A Randomized, Active-Controlled, Partially Blinded, Biomarker Select, Phase III Clinical Trial of Pembrolizumab as Monotherapy and in Combination with Cisplatin+5-Fluorouracil versus Placebo+Cisplatin+5-Fluorouracil as First-Line Treatment in Subjects with Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma - Pembrolizumab+FP/XP vs. Placebo+FP/XP in Biomarker Select, Advanced Gastric or GEJ Adenocarcinoma

MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.0 sites750 target enrollmentJanuary 15, 2021

ConditionsGastric or Gastroesophageal Junction Adenocarcinoma MedDRA version: 21.0Level: PTClassification code 10030137Term: Oesophageal adenocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

DrugsFluorouracile 50 mg/mL soluzione iniettabile Cisplatin Teva® 1mg/ml Capecitabina Capecitabin cell pharm® 150 mg film-coated tablets

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Gastric or Gastroesophageal Junction Adenocarcinoma
Sponsor: MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.
Enrollment: 750
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 15, 2021

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.

Eligibility Criteria

Inclusion Criteria

•1\. Be willing and able to provide written informed consent/assent for the trial. The subject may also provide consent/assent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
•2\. Be \= 18 years of age on day of signing informed consent (or acceptable age according to local regulations, whichever is older).
•3\. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 3 days prior to the
•first dose of trial treatment.
•4\. Have histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma.
•5\. Be HER2/neu negative and PD\-L1 positive.
•6\. Have measurable disease as defined by RECIST 1\.1 as determined by investigator assessment. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
•7\. Have provided tumor tissue sample deemed adequate for PD\-L1 biomarker analysis.
•a. Notification of eligibility must be received prior to randomization.
•b. Additional samples may be required if adequate tissue is not provided.

Exclusion Criteria

•1\. Has squamous cell or undifferentiated gastric cancer.
•2\. Has had previous therapy for locally advanced, unrectable or metastatic gastric/GEJ cancer. Subjects may have received prior neoadjuvant or adjuvant therapy as long as it was completed at least 6 months prior to randomization.
•3\. Has had major surgery, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of study treatment.
•4\. Has had radiotherapy within 14 days of randomization. Subjects who received radiotherapy \>14 days prior to randomization must have completely recovered from any radiotherapy related AEs/toxicities.
•5\. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
•6\. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging at least four weeks prior to the first dose of trial treatment and neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
•7\. Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
•8\. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of munosuppressive therapy within 7 days prior the first dose of trial drug.
•9\. Has a history of (non\-infectious) pneumonitis that required steroids or current pneumonitis.
•10\. Has an active infection requiring systemic therapy.