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NCT03380871 · ClinicalTrials.gov registry record · Phase 1
A Personal Cancer Vaccine (NEO-PV-01) With Pembrolizumab and Chemotherapy for Patients With Lung Cancer
A Phase 1 study of Lung Cancer and Carcinoma, Non-Small Cell Lung, sponsored by BioNTech US.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
- 5
- Study locations
NCT03380871: Completed Phase 1 study of Lung Cancer and Carcinoma, Non-Small Cell Lung, sponsored by BioNTech US.
NCT03380871 is a Phase 1 study of Lung Cancer and Carcinoma, Non-Small Cell Lung that has completed, run by BioNTech US. The registered enrollment target is 38 participants, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (96% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03380871, a Phase 1 study of Lung Cancer and Carcinoma, Non-Small Cell Lung, has completed, sponsored by BioNTech US.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
- 5
- Study locations
Study Summary
The purpose of this study is to find out if treatment with NEO-PV-01 in combination with pembrolizumab and chemotherapy (pembrolizumab/chemotherapy) is safe and useful for patients with lung cancer. The study also will assess if the NEO-PV-01 vaccine, when given together with pembrolizumab and chemotherapy, can improve your response compared with pembrolizumab and chemotherapy treatment alone. All eligible patients will receive NEO-PV-01 + Adjuvant, pembrolizumab and chemotherapy while on this trial.
Primary Outcome
Rate of adverse events and severe adverse events leading to treatment discontinuation and those adverse events and severe adverse events detected during symptom-directed physical examinations (changes in safety laboratory evaluations, physical examination findings. vital signs, and ECOG PS)
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Carboplatin
- DRUG Pemetrexed
- BIOLOGICAL NEO-PV-01
- OTHER Adjuvant
Study Locations (5)
Massachusetts
- Massachusetts General Hospital - Boston
- Dana Farber Cancer Institute - Boston
California
- University of California - Los Angeles - Santa Monica
Missouri
- Washington University in St. Louis - St Louis
Tennessee
- Sarah Cannon Research Institute - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2018-05-04 |
| Est. Completion | 2021-02-05 |
| Phase | Phase 1 |
What the finished NCT03380871 record still lists
NCT03380871 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (96% lower).
The record links to 3 conditions, with Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT03380871 lists 5 locations in 4 states (Massachusetts, California, Missouri).
Frequently Asked Questions
What is clinical trial NCT03380871 about?
NCT03380871 is a clinical study titled "A Personal Cancer Vaccine (NEO-PV-01) With Pembrolizumab and Chemotherapy for Patients With Lung Cancer". The purpose of this study is to find out if treatment with NEO-PV-01 in combination with pembrolizumab and chemotherapy (pembrolizumab/chemotherapy) is safe and useful for patients with lung cancer. The study also will assess if the NEO-PV-01 vaccine, when given together with pembrolizumab and chemo...
What is the current status of trial NCT03380871?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2018-05-04. Estimated completion is 2021-02-05.
What conditions does trial NCT03380871 study?
This clinical trial studies the following conditions: Lung Cancer, Carcinoma, Non-Small Cell Lung, Non-Squamous Non-Small Cell Neoplasm of Lung.
What interventions are being tested in trial NCT03380871?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Carboplatin (DRUG), Pemetrexed (DRUG), NEO-PV-01 (BIOLOGICAL), Adjuvant (OTHER).
Who is sponsoring clinical trial NCT03380871?
This trial is sponsored by BioNTech US, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03380871 being conducted?
This trial has 5 study locations across California, Massachusetts, Missouri, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03380871's enrollment target sits among peer trials
38 304th of 409 higher than 104 of 409 other Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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