An Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Gastric or Gastroesophageal Junction Carcinoma
TerminatedPhase 1, PHASE2Results postedLast updated 15 April 2026
What this trial tests
Phase 1, PHASE2 trial testing Atezolizumab in Gastric and Gastroesophageal Junction Carcinoma in 40 participants. Terminated before completion.
18 and older, any sex, with Gastric and Gastroesophageal Junction Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective Response Rate (ORR)Primary· Up to 42.1 months
ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) on two consecutive occasions, ≥ 4 weeks apart during Stage 1, as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target or non-target lesions. Any pathological lymph nodes (whether target or non-target lesions) must have a reduction in short axis to \< 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. Participants w
Group
Value
95% CI
Atezo + CAPOX
55.6
30.76 – 78.47
Atezo + CAPOX + Tira
40.9
20.71 – 63.65
Progression-free Survival (PFS) After RandomizationSecondary· From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to 42.1 months)
PFS after randomization was defined as the time from randomization to the first occurrence of PD or death from any cause (whichever occurred first) in Stage 1, as determined by the investigator according to RECIST v1.1. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline) or unequivocal progression of existing non-target lesions. Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm. PFS was censored at the day of the last tumor assessment for participants who did not die or di
Group
Value
95% CI
Atezo + CAPOX
9.51
6.97 – 13.08
Atezo + CAPOX + Tira
6.65
4.93 – 9.20
Overall Survival (OS) After RandomizationSecondary· From randomization to death from any cause (up to 42.1 months)
OS was defined as the time from randomization to death from any cause, regardless of stage. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. Median OS was estimated using the K-M method.
Group
Value
95% CI
Atezo + CAPOX
20.85
11.04 – 26.28
Atezo + CAPOX + Tira
12.67
6.60 – 15.67
OS Rates at Specified TimepointsSecondary· At Months 6 and 12
OS was defined as the time from randomization to death from any cause, regardless of stage. OS rate at 6 and 12 months was defined as the percentage of participants who did not experience death from any cause at these timepoints from randomization. OS rates at the specified timepoints were estimated using the K-M method. Percentages have been rounded off.
Month 6
Group
Value
95% CI
Atezo + CAPOX
93.75
81.89 – 100.00
Atezo + CAPOX + Tira
86.36
72.02 – 100.00
Month 12
Group
Value
95% CI
Atezo + CAPOX
68.75
46.04 – 91.46
Atezo + CAPOX + Tira
50.00
29.11 – 70.89
Duration of Response (DOR)Secondary· From first occurrence of CR or PR to PD or death from any cause, whichever occurred first (up to 42.1 months)
DOR was defined as time from the first occurrence of a documented objective response (OR), CR or PR to PD or death from any cause (whichever occurred first) in Stage 1, as determined by the investigator according to RECIST v1.1. CR was defined as disappearance of all target or non-target lesions. Any pathological lymph nodes (whether target/non-target lesions) must have a reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD
Group
Value
95% CI
Atezo + CAPOX
10.38
5.62 – 20.37
Atezo + CAPOX + Tira
8.08
4.14 – 21.98
Disease Control Rate (DCR)Secondary· Up to 42.1 months
DCR was defined as percentage of participants with stable disease (SD) for ≥ 12 weeks or a CR or PR, as determined by the investigator according to RECIST v1.1. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. CR was defined as the disappearance of all target or non-target lesions. Any pathological lymph nodes (whether target or non-target lesions) must have a reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
Group
Value
95% CI
Atezo + CAPOX
77.8
52.36 – 93.59
Atezo + CAPOX + Tira
72.7
49.78 – 89.27
Number of Participants With Adverse Events (AEs)Secondary· Up to 42.1 months
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Group
Value
95% CI
Atezo + CAPOX
18
Atezo + CAPOX + Tira
22
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 42.1 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with advanced gastric carcinoma (GC) or gastroesophageal junction carcinoma (GEJC). The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, and modify the participant population. Cohort 1 will enroll participants with inoperable locally advanced, metastatic, or advanced GC or GEJC, with adenocarcinoma confirmed as the predominant histology, who have not received prior systemic therapy for advanced or metastatic disease. Eligible participants will initially be randomly assigned to one of treatment arms (Stage 1). Participants who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to receive treatment with a different treatment combination (Stage 2). When a Stage 2 treatment combination is available, this will be introduced by amending the protocol.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07388524 — Testing the Impact of an Anti-Cancer Drug, Atezolizumab, After Surgery to Prevent Early Stage Non-small Cell Lung Cancer
· Phase 3
· not yet recruiting
NCT07322341 — SX-682 and Atezolizumab for the Treatment of Advanced or Metastatic, Recurrent Non-small Cell Lung Cancer
· Phase 2
· not yet recruiting
NCT07339059 — Phase II Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Ce
· Phase 2
· recruiting
NCT07461675 — Effects of Neoadjuvant Immunotherapy on Anti-tumour Immunity in Hepatocellular Carcinoma Patients Undergoing Liver Resec
· Phase 3
· not yet recruiting
NCT07291076 — A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants Wit
· Phase 1, PHASE2
· recruiting
Other Hoffmann-La Roche trials
Trials by the same sponsor.
NCT07503340 — A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous O
· Phase 2
· not yet recruiting
NCT07298421 — A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in
· Phase 3
· recruiting
NCT07059273 — A COPD Data Registry for Participants With Frequent Exacerbations
· not yet recruiting
NCT07416526 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A
· Phase 3
· recruiting
NCT05199688 — A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric
· Phase 3
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 15 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05251948.