Trial of Nivolumab With FOLFOX After Chemoradiation in Rectal Cancer Patients

Sponsor
Baruch Brenner
Study ID
NCT03921684
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Capecitabine — DRUG
    Capecitabine 825 mg/m2 orally twice-daily, 5 days a week for a total of 28 days, given with radiation therapy
  • Radiation therapy — RADIATION
    1.8 Gy/day, 5 days a week for a total of 28 days, given with Capecitabine
  • mFOLFOX6 — DRUG
    oxaliplatin 85 mg/m2, leucovorin 400 mg/m2 and fluorouracil 400 mg/m2 IV, fluorouracil 2400 mg/m2 IV (a 46 hrs CI), day 1 of each treatment cycle, every 2 weeks, given with nivolumab
  • Nivolumab — DRUG
    Nivolumab 240mg IV, day 1 of each treatment cycle, every two weeks, given with mFOLFOX6

Study Details

This is a phase II, prospective, open label, one-center study for evaluation of the addition of nivolumab to the chemotherapy phase of the neoadjuvant treatment for locally advanced rectal cancer patients. Subjects must have received no prior treatment for rectal cancer (chemotherapy, radiotherapy or surgery) and no prior treatment with checkpoint inhibitors. Eligible subjects will receive chemoradiation for a period of 5 weeks, 6 cycles of chemo-immunotherapy (mFOLFOX6 + nivolumab) for a period of 12 weeks, once every 2 weeks, and will undergo surgery after 4 weeks. Patients with cCR will be offered the alternative strategy of WW. Post-study systemic treatment, up to 4 cycles of mFOLFOX6, will be left to the discretion of the treating physician. This will be started 4-8 weeks post-operatively, or immediately after the demonstration of cCR in patients determined to undergo WW.

Key Dates

Start date
Apr 10, 2019
Status verified
Dec 2025
Primary completion
Oct 28, 2024
Completion
Oct 31, 2029

Study Design

Enrollment
29 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant Treatment
    All subjects will receive chemoradiation followed by chemotherapy and nivolumab as neoadjuvant treatment

Primary Outcome Measure

pathological complete response (pCR) rate [ Time Frame: Time from start of neoadjuvant treatment until surgical resection, assessed up to 24 months ]

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