Clinical trial NCT03618134: Stereotactic Body Radiation Therapy and Durvalumab With or Without Tremelimumab Before Surgery in Treating Participants With Human Papillomavirus Positive Oropharyngeal Squamous Cell Caner
Official title: Phase Ib/II Trial of Stereotactic Body Radiotherapy (SBRT) in Cominbation With Immunotherapy Prior to Transoral Robotic Surgery (TORS) for Human Papillomavirus Positive (HPV+) Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Conditions: Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC (American Joint Committee on Cancer) v8
Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Human Papillomavirus Positive
Oropharyngeal Squamous Cell Carcinoma
p16 Positive Neoplastic Cells Present
Pathologic Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Summary: This phase Ib/II trial studies the side effects and how well stereotactic body radiation therapy and durvalumab with or without tremelimumab before surgery work in treating participants with human papillomavirus positive oropharyngeal squamous cell cancer. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow and spread. Giving stereotactic body radiation therapy and durvalumab with or without tremelimumab before surgery may work better in treating participants with oropharyngeal squamous cell cancer.
Interventions:
description: Given IV
name: Durvalumab
other_name: Imfinzi
Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer
MEDI-4736
MEDI4736
type: Biological
description: Undergo modified radical neck dissection
name: Modified Radical Neck Dissection
type: Procedure
description: Ancillary studies
name: Quality-of-Life Assessment
other_name: Quality of Life Assessment
type: Other
description: Ancillary studies
name: Questionnaire Administration
type: Other
description: Undergo SBRT
name: Stereotactic Body Radiation Therapy
other_name: SABR
SBRT
Stereotactic Ablative Body Radiation Therapy
type: Radiation
description: Undergo TORS
name: Transoral Robotic Surgery
other_name: TORS
type: Procedure
description: Given IV
name: Tremelimumab
other_name: Anti-CTLA4 Human Monoclonal Antibody CP-675,206
CP-675
CP-675,206
CP-675206
Ticilimumab
type: Biological
Study arms:
design_group_description: Beginning day 0 of course 1, participants undergo stereotactic body radiation therapy 5 days a week for 1 week and receive durvalumab IV over 1 hour on days 0 and 27 in the absence of disease progression or unacceptable toxicity. Participants then undergo transoral robotic surgery and modified radical neck dissection between weeks 6-8. Beginning week 12, participants then receive durvalumab IV over 1 hour every 4 weeks. Treatment repeats every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
design_group_title: Cohort I (SBRT, durvalumab, TORS, neck dissection)
design_group_type: Experimental
design_group_description: Beginning day 0 of course 1, participants undergo stereotactic body radiation therapy 5 days a week for 1 week and receive tremelimumab IV and durvalumab IV over 1 hour on days 0 and 27 in the absence of disease progression or unacceptable toxicity. Participants then undergo transoral robotic surgery and modified radical neck dissection between weeks 6-8. Beginning week 12, participants then receive durvalumab IV over 1 hour every 4 weeks. Treatment repeats every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
design_group_title: Cohort II (SBRT, durvalumab,tremelimumab,TORS,neck dissection)
design_group_type: Experimental
Sponsor: Jonsson Comprehensive Cancer Center
Collaborators: AstraZeneca PLC
Drug name mappings:
name: 曲麦利尤单抗
lang: CN
name: Tremelimumab
lang: EN
name: トレメリムマブ（遺伝子組換え）
lang: JP
name: 度伐利尤单抗
lang: CN
name: Durvalumab
lang: EN
name: デュルバルマブ（遺伝子組換え）
lang: JP