ZANGEA – Phase II Study of Zanidatamab in Combination with Pembrolizumab and Chemotherapy in HER2 and PD-L1 Positive Metastatic Gastroesophageal Adenocarcinoma (GEA) Patients

Conditions

Gastroesophageal Adenocarcinoma

Brief summary

Progression-free survival rate at 12 months (PFS@12), estimated using Kaplan Meier method and defined as proportion of patients alive and progression-free 12 months after start of trial medication

Detailed description

Overall response rate (ORR), defined as proportion of patients achieving complete or partial response (CR/PR) acc. to RECIST v1.1., Disease control rate (DCR), defined as proportion of patients achieving CR, PR, or stable disease (SD) acc. to RECIST v1.1., Duration of response (DoR), defined as time from response initiation (when either CR or PR is first determined) to disease progression acc. to RECIST v1.1 or death due to any cause., Progression-free survival (PFS), defined as time from first treatment until date of progression acc. to RECIST v1.1 or death due to any cause., Overall survival (OS), defined as time from first treatment until date of death due to any cause., Assessment of safety of the treatment as determined by the incidence, nature, causality, frequency, timing, and severity of adverse events using NCI CTCAE v5.0, Assessment of QoL during treatment and follow-up using EORTC QLQ- C30 and EQ-5D-5L questionnaires.

Related papers

No related papers found yet.

Interventions

DRUGOXALIPLATIN

DRUGFOLIC ACID

DRUGPEMBROLIZUMAB

DRUGJZP598

DRUGFLUOROURACIL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free survival rate at 12 months (PFS@12), estimated using Kaplan Meier method and defined as proportion of patients alive and progression-free 12 months after start of trial medication	—

Secondary

Measure	Time frame
Overall response rate (ORR), defined as proportion of patients achieving complete or partial response (CR/PR) acc. to RECIST v1.1., Disease control rate (DCR), defined as proportion of patients achieving CR, PR, or stable disease (SD) acc. to RECIST v1.1., Duration of response (DoR), defined as time from response initiation (when either CR or PR is first determined) to disease progression acc. to RECIST v1.1 or death due to any cause., Progression-free survival (PFS), defined as time from first treatment until date of progression acc. to RECIST v1.1 or death due to any cause., Overall survival (OS), defined as time from first treatment until date of death due to any cause., Assessment of safety of the treatment as determined by the incidence, nature, causality, frequency, timing, and severity of adverse events using NCI CTCAE v5.0, Assessment of QoL during treatment and follow-up using EORTC QLQ- C30 and EQ-5D-5L questionnaires.	—

Measure

Time frame

Overall response rate (ORR), defined as proportion of patients achieving complete or partial response (CR/PR) acc. to RECIST v1.1., Disease control rate (DCR), defined as proportion of patients achieving CR, PR, or stable disease (SD) acc. to RECIST v1.1., Duration of response (DoR), defined as time from response initiation (when either CR or PR is first determined) to disease progression acc. to RECIST v1.1 or death due to any cause., Progression-free survival (PFS), defined as time from first treatment until date of progression acc. to RECIST v1.1 or death due to any cause., Overall survival (OS), defined as time from first treatment until date of death due to any cause., Assessment of safety of the treatment as determined by the incidence, nature, causality, frequency, timing, and severity of adverse events using NCI CTCAE v5.0, Assessment of QoL during treatment and follow-up using EORTC QLQ- C30 and EQ-5D-5L questionnaires.

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Countries

Germany

Outcome results

None listed