Table 6.
Ongoing (until January 2020) esophageal cancer trials evaluating Nivolumab/Ipilimumab combination.
| End Time | Enrollment | Phase | Primary Endpoints | Treatment Arms | Clinical Trial Identifier |
|---|---|---|---|---|---|
| 2022 | 130 | 2 | 12-months PFS | Arm A: Chemoradiation (50Gy in 25 fractions over 5 weeks (i.e., 2Gy per fraction), concurrently with 3 cycles of 2 weeks of FOLFOX) + Nivolumab (IV 240 mg on days 1, 15 and 29) Arm B: Chemoradiation + Nivolumab + Ipilimumab (IV 1 mg/kg on day 1 followed by a maintenance phase) |
NCT03437200 |
| 2021 | 939 | 3 | OS and PFS | Arm A: Nivolumab + Ipilimumab Arm B: Nivolumab + Cisplatin + Fluorouacil Arm C: Cisplatin + Fluorouracil |
NCT03143153 |
| 2021 | 75 | 2 | OS (Time Frame:36 months) | Arm A: Nivolumab/Ipilimumab combination treatment B. Nivolumab monotherapy |
NCT03416244 |
| 2023 | 278 | 2/3 | Pathologic CR (Step I) (Time Frame: Up to 5 weeks) Disease-free survival (DFS) (Step 2) |
Arm A (carboplatin, paclitaxel, radiation therapy) Arm B (carboplatin, paclitaxel, radiation therapy, nivolumab) Arm C (nivolumab) Arm D (nivolumab, ipilimumab) |
NCT03604991 |
| 2022 | 97 | 2 | OS (at 12 months) | Arm A: Chemo-free immunotherapy with Nivolumab, Ipilimumab, Trastuzumab Arm B: Addition of Nivolumab to Standard therapy (chemotherapy and Trastuzumab) |
NCT03409848 |