Trial of Nivolumab With FOLFOX After Chemoradiation in Rectal Cancer Patients

Baruch Brenner

Status and phase

Active, not recruiting

Phase 2

Conditions

Rectal Cancer

Treatments

Radiation: Radiation therapy

Drug: mFOLFOX6

Drug: Nivolumab

Drug: Capecitabine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03921684

CA209-8M4

Details and patient eligibility

About

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.

Enrollment

29 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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