Clinical Trials

Title   NRG-HN004
Principal Investigator/ Physician   Sachin Pai, MD
Protocol┬áNo.   NRG-HN004
Open Date   05/03/2018
Gender   Both
Cancer Site   Head and Neck
Status   Open
Sponsor   NRG
Contact Email   Clinical Trials

Protocol: Randomized Phase II/III Trial of Radiotherapy With Concurrent MEDI4736 (Durvalumab) vs. Radiotherapy With Concurrent Cetuximab in Patients With Stage III-IVB Head and Neck Cancer With a Contraindication to Cisplatin

Inclusion Criteria:  Pathologically confirmed, previously untrested, unresected squamous cell carcinoma of the larynx, hypopharynx, oropharynx, oral cavity, or carcinoma of unknown head/neck primary within 60 days prior to step 1 registration, stage III-IVB head and neck squamous cell carcinoma (HNSCC), Patients must have a contraindication to cisplatin as defined in the following bullet points; sites must complete the online tool at prior to step 1 registration to determine if the patient is eligible; the scores must be recorded on a case report form (CRF), Age < 70 with severe comorbidity or vulnerability to cisplatin, For patients with oropharyngeal or unknown primaries: p16 determination by immunohistochemistry (defined as greater than 70% strong nuclear or nuclear and cytoplasmic staining of tumor cells), confirmed by central pathology review, Note: for patients with oral cavity, laryngeal, and hypopharyngeal primaries, analysis of p16 status prior to step 2 registration/randomization is not required (p16 status will be analyzed centrally post-hoc); step 2 registration for these patients can be completed after step 1 registration

Exclusion Criteria:  prior invasive malignancy withint the past 3 years, prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields, prior immunotherapy, prior systemic therapy including cytoxic chemotherapy, biologic/targeted therapy or immune therapy for the study cancer, distant metastases, Zubrod performance status >= 3, Patients with oral cavity cancer are excluded from participation if the patient is medically operable and resection of the primary tumor is considered technically feasible by an oral or head and neck cancers surgical subspecialist;(please consult the surgical oncology co-principal investigator [PI], Steven Chang, Doctor of Medicine [MD], if clarification is needed on an individual case), Unstable angina and/or congestive heart failure requiring hospitalization within 3 months prior to step 1 registration, Transmural myocardial infarction within 3 months prior to step 1 registration, Respiratory illness requiring hospitalization at the time of step 1 registration, Note: if the respiratory illness is resolved and the patient meets the eligibility status above, then the patient can be considered for the trial, Idiopathic pulmonary fibrosis or other severe interstitial lung disease that requires oxygen therapy or is thought to require oxygen therapy within 1 year prior to step 1 registration, Clinically apparent jaundice and/or known coagulation defects, Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., 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.]), History of active primary immunodeficiency including, but not limited to acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; Note: human immunodeficiency virus (HIV) testing is not required for entry into this protocol; the need to exclude patients with AIDS from this protocol is necessary because the treatment involved in this protocol may be immunosuppressive; patients with known HIV, CD4 counts >= 200/uL, and undetectable viral loads who are stable on an antiretroviral regimen may be included, Current or prior use of immunosuppressive medication within 14 days before step 1 registration, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid, Receipt of live attenuated vaccination within 30 days prior to step 1 registration, Medical or psychiatric illness which would compromise the patient's ability to tolerate treatment or limit compliance with study requirements, Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception during treatment and for 6 months after the last dose of cetuximab or MEDI14736 (durvalumab); this exclusion is necessary because the treatment involved in this study may be significantly teratogenic; women who are breastfeeding are also excluded, Prior allergic reaction or hypersensitivity to cetuximab or MEDI4736 (durvalumab) or any of study drug excipients, History of (non-infectious) pneumonitis that required steroids or current pneumonitis, History of allogenic organ transplantation, Uncontrolled hypertension, Uncontrolled cardiac arrhythmia, Uncontrolled serious chronic gastrointestinal condition associated with diarrhea, Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis [TB] testing in line with local practice), hepatitis B (known positive hepatitis B virus [HBV] surface antigen [HBsAg] result), hepatitis C; 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 (hepatitis C virus [HCV]) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA)

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