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NCT03236935 · ClinicalTrials.gov registry record · Phase 1
Phase Ib of L-NMMA and Pembrolizumab
A Phase 1 study of Non-Small Cell Lung Cancer and Head and Neck Squamous Cell Carcinoma, sponsored by The Methodist Hospital Research Institute.
- Active
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT03236935: Active Phase 1 study of Non-Small Cell Lung Cancer and Head and Neck Squamous Cell Carcinoma, sponsored by The Methodist Hospital Research Institute.
NCT03236935 is a Phase 1 study of Non-Small Cell Lung Cancer and Head and Neck Squamous Cell Carcinoma that is active but no longer recruiting, run by The Methodist Hospital Research Institute. The registered enrollment target is 12 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03236935, a Phase 1 study of Non-Small Cell Lung Cancer and Head and Neck Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by The Methodist Hospital Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this Phase Ib study is to test the safety of NG-monomethyl-L-arginine (L-NMMA) and pembrolizumab when used together in participants with melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), classical Hodgkin lymphoma (cHL), urothelial carcinoma, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Hepatocellular Carcinoma, Merkel Cell Carcinoma, Primary Mediastinal Large B-cell Lymphoma, Renal Cell Carcinoma, Small Cell Lung Cancer, microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) cancer or for the Treatment of Adult Patients with Unresectable or Metastatic Tumor Mutational Burden-High Solid Tumors. Pembrolizumab is a type of treatment that stimulates the immune system to attack cancer cells. The immune system is normally the body's first defense against threats like cancer. However, sometimes cancer cells produce signals like programmed death-1 (PD-1) that prevent the immune system from detecting and killing them. Pembrolizumab blocks PD-1 so your immune system can detect and attack cancer cells. To help further boost the cancer-fighting ability of your immune system, L-NMMA will be used along with pembrolizumab. L-NMMA is a nitric oxide synthase inhibitor. The presence of nitric oxide synthase in the area around the cancer cells blocks the cancer-fighting ability of the immune system. Thus, the use of L-NMMA and pembrolizumab together may make the immune system work harder to attack and destroy the cancer cells.
Primary Outcome
Assess the MTD of L-NMMA in combination with pembrolizumab
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG L-NMMA
Study Locations (1)
Texas
- Houston Methodist Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2018-08-03 |
| Est. Completion | 2025-12-28 |
| Phase | Phase 1 |
What the registry record for NCT03236935 still lists
NCT03236935 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (98% lower).
The record links to 6 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03236935 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03236935 about?
NCT03236935 is a clinical study titled "Phase Ib of L-NMMA and Pembrolizumab". The purpose of this Phase Ib study is to test the safety of NG-monomethyl-L-arginine (L-NMMA) and pembrolizumab when used together in participants with melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), classical Hodgkin lymphoma (cHL), urothelial carcinoma,...
What is the current status of trial NCT03236935?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2018-08-03. Estimated completion is 2025-12-28.
What conditions does trial NCT03236935 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Malignant Melanoma, Urothelial Carcinoma Bladder, Classical Hodgkin Lymphoma.
What interventions are being tested in trial NCT03236935?
The interventions under investigation include: Pembrolizumab (DRUG), L-NMMA (DRUG).
Who is sponsoring clinical trial NCT03236935?
This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03236935 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03236935's enrollment target sits among peer trials
12 437th of 454 higher than 12 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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