Randomized Phase II study of Cisplatin plus Radiotherapy versus Durvalumab plus Radiotherapy followed by Adjuvant Durvalumab versus Durvalumab plus Radiotherapy followed by Adjuvant Tremelimumab and Durvalumab in Intermediate Risk HPV-Positive Locoregionally Advanced Oropharyngeal Squamous Cell Cancer (LA-OSCC)

European Organisation for Research and Treatment of Cancer (EORTC)0 个研究点目标入组 180 人开始时间: 2019年9月2日最近更新: 2021年8月10日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 180

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•- Histologically and/or cytologically confirmed (primary lesion or regional lymph nodes) squamous cell carcinoma of the oropharynx (OSCC) which is locoregionally advanced, intermediate risk and non-metastatic (M0) as defined by the following (UICC/AJCC 8th Edition staging):
•T1-2 N1 (smoking = 10 pack years);
•T3 N0-N1 (smoking = 10 pack years);
•T1-3 N2 (any smoking hx).
•- Human papillomavirus (HPV)-related as determined by positive p16 immunohistochemical staining on any tumour specimens. Positive p16 expression is defined as strong and diffuse nuclear and cytoplasmic staining in 70% or more of the tumour cells. Local testing is acceptable; testing will not be done centrally in real-time.
•- Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (see Appendix I) and a body weight of > 30 kg.
•- Must be = 18 years of age.
•- The following radiological investigations must be done within 8 weeks of randomization:
•CT or MRI of the neck (with PET-CT and head imaging as indicated);
•CT chest or x-ray, other radiology tests as clinically indicated.
•- Women/men of childbearing potential must have agreed to use a highly effective contraceptive method.
•- Women of childbearing potential will have a pregnancy test to determine eligibility as part of the Pre-Study Evaluation.
•- Patient must consent to provision of, and investigator(s) must confirm adequacy, of non-cytology tissue samples and confirm access to and agree to submit within 4 weeks of randomization to the CCTG Central Tumour Bank, a representative formalin fixed paraffin block of non-cytology tumour tissue.
•- Patient must consent to provision of samples of blood, saliva and oropharyngeal swab.
•- Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life and health economics questionnaires in the languages provided.
•- Patients must be accessible for treatment and follow-up.
•- In accordance with CCTG policy, protocol treatment (cisplatin/RT or durvalumab) is to begin within 1 week of randomization.
•- The patient is not receiving anti-cancer therapy in a concurrent clinical study and the patient agrees not to participate in other clinical studies during their participation in this trial while on study treatment.
•- Adequate normal organ and marrow function as defined in the protocol (must be done within 14 days prior to randomization).
•- Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.
•- Patients must be assessed by a radiation oncologist and medical oncologist and deemed suitable for study participation.
•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 32
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 18

排除标准

•- Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for = 5 years.
•- Current history of other non-OSCC malignancies of the head and neck.
•- Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab, or an anti-CTLA4, including tremelimumab.
•- Any previous cisplatin or carboplatin chemotherapy.
•- Any previous induction chemotherapy for current SCCHN.
•- Any previous surgical treatment of the current cancer (except for a diagnostic biopsy) and no major surgery within 28 days prior to randomization.
•- Any previous radiation to the head and neck region that would result in overlap of fields for the current study.
•- Peripheral neuropathy = grade 2 (CTCAE v5.0).
•- Hearing loss/tinnitus = grade 3 (CTCAE v5.0).
•- History of allergic or hypersensitivity reactions to any study drug or their excipients.
•- Mean QT interval corrected for heart rate using Fridericia’s formula (QTcF) = 470 msec in screening ECG measured using standard institutional method or history of familial long QT syndrome.
•- History of primary immunodeficiency, history of allogenic organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of randomization* or a prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy or grade = 3 infusion reaction.
•- Current or prior use of immunosuppressive medication within 28 days of study entry, with the exceptions of intranasal and inhaled corticosteroids or systemic chronic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. Corticosteroids used on study for anti-emetic purpose are allowed. Corticosteroids as premedication for hypersensitivity reactions (e.g. computed tomography [CT] scan premedication) are allowed.
•- 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, celiac disease (controlled by diet alone) or other serious gastrointestinal chronic conditions associated with diarrhea), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis), rheumatoid arthritis, hypophysitis, uveitis, etc., within the past 3 years prior to the start of treatment. There are exceptions in the protocol.
•- Patients with active or uncontrolled intercurrent illness including, but not limited to:
•cardiac dysfunction (symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia);
•active peptic ulcer disease or gastritis;
•active bleeding diatheses;
•psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent;
•known history of previous clinical diagnosis of tuberculosis;
•known human immunodeficiency virus infection (positive HIV 1/2 antibodies);
•known active hepatitis B infection (positive HBV surface antigen (HBsAg).
•known active hepatitis C infection.
•- History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline CT scan.
•- Receipt of live attenuated vaccination (examples include

研究者

发起方

European Organisation for Research and Treatment of Cancer (EORTC)

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