Cisplatin + Radiotherapy vs Durvalumab + Radiotherapy Followed by Durvalumab vs Durvalumab + Radiotherapy Followed by Tremelimumab + Durvalumab in Intermediate-Risk HPV-Positive Oropharyngeal SCC
NCT03410615 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 129
Last updated 2026-03-24
Summary
Sometimes, cancer patients receive an initial treatment, followed by additional treatment to lower the chance of cancer coming back. The standard or usual treatment for this type of disease is initially having radiation therapy at the same time as chemotherapy (with a drug called cisplatin), with no additional therapy afterwards
Conditions
- Oropharyngeal Squamous Cell Carcinoma
Interventions
- RADIATION
-
Radiation
70 Gy in 35 fractions over 7 weeks (i.e. 2 Gy per fraction)
- DRUG
-
100 mg/m2 days 1, 22, 43 concurrently with RT
- DRUG
-
Given in concurrent and adjuvant phase
- DRUG
-
Tremelimumab
ARM CLOSED TO ACCRUAL - 2019
Sponsors & Collaborators
- collaborator INDUSTRY
-
Canadian Cancer Trials Group
lead NETWORK
Principal Investigators
-
Anna Spreafico · UNH/Princess Margaret Cancer Centre, Toronto ON Canada
-
Khalil Sultanem · The Jewish General Hospital, Montreal QC, Canada
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-28
- Primary Completion
- 2026-01-09
- Completion
- 2026-07-31
Countries
- Belgium
- Canada
- Italy
- Spain
Study Locations
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