A Randomized Phase III Study of Nivolumab After Combined Modality Therapy (CMT) in High Risk Anal Cancer

National Cancer Institute (NCI)1725 个研究点分布在 1 个国家目标入组 344 人2018年7月5日

适应症Anal Basaloid Carcinoma Anal Canal Cloacogenic Carcinoma Anal Margin Squamous Cell Carcinoma Stage IIB Anal Cancer AJCC v8 Stage III Anal Cancer AJCC v8

干预措施Computed Tomography High Resolution Anoscopy Magnetic Resonance Imaging Sigmoidoscopy Biospecimen Collection Patient Observation Colonoscopy Biopsy Procedure X-Ray Imaging Nivolumab Proctoscopy Digital Rectal Examination

概览

阶段: 3 期
干预措施: Computed Tomography
疾病 / 适应症: Anal Basaloid Carcinoma
发起方: National Cancer Institute (NCI)
入组人数: 344
试验地点: 1725
主要终点: Disease free survival
状态: 进行中（未招募）
最后更新: 昨天

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

This phase III trial investigates how well nivolumab after combined modality therapy works in treating patients with high risk stage II-IIIB anal cancer. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

详细描述

PRIMARY OBJECTIVE: I. To evaluate whether therapy with nivolumab following combined modality therapy (CMT) improves disease-free survival (DFS) compared with observation in patients with high risk anal carcinoma. SECONDARY OBJECTIVES: I. To compare nivolumab following combined modality therapy (CMT) with observation in patients with high risk anal carcinoma with regard to: Ia. Objective response rate (complete \[CR\] and partial \[PR\]), stable disease and progression. Ib. Severe toxicity interval. Ic. Colostomy-free survival. Id. Overall survival. Ie. Toxicity. OUTLINE: Patients who received standard CMT are randomized to 1 of 2 arms. ARM A: Patients receive nivolumab intravenously (IV) while on study. ARM B: Patients undergo observation while on study Patients undergo sigmoidoscopy, colonoscopy or anoscopy, proctoscopy or digital rectal exam, x-ray, computed tomography (CT) scan, magnetic resonance imaging (MRI), biopsy and blood sample collection throughout the study.

注册库

clinicaltrials.gov

开始日期

2018年7月5日

结束日期

2027年12月31日

最后更新

昨天

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

National Cancer Institute (NCI)

责任方

Sponsor

入排标准

入选标准

•REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Age \>= 18 years
•REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Patients must have histologically proven stage IIB (T3N0M0 only), IIIA (T2N1M0), IIIB (T4N0M0), or IIIC (T3N1M0, T4N1M0) invasive squamous cell carcinoma of the anus or anorectum, according to the American Joint Committee on Cancer (AJCC) 8th edition; this may include tumors of non-keratinizing histology such as basaloid, transitional cell, or cloacogenic histology; individuals with squamous cell carcinoma of the anal margin are eligible if there is evidence of extension of the primary tumor into the anal canal
•REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
•REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Patients must have hemoglobin levels of \> 9 g/dL (within 2 weeks prior to registration)
•REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Patient must have a platelet count of \> 100,000/mm\^3 (within 2 weeks prior to registration)
•REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Patient's absolute neutrophil count (ANC) level must be \> 1500/mm\^3 (within 2 weeks prior to registration)
•REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Serum creatinine must be =\< 1.5 X upper limit of normal (ULN) (within 2 weeks prior to registration)
•REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Total bilirubin must be \< 2 X ULN (within 2 weeks prior to registration)
•REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 2.5 X institutional upper limit of normal (within 2 weeks prior to registration)
•REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Albumin \>= 3.0 g/dL (within 2 weeks prior to registration)

排除标准

•REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: For patients registering to Arm T, patients must not have received prior chemoradiotherapy for anal cancer
•REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Patients with an allogenic bone marrow/stem, cell or solid organ transplant are excluded
•REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Women MUST NOT be pregnant or breast-feeding due to the potential teratogenic harm or abortifacient effects to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used; all patients must also not expect to conceive or father children from study registration and throughout their time on study treatment; for female patients this must continue until at least 5 months after the last dose of nivolumab and for male patients until at least 7 months after the last dose of nivolumab; all females of child bearing potential must have a serum or urine pregnancy test to rule out pregnancy within 2 weeks prior to registration; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
•REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Patients will be excluded if they have a T1 or M1, and T2N0 cancer
•REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Patients must not have had prior potentially curative surgery (abdominal, peritoneal resection) for carcinoma of the anus
•REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Participants may not be receiving any other standard anti-cancer therapy or experimental agent concurrently with the study drugs
•REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Individuals with a history of a different malignancy are ineligible except if they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin
•REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Patient must not have active autoimmune disease in the past 2 years
•NOTE: This does not include patients with autoimmune disease controlled by medication, such as hypothyroidism; this eligibility includes only patients with endocrine disease controlled by hormone replacement, e.g. hypothyroid, adrenal insufficiency, or diabetes mellitus (DM)
•REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Patients must not have known interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity

研究组 & 干预措施

Arm B (clinical observation)

Patients undergo observation while on study. Patients undergo sigmoidoscopy, colonoscopy or anoscopy, proctoscopy or digital rectal exam, x-ray, CT scan, MRI, biopsy and blood sample collection throughout the study.

干预措施: Computed Tomography

Arm A (nivolumab)

主要结局

Disease free survival

时间窗: Up to 5 years

Will be defined as the occurrence of progression of local disease, distant metastases, second primary or death from the date of randomization.

次要结局

Objective response rate(Up to 5 years)
Overall survival(Up to 5 years)
Incidence of toxicities(Up to 5 years)
Colostomy-free survival(Up to 5 years)
Severe toxicity interval(The time between randomization and the occurrence of late severe side effects (up to 5 years))