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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03281369 | A Study of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer (G/GEJ) or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer) | PHASE1 | COMPLETED | 214 | — | — | Oct 13, 2017 | Oct 9, 2025 | Dec 15, 2025 | 28 | United States, Australia +5 |
| Arm | Type | Description |
|---|---|---|
| 1L-Control: mFOLFOX6 (Gastric Cancer) | ACTIVE_COMPARATOR | Participants in the 1L Gastric Cancer Control arm will receive modified FOLFOX6 (mFOLFOX6) treatment consisting of 5-fluorouracil (5-FU), leucovorin (folinic acid), and oxaliplatin. Participants who progressed on treatment may have the option of receiving Atezolizumab + Cobimetinib treatment, provided they meet the eligibility criteria. No longer enrolling participants as of June 2018. |
| 1L-A: mFOLFOX6 + Atezo + Cobi (Gastric Cancer) | EXPERIMENTAL | Participants in the 1L-A Gastric Cancer arm will receive mFOLFOX6 treatment consisting of 5-FU, leucovorin and oxaliplatin in combination with atezolizumab plus cobimetinib. No longer enrolling participants as of June 2018. |
| 1L-A2: Atezo+mFOLFOX6 followed by Atezo+Cobi (Gastric Cancer) | EXPERIMENTAL | Participants in the 1L-A2 Gastric Cancer arm will receive mFOLFOX6 treatment consisting of 5-FU, leucovorin and oxaliplatin in combination with atezolizumab during cycles 1 and 2 followed by atezolizumab plus cobimetinib during cycles 3 and beyond. No longer enrolling participants as of June 2018. |
| 2L-Control: Ramucirumab + Paclitaxel (Gastric Cancer) | ACTIVE_COMPARATOR | Participants in the 2L Gastric Cancer Control arm received ramucirumab plus paclitaxel. Participants who progressed on treatment had the option of receiving Atezolizumab + Cobimetinib treatment, provided they met the eligibility criteria. Enrollment completed as of October 2019. |
| 2L-1: Atezo + Cobi (Gastric Cancer) | EXPERIMENTAL | Participants in the 2L-1 Gastric Cancer arm received atezolizumab in combination with cobimetinib. Enrollment completed as of October 2019. |
| 2L-2: Atezo + PEGPH20 (Gastric Cancer) | EXPERIMENTAL | Participants in the 2L-2 Gastric Cancer arm received atezolizumab in combination with PEGylated recombinant human hyaluronidase (PEGPH20). Participants who progressed on treatment had the option of receiving Atezolizumab + Cobimetinib treatment, provided they met the eligibility criteria. Enrollment completed as of October 2019. |
| 2L-3: Atezo + BL-8040 (Gastric Cancer) | EXPERIMENTAL | Participants in the 2L-3 Gastric Cancer arm received atezolizumab in combination with BL-8040. Participants who progressed on treatment had the option of receiving Atezolizumab + Cobimetinib treatment, provided they met the eligibility criteria. Enrollment completed as of October 2019. |
| 2L-4: Atezo + Linagliptin (Gastric Cancer) | EXPERIMENTAL | Participants in the 2L-4 Gastric Cancer arm received atezolizumab in combination with linagliptin. Participants who progressed on treatment had the option of receiving Atezolizumab + Cobimetinib treatment, provided they met the eligibility criteria. Enrollment completed as of October 2019. |
| 1L-1:Atezo+Tiragolumab+Cisplatin+5FU(Esophageal Cancer Cohort) | EXPERIMENTAL | Participants in the 1L-1 Esophageal Cancer arm will receive atezolizumab in combination with tiragolumab and chemotherapy. |
| 1L-2: Atezo+Cisplatin+5-FU (Esophageal Cancer Cohort) | EXPERIMENTAL | Participants in the 1L-2 Esophageal Cancer arm will receive atezolizumab in combination with chemotherapy. |
| 1L-Control: Cisplatin+5-FU (Esophageal Cancer Cohort) | ACTIVE_COMPARATOR | Participants in the 1L-Control Eophageal Cancer arm will receive chemotherapy. |
| 1L-3: Atezo+Tiragolumab (Esophageal Cancer Cohort) | EXPERIMENTAL | Participants in the 1L-3 Esophageal Cancer arm will receive atezolizumab + tiragolumab treatment. Participants from the cisplatin + 5-FU esophageal cancer cohort arm may be permitted to enroll in this arm if they progress after receiving chemotherapy. |
| Name | Type | Description |
|---|---|---|
| 5-Fluorouracil (5-FU) | DRUG | 5-FU 2400 milligrams per square meter (mg/m\^2) by continuous intravenous (IV) infusion over 46 hours on Days 1 and 2 and Days 15 and 16 of every 28-day cycle. |
| Leucovorin | DRUG | Leucovorin: 100 mg/m\^2 IV over 2 hours on Days 1 and 15 of every 28-day cycle. |
| Oxaliplatin | DRUG | Oxaliplatin: 100 mg/m\^2 administered by IV infusion over 2 hours on Days 1 and 15 of every 28-day cycle. |
| Atezolizumab | DRUG | Atezolizumab: 840 mg by IV infusion on Days 1 and 15 of every 28-day cycle. |
| Cobimetinib | DRUG | Cobimetinib: 60 mg by mouth once a day on Days 1-21 of every 28-day cycle |
| Ramucirumab | BIOLOGICAL | Ramucirumab: 8 mg/kg administered by IV infusion over 60 minutes on Days 1 and 15 of every 28-day cycle. |
| Paclitaxel | DRUG | Paclitaxel: 80 mg/m\^2 administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle. |
| PEGylated recombinant human hyaluronidase (PEGPH20) | BIOLOGICAL | PEGPH20: 3 micrograms per kilogram (mcg/kg) administered by IV infusion on Days 1, 8, and 15 of every 21-day cycle. |
| BL-8040 | DRUG | BL-8040: 1.25 mg/kg administered by subcutaneous (SC) injection on Days 1-5 during the 5-day priming period prior to Cycle 1; 1.25 mg/kg administered by SC injection three times a week (Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of every 21-day cycle). |
| Linagliptin | DRUG | Linagliptin: 5 mg orally once a day of every 21-day cycle. |
| Cisplatin | DRUG | Cisplatin: 80 mg/m\^2 administered by IV infusion on Day 1 of each 21 day cycle. Treatment will be capped after 6 doses. |
| Tiragolumab | DRUG | Tiragolumab: 600 mg administered by IV infusion on Day 1 of every 21 day cycle. |
Inclusion Criteria: Gastric Cancer Cohorts Inclusion Criteria: * Age \>/= 18 years; * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; * Life expectancy \>/= 3 months, as determined by the investigator; * Histologically or cytologically confirmed locally advanced unresectabl...