Durvalumab With or Without Tremelimumab in Resectable Locally Advanced Squamous Cell Carcinoma of the Oral Cavity

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

August 27, 2018

Primary Completion Date

March 24, 2025

Study Completion Date

March 24, 2026

Conditions
Oral Cavity Squamous Cell Carcinoma
Interventions
DRUG

Durvalumab

"All patients will be treated with postoperative radiotherapy (66 Gy in standard fractionation).~In case of positive section margins or extracapsular extension, 3 cycles of cisplatin 100 mg/msq on days 1, 22, and 43 will be added to standard fractionation radiotherapy (66 Gy).~Durvalumab monotherapy (1500 mg) will be administered via IV infusion day -14 and at the start of radiation therapy, with repeat administration every 4 weeks at fixed dose for a total of 6 cycles postoperative."

COMBINATION_PRODUCT

Durvalumab + Tremelimumab

"All patients will be treated with postoperative radiotherapy (66 Gy in standard fractionation).~In case of positive section margins or extracapsular extension, 3 cycles of cisplatin 100 mg/msq on days 1, 22, and 43 will be added to standard fractionation radiotherapy (66 Gy).~Durvalumab + Tremelimumab combination therapy: Tremelimumab (75 mg) will be administered via IV infusion day -14 and at the start of radiation therapy, with repeat administration every 4 weeks at fixed dose for a total of 3 cycles postoperative, Durvalumab (1500 mg) will be administered via IV infusion day -14 and at the start of radiation therapy, with repeat administration every 4 weeks at fixed dose for a total of 6 cycles postoperative."

Trial Locations (1)

3000

UZ Leuven, Leuven

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

collaborator

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

collaborator

Vlaams Instituut voor Biotechnologie (VIB)

UNKNOWN

lead

Universitaire Ziekenhuizen KU Leuven

OTHER

NCT03784066 - Durvalumab With or Without Tremelimumab in Resectable Locally Advanced Squamous Cell Carcinoma of the Oral Cavity | Biotech Hunter | Biotech Hunter