Nivolumab Plus Ipilimumab in Patients With Renal Medullary Carcinoma
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|ClinicalTrials.gov Identifier: NCT03274258|
Recruitment Status : Recruiting
First Posted : September 6, 2017
Last Update Posted : September 14, 2018
Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant.
The goal of this clinical research study is to learn if a combination of nivolumab and ipilimumab can help to control locally advanced or metastatic (has spread) renal medullary carcinoma (RMC).
This is an investigational study. Nivolumab is FDA approved and commercially available to treat many types of cancer, including renal cell cancer after patients have received therapy to control blood vessel growth. Ipilimumab is FDA approved and commercially available to treat metastatic melanoma. It is considered investigational to use nivolumab and ipilimumab to treat RMC.
The study doctor can explain how the study drugs are designed to work.
Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Renal Medullary Carcinoma Other Disorders of Kidney and Ureter||Drug: Nivolumab Drug: Ipilimumab||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Nivolumab Plus Ipilimumab in Patients With Renal Medullary Carcinoma|
|Actual Study Start Date :||December 13, 2017|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
Experimental: Nivolumab + Ipilimumab
During Part A of this study, each study cycle is 21 days (3 weeks). During Part B of this study, each study cycle is 14 days (2 weeks).
During Part A, Nivolumab and Ipilimumab given by vein over about 30 minutes each on Day 1 of Cycles 1-4.
During Part B, Nivolumab given alone by vein over about 60 minutes on Day 1 of each cycle.
Study drugs given in combination for up to 4 cycles. After that, Nivolumab given alone for up to 2 years or until the disease gets worse, whichever comes first.
During Part A, Nivolumab 3 mg/kg given by vein over about 30 minutes each on Day 1 of Cycles 1-4.
During Part B, Nivolumab 480 mg by vein every 4 weeks for up to 2 years, or until disease progression or unacceptable treatment-related toxicity.
During Part A, Ipilimumab 1 mg/kg given by vein over about 30 minutes each on Day 1 of Cycles 1-4.
- Overall Response Rate (ORR) of Nivolumab Plus Ipilimumab in Patients With Renal Medullary Carcinoma [ Time Frame: Day 1 of treatment up to 2 years ]ORR defined as the proportion of patients with a best response of complete response (CR) or partial response (PR) by RECIST criteria recorded between Day 1 of the study and the date of objectively documented progression per RECIST or the date of subsequent anti-cancer therapy, whichever occurs first.
- Progression-Free Survival (PFS) of Nivolumab Plus Ipilimumab in Patients With Renal Medullary Carcinoma [ Time Frame: Day 1 of treatment up to 2 years ]PFS determined by RECIST criteria.
- Safety of Nivolumab Plus Ipilimumab in Patients With Renal Medullary Carcinoma by CTCAE v4.03 [ Time Frame: Day 1 up to 100 days after treatment ]Safety determined by Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03274258
|Contact: Pavlos Msaouel, MDemail@example.com|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Pavlos Msaouel, MD||M.D. Anderson Cancer Center|