Cisplatin + Radiotherapy vs Durvalumab + Radiotherapy Followed by Durvalumab vs Durvalumab + Radiotherapy Followed by Tremelimumab + Durvalumab in Intermediate-Risk HPV-Positive Oropharyngeal SCC

Sponsor
Canadian Cancer Trials Group
Study ID
NCT03410615
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Oropharyngeal Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Radiation — RADIATION
    70 Gy in 35 fractions over 7 weeks (i.e. 2 Gy per fraction)
  • Cisplatin — DRUG
    100 mg/m2 days 1, 22, 43 concurrently with RT
  • Durvalumab — DRUG
    Given in concurrent and adjuvant phase
  • Tremelimumab — DRUG
    ARM CLOSED TO ACCRUAL - 2019

Study Details

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

Key Dates

Start date
May 28, 2018
Status verified
Mar 2026
Primary completion
Jan 9, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
129 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Radiation/Cisplatin
    All patients will receive standard fractionation radiation therapy (RT) scheme: 70 Gy in 35 fractions over 7 weeks (i.e. 2 Gy per fraction) Cisplatin IV 100 mg/m2 days 1, 22, 43 concurrently with RT
  • Experimental: Radiation/Durvalumab + Adjuvant Durvalumab
    All patients will receive standard fractionation radiation therapy (RT) scheme: 70 Gy in 35 fractions over 7 weeks (i.e. 2 Gy per fraction) Concurrent Phase: Durvalumab IV 1500 mg, days -7 and 22 (the second dose is given concurrently with RT). Adjuvant Phase (to start 4 weeks after completion of concurrent phase): Durvalumab IV 1500 mg q4 weekly for 6 doses.
  • Experimental: Radiation/Durvalumab + Adjuvant Durvalumab/Tremelimumab
    ARM CLOSED TO ACCRUAL WITH AMENDMENT #1

Primary Outcome Measure

3 year event-free survival [ Time Frame: 3 years ]

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