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PD-1/PD-L1 Checkpoint Inhibitor

Combination Immunotherapy for Cancer

Phase 2
Waitlist Available
Research Sponsored by ImmunityBio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Patients with genomic tumor aberrations should have received prior treatment with an FDA-approved targeted therapy (if available)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial is studying a combination of immunotherapies to see if they help patients with cancer that has progressed after treatment with a PD-1/PD-L1 checkpoint inhibitor. The study has five cohorts of patients. All patients will receive N-803 once every 3 weeks. Patients in Cohorts 1-4 will receive the combination treatment of PD-1/PD-L1 checkpoint inhibitor plus N-803 for up to 17 cycles. Some patients who experience disease progression while on study in Cohorts 1-4 may roll over into Cohort 5 and receive combination therapy with a PD-1/PD-L1 checkpoint inhibitor, N

Who is the study for?
This trial is for adults (18+) who've had prior treatment with PD-1/PD-L1 checkpoint inhibitors for various cancers, including lung, colorectal, and melanoma. They should have an ECOG performance status of 0 or 1, indicating they are fully active or restricted in physically strenuous activity but ambulatory. Participants must not be pregnant or nursing and agree to use effective contraception.Check my eligibility
What is being tested?
The study tests combinations of immunotherapies: N-803 with different checkpoint inhibitors like Nivolumab and Avelumab, plus a cellular therapy called PD-L1 t-haNK for some patients. It's an open-label Phase IIb trial where treatments last up to two years with cycles every six weeks.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system such as inflammation in organs, infusion-related reactions which can range from mild discomfort to more severe symptoms at the injection site, fatigue, possible increased risk of infections due to immune modulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have had FDA-approved targeted therapy for my tumor's genetic changes.
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I received immunotherapy after my standard cancer treatment didn't work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate
Secondary outcome measures
Disease-specific Survival
Duration of Response
Incidence of Adverse Events
+4 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Cohort 5Experimental Treatment5 Interventions
Patients that have experienced disease progression by Investigator-assessment per irRECIST while receiving treatment in Cohorts 1-4.
Group II: Cohort 4Experimental Treatment5 Interventions
Patients who are currently receiving PD-1/PD-L1 checkpoint inhibitor therapy and have disease progression after experiencing stable disease (SD) for at least 6 months during their previous treatment with PD-1/PD-L1 checkpoint inhibitor therapy.
Group III: Cohort 3Experimental Treatment2 Interventions
Patients with NSCLC who had an initial CR or PR but subsequently relapsed on maintenance PD-1 checkpoint inhibitor therapy when they initially received checkpoint inhibitor therapy in combination with chemotherapy as first-line treatment.
Group IV: Cohort 2Experimental Treatment2 Interventions
Patients with NSCLC whose tumors have high PD-L1 expression (TPS ≥ 50%) and who relapsed on a PD-1 checkpoint inhibitor after experiencing an initial CR or PR when they received checkpoint inhibitor as a single-agent for first-line treatment.
Group V: Cohort 1Experimental Treatment5 Interventions
Patients with any of the cancers listed below who have progressed on or after single-agent checkpoint inhibitor therapy after experiencing an initial complete response (CR) or partial response (PR) while taking a checkpoint inhibitor. 1a - Non-small cell lung cancer 1b - Small cell lung cancer 1c - Urothelial carcinoma 1d - Head and neck squamous cell carcinoma 1e - Merkel cell carcinoma 1f - Melanoma 1g - Renal cell carcinoma 1h - Gastric cancer 1i - Cervical cancer 1j - Hepatocellular carcinoma 1k - Microsatellite instability-high or mismatch repair deficient solid tumor cancer or colorectal cancer

Find a Location

Who is running the clinical trial?

ImmunityBio, Inc.Lead Sponsor
63 Previous Clinical Trials
4,989 Total Patients Enrolled
Chad Garner, PhDStudy DirectorImmunityBio, Inc.
3 Previous Clinical Trials
2,135 Total Patients Enrolled

Media Library

Avelumab (PD-1/PD-L1 Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03228667 — Phase 2
Kidney Cancer Research Study Groups: Cohort 1, Cohort 2, Cohort 4, Cohort 5, Cohort 3
Kidney Cancer Clinical Trial 2023: Avelumab Highlights & Side Effects. Trial Name: NCT03228667 — Phase 2
Avelumab (PD-1/PD-L1 Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03228667 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to participate in this clinical exploration?

"According to information available on clinicaltrials.gov, this medical experiment is currently not accepting participants. It was initially posted on December 11th 2018 and last updated April 4th 2022; however, there are an abundance of other trials actively recruiting patients at the present moment (9335 as of writing)."

Answered by AI

To what disease states is the combination of N-803, Pembrolizumab and PD-L1 t-haNK typically employed?

"N-803 + Pembrolizumab + PD-L1 t-haNK is frequently prescribed as a treatment for malignant neoplasms, but can also be used to manage cases of microsatellite instability high and unresectable melanoma or squamous cell carcinoma."

Answered by AI

Have any other studies explored the efficacy of combining N-803, Pembrolizumab and PD-L1 t-haNK?

"Originally studied in 2008 at SCRI Tennessee Oncology Chattanooga, the N-803 + Pembrolizumab + PD-L1 t-haNK combination has been extensively researched with 717 completed studies to date. Currently, 2395 trials are still ongoing across various locations including Miami in Florida."

Answered by AI

Has the combination of N-803, Pembrolizumab and PD-L1 t-haNK been granted authorization by the FDA?

"This combination treatment has garnered a safety rating of 2 from Power due to the lack of efficacy data available, even though there is evidence confirming its security."

Answered by AI

In what geographic areas can this clinical trial be accessed?

"Currently, the trial is taking place across 35 sites, with options in Miami, Lexington and Minneapolis. To reduce commutes associated with participation, it would be wise to choose a center close by."

Answered by AI

Does this research endeavor have an antecedent?

"N-803 + Pembrolizumab + PD-L1 t-haNK has been subject to research since 2008, when it was initially tested by Hoffmann-La Roche in a study involving 720 participants. After receiving Phase 2 drug approval due to the results of its first clinical trial, 2395 active investigations are ongoing for N-803 + Pembrolizumab + PD-L1 t-haNK across 79 nations and 4231 cities."

Answered by AI

How many participants are contributing to this clinical experiment?

"This trial is no longer accepting applicants. It was first made available on December 11th 2018 and last modified on April 4th 2022. For those still looking for a clinical study, there are currently 6940 active studies recruiting melanoma patients and 2395 trials searching for individuals with N-803 + Pembrolizumab + PD-L1 t-haNK."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors
2018. "QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03228667.
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