Ipilimumab for Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Vanderbilt University/Ingram Cancer Center, Nashville, TN
Carcinoma+5 More
Ipilimumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This phase II trial tests whether using genetic testing of tumor tissue to select the optimal treatment regimen works in treating patients with clear cell renal cell (kidney) cancer that has spread to other places in the body (advanced or metastatic). The current Food and Drug Administration (FDA)-approved regimens for advanced kidney cancer fall into two categories. One treatment combination includes two immunotherapy drugs (nivolumab plus ipilimumab), which are delivered by separate intravenous infusions into a vein. The other combination is one immunotherapy drug (nivolumab infusion) plus an oral pill taken by mouth (cabozantinib). Nivolumab and ipilimumab are "immunotherapies" which release the brakes of the immune system, thus allowing the patient's own immune system to better kill cancer cells. Cabozantinib is a "targeted therapy" specifically designed to block certain biological mechanisms needed for growth of cancer cells. In kidney cancer, cabozantinib blocks a tumor's blood supply. The genetic (DNA) makeup of the tumor may affect how well it responds to therapy. Testing the makeup (genes) of the tumor, may help match a treatment (from one of the above two treatment options) to the specific cancer and increase the chance that the disease will respond to treatment. The purpose of this study is to learn if genetic testing of tumor tissue may help doctors select the optimal treatment regimen to which advanced kidney cancer is more likely to respond.

Eligible Conditions

  • Carcinoma
  • Renal Cell Carcinoma
  • Advanced Clear Cell Renal Cell Carcinoma
  • Stage IV Renal Cell Cancer AJCC v8
  • Stage III Renal Cell Cancer AJCC v8

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: Up to 4 years

At 6 months
Depth of response > 80%
Up to 4 years
Incidence of immune-related adverse events
Overall response rate (Arm 2)
Overall response rate (ORR) (Arm 1)
Progression free survival

Trial Safety

Safety Progress

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

Trial Design

2 Treatment Groups

Arm II (nivolumab, cabozantinib)
1 of 2
Arm I (ipilimumab, nivolumab)
1 of 2
Experimental Treatment

54 Total Participants · 2 Treatment Groups

Primary Treatment: Ipilimumab · No Placebo Group · Phase 2

Arm II (nivolumab, cabozantinib)Experimental Group · 2 Interventions: Nivolumab, Cabozantinib · Intervention Types: Biological, Drug
Arm I (ipilimumab, nivolumab)Experimental Group · 2 Interventions: Nivolumab, Ipilimumab · Intervention Types: Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~5540
Cabozantinib
2013
Completed Phase 2
~2520
Ipilimumab
2014
Completed Phase 3
~3350

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 4 years
Closest Location: Vanderbilt University/Ingram Cancer Center · Nashville, TN
Photo of Nashville 1Photo of Nashville 2Photo of Nashville 3
2013First Recorded Clinical Trial
93 TrialsResearching Carcinoma
82 CompletedClinical Trials

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
12,930 Previous Clinical Trials
41,294,406 Total Patients Enrolled
1,294 Trials studying Carcinoma
390,522 Patients Enrolled for Carcinoma
Vanderbilt-Ingram Cancer CenterLead Sponsor
202 Previous Clinical Trials
64,458 Total Patients Enrolled
8 Trials studying Carcinoma
59 Patients Enrolled for Carcinoma
Brian I Rini, MDPrincipal InvestigatorVanderbilt University/Ingram Cancer Center
1 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Carcinoma
50 Patients Enrolled for Carcinoma

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Tumor tissue must be available for RNA-sequencing.
You have histological confirmation of RCC with a clear cell component.
You have advanced or metastatic renal cell carcinoma.
You are or will be at least 18 years of age at the time of informed consent.
You have not received prior systemic therapy for RCC in the neoadjuvant, adjuvant or metastatic setting.
You have at least one measurable lesion as defined by RECIST 1.1.1.1.1.1.
Calculated creatinine clearance > 30 mL/min per the Cockcroft and Gault formula.
Total bilirubin =< 1.5 times the ULN.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.