A Phase 3, Double-blind, Randomized Study of Zolbetuximab in Combination with Pembrolizumab and Chemotherapy (CAPOX or mFOLFOX6) in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in Participants Whose Tumors are HER2-negative, Claudin (CLDN) 18.2-positive and Programmed Death-ligand 1 (PD-L1)-positive

Conditions

Gastroesophageal Junction Adenocarcinoma, Gastric Cancer, Gastric Adenocarcinoma

Brief summary

Overall Survival, defined as the time from the date of randomization until the documented date of death from any cause

Detailed description

Progression-free survival, defined as the time from the date of randomization until the date of radiologic disease progression (investigator-assessed per RECIST V1.1) or death from any cause, whichever is earlier, Objective response rate, defined as the proportion of participants who have a best overall response of complete response or partial response as investigator-assessed per RECIST V1.1, Duration of response, defined as the time from the date of the first response (complete response/partial response) until the date of disease progression as investigator-assessed per RECIST V1.1 or date of death from any cause, whichever is earlier, Safety and tolerability of zolbetuximab in combination with pembrolizumab and chemotherapy as evaluated by adverse events, electrocardiogram, vital signs, Eastern Cooperative Oncology Group performance status and safety laboratory assessments (NCI-CTCAE version 5.0), Serum concentrations of zolbetuximab: end of infusion concentrations and concentration immediately prior to dosing at multiple dosing, Measurement of frequency of antidrug antibody-positive participants

Related papers

No related papers found yet.

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion.

DRUGOXALIPLATIN

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGASP8951

DRUGVyloy 100 mg powder for concentrate for solution for infusion.

DRUGSodium chloride 0.9% intravenous infusion

DRUGFOLINIC ACID

DRUGCAPECITABINE

DRUGFLUOROURACIL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall Survival, defined as the time from the date of randomization until the documented date of death from any cause	—

Secondary

Measure	Time frame
Progression-free survival, defined as the time from the date of randomization until the date of radiologic disease progression (investigator-assessed per RECIST V1.1) or death from any cause, whichever is earlier, Objective response rate, defined as the proportion of participants who have a best overall response of complete response or partial response as investigator-assessed per RECIST V1.1, Duration of response, defined as the time from the date of the first response (complete response/partial response) until the date of disease progression as investigator-assessed per RECIST V1.1 or date of death from any cause, whichever is earlier, Safety and tolerability of zolbetuximab in combination with pembrolizumab and chemotherapy as evaluated by adverse events, electrocardiogram, vital signs, Eastern Cooperative Oncology Group performance status and safety laboratory assessments (NCI-CTCAE version 5.0), Serum concentrations of zolbetuximab: end of infusion concentrations and concentration	—

Measure

Time frame

Progression-free survival, defined as the time from the date of randomization until the date of radiologic disease progression (investigator-assessed per RECIST V1.1) or death from any cause, whichever is earlier, Objective response rate, defined as the proportion of participants who have a best overall response of complete response or partial response as investigator-assessed per RECIST V1.1, Duration of response, defined as the time from the date of the first response (complete response/partial response) until the date of disease progression as investigator-assessed per RECIST V1.1 or date of death from any cause, whichever is earlier, Safety and tolerability of zolbetuximab in combination with pembrolizumab and chemotherapy as evaluated by adverse events, electrocardiogram, vital signs, Eastern Cooperative Oncology Group performance status and safety laboratory assessments (NCI-CTCAE version 5.0), Serum concentrations of zolbetuximab: end of infusion concentrations and concentration

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Countries

Belgium, Czechia, France, Germany, Italy, Lithuania, Netherlands, Poland, Portugal, Romania, Spain

Outcome results

None listed