A Randomized, Phase Ⅲ Study of Rilvegostomig in Combination with Fluoropyrimidine and Trastuzumab Deruxtecan versus Trastuzumab, Chemotherapy, and Pembrolizumab for the First line Treatment of HER2-positive Gastric Cancer (ARTEMIDE-Gastric01).

Conditions

HER2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.

Brief summary

Progression-free Survival (PFS) per RECIST v1.1, Overall Survival (OS)

Detailed description

PFS based on RECIST v1.1., Objective Response Rate (ORR) according to RECIST v1.1., Duration of Response (DoR) according to RECIST v1.1., Time to second progression or death., Progression-free Survival (PFS) at 6 and 12 months (PFS6 and PFS12)., Overall Survival (OS) at 12 and 24 months (OS12 andOS24)., Occurrence of AEs, SAEs, AESIs., Changes from baseline in laboratory parameters, vitalsigns, electrocardiogram data, and results ofechocardiogram/multiple gated acquisition., Serum concentration of rilvegostomig, T-DXd, total anti-HER2 antibody, T-DXd, plasma concentration of 5-FU andcapecitabine., Presence of anti-drug antibodies for rilvegostomig and T-DXd., Time to increase in enteral feeding assistance and/or eating difficulties., The proportion of time on study intervention with highside-effect bother., The proportion of participants with stable or improvedphysical function while on treatment.

Related papers

No related papers found yet.

Interventions

DRUGCAPECITABINE

DRUGDS-8201a

DRUGINFLIXIMAB

DRUGCISPLATIN

DRUGMYCOPHENOLATE MOFETIL

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGFLUOROURACIL

DRUGRilvegostomig

DRUGOXALIPLATIN

DRUGTRASTUZUMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
PFS based on RECIST v1.1., Objective Response Rate (ORR) according to RECIST v1.1., Duration of Response (DoR) according to RECIST v1.1., Time to second progression or death., Progression-free Survival (PFS) at 6 and 12 months (PFS6 and PFS12)., Overall Survival (OS) at 12 and 24 months (OS12 andOS24)., Occurrence of AEs, SAEs, AESIs., Changes from baseline in laboratory parameters, vitalsigns, electrocardiogram data, and results ofechocardiogram/multiple gated acquisition., Serum concentration of rilvegostomig, T-DXd, total anti-HER2 antibody, T-DXd, plasma concentration of 5-FU andcapecitabine., Presence of anti-drug antibodies for rilvegostomig and T-DXd., Time to increase in enteral feeding assistance and/or eating difficulties., The proportion of time on study intervention with highside-effect bother., The proportion of participants with stable or improvedphysical function while on treatment.	—

Measure

Time frame

PFS based on RECIST v1.1., Objective Response Rate (ORR) according to RECIST v1.1., Duration of Response (DoR) according to RECIST v1.1., Time to second progression or death., Progression-free Survival (PFS) at 6 and 12 months (PFS6 and PFS12)., Overall Survival (OS) at 12 and 24 months (OS12 andOS24)., Occurrence of AEs, SAEs, AESIs., Changes from baseline in laboratory parameters, vitalsigns, electrocardiogram data, and results ofechocardiogram/multiple gated acquisition., Serum concentration of rilvegostomig, T-DXd, total anti-HER2 antibody, T-DXd, plasma concentration of 5-FU andcapecitabine., Presence of anti-drug antibodies for rilvegostomig and T-DXd., Time to increase in enteral feeding assistance and/or eating difficulties., The proportion of time on study intervention with highside-effect bother., The proportion of participants with stable or improvedphysical function while on treatment.

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Primary

Measure	Time frame
Progression-free Survival (PFS) per RECIST v1.1, Overall Survival (OS)	—

Countries

Austria, Belgium, France, Germany, Hungary, Italy, Netherlands, Poland, Spain

Outcome results

None listed