SBRT + Immunotherapy for Head and Neck Squamous Cell Carcinoma

Recruiting at 2 trial locations

Overseen By Diane Trudel, RN

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

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

Must not be taking: Immunosuppressants, Live vaccines

Disqualifiers: Nasopharyngeal carcinoma, Autoimmune disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

45 Participants Needed

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Durvalumab and Tremelimumab every 4 weeks for 4 doses, with SBRT administered between cycle 2 and 3, completed within a 3-week period

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Long-term follow-up

Participants are monitored for overall survival and progression-free survival

2 years

Treatment Details

Interventions

• Durvalumab
• SBRT
• Tremelimumab

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 European Union, United States, Japan for the following indications:

Approved in European Union as Imfinzi for:

• Locally advanced, unresectable non-small cell lung cancer (NSCLC)

Approved in United States as Imfinzi for:

• Extensive-stage small cell lung cancer (ES-SCLC)
• Limited-stage small cell lung cancer (LS-SCLC)
• Locally advanced or metastatic urothelial carcinoma

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+

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