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Immunotherapy

IRX-2 Regimen + Durvalumab for Squamous Cell Carcinoma

Phase 1

Waitlist Available

Led By Christine Chung, M.D.

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have histologically or cytologically confirmed squamous cell carcinoma of specified areas

Participants must have adequate normal organ and marrow function

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

Study Summary

This trial will test a new cancer treatment to see if it is safe and if it boosts the immune system to fight the cancer.

Who is the study for?

Adults with squamous cell carcinoma in areas like the mouth, throat, or larynx that can't be cured by surgery or radiation. They must have a tumor that can be measured and biopsied, weigh over 30 Kg, and have an ECOG score of 0-2 indicating they are relatively active. Women must not be pregnant and all participants should agree to use birth control.Check my eligibility

What is being tested?

The trial is testing if combining the IRX-2 regimen with Durvalumab improves immune response within tumors compared to before treatment. The safety profile of this combination will also be assessed for people with incurable head and neck squamous cell carcinoma.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system affecting organs, fatigue, digestive issues such as gastritis or peptic ulcers, blood disorders increasing infection risk, potential heart problems like arrhythmias or myocardial infarction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is confirmed as squamous cell carcinoma in the specified areas.

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My organs and bone marrow are functioning well.

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My body weight is over 30 Kg.

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My tumor can be safely biopsied multiple times.

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I am 18 years old or older.

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I can take care of myself and am up and about more than 50% of my waking hours.

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My head or neck cancer has returned or spread and cannot be cured with surgery or radiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 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

Phase 1 - Maximum Tolerated Dose (MTD)

Secondary outcome measures

Median Overall Survival (OS)

Median Progression-free Survival

Phase 2 - Objective Clinical Response Rate

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 2 - Dose ExpansionExperimental Treatment2 Interventions

14 patients will be enrolled at the recommended dose level from the dose finding phase for a total enrollment of 20 patients; however, investigators will replace patients with any missing tumor sample collection and continue enrollment until there are at least 20 pre- and post-treatment paired tumors (i.e. minimum 2 of 3 tumors per patient). The 6 patients treated at the recommended dose in the dose finding phase of the study will be counted as a part of the dose expansion patient population,

Group II: Phase 1 - Dose EscalationExperimental Treatment2 Interventions

Six patients will be enrolled at Dose Level 1 with IRX-2 230 units/day in combination with cyclophosphamide and durvalumab and treated sequentially at least 1 week apart. If less than 2 out of 6 patients have DLTs in Dose Level 1, the dose will be escalated to administration of IRX-2 460 Units/day in combination with cyclophosphamide and durvalumab as Dose Level 2. If 2 of 6 patients have DLTs, stop accrual and re-evaluate. In the next safety phase, six patients at IRX-2 460 Units/day in combination with cyclophosphamide and durvalumab will be enrolled and treated sequentially (at least 1 week apart). If DLT occurs in less than 2 of 6 patients during the first 6 weeks of treatment, enrollment can continue in the dose expansion phase at Dose Level 2. If DLT is observed in 2 of 6 patients, accrual will be stopped and Dose Level 1 will resume in the dose expansion phase.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3870

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brooklyn ImmunoTherapeutics, LLCIndustry Sponsor

7 Previous Clinical Trials

5,461 Total Patients Enrolled

AstraZenecaIndustry Sponsor

4,265 Previous Clinical Trials

288,605,263 Total Patients Enrolled

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

542 Previous Clinical Trials

135,473 Total Patients Enrolled

Media Library

Squamous Cell Carcinoma Research Study Groups: Phase 1 - Dose Escalation, Phase 2 - Dose Expansion

Squamous Cell Carcinoma Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT03381183 — Phase 1

Frequently Asked Questions

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

To what extent is Durvalumab hazardous to an individual's health?

"Due to the limited data surrounding Durvalumab's safety and efficacy, it has been assigned a score of 1 on our team's risk assessment scale."

Answered by AI

In what medical conditions has Durvalumab been found to be effective?

"Durvalumab is prescribed to patients with unresectable stage 3 non-small cell lung cancer, as well as those struggling with metastatic ureteral carcinoma and advanced directives."

Answered by AI

What are the results of prior research involving Durvalumab?

"First researched at City of Hope in 2010, durvalumab has now been subject to 108 completed studies. Presently, there are 337 ongoing trials taking place around the world, many located near Ann Arbor, Michigan."

Answered by AI

How many participants are the researchers expecting to accept into this experiment?

"This clinical trial is now closed to recruitment. It was initially posted on August 21st 2019, with the last update taking place on September 30th 2022. However, there are still 2686 trials looking for patients with oral squamous cell carcinoma and 337 studies recruiting for Durvalumab treatments."

Answered by AI

Is this experiment currently open to participants?

"The clinical trial listing on clinicaltrials.gov reveals that enrollment has been closed since September 30th 2022. Prior to this, the study was posted in August 2019 and accepted 100 participants over its duration. However, there are still 3,023 trials recruiting patients right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

IRX-2 Regimen and Durvalumab, for Incurable H&N Squamous Cell Carcinoma

2019. "IRX-2 Regimen and Durvalumab, for Incurable H&N Squamous Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03381183.

All > Squamous Cell Carcinoma