Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 4:05 AM
Study NCT ID:
NCT07392892
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-06
First Post:
2026-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Gastroesophageal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'C562730', 'term': 'Adenocarcinoma Of Esophagus'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D000077594', 'term': 'Nivolumab'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Phase 2 is open-label, whereas Phase 3 is double-blind, randomized design'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 840}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2032-07-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-30', 'studyFirstSubmitDate': '2026-01-30', 'studyFirstSubmitQcDate': '2026-01-30', 'lastUpdatePostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-07-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 2: Confirmed Objective response rate (ORR) using RECIST 1.1 as assessed by investigator', 'timeFrame': 'Approximately 4 years', 'description': '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.'}, {'measure': 'Phase 2: Number of participants with treatment-emergent adverse events', 'timeFrame': 'Through 90 days after the last study intervention; Approximately 4 years', 'description': 'Adverse Events (AEs) as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.'}, {'measure': 'Phase 3: Progression Free Survival (PFS) using RECIST 1.1 as assessed by BICR', 'timeFrame': 'Approximately 4 years', 'description': '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.'}, {'measure': 'Phase 3: Overall Survival (OS)', 'timeFrame': 'Approximately 4 years', 'description': 'OS is defined as the time from the date of randomization to the date of death due to any cause.'}], 'secondaryOutcomes': [{'measure': 'Phase 2: Duration of Response (DOR) using RECIST 1.1 as assessed by investigator', 'timeFrame': 'Approximately 4 years', 'description': '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.'}, {'measure': 'Phase 2: Progression Free Survival (PFS) using RECIST 1.1 as assessed by investigator', 'timeFrame': 'Approximately 4 years', 'description': '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.'}, {'measure': 'Phase 2: Overall Survival (OS)', 'timeFrame': 'Approximately 4 years', 'description': 'OS is defined as the time from the date of first dose to the date of death due to any cause.'}, {'measure': 'Phase 2: Number of participants with laboratory abnormalities', 'timeFrame': 'Through 90 days after the last study intervention; Approximately 4 years', 'description': '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.'}, {'measure': 'Phase 2: Serum concentrations of PF-08634404', 'timeFrame': 'Approximately 21 months', 'description': 'Predose and postdose concentrations of PF-08634404'}, {'measure': 'Phase 2: Incidence of Anti-Drug Antibody (ADA) against PF-08634404', 'timeFrame': 'Approximately 21 months'}, {'measure': 'Phase 3: ORR using RECIST 1.1 as assessed by BICR', 'timeFrame': 'Approximately 4 years', 'description': '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.'}, {'measure': 'Phase 3: ORR using RECIST 1.1 as assessed by investigator', 'timeFrame': 'Approximately 4 years', 'description': '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.'}, {'measure': 'Phase 3: Progression free survival (PFS) using RECIST 1.1 as assessed by investigator', 'timeFrame': 'Approximately 4 years', 'description': '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'}, {'measure': 'Phase 3: DOR using RECIST 1.1 as assessed by BICR', 'timeFrame': 'Approximately 4 years', 'description': '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.'}, {'measure': 'Phase 3: DOR using RECIST 1.1 as assessed by investigator', 'timeFrame': 'Approximately 4 years', 'description': '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.'}, {'measure': 'Phase 3: PFS2 (PFS after next-line therapy) by investigator', 'timeFrame': 'Approximately 4 years', 'description': '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'}, {'measure': 'Phase 3: Number of participants with treatment-emergent adverse events', 'timeFrame': 'Through 90 days after the last study intervention; Approximately 4 years', 'description': 'AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to study intervention(s)'}, {'measure': 'Phase 3: Number of participants with laboratory abnormalities', 'timeFrame': 'Through 90 days after the last study intervention; Approximately 4 years', 'description': '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.'