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cabozantinib for Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Memorial Sloan Kettering Commack, Commack, NYAdvanced or Metastatic Non-Clear Cell Renal Cell Carcinoma+6 Morecabozantinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma
  • Renal Cell Carcinoma
  • Collecting Duct Renal Cell Carcinoma
  • Fumarate Hydratase Deficient Renal Cell Carcinoma
  • Chromophobe Renal Cell Carcinoma
  • Kidney Papillary Cell Carcinoma
  • Succinate Dehydrogenase Deficient Renal Cell Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Phase 1b Dose Escalation

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 2 years

2 years
objective response rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Clostridium butyricum CBM 588 Probiotic Strain
1
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1
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Trial Design

4 Treatment Groups

Cohort 4: Unclassified, papillary, and HL RCC
1 of 4
Cohort 1: Unclassified, papillary, and HL RCC
1 of 4
Cohort 2: Chromophobe RCC
1 of 4
Cohort 3: Unclassified, papillary, and HL RCC
1 of 4

Experimental Treatment

97 Total Participants · 4 Treatment Groups

Primary Treatment: cabozantinib · No Placebo Group · Phase 2

Cohort 4: Unclassified, papillary, and HL RCCExperimental Group · 2 Interventions: cabozantinib, nivolumab · Intervention Types: Drug, Drug
Cohort 1: Unclassified, papillary, and HL RCCExperimental Group · 2 Interventions: cabozantinib, nivolumab · Intervention Types: Drug, Drug
Cohort 2: Chromophobe RCCExperimental Group · 2 Interventions: cabozantinib, nivolumab · Intervention Types: Drug, Drug
Cohort 3: Unclassified, papillary, and HL RCCExperimental Group · 2 Interventions: cabozantinib, nivolumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
FDA approved
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,846 Previous Clinical Trials
589,928 Total Patients Enrolled
Chung-Han Lee, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be at least 18 years old to participate.
You are able to perform daily activities without needing much help.
You have signed a form that explains the study and gives your permission to participate.
You have non-clear cell renal cell carcinoma that has spread and cannot be removed with surgery.
You have not received more than one type of systemic treatment, including treatment given after surgery.
You have a tumor sample available that was collected during a surgery or biopsy, which confirms that you have renal cell carcinoma (RCC).
You have a disease that can be measured according to a specific standard called RECIST 1.1.
You have recovered from any previous treatments' side effects to a level that is close to how you felt before the treatment. If you have any remaining side effects, they should be minor and manageable.
Your blood cell count (ANC) must be at least 1500 cells per microliter, and you cannot have taken granulocyte colony stimulating factor medication within the two weeks before the start of the trial.
Your white blood cell count is between 2500 and 15,000 per microliter without the use of a medication called G-CSF.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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