Study to Nivolumab Following Preoperative Chemoradiotherapy

Sponsor
Takayuki Yoshino
Study ID
NCT02948348
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Cancer of Rectum

Eligibility Criteria

Sex
ALL
Age
20 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    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).
  • Ipilimumab — DRUG
    For only Cohort D,1 mg/kg at six-week intervals

Study Details

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.

Key Dates

Start date
Oct 31, 2016
Status verified
Sep 2021
Primary completion
Dec 31, 2021
Completion
Aug 31, 2022

Study Design

Enrollment
90 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab & Ipilimumab(Only Cohort D)
    chemoradiotherapy with capecitabine+ Nivolumab + Ipilimumab(Only Cohort D) + surgical therapy

Primary Outcome Measure

Pathological complete response [ Time Frame: 1 year ]

Central Contacts

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