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Nivolumab After Combined Modality Therapy in Treating Patients With High Risk Stage II-IIIB Anal Cancer | Clinical Trials | Clareo Health

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Nivolumab After Combined Modality Therapy in Treating Patients With High Risk Stage II-IIIB Anal Cancer

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

NCT03233711•National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Age \>= 18 years
•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)
•REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Patients known to be human immunodeficiency virus (HIV)+ are permitted; patients with CD4 \> 200 and serum HIV viral load of \< 200 copies/mm\^3 are eligible, and in addition:
+49 more criteria

Exclusion Criteria

•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

Locations (899)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Anchorage Associates in Radiation Medicine