Ipilimumab and Nivolumab in Leptomeningeal Metastases
Phase II Trial of Ipilimumab and Nivolumab in Leptomeningeal Metastases
Sponsor: Bristol-Myers Squibb
Listed as NCT02939300, this PHASE2 trial focuses on Leptomeningeal Carcinomatosis and remains completed. Sponsored by Bristol-Myers Squibb, it has been updated 15 times since 2018, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)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
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
Status Flow
Change History
15 versions recorded-
Dec 2025 — Present [monthly]
Completed PHASE2
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Sep 2024 — Dec 2025 [monthly]
Completed PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
-
Jan 2023 — Jul 2024 [monthly]
Completed PHASE2
-
Dec 2022 — Jan 2023 [monthly]
Completed PHASE2
Status: Unknown Status → Completed
▶ Show 10 earlier versions
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Nov 2022 — Dec 2022 [monthly]
Unknown Status PHASE2
Status: Active Not Recruiting → Unknown Status
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Jan 2021 — Nov 2022 [monthly]
Active Not Recruiting PHASE2
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Oct 2020 — Jan 2021 [monthly]
Active Not Recruiting PHASE2
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Sep 2019 — Oct 2020 [monthly]
Active Not Recruiting PHASE2
Status: Recruiting → Active Not Recruiting
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Mar 2019 — Sep 2019 [monthly]
Recruiting PHASE2
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Oct 2018 — Mar 2019 [monthly]
Recruiting PHASE2
-
Jun 2018 — Oct 2018 [monthly]
Recruiting PHASE2
-
Mar 2017 — Jun 2018 [monthly]
Recruiting PHASE2
Status: Not Yet Recruiting → Recruiting
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Feb 2017 — Mar 2017 [monthly]
Not Yet Recruiting PHASE2
-
Jan 2017 — Feb 2017 [monthly]
Not Yet Recruiting PHASE2
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- Bristol-Myers Squibb
- Massachusetts General Hospital
For direct contact, visit the study record on ClinicalTrials.gov .