squamous cell carcinoma, as well as metastatic esophageal adenocarcinoma."
Answered by AI
What is the estimated sample size of this research endeavor?
"Confirmed. Clinicaltrials.gov has data confirming that the trial initiated on August 13th, 2018 is currently enrolling participants - 97 individuals from 7 different medical centres are needed for this study to be successful."
Answered by AI
Could you elucidate on other research efforts involving cabozantinib?
"At the time of writing, 793 cabozantinib studies are operational worldwide. Of these active trials, a notable 90 have advanced to Phase 3. Although Zurich is identified as one of the prime locations for this treatment's clinical trials, there exist 43550 other sites in which research into cabozantinib is being conducted."
Answered by AI
Are any spots still available to volunteer for this research project?
"Affirmative, according to the information displayed on clinicaltrials.gov this medical trial is currently in need of participants. It was first posted on August 13th 2018 and recently updated October 26th 2022 with a requirement for 97 patients from 7 sites."
Answered by AI
What have been the effects of cabozantinib on human subjects?
"Our team at Power assigned cabozantinib a safety rating of 2, as this is a Phase 2 trial and there is thus evidence for its safety but not yet efficacy."
Answered by AI
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