SBRT + Immunotherapy for Head and Neck Squamous Cell Carcinoma

Recruiting at2 trial locations

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.

Research Team

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.

Inclusion Criteria

ECOG/WHO performance status score of ≤ 1

Adequate normal organ and marrow function

Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients

Exclusion Criteria

You have a severe, ongoing health issue that is not being managed or controlled.

You have cancer that has spread to your brain or spinal cord.

You have received a live vaccine within 30 days before the first dose of the study medication.

Treatment Details

Interventions

• Durvalumab (Checkpoint Inhibitor)
• SBRT (Radiation)
• Tremelimumab (Checkpoint Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Durvalumab + tremelimumab and SBRT Experimental Treatment 3 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 Japan for the following indications:

Approved in Japan as Imfinzi for:

• Not specified in provided sources

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Dr. Réjean Lapointe

Centre hospitalier de l'Université de Montréal (CHUM)

Chief Medical Officer since 2023

MD from Université de Montréal

Dr. Fabrice Brunet

Centre hospitalier de l'Université de Montréal (CHUM)

Chief Executive Officer since 2015

MD from Université de Montréal

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology