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NCT04847466 · ClinicalTrials.gov registry record · Phase 2
Immunotherapy Combination: Irradiated PD-L1 CAR-NK Cells Plus Pembrolizumab Plus N-803 for Subjects With Recurrent/Metastatic Gastric or Head and Neck Cancer
A Phase 2 study of Gastroesophageal Junction (GEJ) Cancers and Advanced HNSCC, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT04847466 is a Phase 2 study of Gastroesophageal Junction (GEJ) Cancers and Advanced HNSCC that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 18 participants. The trial reports 1 study location across 1 state.
The verdict
NCT04847466, a Phase 2 study of Gastroesophageal Junction (GEJ) Cancers and Advanced HNSCC, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Immunotherapy is a powerful tool in the fight against cancer. It uses the body s own immune system to fight the cancer. Unfortunately, cancer cells can find ways to escape from destruction by the body s immune system, even when immunotherapy is used. Natural killer (NK) cells are an important part of the body s immune system and can help fight cancer. In combination with immunotherapy, researchers are using engineered NK cells that recognize and kill cancer cells trying to escape destruction by the immune system. Objective: To test the effectiveness of irradiated PD-L1 CAR-NK cells, combined with pembrolizumab and N-803, in people with advanced forms of gastric or head and neck cancer. Eligibility: Adults ages 18 and older with advanced gastric or head and neck cancer who have already had standard cancer treatment. Design: Participants will be screened with a medical history and physical exam. Their symptoms and ability to do normal activities will be assessed. They will have blood and urine tests. They will have imaging scans of the chest, abdomen, and pelvis. Participants will get PD-L1 CAR-NK cells by intravenous (IV) infusion. They will get the cells once a week for 6 weeks. Then they will get the cells once every 2 weeks. Before each infusion, an IV catheter will be placed in a large arm vein for infusion of these treatments. Participants will get pembrolizumab by IV every 6 weeks. They will get N-803 under the skin every 4 weeks. Participants will get the study drugs for up to 2 years. They will have study visits every 1-2 weeks during treatment. They will have a safety visit 28 days after treatment ends. After treatment ends, participants will be contacted for follow-up every 2 months for a year. Then they will be contacted every 6 months. They will have tumor scans every 6-12 weeks until their cancer gets worse.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG N-803
- BIOLOGICAL PD-L1 t-haNK
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2021-12-14 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04847466
The ClinicalTrials.gov registry entry for NCT04847466 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Gastroesophageal Junction (GEJ) Cancers appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT04847466 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT04847466 about?
NCT04847466 is a clinical study titled "Immunotherapy Combination: Irradiated PD-L1 CAR-NK Cells Plus Pembrolizumab Plus N-803 for Subjects With Recurrent/Metastatic Gastric or Head and Neck Cancer". Background: Immunotherapy is a powerful tool in the fight against cancer. It uses the body s own immune system to fight the cancer. Unfortunately, cancer cells can find ways to escape from destruction by the body s immune system, even when immunotherapy is used. Natural killer (NK) cells are an im...
What is the current status of trial NCT04847466?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2021-12-14. Estimated completion is 2027-12-31.
What conditions does trial NCT04847466 study?
This clinical trial studies the following conditions: Gastroesophageal Junction (GEJ) Cancers, Advanced HNSCC.
What interventions are being tested in trial NCT04847466?
The interventions under investigation include: Pembrolizumab (DRUG), N-803 (DRUG), PD-L1 t-haNK (BIOLOGICAL).
Who is sponsoring clinical trial NCT04847466?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04847466 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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