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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02545504 | Andecaliximab With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma | PHASE3 | COMPLETED | 432 | — | — | Oct 13, 2015 | May 15, 2019 | May 26, 2020 | 134 | United States, Australia +14 |
| NCT02864381 | Study to Evaluate the Efficacy and Safety of Andecaliximab Combined With Nivolumab Versus Nivolumab Alone in Adults With Unresectable or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma | PHASE2 | COMPLETED | 144 | — | — | Sep 1, 2016 | Aug 23, 2019 | Sep 18, 2020 | 34 | United States, Australia +7 |
OS was defined as the time interval from the date of randomization to death from any cause.
ORR was defined as the percentage of participants with confirmed overall best response of complete response (CR) or partial response (PR) after starting study drug but before starting any new chemotherapy or radiotherapy as assessed by the investigator according to Response Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as the disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
| Arm | Type | Description |
|---|---|---|
| Andecaliximab | EXPERIMENTAL | Andecaliximab plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by andecaliximab plus LV+5-FU during subsequent cycles |
| Placebo | PLACEBO_COMPARATOR | Placebo plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by placebo plus LV+5-FU during subsequent cycles |
| Andecaliximab + Nivolumab | EXPERIMENTAL | Andecaliximab 800 mg plus nivolumab 3 mg/kg administered every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 34 weeks at the time of the primary efficacy analysis; up to 101 weeks at the time of the safety follow-up analysis). |
| Nivolumab | ACTIVE_COMPARATOR | Nivolumab 3 mg/kg administered every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 41 weeks at the time of the primary efficacy analysis; up to 97 weeks at the time of the safety follow-up analysis). |
| Name | Type | Description |
|---|---|---|
| Andecaliximab | DRUG | 800 mg administered intravenously on Days 1 and 15 of each 28-day treatment cycle |
| Placebo | DRUG | Administered intravenously on Days 1 and 15 of each treatment cycle |
| Leucovorin | DRUG | Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle |
| 5-fluorouracil | DRUG | Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle |
| Oxaliplatin | DRUG | Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle |
| Nivolumab | DRUG | 3 mg/kg administered via IV infusion |
Key Inclusion Criteria: * Adults with histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction that is inoperable, locally advanced or metastatic and not amenable to curative therapy * Adequate hematologic, liver, coagulation and kidney function * Eastern Cooperative Onco...