Two-arm randomized phase II trial to assess the feasibility and efficacy of a treatment with Durvalumab a PDL1-Inhibitor plus Tremelimumab a CTLA-4- Inhibitor in combination with radiotherapy and a treatment with Durvalumab in combination with radiotherapy as first-line therapy for patients with non-resectable locally advanced HPV negative HNSCC- A COMPARISON WITH A HISTORICAL CONTROL GROUP--DuTRe-raD - DURTRE-RAD

Charite Universitätsmedizin Berlin0 sites66 target enrollmentNovember 13, 2017

Overview

No summary available.

Registry

who.int

Start Date

November 13, 2017

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Charite Universitätsmedizin Berlin

•Patients with locally advanced histopathologically confirmed HNSCC not candidate for primary surgical treatment
•? No distant metastasis (M0\)
•? Patients that are planned for radiotherapy
•? Tumor tissue available for central testing Patients with HPV/p16 negative disease (\=70% positively stained cells) as determined by central testing
•? Adequate normal organ and marrow function
•? Measurable tumor according to RECIST
•? Patients must be expected to complete the treatment.
•? Age \> 18 years at time of study entry
•? Female patients must either be of non\-reproductive potential or must have a negative serum pregnancy test upon study entry and be willing to use adequate contraceptive measurements as described in the protocol
•? Non\-sterilized males who are sexually active with a female partner of childbearing potential must be willing to use adequate contraceptive measurements as described in the protocol

•? •Participation in another clinical study with an investigational product during the last 3 months
•Prior or current anticancer treatment to the head and neck area (e.g. radical attempted or tumor reductive surgery, neo\-adjuvant chemotherapy, EGFR inhibitors or radiotherapy).
•Any previous treatment with a PD1 or PD\-L1 inhibitor, including durvalumab or an anti\-CTLA4, including tremelimumab
•Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis or Crohn's disease], diverticulitis \[with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
•oPatients with vitiligo or alopecia
•oPatients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement
•oAny chronic skin condition that does not require systemic therapy
•oPatients without active disease in the last 5 years may be included but only after consultation with the study physician
•oPatients with celiac disease controlled by diet alone
•History of primary immunodeficiency