}, {'measure': 'Phase 3: Serum concentrations of PF-08634404', 'timeFrame': 'Approximately 21 months', 'description': 'Predose and postdose concentrations of PF-08634404'}, {'measure': 'Phase 3: Incidence of ADA against PF-08634404', 'timeFrame': 'Approximately 21 months'}, {'measure': 'Phase 3: Change from baseline in Functional Assessment of Cancer Therapy - Gastric (FACT-Ga) Total score', 'timeFrame': 'Approximately 4 years'}, {'measure': 'Phase 3: Time to definitive deterioration in FACT-Ga Total score', 'timeFrame': 'Approximately 4 years'}, {'measure': 'Phase 3: Time to definitive deterioration in Gastric Cancer Subscale (GaCS) score', 'timeFrame': 'Approximately 4 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gastric cancer', 'gastroesophageal junction cancer', 'esophageal adenocarcinoma'], 'conditions': ['Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction , or Esophageal Adenocarcinoma', 'Metastatic Gastric Cancer', 'Gastroesophageal Junction Cancer', 'Esophageal Adenocarcinoma']}, 'descriptionModule': {'briefSummary': '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.\n\nTo join the study, participants must meet the following conditions:\n\nBe 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.\n\nThe study has two parts:\n\n* In the first part, researchers will check how safe the study medicine in combination with chemotherapy is and how well people respond to it.\n* In the second part, they will compare study medicine plus chemotherapy to another approved treatment (nivolumab plus chemotherapy) to see which works better.\n\nThe treatment will be given in repeated time periods called cycles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological or cytological confirmed gastric, gastroesophageal junction or esophageal adenocarcinoma.\n* Evidence of locally advanced or metastatic disease.\n* Eastern Cooperative Oncology Group performance status (ECOG) 0-1\n* No prior systemic therapy for advanced or metastatic disease.\n* Adequate hepatic, liver, and renal function\n\nExclusion Criteria:\n\n* Participants with known active CNS metastases, including leptomeningeal, brainstem, meningeal, or spinal cord metastases or compression\n* Clinically significant risk of hemorrhage or fistula\n* Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study\n* History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n* Any Grade ≥3 bleeding/hemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events\n* Clinically significant cardiovascular disease, or other comorbidities, within 6 months prior to first dose\n* Participants with active autoimmune diseases requiring systemic treatment within the past 2 years\n* Evidence of non-infectious or drug-induced interstitial lung disease (ILD) pneumonitis'}, 'identificationModule': {'nctId': 'NCT07392892', 'briefTitle': 'A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Gastroesophageal Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 2/3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC GASTRIC, GASTROESOPHAGEAL JUNCTION, OR ESOPHAGEAL ADENOCARCINOMA', 'orgStudyIdInfo': {'id': 'C6461016'}, 'secondaryIdInfos': [{'id': '2025-524717-86-00', 'type': 'REGISTRY', 'domain': 'CTIS (EU)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 2 Portion', 'description': 'PF-08634404 + Chemotherapy', 'interventionNames': ['Biological: PF-08634404', 'Drug: Chemotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 3: Arm A', 'description': 'PF-08634404 + Chemotherapy', 'interventionNames': ['Biological: PF-08634404', 'Drug: Chemotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Phase 3: Arm B', 'description': 'Nivolumab + Chemotherapy', 'interventionNames': ['Drug: Chemotherapy', 'Biological: Nivolumab']}], 'interventions': [{'name': 'PF-08634404', 'type': 'BIOLOGICAL', 'otherNames': ['SSGJ-707'], 'description': 'Participants will receive PF-08634404 intravenously.', 'armGroupLabels': ['Phase 2 Portion', 'Phase 3: Arm A']}, {'name': 'Chemotherapy', 'type': 'DRUG', 'description': 'Participants will receive PF-08634404 intravenously in combination with Chemotherapy.', 'armGroupLabels': ['Phase 2 Portion', 'Phase 3: Arm A', 'Phase 3: Arm B']}, {'name': 'Nivolumab', 'type': 'BIOLOGICAL', 'description': 'Participants will receive Nivolumab intravenously.', 'armGroupLabels': ['Phase 3: Arm B']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Pfizer CT.gov Call Center', 'role': 'CONTACT', 'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021'}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'url': 'https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests', 'ipdSharing': 'YES', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}