Study Summary
This trial is designed to study the safety and effectiveness of immunotherapy-based treatment combinations in patients with gastric or esophageal cancer.
Eligible Conditions
- Esophageal Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 13 Secondary · Reporting Duration: From randomization up to death from any cause (up to approximately 3-6 years)
Day 15
Plasma Concentration of Linagliptin
Day 28
For Arm 1L-A : Percentage of Participants with Serious and Non-serious Treatment-related AEs
Year 6
Percentage of Participants With Objective Response, as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)
Year 6
Percentage of Participants with Adverse Events (AEs)
Year 6
Percentage of Participants With Disease Control, as Determined by the Investigator per RECIST v1.1
Year 6
Overall Survival (OS)
Year 6
Progression-Free Survival (PFS), as Determined by Investigator According to RECIST v1.1
Year 6
Duration of Response, as Determined by Investigator According to RECIST v1.1
Month 6, Month 12
Percentage of Participants Who Are Alive at Month 6 and at Month 12
Year 6
Percentage of Participants With ADA to BL-8040
Plasma Concentration of BL-8040
Year 6
Serum Concentration of Atezolizumab
Year 6
Plasma Concentration of PEGPH20
Year 6
Percentage of Participants With ADA to PEGPH20
Year 6
Percentage of Participants With Anti-Drug Antibody (ADA) to Atezolizumab
Day 28
Plasma Concentration of Cobimetinib
Trial Safety
Safety Progress
Trial Design
12 Treatment Groups
1L-Control: mFOLFOX6 (Gastric Cancer)
1 of 12
2L-Control: Ramucirumab + Paclitaxel (Gastric Cancer)
1 of 12
1L-Control: Cisplatin+5-FU (Esophageal Cancer Cohort)
1 of 12
1L-3: Atezo+Tiragolumab (Esophageal Cancer Cohort)
1 of 12
1L-A2: Atezo+mFOLFOX6 followed by Atezo+Cobi (Gastric Cancer)
1 of 12
2L-4: Atezo + Linagliptin (Gastric Cancer)
1 of 12
2L-3: Atezo + BL-8040 (Gastric Cancer)
1 of 12
1L-1:Atezo+Tiragolumab+Cisplatin+5FU(Esophageal Cancer Cohort)
1 of 12
1L-2: Atezo+Cisplatin+5-FU (Esophageal Cancer Cohort)
1 of 12
2L-2: Atezo + PEGPH20 (Gastric Cancer)
1 of 12
1L-A: mFOLFOX6 + Atezo + Cobi (Gastric Cancer)
1 of 12
2L-1: Atezo + Cobi (Gastric Cancer)
1 of 12
Active Control
Experimental Treatment
410 Total Participants · 12 Treatment Groups
Primary Treatment: Atezolizumab · No Placebo Group · Phase 1 & 2
1L-3: Atezo+Tiragolumab (Esophageal Cancer Cohort)Experimental Group · 2 Interventions: Atezolizumab, Tiragolumab · Intervention Types: Drug, Drug
1L-A2: Atezo+mFOLFOX6 followed by Atezo+Cobi (Gastric Cancer)Experimental Group · 5 Interventions: Oxaliplatin, 5-Fluorouracil (5-FU), Atezolizumab, Cobimetinib, Leucovorin · Intervention Types: Drug, Drug, Drug, Drug, Drug
2L-4: Atezo + Linagliptin (Gastric Cancer)Experimental Group · 2 Interventions: Atezolizumab, Linagliptin · Intervention Types: Drug, Drug
2L-3: Atezo + BL-8040 (Gastric Cancer)Experimental Group · 2 Interventions: BL-8040, Atezolizumab · Intervention Types: Drug, Drug
1L-1:Atezo+Tiragolumab+Cisplatin+5FU(Esophageal Cancer Cohort)Experimental Group · 4 Interventions: 5-Fluorouracil (5-FU), Cisplatin, Atezolizumab, Tiragolumab · Intervention Types: Drug, Drug, Drug, Drug
1L-2: Atezo+Cisplatin+5-FU (Esophageal Cancer Cohort)Experimental Group · 3 Interventions: 5-Fluorouracil (5-FU), Cisplatin, Atezolizumab · Intervention Types: Drug, Drug, Drug
2L-2: Atezo + PEGPH20 (Gastric Cancer)Experimental Group · 2 Interventions: PEGylated recombinant human hyaluronidase (PEGPH20), Atezolizumab · Intervention Types: Biological, Drug
1L-A: mFOLFOX6 + Atezo + Cobi (Gastric Cancer)Experimental Group · 5 Interventions: Oxaliplatin, 5-Fluorouracil (5-FU), Atezolizumab, Cobimetinib, Leucovorin · Intervention Types: Drug, Drug, Drug, Drug, Drug
2L-1: Atezo + Cobi (Gastric Cancer)Experimental Group · 2 Interventions: Atezolizumab, Cobimetinib · Intervention Types: Drug, Drug
1L-Control: mFOLFOX6 (Gastric Cancer)ActiveComparator Group · 3 Interventions: Oxaliplatin, 5-Fluorouracil (5-FU), Leucovorin · Intervention Types: Drug, Drug, Drug
2L-Control: Ramucirumab + Paclitaxel (Gastric Cancer)ActiveComparator Group · 2 Interventions: Ramucirumab, Paclitaxel · Intervention Types: Biological, Drug
1L-Control: Cisplatin+5-FU (Esophageal Cancer Cohort)ActiveComparator Group · 2 Interventions: 5-Fluorouracil (5-FU), Cisplatin · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxaliplatin
FDA approved
Motixafortide
Not yet FDA approved
Fluorouracil
FDA approved
Cisplatin
FDA approved
Atezolizumab
FDA approved
Cobimetinib
FDA approved
Leucovorin
FDA approved
Linagliptin
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from randomization up to death from any cause (up to approximately 3-6 years)
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,362 Previous Clinical Trials
1,067,736 Total Patients Enrolled
Halozyme TherapeuticsIndustry Sponsor
45 Previous Clinical Trials
2,934 Total Patients Enrolled
BioLineRx, Ltd.Industry Sponsor
21 Previous Clinical Trials
1,666 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,149 Previous Clinical Trials
875,826 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- For women not of childbearing potential: agreement to remain abstinent ( refrained from heterosexual intercourse) or use contraceptive measures as outlined for each specific treatment arm.
For women: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures.
This study is for people with locally advanced unresectable or metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not had any previous systemic therapy for their disease
The patient must have normal blood counts and kidney and liver function test results in order to participate in the study.
at least one measurable lesion on CT or MRI scan
"At least one measurable lesion" means that there is a detectable change in the size of a lesion on imaging.
life expectancy of greater than 3 months
The individual has a relatively good performance status (0 or 1 on the ECOG scale) and a life expectancy of more than 3 months.
The patient's life expectancy is greater than or equal to three months, as determined by the investigator.
The availability of a representative tumor specimen that is suitable for determination of PD-L1 and TIGIT levels by IHC and/or additional biomarker status by means of retrospective central testing.
The person is at least 18 years old.
patients with early-stage (I/II) disease; and no prior systemic therapy
The 1L Gastric Cancer Cohort should include patients who have human epidermal growth factor receptor 2 (HER2)-negative tumors, early-stage (I/II) disease, and have not received prior systemic therapy.
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Conditions
Cancer Related
Treatments