NCT03921684Active, not recruitingPhase 2

Trial of Nivolumab With FOLFOX After Chemoradiation in Rectal Cancer Patients

Phase II Trial to Evaluate the Addition of Nivolumab to Neoadjuvant Chemoradiation With FOLFOX for Locally Advanced Rectal Cancer

Source: ClinicalTrials.gov · Last updated 5 Jan 2026

Brief summary (registry, in English)

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.

Status (registry): Active, not recruiting
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 29 (actual)
First submitted: 14 Apr 2019
Start date: 10 Apr 2019
Primary completion date: 28 Oct 2024
Lead sponsor: Baruch Brenner
Diseases: Colorectal cancer
NCT number: NCT03921684

What you commit to

Study type: Interventional · Phase 2
Participants enrolled: 29
From 10 Apr 2019 to the primary completion date, 28 Oct 2024
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Other illness

Active autoimmune disease. \[Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll\]
Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)

Other

Pregnancy or breastfeeding

Who the study is looking for

Signed written IRB approved informed consent
Age ≥ 18 years
ECOG PS 0-1
Subjects with histologically confirmed primary (non-recurrent) locally advanced rectal adenocarcinoma
Stage T3-4 N0 or TX N+ according to baseline rectal EUS and PET-CT
Patients who are planned for neoadjuvant chemoradiation and are surgical candidates
No prior chemotherapy, radiotherapy or surgery for rectal cancer
No prior radiotherapy to the pelvis, for any reason
Presence of adequate contraception in fertile patients
Women of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug
Women must not be breastfeeding
Ability to swallow tablets
No previous (within the last 5 years) or concurrent malignancies, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix or basal cell carcinoma of the skin

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Rabin Medical Center- Beilinson Hospital Coordinator of this site? Confirm its status	Petah Tikva	Israel	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.