Overview

Trial of Nivolumab With FOLFOX After Chemoradiation in Rectal Cancer Patients

Status:
Recruiting
Trial end date:
2025-10-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Baruch Brenner
Collaborator:
Bristol-Myers Squibb
Treatments:
Capecitabine
Nivolumab
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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]

- 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

- Known history of positive test for human immunodeficiency virus (HIV) or known
acquired immunodeficiency syndrome (AIDS)

- Pregnancy or breastfeeding