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PF-08634404 is an investigational compound. Its safety and efficacy have not been established.
Active enrolling
United States, Puerto Rico
for more information at clinicaltrials.gov
EXPERIMENTAL: Phase 2 Portion
PF-08634404 + Chemotherapy
BIOLOGICAL: PF-08634404
Participants will receive PF-08634404 intravenously.
DRUG: Chemotherapy
Participants will receive PF-08634404 intravenously in combination with Chemotherapy.
EXPERIMENTAL: Phase 3: Arm A
PF-08634404 + Chemotherapy
BIOLOGICAL: PF-08634404
Participants will receive PF-08634404 intravenously.
DRUG: Chemotherapy
Participants will receive PF-08634404 intravenously in combination with Chemotherapy.
ACTIVE_COMPARATOR: Phase 3: Arm B
Nivolumab + Chemotherapy
DRUG: Chemotherapy
Participants will receive PF-08634404 intravenously in combination with Chemotherapy.
BIOLOGICAL: Nivolumab
Participants will receive Nivolumab intravenously.
Phase 2: Confirmed Objective response rate (ORR) using RECIST 1.1 as assessed by investigator
Confirmed ORR by investigator is defined as the proportion of participants with confirmed Complete Response (CR) or Partial Response (PR) per RECIST v1.1 as assessed by investigator.
Approximately 4 years
Phase 2: Number of participants with treatment-emergent adverse events
Adverse Events (AEs) as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.
Through 90 days after the last study intervention; Approximately 4 years
Phase 3: Progression Free Survival (PFS) using RECIST 1.1 as assessed by BICR
PFS by BICR is defined as the time from the date of randomization to the date of first documented disease progression per RECIST 1.1 as assessed by BICR, or death due to any cause, whichever occurs first.
Approximately 4 years
Phase 3: Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause.
Approximately 4 years
Phase 2: Duration of Response (DOR) using RECIST 1.1 as assessed by investigator
DOR by investigator is defined as the time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of first documented disease progression per RECIST 1.1 as assessed by investigator, respectively, or death due to any cause, whichever occurs first.
Approximately 4 years
Phase 2: Progression Free Survival (PFS) using RECIST 1.1 as assessed by investigator
PFS by investigator is defined as the time from the date of first dose to the date of first documented disease progression per RECIST 1.1 as assessed by investigator, or death due to any cause, whichever occurs first.
Approximately 4 years
Phase 2: Overall Survival (OS)
OS is defined as the time from the date of first dose to the date of death due to any cause.
Approximately 4 years
Phase 2: Number of participants with laboratory abnormalities
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing. For laboratory tests without CTCAE grade definitions, results will be categorized as normal, high, low, or not done and be listed.
Through 90 days after the last study intervention; Approximately 4 years
Phase 2: Serum concentrations of PF-08634404
Predose and postdose concentrations of PF-08634404
Approximately 21 months
Phase 2: Incidence of Anti-Drug Antibody (ADA) against PF-08634404
Approximately 21 months
Phase 3: ORR using RECIST 1.1 as assessed by BICR
ORR by BICR is defined as the proportion of participants with a Best Overall Response (BOR) of confirmed CR or confirmed PR per RECIST 1.1 as assessed by BICR.
Approximately 4 years
Phase 3: ORR using RECIST 1.1 as assessed by investigator
ORR by investigator is defined as the proportion of participants with a BOR of confirmed CR or confirmed PR per RECIST 1.1 as assessed by investigator.
Approximately 4 years
Phase 3: Progression free survival (PFS) using RECIST 1.1 as assessed by investigator
PFS by investigator is defined as the time from the date of randomization to the date of first documented disease progression per RECIST 1.1 as assessed by investigator, or death due to any cause, whichever occurs first
Approximately 4 years
Phase 3: DOR using RECIST 1.1 as assessed by BICR
DOR is defined as the time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of first documented disease progression per RECIST 1.1 as assessed by BICR, respectively, or death due to any cause, whichever occurs first.
Approximately 4 years
Phase 3: DOR using RECIST 1.1 as assessed by investigator
DOR is defined as the time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of first documented disease progression per RECIST 1.1 as assessed by investigator, respectively, or death due to any cause, whichever occurs first.
Approximately 4 years
Phase 3: PFS2 (PFS after next-line therapy) by investigator
PFS2 is defined as the time from the date of randomization to the date of second objective disease progression or death due to any cause, whichever occurs first
Approximately 4 years
Phase 3: Number of participants with treatment-emergent adverse events
AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to study intervention(s)
Through 90 days after the last study intervention; Approximately 4 years
Phase 3: Number of participants with laboratory abnormalities
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing. For laboratory tests without CTCAE grade definitions, results will be categorized as normal, high, low, or not done and be listed.
Through 90 days after the last study intervention; Approximately 4 years
Phase 3: Serum concentrations of PF-08634404
Predose and postdose concentrations of PF-08634404
Approximately 21 months
Phase 3: Incidence of ADA against PF-08634404
Approximately 21 months
Phase 3: Change from baseline in Functional Assessment of Cancer Therapy - Gastric (FACT-Ga) Total score
Approximately 4 years
Phase 3: Time to definitive deterioration in FACT-Ga Total score
Approximately 4 years
Phase 3: Time to definitive deterioration in Gastric Cancer Subscale (GaCS) score
Approximately 4 years
840
Sponsor: Pfizer
Collaborator: None
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number:
NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
NCT07392892
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