Ipilimumab and Nivolumab in Leptomeningeal Metastases
NCT02939300 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2025-11-14
Summary
This research study is studying a combination of two drugs as a possible treatment for Leptomeningeal Metastases.
The names of the study interventions involved in this study are:
* Ipilimumab
* Nivolumab
Conditions
- Leptomeningeal Carcinomatosis
Interventions
- DRUG
-
* Melanoma: \- Combination therapy with Nivolumab 1 mg/kg for 4 doses followed by monotherapy Nivolumab 480 mg per cycle. * Non-small Cell Lung Cancer / Head and Neck Cancer: \- Combination therapy with Nivolumab 3 mg/kg * Small Cell Lung Cancer / Breast Cancer / Bladder Cancer: \- Combination therapy with Nivolumab 1 mg/kg for 4 doses followed by monotherapy Nivolumab 240 mg per cycle. * Renal Cell Carcinoma / Other Solid Tumors (not listed above): * Combination therapy with Nivolumab 3 mg/kg for 4 doses followed by monotherapy Nivolumab 480 mg per cycle.
- DRUG
-
* Non-small Cell Lung Cancer / Head and Neck Cancer: \- Combination therapy with Ipilimumab 1 mg/kg * Small Cell Lung Cancer / Breast Cancer / Bladder Cancer: \- Combination therapy with Ipilimumab 3 mg/kg for 4 doses * Renal Cell Carcinoma / Other Solid Tumors (not listed above): * Combination therapy with Ipilimumab 3 mg/kg for 4 doses
Sponsors & Collaborators
- collaborator INDUSTRY
-
Massachusetts General Hospital
lead OTHER
Principal Investigators
-
Priscilla Brastianos, MD · Massachusetts General Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-02-15
- Primary Completion
- 2021-07-22
- Completion
- 2021-07-22
- FDA Drug
- Yes
Countries
- United States
Study Locations
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