A Phase II Clinical Trial of Pembrolizumab as Monotherapy and in Combination with Cisplatin+5-Fluorouracil in Subjects with Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (KEYNOTE-059) - A Phase II Study of Pembrolizumab in Subjects with Gastric Cancer

MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.0 sites315 target enrollmentFebruary 2, 2021

ConditionsGastric cancer MedDRA version: 20.0Level: PTClassification code 10001150Term: Adenocarcinoma gastricSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

DrugsFluorouracil - GRY ¿ 50 mg/mL soluzione iniettabile Cisplatin Teva ¿ 1 mg/ml

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Gastric cancer
Sponsor: MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.
Enrollment: 315
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 2, 2021

End Date

July 23, 2021

Last Updated

2 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

•For potential subjects in Cohort 1 (3L\+ cohort):
•1\. Have received, and progressed on, at least two prior chemotherapy regimens. For the purposes of this study, perioperative, neoadjuvant, adjuvant chemotherapy regimens will not count as a prior regimen, unless the patient progressed while receiving adjuvant therapy or within 6 months of receiving adjuvant treatment. The date of progression and how progression was determined must be known with documentation available confirming progression on or after treatment. Previous treatment regimens must have included a fluoropyridine and platinum doublet (as part of either a line oftherapy or adjuvant treatment.
•2\. Be HER\-2/neu \-, or, if HER2/neu \+, must have previously received treatment with trastuzumab
•For potential subjects in Cohorts 2 or 3 (1L cohorts):
•3\. Is HER2/neu –
•4\. Have not received prior systemic anti\-cancer therapy for their metastatic or advanced gastric or gastroesophageal junction adenocarcinoma. For the purposes of this study, perioperative, neoadjuvant, adjuvant chemotherapy regimens will not count as a prior regimen, unless disease progression has occurred during or within 6 months of adjuvant chemotherapy.
•For all potential subjects:
•5\. Be willing and able to provide written informed consent for the trial. The subject may also provide consent for FBR. However, the subject may participate in the main trial without participating in FBR.
•6\. Be ¿¿18 years of age on day of signing informed consent.
•7\. Have histologically or cytologically\-confirmed recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma that is considered incurable by local therapies.

Exclusion Criteria

•The subject must be excluded from participating in the trial if the subject:
•1\. Experienced weight loss \> 10 % over 2 months prior to first dose of study therapy.
•2\. Has clinical evidence of ascites by physical exam.
•3\. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation al device within 4 weeks of the first dose of treatment.
•4\. Has active autoimmune disease that has required systemic treatment in past 2 years. Replacement therapy is not considered a form of systemic treatment.
•5\. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. The use of physiologic doses of corticosteroids (prednisone 10 mg or equivalent) may be approved after consultation with the Sponsor.
•6\. Has had a prior anti\-cancer mAb within 4 weeks prior to study Day 1 or who has not recovered (i.e., \= Grade 1 or at baseline) from AE due to agents administered more than 4 weeks earlier.
•7\. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to Day 1 or who has not recovered (i.e., \= Grade 1 or at baseline) from AE due to a previously administered agent.
•8\. Has a known additional malignancy that is progressing or requires active treatment
•9\. Has known active CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable, 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.