Phase II study of pembrolizumab + capecitabine/oxaliplatin (CapeOx) in metastatic GC as first-line treatment
- Conditions
- Neoplasms
- Registration Number
- KCT0004775
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 68
1.Be willing and able to provide written informed consent/assent for the trial. The subject may also provide consent for Biomedical Research. However, the subject may participate in the main trial without participating in Biomedical Research.
2.Be ? 19 years of age on day of signing informed consent (or acceptable age according to local regulations, whichever is older).
3.Have histologically or cytologically-confirmed diagnosis of gastric or GEJ
adenocarcinoma. (EBV positive GC and MSI-H GC will be excluded from this study). The patients must have EBV negative and MSS (or MMR-proficient) GC to enter this study.
4.Have metastatic disease or locally advanced, unresectable disease.
5.Have measurable disease based on RECIST 1.1. as determined by investigator. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
a.Note: The exact same image acquisition and processing parameters should be used throughout the study.
6.Newly obtained fresh biopsy is required before enrollment (stomach biopsy required but if stomach cancer is not intact due to previous surgery, metastatic lesion biopsy can substitute)
a.Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1.
7.Have a performance status of 0 or 1 on the ECOG Performance Scale.
8.Demonstrate adequate organ function as defined in Table 1, all screening labs should be performed within 10 days of treatment initiation.
Table 1. Adequate Organ Function Laboratory Values
SystemLaboratory Value
Hematological
Absolute neutrophil count (ANC)=1,500 /mcL
Platelets=100,000 / mcL
Hemoglobin b=9 g/dL or =5.6 mmol/L
Renal
Serum creatinine OR
Measured or calculateda creatinine clearance
(GFR can also be used in place of creatinine or CrCl)=1.5 X upper limit of normal (ULN) OR
=60 mL/min for subject with creatinine levels > 1.5 X institutional ULN
Hepatic
Serum total bilirubin= 1.5 X ULN OR
Direct bilirubin = ULN for subjects with total bilirubin levels > 1.5 ULN
AST (SGOT) and ALT (SGPT)= 2.5 X ULN OR
= 5 X ULN for subjects with liver metastases
Albumin>2.5 mg/dL
Coagulation
International Normalized Ratio (INR) or Prothrombin Time (PT)
Activated Partial Thromboplastin Time (aPTT)=1.5 X ULN unless subject is receiving anticoagulant therapy
as long as PT or PTT is within therapeutic range of intended use of anticoagulants
=1.5 X ULN unless subject is receiving anticoagulant therapy
as long as PT or PTT is within therapeutic range of intended use of anticoagulants
a Creatinine clearance should be calculated per institutional standard.
b.Criteria must be met without erythropoietin dependency and without packed red blood cell(pRBC) transfusion within last 2 weeks.
9.Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
10.Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication . Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
11.Male subjects should
1.Is currently participating 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 of the first dose of treatment.
Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent. squamous cell or undifferentiated gastric cancer.
2.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 immunosuppressive therapy within 7 days prior the first dose of study drug.
3.squamous cell or undifferentiated gastric cancer.
4.Has pre-existing peripheral neuropathy >Grade 1.
5.Is a WOCBP who has a positive urine pregnancy test within 72 hours prior to treatment . If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Note: In the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for participant to start receiving study medication.
6.Has active TB (Bacillus Tuberculosis)
7.Hypersensitivity to pembrolizumab or any of its excipients.
8.Has a known sensitivity to any component of oxaliplatin or xeloda
9.Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., = Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
10.Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., = Grade 1 or at baseline) from adverse events due to a previously administered agent.
a.Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
11.Has a known history of prior malignancy except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 2 years since initiation of that therapy.
Note: The time requirement for no evidence of disease for 2 years does not apply to the GEJ tumor for which a participant is enrolled in the study. The time requirement also does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers. Has clinically active diverticulitis, intra-abdominal abscess, GI obstruction.
12.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 for at least four weeks prior to the first dose of trial treatment and any 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.
13.Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agent
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method objective response rate, ORR
- Secondary Outcome Measures
Name Time Method Genomic analysis