NCT03283605

Immunotherapy and SBRT for Metastatic Head and Neck Carcinomas

Phase I/II of Durvalumab (MEDI4736) + Tremelimumab + Stereotactic Body Radiotherapy for Metastatic Head and Neck Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Head and Neck Squamous Cell Carcinoma
• Metastatic Squamous Cell Carcinoma

Interventions

Type	Name	Description
RADIATION	SBRT	SBRT to 2-5 oligometastases will be administered between Cycle 2 and 3 of durvalumab and tremelimumab. All SBRT will be completed within a 3-week period.
DRUG	Durvalumab	Durvalumab (1500 mg IV q4weeks) for 4 cycles in combination with tremelimumab. Then, durvalumab alone until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or other discontinuation criteria met.
DRUG	Tremelimumab	Tremelimumab (75mg IV q4weeks) for 4 cycles in combination with Durvalumab.

Timeline

• Start date: 2018-07-17
• Primary completion: 2024-07-31
• Completion: 2024-12-31
• First posted: 2017-09-14
• Last updated: 2024-06-28

Locations

3 sites across 1 country: Canada