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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04413123
Other study ID # 19-789
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date November 5, 2020
Est. completion date December 20, 2025

Study information

Verified date January 2024
Source Dana-Farber Cancer Institute
Contact Bradley McGregor, MD
Phone (617) 632-1914
Email Bmcgregor@partners.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This research study will assess whether cabozantinib, nivolumab and ipilimumab in combination are safe and effective in slowing down the growth of kidney cancer(renal cell carcinoma or RCC) that has advanced or spread to other areas the body.


Description:

This research study involves an investigational drug combination not approved by the FDA (the U.S. Food and Drug Administration) for your kidney cancer. The names of the study drugs in this investigational combination are: - Cabozantinib - Nivolumab - Ipilimumab The research study procedures include screening for eligibility, study treatment, participant evaluations and safety follow-up visits, in addition to general health status follow-up after study treatment. It is expected that about 40 people will take part in this research study.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Cabozantinib
Cabozantinib predetermined protocol dosage po daily
Nivolumab
Nivolumab predetermined protocol dosage via IV every 3 weeks
Ipilimumab
Ipilimumab predetermined protocol dosage via IV every 3 weeks

Locations

Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Brigham & Woman's Hospital Boston Massachusetts
United States Dana Farber Cancer Institute Boston Massachusetts
United States UT Southwestern Medical Dallas Texas

Sponsors (3)

Lead Sponsor Collaborator
Bradley A. McGregor, MD Bristol-Myers Squibb, Exelixis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Response Rate Percent of patients who achieve overall response (CR or PR) by RECIST 1.1 will be summarized with 80% two-sided exact binomial confidence intervals (CI) tart of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started up to 21 Months
Secondary Duration of response (DOR) will be estimated using the method of Kaplan-Meier, for all patients and by histology subtypes. M first documentation of response, to the earlier of the first documentation of disease progression or death from any cause, and calculated for patients with a best confirmed response of CR up to 21 Months
Secondary Progression-free survival (PFS) the method of Kaplan-Meier, for all patients and by histology subtypes evaluation. trial treatment start to the earlier of progression or death due to any cause per investigator assessment. Participants alive without disease progression are censored at date of last disease evaluation up to 21 Months
Secondary Overall survival (OS) the method of Kaplan-Meier, for all patients and by histology subtypes from trial treatment start to death due to any cause or censored at date last known alive up to 21 Months
Secondary "Number of Participants with TreatmentRelated Adverse Events as Assessed by CTCAE version 5. For toxicity reporting, all adverse events will be graded and analyzed using CTCAE version 5. Baseline, day 1 of every cycle (21 days for first 4 cycles and then 28 days for each cycle tehreafter) and End of Treatment up 21 months
Secondary Quality of life- FKSI-19 Scale The Functional Assessment of Cancer Therapy-Kidney Symptom (FKSI-19) is a 19 item questionnaire with each item scored on a scale of 0-4 for a total score of 0-76 with higher scores indicating fewer symptom 12 weeks for the first assessment, then every 8 weeks (+/- 7 days) for the first 6 months. Then take place every 12 weeks (+/- 7 days)
Secondary Quality of life-BFI Questionaire The Brief Fatigue Inventory (BFI) is a 9-item questionnaire with each item scored on a scale of 0-10.
Scores are categorized as mild (1-3), moderate (4-6), or severe (7-10). A global fatigue score can be found by averaging the score obtained on each test item completed
2 weeks for the first assessment, then every 8 weeks (+/- 7 days) for the first 6 months. Then take place every 12 weeks (+/- 7 days)
Secondary Objective response rate (ORR) ORR by RECIST 1.1 according to histology subtypes (Papillary RCC versus other histology types) will be summarized with 80% two-sided exact CIs. defined as the percentage of patients with partial (PR) or complete response (CR) as best overall response according to RECIST 1.1 by investigator assessment up to 21 Months
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