Study of Concurrent Intravenous and Intrathecal Nivolumab for Patients With Leptomeningeal Disease (LMD)
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|ClinicalTrials.gov Identifier: NCT03025256|
Recruitment Status : Recruiting
First Posted : January 19, 2017
Last Update Posted : May 3, 2018
This clinical research study consists of 2 phases: dose escalation (Phase 1) and dose expansion (Phase 2).
The goal of Phase 1 of this research study is to find the highest tolerable dose level of nivolumab that can be given both by intravenous (IV) infusion and intrathecal (IT) injection to patients with leptomeningeal disease (LMD). IV infusions are given by vein, while IT injections are given directly into the cerebrospinal fluid (CSF).
The goal of Phase 2 of this research study is to learn if the highest tolerable dose level combination found during Phase 1 can help to control the disease.
The safety of the drug combination will also be studied in both phases.
This is an investigational study. Nivolumab is FDA approved and commercially available for the treatment of several types of cancer. Its use in LMD is considered investigational. The method of injecting nivolumab into the CSF is investigational. The study doctor can explain how the study drug is 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|
|Melanoma and Other Malignant Neoplasms of Skin Leptomeningeal Disease||Drug: Nivolumab||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/Ib Study of Concurrent Intravenous and Intrathecal Nivolumab for Patients With Leptomeningeal Disease (LMD)|
|Actual Study Start Date :||May 2, 2018|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2022|
Dose Escalation: Participants receive intrathecal (IT) Nivolumab every 14 days. Cycle 1 consists of IT Nivolumab only, but in subsequent cycles the IT Nivolumab dose is followed by an intervenous dose of Nivolumab.
Intrathecal dose administered by accessing the Ommaya.
Dose Expansion: Maximum tolerated dose from Dose Escalation.
Dose Escalation Intrathecal Nivolumab Starting Dose: 5 mg as an injection directly into CSF through Ommaya reservoir on Day 1 of each 14 day cycle for 2 cycles.
No intrasubject dose escalation, and subjects receive the same IT dose level during all subsequent cycles for up to 2 years, given tolerability.
Intravenous dose is 3mg/kg for all participants.
Dose Expansion Intrathecal Nivolumab: Recommended dose from Intrathecal Nivolumab Dose Escalation Phase
- Recommended Dose of Combined IT and IV Nivolumab [ Time Frame: 28 days ]Recommended dose defined as the highest dose for which the posterior probability of toxicity is closest to 30%.
- Overall Survival (OS) with Combined IT and IV Nivolumab [ Time Frame: 12 months ]Kaplan-Meier method used to estimate the distribution of OS from the start of study treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03025256
|Contact: Isabella C. Glitza, MD, PHD||713-792-2921||CR_Study_Registration@mdanderson.org|
|Contact: Clinical Research Operations MD Anderson Cancer Center||713-792-7734||CR_Study_Registration@mdanderson.org|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Isabella C. Glitza, MD, PHD||M.D. Anderson Cancer Center|