Trial with immunotherapie for patients with locally advanced head and neck cancer
- Conditions
- MedDRA version: 21.1Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)ON-RESECTABLE LOCALLY ADVANCED HPV NEGATIVE HNSCCTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-003175-22-DE
- Lead Sponsor
- Charite Universitätsmedizin Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 66
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 38
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22
?
? •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
•History of allogeneic organ transplant
•History of another primary malignancy except for
oMalignancy treated with curative intent and with no known active disease =5 years before the first dose of IP and of low potential risk for recurrence
oAdequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
oAdequately treated carcinoma in situ without evidence of disease
•History of hypersensitivity to durvalumab or any excipient
•Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
•Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
•Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
•Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control as described in the protocol from screening to 90 days after the last dose of durvalumab monotherapy
•Distant metastasis
•Patients who are institutionalised by official order
•Mean QT interval corrected for heart rate (QTc) =470 ms calculated from 3 electrocardiograms (ECGs) using Fredericia’s Correction
•Receipt of live attenuated vaccination within
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method