Trial · NCT03091478

Pembrolizumab in Patients With Leptomeningeal Disease

NCT03091478, Phase 2, Terminated, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; results first posted 2021-01-26

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Pembrolizumab in Patients With Leptomeningeal Disease. Trials, record NCT03091478. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03091478

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Pembrolizumab in Patients With Leptomeningeal Disease
NCT number: NCT03091478
Status: Terminated
Phases: Phase 2
Enrollment: 13 participants, actual
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions: Patients With Leptomeningeal Disease
Interventions: Pembrolizumab
First posted: 2017-03-27
Last updated: 2021-01-26
Results first posted: 2021-01-26

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With a Response	At 12 weeks	Eligible patients who receive at least one dose of pembrolizumab.
Secondary	CNS Progression-free Survival in Patients With LMD From Solid Tumors Receiving Pembrolizumab	From the date of study entry until date of death from any cause, assessed up to 24 months	To determine whether pembrolizumab administered in patients with Leptomeningeal disease (LMD) from solid tumors improves central nervous system (CNS) progression-free survival (PFS).
Secondary	Overall Survival in Patients With LMD From Solid Tumors Receiving Pembrolizumab	From the date of study entry until date of death from any cause, assessed up to 24 months	To determine whether pembrolizumab administered in patients with LMD from solid tumors improves overall survival (OS).

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Number of Participants With a Response	At 12 weeks	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	CNS Progression-free Survival in Patients With LMD From Solid Tumors Receiving Pembrolizumab	From the date of study entry until date of death from any cause, assessed up to 24 months	Months	MEDIAN
SECONDARY	Overall Survival in Patients With LMD From Solid Tumors Receiving Pembrolizumab	From the date of study entry until date of death from any cause, assessed up to 24 months	Months	MEDIAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Participants With a Response	Pembrolizumab 200 mg	Complete Response	2		Participants
Number of Participants With a Response	Pembrolizumab 200 mg	Partial Response	1		Participants
Number of Participants With a Response	Pembrolizumab 200 mg	Stable Disease	2		Participants
Number of Participants With a Response	Pembrolizumab 200 mg	Progressive Disease	8		Participants
CNS Progression-free Survival in Patients With LMD From Solid Tumors Receiving Pembrolizumab	Pembrolizumab 200 mg		2.9	95% Confidence Interval 1.3 to NA	Months
Overall Survival in Patients With LMD From Solid Tumors Receiving Pembrolizumab	Pembrolizumab 200 mg		4.9	95% Confidence Interval 3.7 to NA	Months

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Pembrolizumab 200 mg	13
Overall Study	COMPLETED	Pembrolizumab 200 mg	13
Overall Study	NOT COMPLETED	Pembrolizumab 200 mg	0

Source ClinicalTrials.gov

Adverse events80

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Hypothyroidism	Endocrine disorders	Pembrolizumab 200 mg	1	13	1
other	Anisocoria	Eye disorders	Pembrolizumab 200 mg	1	13	1
other	Blurred Vision	Eye disorders	Pembrolizumab 200 mg	1	13	2
other	Dry Eye	Eye disorders	Pembrolizumab 200 mg	1	13	1
other	Twitching Eyelid	Eye disorders	Pembrolizumab 200 mg	1	13	1
other	Abdominal Pain	Gastrointestinal disorders	Pembrolizumab 200 mg	1	13	1
other	Constipation	Gastrointestinal disorders	Pembrolizumab 200 mg	3	13	5
other	Diarrhea	Gastrointestinal disorders	Pembrolizumab 200 mg	2	13	2
other	Dry Mouth	Gastrointestinal disorders	Pembrolizumab 200 mg	2	13	2
other	Dyspepsia	Gastrointestinal disorders	Pembrolizumab 200 mg	1	13	1

1 to 10 of 80Source ClinicalTrials.gov

See all 80 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pembrolizumab 200 mg	9	13
Total, other adverse events	Pembrolizumab 200 mg	13	13
Total, serious adverse events	Pembrolizumab 200 mg	7	13

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34380662	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03091478

GET https://conductscience.org/api/trials/v1/NCT03091478/events?page=2

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