NCT02939300

Ipilimumab and Nivolumab in Leptomeningeal Metastases

Phase II Trial of Ipilimumab and Nivolumab in Leptomeningeal Metastases

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This research study is a Phase II clinical trial. Researchers hope to study the effects of the combination of Nivolumab and Ipilimumab. Many cancers use specific pathways, such as programmed death-1 (PD-1), programmed death-ligand-1 (PD-L1), and cytotoxic T lymphocyte antigen-4 (CTLA-4), to evade the body's immune system. Nivolumab and ipilimumab work by blocking the PD-1/PD-L1 and CTLA-4 pathways and thus releasing the brakes on the immune system so it can stop or slow cancer. The FDA (the U.S. Food and Drug Administration) has approved Nivolumab and Ipilimumab as a treatment option for melanoma, but has not approved them for use when cancer cells spread to the cerebrospinal fluid

Conditions

• Leptomeningeal Carcinomatosis

Interventions

Type	Name	Description
DRUG	Nivolumab	* 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	Ipilimumab	* 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

Timeline

• Start date: 2018-02-15
• Primary completion: 2021-07-22
• Completion: 2021-07-22
• First posted: 2016-10-20
• Last updated: 2025-11-14
• Results posted: 2022-11-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study