IRX-2 Regimen + Durvalumab for Squamous Cell Carcinoma

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byChristine Chung, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

Participants must be willing and able to give informed consent and adhere to protocol therapy

Participants must have measurable disease as per RECIST version 1.1

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

+9 more

Exclusion Criteria

I have no medical conditions or past treatments that would prevent me from receiving certain cancer therapies.

Known infection with specific viruses

Allergy to specific medications

+22 more

Participant Groups

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.

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.

Durvalumab is already approved in European Union, United States, Japan for the following indications:

🇪🇺 Approved in European Union as Imfinzi for: