GASTROESOPHAGEAL JUNCTION, LOCALLY ADVANCED OR METASTATIC GASTRIC, OR ESOPHAGEAL ADENOCARCINOMA
Conditions
Brief summary
Phase 2; Confirmed objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) as assessed by investigator, Phase 2; Adverse events (AEs) as characterized by type, frequency, severity (as graded by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 5.0), timing, seriousness, and relationship to study intervention, Phase 3; PFS using RECIST 1.1 as assessed by BICR, Phase 3; OS
Detailed description
Phase 2; - Duration of response (DOR) using RECIST 1.1 as assessed by investigator - Progression-free survival (PFS) using RECIST 1.1 as assessed by investigator - Overall survival (OS), Phase 2; Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing, Phase 2; Predose and postdose concentrations of PF-08634404, Phase 2; Incidence of anti-drug antibodies (ADA) against PF-08634404, Phase 3; - ORR using RECIST 1.1 as assessed by BICR and by investigator - PFS using RECIST 1.1 as assessed by investigator - DOR using RECIST 1.1 as assessed by BICR and by investigator - PFS2 (PFS after, Phase 3; - AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to study intervention(s) - Laboratory test abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0) and timing, Phase 3; Predose and postdose concentrations of PF-08634404, Phase 3; Incidence of ADA against PF- 08634404, Phase 3; - Change from baseline in Functional Assessment of Cancer Therapy – Gastric (FACT-Ga) Total score and Gastric Cancer Subscale (GaCS) score - Time to definitive deterioration in FACT-Ga total score - Time to definitive deterioration in Gastric
Interventions
DRUGNIVOLUMAB
DRUGPF-08634404
DRUGSODIUM CHLORIDE
DRUGCAPECITABINE
DRUGFLUOROURACIL
DRUGOXALIPLATIN
DRUGCALCIUM FOLINATE
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 2; Confirmed objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) as assessed by investigator, Phase 2; Adverse events (AEs) as characterized by type, frequency, severity (as graded by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 5.0), timing, seriousness, and relationship to study intervention, Phase 3; PFS using RECIST 1.1 as assessed by BICR, Phase 3; OS | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 2; - Duration of response (DOR) using RECIST 1.1 as assessed by investigator - Progression-free survival (PFS) using RECIST 1.1 as assessed by investigator - Overall survival (OS), Phase 2; Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing, Phase 2; Predose and postdose concentrations of PF-08634404, Phase 2; Incidence of anti-drug antibodies (ADA) against PF-08634404, Phase 3; - ORR using RECIST 1.1 as assessed by BICR and by investigator - PFS using RECIST 1.1 as assessed by investigator - DOR using RECIST 1.1 as assessed by BICR and by investigator - PFS2 (PFS after, Phase 3; - AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to study intervention(s) - Laboratory test abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0) and timing, Phase 3; Predose and postdose concentrations of PF-08634404 | — |
Outcome results
None listed