Feasibility & Efficacy of Durvalumab+Tremelimumab+RT and Durvalumab+RT in Non-resect. Locally Advanced HPVnegativ HNSCC
Status:
Recruiting
Trial end date:
2023-08-01
Target enrollment:
Participant gender:
Summary
Phase II trial evaluating to assess the feasibility and efficacy as first-line therapy for
patients with non-resectable locally advanced HPV negative HNSCC of Durvalumab a
PDL1-Inhibitor plus Tremelimumab a CTLA-4- Inhibitor in combination with radiotherapy and
Durvalumab in combination with radiotherapy as first-line therapy.
2-arm, randomized, multicenter, phase II. Step 1 is Registration. All patients need to sign
the informed consent form for registration. Tumor tissue then be send to the central lab for
defining the HPV status. If the patient is HPV negative the site will be notified if they can
further proceed to patient randomization.
Step 2 is Randomization of all eligible patients with a centrally diagnosed, HPV negative
tumor in one of the two arms (Durvalumab plus Tremelimumab + radiotherapy; Durvalumab +
radiotherapy) after signing the informed consent form for step 2.