Phase IIb study of Pembrolizumab in combination with TS-1+Cisplatin or TS-1+Oxaliplatin in GC
- Conditions
- Gastric Adenocarcinoma
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 90
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale at the timing of enrollment.
- Have histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma.
- Have a PD-L1 positive tumor as determined by IHC at a central laboratory.
- 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.
- Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication.
- Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy.
- Demonstrate adequate organ function.
- Has squamous cell or undifferentiated gastric cancer.
- Participants with human epidermal growth factor receptor 2 (HER2)-positive status.
- Has had previous therapy for locally advanced, unresectable or metastatic gastric/GEJ cancer.
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Has received prior therapy with a platinum-based anti-cancer drug.
- Has had major surgery, open biopsy or significant traumatic injury within 28 days prior to enrollment, or anticipation of the need for major surgery during the course of study treatment.
- Has had radiotherapy within 14 days of enrollment.
- Has a known additional malignancy that is progressing or has required active treatment within the past 5 years.
Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that have undergone potentially curative therapy are not excluded.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has an active autoimmune disease that has required systemic treatment in past 2 years.
- 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.
- Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- Has an active infection requiring systemic therapy.
- Being on flucytosine at the time of enrollment.
- Has grade 2 or more peripheral sensory neuropathy.
- Has poorly controlled diarrhea (e.g., watery stool, uncontrollable bowel movement with drugs, grade 2 or more and number of defecations, 5 or more/day).
- Accumulation of pleural, ascitic, or pericardial fluid requiring drainage within 2 weeks prior to enrollment.
- Has a history or current evidence of any condition (e.g. known deficiency of the enzyme dihydropyrimidine dehydrogenase [DPD]), therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor.
- Has a known history of Human Immunodeficiency Virus (HIV).
- Has a known history of Hepatitis B or known active Hepatitis C virus infection.
- Is currently participating in and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the first dose of trial treatment.
- Has received a live vaccine within 30 days of planned start of study therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Overall Response Rate (ORR)<br>To evaluate Overall Response Rate (ORR) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR).
- Secondary Outcome Measures
Name Time Method efficacy<br>Duration of Response (DOR)<br>To evaluate the Duration of Response (DOR) per RECIST 1.1 and per iRECIST as assessed by BICR.