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)
- Conditions
- -C16 Malignant neoplasm of stomachMalignant neoplasm of stomachC16
- Registration Number
- PER-017-15
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 1
Cohort 1:
1 Have received, and progressed on, at least 2 prior chemotherapy regimens
2 HER-2/neu neg, or, HER2/neu pos previously treated with trastuzumab
Cohorts 2 or 3:
3 HER2/neu neg
4 Have not received prior systemic anti-cancer therapy for their metastatic or advanced gastric or gastroesophageal junction adenocarcinoma
For all potential subjects:
5 Provide written informed consent
6 Be >= 18 years of age
7 Have histologically or cytologically-confirmed recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma incurable by local therapies
8 Provide tissue for PD-L1 biomarker analysis from a newly-obtained endoscopic tumor biopsy from the stomach and/or gastroesophageal junction
9 Be PD-L1 pos, if allocated to a cohort only enrolling PD-L1 pos subjects
10 Have measurable disease based on RECIST 1.1
11 Have a performance status of 0 or 1 on the ECOG Performance Scale
12 Female of childbearing potential should use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 or 180 days after the last dose of study drug
Male should use an adequate method of contraception starting with the first dose of study through 120 or 180 days after the last dose of study drug
13 Demonstrate adequate organ function
14 Female of childbearing potential have a negative urine or serum pregnancy test within 72h prior to receiving the first dose of study drug.
1 Is or has participated in a study of an investigational agent
2 Has active autoimmune disease
3 Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy
4 Has had a prior anti-cancer monoclonal antibody (mAb)
5 Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy
6 Has a known additional malignancy that is progressing or requires active treatment.
7 Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
8 Has known history of, or any evidence of active, non-infectious pneumonitis.
9 Has an active infection requiring systemic therapy.
10 Has a history or current evidence of any condition, therapy, or laboratory abnormality
11 Has known psychiatric or substance abuse disorders
12 Is pregnant or breastfeeding, or expecting to conceive or father children within the trial, through 120 or 180 days after the last dose of treatment
13 Has received prior therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent, or has previously in Merck MK-3475 clinical trials
14 Has a known history of HIV
15 Has known active Hepatitis B or C
16 Has received a live vaccine within 30 days of start of therapy
17 Is or has an immediate family member who is investigational site or sponsor staff directly involved with this trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method