Combining nivolumab with chemotherapy for rectal cancer treatment
Phase II Trial to Evaluate the Addition of Nivolumab to Neoadjuvant Chemoradiation With FOLFOX for Locally Advanced Rectal Cancer
This study is testing if adding nivolumab to standard chemotherapy can help people with locally advanced rectal cancer feel better and improve their treatment outcomes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 29 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rabin Medical Center Academic / other |
| Drugs / interventions | chemotherapy, nivolumab, immunotherapy |
| Locations | 1 site (Petach Tikva) |
| Trial ID | NCT03921684 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial evaluates the effectiveness of adding nivolumab, an anti-PD-1 antibody, to the chemotherapy regimen of mFOLFOX6 in patients with locally advanced rectal cancer. Participants will first undergo a 5-week chemoradiation treatment, followed by 12 weeks of chemo-immunotherapy, and then surgery. The study aims to assess the safety and efficacy of this combination in patients who have not received prior treatments for rectal cancer.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed, locally advanced rectal adenocarcinoma who have not received prior treatments.
Not a fit: Patients with active autoimmune diseases or those who have received prior treatments for rectal cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with locally advanced rectal cancer.
How similar studies have performed: Other studies have shown promise in using immunotherapy in combination with chemotherapy for various cancers, suggesting potential success for this approach in rectal cancer.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Petach Tikva
- Rabin Medical Center, Beilinson Hospital — Petach Tikva, Israel (Recruiting)
Study contacts
- Principal investigator: Baruch Brenner, Prof — Rabin Medical Center
- Study coordinator: Baruch Brenner, Prof
- Email: brennerb@clalit.org.il
- Phone: 972-3-9378002
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.