Table 2.
Selected ongoing trials in metastatic esophageal cancer.
| Clinical Trial Identifier | Setting | Line | Phase | Site and Histology | Treatment Arm(s) | Primary Endpoint |
Recruiting | Target Accrual |
|---|---|---|---|---|---|---|---|---|
|
NCT03143153 CheckMate-648 |
Metastatic | 1 | III | ESCC | Nivo + Ipi vs. Nivo + CT (5FU+CDDP) vs. CT | OS, PFS in PD-L1 ≥ 1% |
Active, not recruiting | 939 |
|
NCT03189719 KEYNOTE-590 |
Metastatic | 1 | III | EAC, ESCC, adenocarcinoma of GEJ (Siewert type 1) | Pembro + CT (5FU+CDDP) vs. placebo + CT | OS, PFS in ITT and in PD-L1 (CPS ≥10%) |
Active, not recruiting | 700 |
|
NCT03783442 BGB-A317-306 |
Metastatic | 1 | III | ESCC | Tisle + CT (Platinum+5FU/PTX/cape) vs. placebo + CT | PFS, OS | Recruiting | 480 |
|
NCT03469557 BGB-A317-205 |
Metastatic | 1 | II | ESCC and GC/GEJ carcinoma | ESCC: Tisle+ CT (CDDP+5FU) GC/GEJ carcinoma: Tisle + CT (LOHP+cape) | ORR, DoR, DCR, PFS, pharmacokinetic valuations, host immunogenicity | Active, not recruiting | 30 |
|
NCT03430843 BGB-A317-302 |
Metastatic | 2 | III | ESCC | Tisle vs. CT (PTX/TXT/CPT-11) | OS | Recruiting | 450 |
|
NCT03416244 RAMONA trial |
Metastatic elderly (>65 years) | 2 | II | ESCC | Nivo + Ipi vs. Nivo | OS | Recruiting | 75 |
|
NCT03811379 PD-1/SCCE |
Metastatic | ≥2 | II | SCEC | Toripalimab | ORR | Recruiting | 43 |
|
NCT03544736 INEC-study |
Cohort A: advanced |
Cohort A: palliative | I/II | EC/GEJ carcinoma | Cohort A: Nivo + palliative RT | Safety | Recruiting | 54 |
|
NCT02735239 LUD2015-005 |
Cohorts A and B: metastatic | Cohorts A and B: 1 | I/II | Esophageal and GEJ carcinoma | Cohorts A and B: Durva +/- Treme → Durva +/- Treme + FOLFOX | DLT, safety | Recruiting | 75 |
Abbreviations: cape: capecitabine; cCRR: clinical complete response rate; CDDP: cisplatin; CPS: combined positive score; CPT-11: irinotecan; CT: chemotherapy; d: day; DCR: disease control rate; DLT: dose-limiting toxicity; DoR: duration of response; Durva: durvalumab; EAC: esophageal adenocarcinoma; EC: esophageal cancer; ESCC: esophageal squamous cell cancer; GC: gastric cancer; GEJ: esophagogastric junction; Ipi: ipilimumab; ITT: intention-to-treat; LOHP: oxaliplatin; NCT: number of clinical trial (https://clinicaltrials.gov/); Nivo: nivolumab; ORR: objective response rate; OS: overall survival; Pembro: pembrolizumab; PFS: progression free survival; PTX: paclitaxel; RFS: relapse free survival rates; SCeE: small cell esophageal cancer; TXT: docetaxel; Treme: tremelimumab; 5FU: 5-fluorouracil.