What side effects are associated with this type of intervention?

Cytokine-based immunotherapy, such as the IRX-2 regimen, can cause side effects including flu-like symptoms (fever, chills, fatigue), injection site reactions, and potential immune-related adverse events. Durvalumab, a PD-L1 inhibitor, is associated with immune-related side effects such as pneumonitis, colitis, hepatitis, endocrinopathies (e.g., hypothyroidism), and skin reactions. Both treatments may also lead to general side effects like fatigue, decreased appetite, and infusion-related reactions.

What prior FDA approvals exist?

For the treatment of Squamous Cell Carcinoma, the FDA has approved several immunotherapies targeting the PD-1/PD-L1 pathway. Pembrolizumab (Keytruda) and Nivolumab (Opdivo) are PD-1 inhibitors approved for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) following platinum-based chemotherapy. Atezolizumab (Tecentriq), another PD-L1 inhibitor, has shown efficacy in non-small cell lung cancer (NSCLC) but is less commonly used for squamous cell carcinoma. While cytokine-based immunotherapies like IRX-2 are still under investigation, these PD-1/PD-L1 inhibitors represent significant advancements in the treatment landscape for squamous cell carcinoma.

What other types of research exist?

Promising novel alternatives for Squamous Cell Carcinoma patients include Pembrolizumab (a PD-1 inhibitor) which has shown efficacy in various trials, and combination therapies such as Nivolumab plus Ipilimumab (a CTLA-4 inhibitor) which have demonstrated improved overall survival in metastatic settings. Additionally, small molecule tyrosine kinase inhibitors like Afatinib and Gefitinib are being explored, although their clinical roles are still being established.

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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

Must not have

Uncontrolled intercurrent illness

History of allogenic organ transplantation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of treatments that boost the immune system and help it attack cancer cells. It targets patients with specific types of head and neck cancers that cannot be cured with standard treatments. The goal is to see if these treatments are safe and effective in improving the body's ability to fight 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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any uncontrolled illnesses.

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I have received an organ transplant from another person.

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I am showing signs of a bacterial infection throughout my body.

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I have not had a stroke or symptoms of poor brain blood flow in the last 3 months.

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I am currently taking blood thinners.

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I have severe stomach inflammation or ulcers.

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I do not have any active infections.

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I have not had radiation aimed at curing my cancer within the last 30 days.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1 - Maximum Tolerated Dose (MTD)

Secondary study objectives

Median Overall Survival (OS)

Median Progression-free Survival

Phase 2 - Objective Clinical Response Rate

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~3750

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cytokine-based immunotherapy, such as the IRX-2 regimen, enhances the body's immune response by administering cytokines that increase immune cell activity to target and destroy cancer cells. PD-L1 inhibitors like Durvalumab block the interaction between PD-L1 proteins on cancer cells and PD-1 receptors on T-cells, preventing cancer cells from evading the immune system and allowing T-cells to attack the tumor. These treatments are important for Squamous Cell Carcinoma patients as they offer targeted approaches to boost the immune system's ability to fight cancer, potentially leading to better outcomes and fewer side effects compared to traditional therapies.

Human Papillomavirus Induced Cervical and Oropharyngeal Cancers: From Mechanisms to Potential Immuno-therapeutic Strategies.Current Prospects of Molecular Therapeutics in Head and Neck Squamous Cell Carcinoma.The State of Immune Checkpoint Inhibition in Urothelial Carcinoma: Current Evidence and Future Areas of Exploration.