Study to Nivolumab Following Preoperative Chemoradiotherapy
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
1 other identifier
interventional
90
1 country
3
Brief Summary
This is a phase Ib/II, open-label, single-arm, multicenter study to investigate the safety, efficacy, and proof of concept (POC) of monotherapy with nivolumab, an anti-PD-1 antibody drug, as a sequential therapy following chemoradiotherapy (CRT) with capecitabine and subsequent surgical therapy in patients with locally advanced resectable rectal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2016
Longer than P75 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedFirst Posted
Study publicly available on registry
October 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedSeptember 16, 2021
September 1, 2021
5.2 years
September 8, 2016
September 7, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Pathological complete response
Pathological complete response will be evaluated with American Joint Committee on Cancer (AJCC) Cancer Staging
1 year
Secondary Outcomes (9)
Objective response rate
1 year
Recurrence pattern (local or distant)
1 year
Disease-free survival (DFS)
5years
Overall survival (OS)
5years
Incidence of adverse events (AEs)
1 year
- +4 more secondary outcomes
Study Arms (1)
Nivolumab & Ipilimumab(Only Cohort D)
EXPERIMENTALchemoradiotherapy with capecitabine+ Nivolumab + Ipilimumab(Only Cohort D) + surgical therapy
Interventions
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).
For only Cohort D,1 mg/kg at six-week intervals
Eligibility Criteria
You may qualify if:
- (A. Phase Ib and Cohorts A and D only)
- A1. Rectal cancer patients who have not undergone treatment for pre-CRT tumors situated 12 cm or less from the lower edge of the AV.
- A2. The primary rectal lesion is histopathologically diagnosed as adenocarcinoma.
- A3. Pre-CRT clinical stage is clinical T3-4 N-any M0.
- A4. Macroscopic radical resection is deemed possible on pre-CRT image diagnosis.
- A5. Aged between 20 and 80 years at the time of enrollment.
- (B. Cohort B only)
- B1. Clinically diagnosed with local recurrence after rectal surgery.
- B2. The main site of recurrence is limited to the pelvis by pre-CRT imaging diagnosis.
- B3. Macroscopic radical resection is deemed possible on pre-CRT imaging diagnosis.
- B4. Aged between 20 and 75 years at the time of enrollment.
- (C. Cohort C only)
- C1. Rectal cancer patients who have not undergone pretreatment for a pre-CRT tumor which is 12 cm or less from the lower AV.
- C2. The primary rectal lesion is histopathologically diagnosed as adenocarcinoma.
- C3. The pre-CRT clinical stage is clinical T3-4 N-any M1a (liver) M1a (lungs).
- +11 more criteria
You may not qualify if:
- Patients diagnosed with active double cancer (synchronous double cancer and double cancer with disease-free period within five years from enrollment).
- However, lesions equivalent to intraepithelial or mucosal carcinoma deemed cured by localized treatment are not classified as active double cancer.
- Patients with a history of pelvic irradiation prior to this rectal cancer treatment.
- Patients who have not given consent through the informed consent form.
- Patients deemed by the investigator to be ineligible for the trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takayuki Yoshinolead
- Ono Pharmaceutical Co. Ltdcollaborator
Study Sites (3)
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Hokkaido University
Sapporo, Hokkaido, Japan
Osaka National Hospital
Osaka, Japan
Related Publications (1)
Tsukada Y, Bando H, Inamori K, Wakabayashi M, Togashi Y, Koyama S, Kotani D, Yuki S, Komatsu Y, Homma S, Taketomi A, Uemura M, Kato T, Fukui M, Nakamura N, Kojima M, Kawachi H, Kirsch R, Yoshida T, Sato A, Nishikawa H, Ito M, Yoshino T. Three-year outcomes of preoperative chemoradiotherapy plus nivolumab in microsatellite stable and microsatellite instability-high locally advanced rectal cancer. Br J Cancer. 2024 Jul;131(2):283-289. doi: 10.1038/s41416-024-02730-7. Epub 2024 Jun 4.
PMID: 38834744DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Takayuki Yoshino, Dr
Gastrointestinal Oncology Division National Cancer Center Hospital East
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of Gastrointestinal Oncology Division
Study Record Dates
First Submitted
September 8, 2016
First Posted
October 28, 2016
Study Start
October 1, 2016
Primary Completion
December 1, 2021
Study Completion
August 1, 2022
Last Updated
September 16, 2021
Record last verified: 2021-09