Clinical trial · Interventional
Andecaliximab With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5745 Combined With mFOLFOX6 as First Line Treatment in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
NCT02545504CI-TRIAL-00045239GAMMA-1completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of this study is to compare the efficacy of andecaliximab (GS-5745) versus placebo in combination with modified fluorouracil (5-FU), leucovorin (LV), and oxaliplatin (OXA) (mFOLFOX6) as measured by overall survival.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Adenocarcinoma | Gastric Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil | Drug | Fluorouracil | ALIAS |
| Andecaliximab | Drug | — | UNRESOLVED |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Andecaliximab
- description
- Andecaliximab plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by andecaliximab plus LV+5-FU during subsequent cycles
- interventionNames
- Drug: Andecaliximab
- Drug: Leucovorin
- Drug: 5-fluorouracil
- Drug: Oxaliplatin
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by placebo plus LV+5-FU during subsequent cycles
- interventionNames
- Drug: Placebo
- Drug: Leucovorin
- Drug: 5-fluorouracil
- Drug: Oxaliplatin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 Oncology Group (ECOG) ≤ 1 * Evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 Key Exclusion Criteria: * Previous chemotherapy for locally advanced or metastatic gastric cancer. * Human Epidermal Growth Factor Receptor 2 (HER2)-positive gastric cancer * HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection * Pregnant or breast feeding women * Individuals with known or suspected central nervous system metastases or individuals requiring chronic daily treatment with oral corticosteroids * Grade ≥ 2 peripheral neuropathy Note: Other protocol defined Inclusion/Exclusion criteria may apply.
References
Publications (1)
- BACKGROUNDShah MA, Bodoky G, Starodub A, Cunningham D, Yip D, Wainberg ZA, Bendell J, Thai D, He J, Bhargava P, Ajani JA. Phase III Study to Evaluate Efficacy and Safety of Andecaliximab With mFOLFOX6 as First-Line Treatment in Patients With Advanced Gastric or GEJ Adenocarcinoma (GAMMA-1). J Clin Oncol. 2021 Mar 20;39(9):990-1000. doi: 10.1200/JCO.20.02755. Epub 2021 Feb 12. PMID 33577358