A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Gastroesophageal Cancer

Phase 3RecruitingNCT07392892

Pfizer840 enrolled

Overview

This study is being done to learn more about a new medicine called PF-08634404 and how well it works when given with chemotherapy to people with gastroesophageal cancer that is locally advanced (spread to nearby tissues) or has spread to other parts of the body. To join the study, participants must meet the following conditions: Be 18 years or older. Have locally advanced or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma Be treatment naïve for advanced or metastatic disease Be in good physical condition and have healthy organs based on medical tests. The study has two parts: * In the first part, researchers will check how safe the study medicine in combination with chemotherapy is and how well people respond to it. * In the second part, they will compare study medicine plus chemotherapy to another approved treatment (nivolumab plus chemotherapy) to see which works better. The treatment will be given in repeated time periods called cycles.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

840

Conditions

Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction , or Esophageal Adenocarcinoma Metastatic Gastric Cancer

Interventions

PF-08634404BIOLOGICAL

Participants will receive PF-08634404 intravenously.

ChemotherapyDRUG

Participants will receive PF-08634404 intravenously in combination with Chemotherapy.

NivolumabBIOLOGICAL

Participants will receive Nivolumab intravenously.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histological or cytological confirmed gastric, gastroesophageal junction or esophageal adenocarcinoma. * Evidence of locally advanced or metastatic disease. * Eastern Cooperative Oncology Group performance status (ECOG) 0-1 * No prior systemic therapy for advanced or metastatic disease. * Adequate hepatic, liver, and renal function * HER-2 negative status based on local testing * PD-L1 positive status based on local testing Exclusion Criteria: * Participants with known active CNS metastases, including leptomeningeal, brainstem, meningeal, or spinal cord metastases or compression * Clinically significant risk of hemorrhage or fistula * Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study * History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. * Any Grade ≥3 bleeding/hemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events * Clinically significant cardiovascular disease, or other comorbidities, within 6 months prior to first dose * Participants with active autoimmune diseases requiring systemic treatment within the past 2 years * Evidence of non-infectious or drug-induced interstitial lung disease (ILD) pneumonitis

Locations (58)

Rocky Mountain Cancer Centers, LLP

Aurora, Colorado, United States

RECRUITING

Rocky Mountain Cancer Centers, LLP

Boulder, Colorado, United States

RECRUITING

Rocky Mountain Cancer Centers, LLP

Centennial, Colorado, United States

RECRUITING

Rocky Mountain Cancer Centers, LLP

Colorado Springs, Colorado, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Approximately 4 years

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: Approximately 21 months

Phase 2: Incidence of Anti-Drug Antibody (ADA) against PF-08634404

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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)

Time frame: Through 90 days after the last study intervention; Approximately 4 years

Phase 3: Number of participants with laboratory abnormalities

Time frame: 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

Time frame: Approximately 21 months

Phase 3: Incidence of ADA against PF-08634404

Time frame: Approximately 21 months

Phase 3: Change from baseline in Functional Assessment of Cancer Therapy - Gastric (FACT-Ga) Total score

Time frame: Approximately 4 years

Phase 3: Time to definitive deterioration in FACT-Ga Total score

Time frame: Approximately 4 years

Phase 3: Time to definitive deterioration in Gastric Cancer Subscale (GaCS) score

Time frame: Approximately 4 years

A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Gastroesophageal Cancer

Overview

Conditions

Interventions

Eligibility

Locations (58)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts