Study to Nivolumab Following Preoperative Chemoradiotherapy
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|ClinicalTrials.gov Identifier: NCT02948348|
Recruitment Status : Unknown
Verified February 2017 by Takayuki Yoshino, National Cancer Center Hospital East.
Recruitment status was: Recruiting
First Posted : October 28, 2016
Last Update Posted : February 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cancer of Rectum||Drug: Nivolumab||Phase 1 Phase 2|
After preoperative CRT, to sequentially administer nivolumab in combination for patients with locally advanced resectable rectal cancer. To evaluate the safety of nivolumab in sequential combination therapy, the onset of dose-limiting toxicity (DLT) and the safety of subsequent surgical therapy, and to decide on a recommended dose (RD) for the phase II part.
To evaluate the efficacy and safety when nivolumab is sequentially administered in combination at the RD determined in the phase Ib part, following preoperative CRT in patients with locally advanced resectable rectal cancer and to identify biomarkers related to the therapeutic response. To also evaluate the safety of surgical therapy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b/2 Multicenter Study to Investigate the Safety, Efficacy and Proof of Concept (POC) of Nivolumab Monotherapy as a Sequential Therapy Following Preoperative Chemoradiotherapy Patients With Locally Advanced Resectable Rectal Cancer|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||June 2020|
chemoradiotherapy with capecitabine+ Nivolumab + surgical therapy
Capecitabine:Dose of 1650mg/m2,14days, Radiation:45Gy/25 fractions, Nivolumab :240mg on day1 of each cycle, Surgical therapy:The resection (LAR), intersphincteric resection (ISR), or abdominoperineal resection (APR).
- Pathological complete response [ Time Frame: 1 year ]Pathological complete response will be evaluated with American Joint Committee on Cancer (AJCC) Cancer Staging
- Objective response rate [ Time Frame: 1 year ]
- Mode of recurrence [ Time Frame: 1 year ]Evaluation Criteria In Solid Tumors (RECIST)
- Disease-free survival (DFS) [ Time Frame: 5years ]
- Overall survival (OS) [ Time Frame: 5years ]
- Incidence of adverse events (AEs) [ Time Frame: 1 year ]
- Rate of completing the protocol therapy [ Time Frame: 1 year ]
- Rate of radical resection [ Time Frame: 1 year ]
- Safety evaluation [ Time Frame: 5years ]Safety will be evaluated with CTCAE v4.0
- macroscopic evaluation of (rectal cancer) resected specimen [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02948348
|Contact: Hideaki Bando, Dr||+81-4-7133-1111 ext firstname.lastname@example.org|
|Contact: Yuichiro Tsukada, Dr||+81-4-7133-1111 ext email@example.com|
|National Cancer Center Hospital East||Recruiting|
|Kashiwa, Chiba, Japan|
|Study Chair:||Takayuki Yoshino, Dr||Gastrointestinal Oncology Division National Cancer Center Hospital East|