MGCD516 Combined With Nivolumab in Renal Cell Cancer (RCC)
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|ClinicalTrials.gov Identifier: NCT03015740|
Recruitment Status : Recruiting
First Posted : January 10, 2017
Last Update Posted : July 31, 2018
The goal of this clinical research study is to find the highest tolerable or recommended dose of MGCD5 that can be given with nivolumab to patients with kidney cancer. Researchers also want to learn if this dose can help to control the disease. The safety of this drug combination will also be studied.
This is an investigational study. MGCD516 is not FDA approved or commercially available. It is currently being used for research purposes only. Nivolumab is FDA approved and commercially available for the treatment of many types of cancer, including kidney cancer.
The study doctor can explain how the study drugs are designed to work.
Up to 60 participants will be enrolled in this study. All will take part at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Neoplasms of Urinary Tract Other Disorders of Kidney and Ureter Renal Cell Carcinoma||Drug: MGCD516 Drug: Nivolumab||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Trial of MGCD516 Combined With Nivolumab in Patients With Advanced Clear Cell Renal Cell Cancer That Progressed on Prior VEGF-Targeted Therapy|
|Actual Study Start Date :||April 23, 2017|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||April 2023|
Experimental: MGCD516 + Nivolumab
Participants treated with a pre-specified daily oral dose of MGCD516 determined by the Lo-EffTox method on Day 1 of the study.
Following 2 weeks of MGCD516 monotherapy, Nivolumab additionally initiated on Day 1 of Cycles 2 and beyond.
Participants continue to receive combination therapy of MGCD516 plus Nivolumab until disease progression or unacceptable treatment-related toxicity.
First cohort treated at prespecified dose of 80 mg of MGCD516 by mouth every day.
All successive doses chosen by the Lo- EffTox method, and no untried dose level skipped when escalating.
240 mg/kg by vein every 2 weeks on Day 1 of Cycles 2 and beyond.
- Optimal Dose of MGCD516 Combined with Nivolumab in Participants with Advanced Clear Cell Renal Cell Cancer That Progressed on Prior VEGF-Targeted Therapy [ Time Frame: 12 weeks from the start of therapy ]
Optimum dosage determined by occurrence of toxicities within 12 weeks from the start of therapy.
Dose-limiting toxicity (DLT) judged by the Investigator to be clinically relevant and related (possibly or probably) to administration of either or both study drug(s).
- Efficacy of MGCD516 Combined with Nivolumab in Participants with Advanced Clear Cell Renal Cell Cancer That Progressed on Prior VEGF-Targeted Therapy [ Time Frame: 6 weeks ]Efficacy defined as achieving complete response (CR), partial response (PR), or stable disease within 6 weeks.
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): NCT03015740
|Contact: Nizar M. Tannir, MDemail@example.com|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Nizar M. Tannir, MD||M.D. Anderson Cancer Center|