Nivolumab After Combined Modality Therapy in Treating Patients With High Risk Stage II-IIIB Anal Cancer
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|ClinicalTrials.gov Identifier: NCT03233711|
Recruitment Status : Recruiting
First Posted : July 31, 2017
Last Update Posted : November 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anal Basaloid Carcinoma Anal Canal Cloacogenic Carcinoma Anal Margin Squamous Cell Carcinoma Stage IIB Anal Cancer AJCC v8 Stage IIIA Anal Cancer AJCC v8 Stage IIIB Anal Cancer AJCC v8 Stage IIIC Anal Cancer AJCC v8||Biological: Nivolumab Other: Patient Observation||Phase 2|
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.
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) over 30 minutes on day 1. Treatment repeats every 4 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
ARM B: Patients undergo observation for up to 6 months.
After completion of study treatment, patients are followed up at 6 weeks, every 3 months for 2 years, and then every 6 months for 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase II Study of Nivolumab After Combined Modality Therapy (CMT) in High Risk Anal Cancer|
|Actual Study Start Date :||April 13, 2018|
|Estimated Primary Completion Date :||December 30, 2019|
|Estimated Study Completion Date :||December 30, 2019|
Experimental: Arm A (nivolumab)
Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 4 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Arm B (clinical observation)
Patients undergo observation for up to 6 months.
Other: Patient Observation
- Disease free survival [ Time Frame: 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.
- Objective response rate [ Time Frame: Up to 5 years ]Will be defined by complete and partial response.
- Severe toxicity interval [ Time Frame: The time between randomization and the occurrence of late severe side effects (up to 5 years) ]The following late side effects are considered as severe: any anal/rectal damage (ulcer, fistula, or perforation), rectal stenosis that required colostomy, skin ulceration, and severe fibrosis. This parameter estimates the probability of being free of late side effects for patients under loco-regional control.
- Colostomy-free survival [ Time Frame: Up to 5 years ]
- Overall survival [ Time Frame: Up to 5 years ]
- Incidence of toxicities [ Time Frame: Up to 5 years ]Will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03233711
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|Principal Investigator:||Lakshmi Rajdev||ECOG-ACRIN Cancer Research Group|