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Pembrolizumab in Patients With Leptomeningeal Disease
Phase 2 trial testing Pembrolizumab in Patients With Leptomeningeal Disease in 13 participants. Terminated before completion.
| Lead sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 13 |
| Start date | 12 April 2017 |
| Primary completion | 14 December 2019 |
| Estimated completion | 14 December 2019 |
| Sites | 1 location across United States |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — full company profile →
Adults 18 to 100, any sex, with Patients With Leptomeningeal Disease. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Eligible patients who receive at least one dose of pembrolizumab.
| Group | Value | 95% CI |
|---|---|---|
| Pembrolizumab 200 mg | 2 | |
| Pembrolizumab 200 mg | 1 | |
| Pembrolizumab 200 mg | 2 | |
| Pembrolizumab 200 mg | 8 |
To determine whether pembrolizumab administered in patients with Leptomeningeal disease (LMD) from solid tumors improves central nervous system (CNS) progression-free survival (PFS).
| Group | Value | 95% CI |
|---|---|---|
| Pembrolizumab 200 mg | 2.9 | 1.3 – NA |
To determine whether pembrolizumab administered in patients with LMD from solid tumors improves overall survival (OS).
| Group | Value | 95% CI |
|---|---|---|
| Pembrolizumab 200 mg | 4.9 | 3.7 – NA |
Time frame: For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Pembrolizumab 200 mg |
|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Generalized Muscle Weakness | Musculoskeletal and connective tissue disorders | — |
| Confusion | Psychiatric disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Bone Pain | Musculoskeletal and connective tissue disorders | — |
| Muscle Weakness, Lower Limb | Musculoskeletal and connective tissue disorders | — |
| Paresthesia | Nervous system disorders | — |
| Urinary Tract Obstruction | Renal and urinary disorders | — |
| Pelvic Pain | Reproductive system and breast disorders | — |
| Thrombolic Event- PE | Vascular disorders | — |
| Reaction | System | Pembrolizumab 200 mg |
|---|---|---|
| Fatigue | General disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | — |
| Headache | Nervous system disorders | — |
| Pruritus | Skin and subcutaneous tissue disorders | — |
| Generalized Muscle Weakness | Musculoskeletal and connective tissue disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Edema Limbs | General disorders | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Back Pain | Musculoskeletal and connective tissue disorders | — |
| Dry Skin | Skin and subcutaneous tissue disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Dry Mouth | Gastrointestinal disorders | — |
| Urinary Tract Infection | Renal and urinary disorders | — |
| Weight Loss | Investigations | — |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | — |
| Neck Pain | Musculoskeletal and connective tissue disorders | — |
| Ataxia | Nervous system disorders | — |
| Memory Impairment | Nervous system disorders | — |
| Paresthesia | Nervous system disorders | — |
| Urinary Incontinence | Renal and urinary disorders | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — |
| Confusion | Nervous system disorders | — |
| Hypothyroidism | Endocrine disorders | — |
| Anisocoria | Eye disorders | — |
| Blurred Vision | Eye disorders | — |
| Dry Eye | Eye disorders | — |
| Twitching Eyelid | Eye disorders | — |
| Abdominal Pain | Gastrointestinal disorders | — |
| Dyspepsia | Gastrointestinal disorders | — |
| Dysphagia | Gastrointestinal disorders | — |
| Face Edema | General disorders | — |
| Fever | General disorders | — |
| Infusion Related Reaction | General disorders | — |
| Non-cardiac Chest Pain | General disorders | — |
| Creatinine Increased | Investigations | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Muscle Twitching | Musculoskeletal and connective tissue disorders | — |
Most-reported serious reactions: Back pain, Generalized Muscle Weakness, Confusion, Nausea, Bone Pain, Muscle Weakness, Lower Limb, Paresthesia, Urinary Tract Obstruction.
Data from ClinicalTrials.gov NCT03091478 adverse events section.
This is an open-label phase II study of pembrolizumab in patients with advanced solid tumors with leptomeningeal carcinomatosis (LMD). Approximately 18 subjects in this study will receive pembrolizumab at a dose of 200mg intravenously (IV) every 3 weeks (Q3W) for 4 doses.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03091478.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing