N-803 for Advanced HNSCC

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
National Institutes of Health Clinical Center, Bethesda, MD
Advanced HNSCC+2 More
N-803 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Immunotherapy Combination: Irradiated PD-L1 CAR-NK Cells Plus Pembrolizumab Plus N-803 for Subjects With Recurrent/Metastatic Gastric or Head and Neck Cancer

See full description

Eligible Conditions

  • Advanced HNSCC
  • Gastroesophageal Junction (GEJ) Cancers

Treatment Effectiveness

Study Objectives

This trial is evaluating whether N-803 will improve 1 primary outcome and 3 secondary outcomes in patients with Advanced HNSCC. Measurement will happen over the course of Until progression or death.

Day 28
To assess the safety and tolerability of irradiated PD-L1 CAR-NK cells in combination with N-803 plus pembrolizumab in patients with head and neck squamous cell carcinoma and/or gastric/GEJ cancer
Until progression or death
To assess duration of response in patients with HNSCC and/or gastric/GEJ cancer treated with irradiated PD-L1 CAR-NK cells in combination with N-803 plus pembrolizumab
To assess the progression free survival (PFS) in patients with HNSCC and/or gastric/GEJ cancer treated with irradiated PD-L1 CAR-NK cells in combination with N-803 plus pembrolizumab
every 6 weeks
To determine the clinical response rate (CR+PR) with irradiated PD-L1 CAR-NK cells in combination with N-803 plus pembrolizumab in patients with head and neck squamous cell carcinoma and gastric/GEJ cancer.

Trial Safety

Trial Design

1 Treatment Group

1/Arm 1
1 of 1
Experimental Treatment

This trial requires 55 total participants across 1 different treatment group

This trial involves a single treatment. N-803 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

1/Arm 11-week lead in for PD-L1 CAR NK cell monotherapy followed by combination therapy of Pembrolizumab plus N-803
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: every 6 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly every 6 weeks for reporting.

Closest Location

National Institutes of Health Clinical Center - Bethesda, MD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Advanced HNSCC or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Participants must have metastatic or unresectable locally advanced Gastric/GEJ cancer that has been histologically confirmed.
Participants must have measurable disease by RECISTv1.1.
Participants must have received or been ineligible to receive first line systemic chemotherapy for Gastric/GEJ cancer. Participants with HER2 positive disease must have received HER2-targeted therapy.
Head and neck squamous cell carcinoma Cohort
Participants must have metastatic or unresectable locally advanced HNSCC that has been histologically confirmed.
Participants must have received or been ineligible to receive first-line systemic chemotherapy and must have received systemic anti-PD-1 therapy (in the first-line or subsequent-line setting).
Age >=18 years. Because no dosing or adverse event data are currently available on the use of this investigation combination therapy in participants <18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.
ECOG performance status <2
leukocytes greater than or equal to 3,000/mcL
absolute neutrophil count greater than or equal to 1,500/mcL

Patient Q&A Section

What are common treatments for head neoplasms?

"In the first stage of treatment for head neoplasms, most patients have surgery as an initial alternative to radiation therapy. If surgery is not feasible, radiation therapy or chemotherapy may be preferred as initial treatment options. The choice of treatment depends upon factors such as age, tumor type and patient's willingness to accept radiation therapy or chemotherapy. In spite of the frequent use of surgery in patients' treatment, patients with head neoplasms usually have a good or good to excellent outcome without surgery." - Anonymous Online Contributor

Unverified Answer

What causes head neoplasms?

"As of 1999 the most accepted hypothesis is that many head neoplasms arise in the brain due to the formation of benign brain tumors along the dural venous sinuses via leakage of blood brain barrier as a complication of trauma and hemorrhage. Another, not definitely proven, hypothesis is that the cause lies behind the development of cranial hypertension, in particular, the development of a cranial sinus that drains a hydrocephalic fluid. These two theories have been confirmed by radiological imaging." - Anonymous Online Contributor

Unverified Answer

What is head neoplasms?

"A head neoplasm is a disease that forms in the brain and that is caused by unregulated growth of abnormal cells. Head neoplasms are the leading cause of death from cancer in children under 20 years of age. A head and neck neoplasm are tumors that form in and around the nose and throat, including the skin, larynx, and mouth.\n" - Anonymous Online Contributor

Unverified Answer

Can head neoplasms be cured?

"In contrast to most benign tumors of the nervous system, the majority of head neoplasms are, in most cases, not curable, and must be followed for clinical progression. Patients must not be misdiagnosed, and surgeons must be apprised of the nature of their disease if any operation is going to be performed for these tumors." - Anonymous Online Contributor

Unverified Answer

How many people get head neoplasms a year in the United States?

"around 1.5 million [head and neck cancer](https://www.withpower.com/clinical-trials/head-and-neck-cancer) cases are diagnosed a year in the United States. The cancer most commonly diagnosed in non-Hispanic, non-black males is squamous cell carcinoma of the lip or oral cavity (1.3 per 100,000). The most common cancer in female non-Hispanic, non-black patients is breast cancer (3.8 per 100,000). Most cancers are diagnosed late in the course of their disease (54% in stage 4). In addition, 16% of patients die from the cancer within the first two years after the diagnosis is made, and 24% live less than a year after diagnosis." - Anonymous Online Contributor

Unverified Answer

What are the signs of head neoplasms?

"Neoplastic disease is a frequent cause of head and neck discomfort. A clinical approach that focuses on the physical examination complemented with appropriate medical imaging may help to diagnose the correct diagnosis of disease." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in n-803 for therapeutic use?

"Recently, n-803 demonstrated anti-tumor activity against head and neck cancers and melanoma metastases in nude mice models. Furthermore, when combined with standard anticancer therapy, n-803 treatment resulted in tumor growth inhibition, stabilization of a tumor, improvement of chemotherapy response and increased survival in mice with head and neck cancer. However, further clinical investigations are necessary to further validate these promising preclinical studies." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets head neoplasms?

"Although the age of diagnosis was approximately the same (60 years), the median age of diagnosis of the two subgroups was significantly younger: 57 years with 1-4 tumors and 52 with 1-3 tumors (P = 0.001). Younger age of younger is compatible with slower growth rates." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating head neoplasms?

"With new types of treatments coming out and new advances in the field of clinical neuroscience, head neurosurgeons can still use this new information in to help and improve the quality of life while treating patients with head neoplasms.\n" - Anonymous Online Contributor

Unverified Answer

How serious can head neoplasms be?

"Although some of the tumors had a high recurrence rate, the overall survival and recurrence rate were relatively good. After surgery, even if residual tumor is detected by recurrence, the prognosis is generally good. Even if recurrent tumors of the primary tumor are detected, secondary brain metastases do not appear. For primary metastases, surgical removal with a cure is the best choice, even if they are in an unresectable or recurrent form.." - Anonymous Online Contributor

Unverified Answer

Is n-803 safe for people?

"N-803 was found to be safe in clinical trials previously undertaken at Sun Life Assurance. However, there was no evidence that n-803 would result in harm in this study." - Anonymous Online Contributor

Unverified Answer

Does head neoplasms run in families?

"Head and neck tumors were very frequent among the families presenting neoplasms to the Cancer Genetics Unit of the M.D. Anderson Breast/Head/Neck Center. Further, our data imply that families with head and neck malignancies tend to transmit disease mutations in tumors of the head/neck." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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