SBRT + Immunotherapy for Head and Neck Squamous Cell Carcinoma

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?Immunotherapy targeting the PD-1/PD-L1 pathway had previously been shown to be efficacious in the treatment of patients with metastatic head and neck squamous cell carcinomas. Stereotactic Body Radiotherapy (SBRT) to metastatic lesions causes localized cancer cell killing and the release of cancer cell debris, which could stimulate the immune system in the presence of immunotherapy. The purpose of this study is to assess the tolerability and efficacy of combining Durvalumab (MEDI4736), Tremelimumab and SBRT in controlling cancer progression. SBRT will be administered to patients while they are receiving Durvalumab and Tremelimumab.

Eligibility Criteria

This trial is for adults with metastatic head and neck squamous cell carcinoma who have a good performance status, functioning organs, and marrow. They must not be pregnant or breastfeeding and agree to use birth control. Those with up to four prior systemic therapies are eligible but cannot have brain metastases, uncontrolled illnesses, or recent major surgeries.

Treatment Details

The study tests the combination of Durvalumab (MEDI4736) and Tremelimumab immunotherapies with SBRT (a precise radiation therapy). It aims to see if this combo can better control cancer progression in patients by using the body's immune system alongside targeted radiation.

1Treatment groups

Experimental Treatment

Group I: Durvalumab + tremelimumab and SBRTExperimental Treatment3 Interventions

All subjects will receive durvalumab (1500 mg IV q4week) and tremelimumab (75mg q4week) for 4 doses, followed by durvalumab alone (1500 mg IV q4week) until disease progression, unacceptable toxicity or patient withdrawal. SBRT will be administered between cycle 2 and 3 of durvalumab and tremelimumab. All SBRT will be completed within a 3-week period.

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

🇪🇺 Approved in European Union as Imfinzi for: