PEMBROLIZUMAB/PLACEBO PLUS CHEMOTHERAPY AS FIRST-LINE THERAPY IN PARTICIPANTS WITH HER2 NEGATIVE ADVANCED GASTRIC OR GEJ ADENOCARCINOMA

Not Applicable

Recruiting

• Conditions: -C16 Malignant neoplasm of stomach; Malignant neoplasm of stomach; C16

• Registration Number: PER-041-18
• Lead Sponsor: Merck Sharp & Dohme Corp., una subsidiaria de Merck & Co. Inc.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-07
• Study Completion: 2022-04-28
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

1. Has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma, with known PD-L1 expression status.
2. Has HER2 negative cancer.
3. Is at least 18 years of age at the time of signing the informed consent.
4. Participant is:
- a female that is not pregnant, not breastfeeding, and is either not of childbearing potential (WOCBP) OR is a WOCBP who agrees to follow the contraceptive guidance per protocol during the treatment period and through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab or
- a male that agrees to follow the contraceptive guidance per protocol during the treatment period and through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab.
5. The participant provides written informed consent for the study.
6. Has measurable disease per RECIST 1.1 as assessed by investigator assessment.
7. Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
8. Has provided tumor tissue sample deemed adequate for PD-L1 biomarker analysis.
9. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (within 3 days prior to the start of study intervention).
10. Has adequate organ function.

Exclusion Criteria

1. Has squamous cell or undifferentiated gastric cancer.
2. Has pre-existing peripheral neuropathy >Grade 1.
3. Has a positive urine pregnancy test within 72 hours prior to randomization or treatment allocation.
4. Has had previous therapy for locally advanced, unresectable or metastatic gastric/GEJ cancer.
5. Has received prior systemic anticancer therapy including investigational agents within 4 weeks prior to randomization.
6. Has received prior radiotherapy within 2 weeks prior to start of study intervention.
7. Has received a live vaccine within 30 days prior to the first dose of study intervention.
8. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years or has known active CNS metastases and/or carcinomatous meningitis.
9. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis or has an active infection requiring systemic therapy.
10. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of
immunosuppressive therapy within 7 days prior to the first dose of study intervention or has an active autoimmune disease that has required systemic treatment in past 2 years.
11. Has a known history of human immunodeficiency virus (HIV) infection, known history of Hepatitis B or known active Hepatitis C virus or known history of active tuberculosis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified