Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03921684 | Trial of Nivolumab With FOLFOX After Chemoradiation in Rectal Cancer Patients | PHASE2 | ACTIVE NOT_RECRUITING | 29 | — | — | Apr 10, 2019 | Oct 1, 2029 | Jan 5, 2026 | 1 | Israel |
pCR is defined when no tumor is found on pathology review of the surgical specimen (TRG -0)
Treatment-emergent AEs will be graded according to NCI CTCAE v4.0, vital signs and clinical laboratory
We defined a novel primary endpoint, combining pathological complete response (pCR) rate among operated patients and long-term (≥12 months) clinical complete response (cCR) rate for those electing watchful waiting, into a composite endpoint of modified pCR (mpCR) rate.
| Arm | Type | Description |
|---|---|---|
| Neoadjuvant Treatment | EXPERIMENTAL | All subjects will receive chemoradiation followed by chemotherapy and nivolumab as neoadjuvant treatment |
| Name | Type | Description |
|---|---|---|
| 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 |
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 f...