Ipilimumab and Nivolumab in Leptomeningeal Metastases

Conditions

• Leptomeningeal Carcinomatosis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nivolumab — 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.
• Ipilimumab — 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

Study Details

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

Key Dates

Start date

Feb 15, 2018

Status verified

Oct 2025

Primary completion

Jul 22, 2021

Completion

Jul 22, 2021

Study Design

Enrollment

18 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Combination Of Nivolumab with Ipilimumab
  All patients will be treated based on their primary tumor diagnosis with a combination regimen of Nivolumab and Ipilimumab. Each treatment cycle is 6 weeks; exceptions below. * Melanoma: * Nivolumab 1 mg/kg and Ipilimumab 3 mg/kg, every 3 weeks for 4 doses. * Followed by Nivolumab 480 mg every 4 weeks until disease progression. Each cycle of monotherapy is defined as 8 weeks. * Non-small Cell Lung Cancer / Head and Neck Cancer: \- Nivolumab 3 mg/kg every 2 weeks, and Ipilimumab 1 mg/kg every 6 weeks. * Small Cell Lung Cancer / Breast Cancer / Bladder Cancer: * Nivolumab 1 mg/kg and Ipilimumab 3 mg/kg, every 3 weeks for 4 doses. * Followed by Nivolumab 240 mg every 2 weeks until disease progression. * Renal Cell Carcinoma / Other Solid Tumors (not listed above): * Nivolumab 3 mg/kg and Ipilimumab 3 mg/kg, every 3 weeks for 4 doses. * Followed by Nivolumab 480 mg every 4 weeks until disease progression. Each cycle of monotherapy is defined as 8 weeks.

Primary Outcome Measure

Percentage of Participants With Overall Survival [ Time Frame: 3 months ]

Locations (2)

Find similar trials in Boston, MA