21
Participants
Start Date
January 31, 2025
Primary Completion Date
January 31, 2027
Study Completion Date
January 31, 2028
Durvalumab (MEDI4736)
Durvalumab will be administered via IV infusion at a dose of 1500 mg on day 8 Q4W until confirmed disease progression unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.
Ceralasertib
Ceralasertib dose will be administered orally, 240mg BID, approximately 12 ± 2 hours apart, days 1 to 7 q28 (Q4W), up to progression or unacceptable toxicity.
radiotherapy
Loco-regional recurrences of the primary tumor and regional lymph node metastases will be treated with a total dose of 36 to 50 Gy in daily fractions with a dose of 2 to 3 Gy per fraction. Two weeks from the last dose of radiotherapy, a systemic treatment with durvalumab and ceralasertib will be started.
ASST degli Spedali Civili di Brescia, Brescia
Azienda Ospedaliero Universitaria Careggi, Florence
IRCCS Ospedale Policlinico San Martino, Genova, Genova
ASST Grande Ospedale Metropolitano Niguarda, Milan
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan
Azienda ospedaliera di Padova, Padua
Azienda Ospedaliero - Universitaria di Parma, Parma
University Hospital of Geneva, Geneva
University Hospital Zurich, Zurich
Mario Negri Institute for Pharmacological Research
OTHER