Phase I/II trial of Durvalumab plus Tremelimumab and stereotactic body radiotherapy for metastatic head and neck carcinoma

Autor: Louise Lambert, Felix-Phuc Nguyen-Tan, Eric Bissada, Houda Bahig, Denis Soulières, Mustapha Tehfe, Philip Wong, Apostolos Christopoulos, Rahima Jamal, Tareck Ayad, Olguta Gologan, Francine Aubin, Olivier Ballivy, Danielle Charpentier, John Stagg, Louis Guertin, Edith Filion
Jazyk: angličtina
Rok vydání: 2019
Předmět:
0301 basic medicine
Oncology
Cancer Research
medicine.medical_specialty
Durvalumab
medicine.medical_treatment
Antibodies
Monoclonal
Humanized
Radiosurgery
lcsh:RC254-282
03 medical and health sciences
Study Protocol
0302 clinical medicine
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
Genetics
medicine
Clinical endpoint
Biomarkers
Tumor
Humans
Progression-free survival
Neoplasm Metastasis
Head and neck cancer
Neoplasm Staging
SBRT
business.industry
Antibodies
Monoclonal
Common Terminology Criteria for Adverse Events
Immunotherapy
medicine.disease
lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Head and neck squamous-cell carcinoma
Combined Modality Therapy
Clinical trial
030104 developmental biology
Treatment Outcome
Head and Neck Neoplasms
030220 oncology & carcinogenesis
Metastatic
business
Tremelimumab
medicine.drug
Zdroj: BMC Cancer, Vol 19, Iss 1, Pp 1-15 (2019)
BMC Cancer
ISSN: 1471-2407
DOI: 10.1186/s12885-019-5266-4
Popis: The efficacy of immunotherapy targeting the PD-1/PD-L1 pathway has previously been demonstrated in metastatic head and neck squamous cell carcinoma (HNSCC). Stereotactic Body Radiotherapy (SBRT) aims at ablating metastatic lesions and may play a synergistic role with immunotherapy. The purpose of this study is to assess the safety and efficacy of triple treatment combination (TTC) consisting of the administration of durvalumab and tremelimumab in combination with SBRT in metastatic HNSCC. This is a phase I/II single arm study that will include 35 patients with 2–10 extracranial metastatic lesions. Patients will receive durvalumab (1500 mg IV every 4 weeks (Q4W)) and tremelimumab (75 mg IV Q4W for a total of 4 doses) until progression, unacceptable toxicity or patient withdrawal. SBRT to 2–5 metastases will be administered between cycles 2 and 3 of immunotherapy. The safety of the treatment combination will be evaluated through assessment of TTC-related toxicities, defined as grade 3–5 toxicities based on Common Terminology Criteria for Adverse Events (v 4.03), occurring within 6 weeks from SBRT start, and that are definitely, probably or possibly related to the combination of all treatments. We hypothesize that dual targeting of PD-L1 and CTLA-4 pathways combined with SBRT will lead to
Databáze: OpenAIRE
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