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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02213289 | PANGEA-IMBBP: Personalized Antibodies for Gastro-Esophageal Adenocarcinoma - A 1st Pilot Metastatic Trial of Biologics Beyond Progression | PHASE2 | COMPLETED | 80 | — | — | Jan 20, 2015 | Aug 20, 2020 | Apr 8, 2021 | 1 | United States |
Time from enrollment to death from any cause.
| Arm | Type | Description |
|---|---|---|
| ITT-PTS: Personalized Treatment Strategy (Immuno-oncology) | EXPERIMENTAL | For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows: Immuno-oncology included PD-L1 IHC combined positivity score \>10, high microsatellite instability, tumor mutation burden \>15 mutations per megabase, and/or Epstein-Barr virus positive. These patients received standard cytotherapy plus Nivolumab. |
| ITT-PTS: Personalized Treatment Strategy (HER2 amplified) | EXPERIMENTAL | HER2 amplified. These patients received standard cytotherapy plus Trastuzumab. |
| ITT-PTS: Personalized Treatment Strategy (EFGR amplified) | EXPERIMENTAL | EGFR amplified. These patients received ABT-806. |
| ITT-PTS: Personalized Treatment Strategy (FGFR2 amplified) | EXPERIMENTAL | FGFR2 amplified. These patients received standard cytotherapy plus Bemarituzumab. |
| ITT-PTS: Personalized Treatment Strategy (MAPK/PIK3CA aberrant) | EXPERIMENTAL | MAPK/PIK3CA aberrant. These patients received standard cytotherapy plus Ramucirumab. |
| ITT-PTS: Personalized Treatment Strategy (EGFR expressing) | EXPERIMENTAL | EGFR expressing. These patients received standard cytotherapy plus ABT 806. |
| ITT-PTS: Personalized Treatment Strategy (All negative) | EXPERIMENTAL | All negative. These patients received standard cytotherapy plus Ramucirumab. |
| Non-ITT: Standard Therapy | OTHER | Patients without monoclonal antibodies available received standard cytotherapy. |
| Name | Type | Description |
|---|---|---|
| Trastuzumab | DRUG | Trastuzumab |
| ABT-806 | DRUG | ABT-806 |
| Bemarituzumab | DRUG | Bemarituzumab |
| Ramucirumab | DRUG | Ramucirumab |
| Nivolumab | DRUG | Nivolumab |
| Standard cytotherapy | DRUG | FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line) |
Inclusion Criteria: 1. Histologically confirmed metastatic gastric or esophagogastric junction (type I,II,III Siewert) adenocarcinoma 2. Newly-diagnosed chemo-naïve or recurrent after curative-intent surgery * \>6 months after completion of adjuvant therapy (including chemotherapy and/or radiot...