Phase II study of pembrolizumab in Subjects with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma who Progressed after First-Line Therapy with Platinum and Fluoropyrimidine: integration of molecular subtypes through integrative genomic analysis.
- Conditions
- Neoplasms
- Registration Number
- KCT0003562
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
In order to be eligible to participate in this trial, the subjects should be:
(1) If you are willing to write a written consent form for this test,The patient. The person to be tested may also prepare a consent form for studying the human body in the future. However, you can participate in the main clinical trials without agreeing to the Human Derivatives Study Agreement.
(2) Patient who is 19 years old or older at the time of signature
(3) Histologically or cytologically confirmed gastric adenocarcinoma or gastric esophageal adenocarcinoma
(4) during or after the first-line treatment with platinum / fluoropyrimidine dual therapy, Patients with proven objective evidence of clinical disease progression. (According to the judgment of the researcher,Possible)
a. To be considered a second-line therapy, you must demonstrate that the disease progression has occurred during the first-line treatment. There must be documented evidence. Disease progression can be confirmed by CT scan or clinical evidence A cytology analysis report of pleural effusion, etc.).
b. New or worsened malignant effusions (evidenced by ultrasound) should, where appropriate, And / or cytology).
c. Patients with clinical disease progression during or after 6 months of follow-up therapy If required, platinum / fluoropyrimidine dual therapy is appropriate for this studyd. Patients who previously received at least one dose of platinum and fluoropyrimidine. Which of One dose reduction and permanent interruption, and the first choice treatment with other drugs and new drugs Additions are allowed, but evidence documents that the disease progression occurred during or after the first-line treatment must be. Thus, during the first-line treatment, treatment may be required for adverse events before disease progression occurs. Patients who are permanently discontinued are not eligible for this study unless the disease progress is evidenced in the supporting documentation. (If HER2-positive, registration is possible if there is a history of chemotherapy including HER2 target treatment) Patients with measurable lesions as defined by the mRECIST to be evaluated by the tester. Before Tumor lesions in the area treated with radiotherapy are measurable only when the disease progress has been proven. a. Note: The same imaging test method and test parameters should be used throughout the study.
(5) There is a willingness to provide tissue samples for biomarker analysis,Patients eligible for analysis. Patients who can not provide adequate tissue samples may need to repeat sample collection have. Newly collected endoscopic biopsy specimens rather than archived specimens are preferred, and FFPE blocks Samples are preferred.
a. Newly collected specimens are defined as the specimens taken within 6 weeks (42 days) prior to the start of the first test.Patients who are unable to collect new endoscopic specimens (eg, in areas where the lesion is inaccessible,
If this is the case), you can submit the stored sample. (A sample stored in a biobank It is also possible to use.)
b. To compare and evaluate the clinical efficacy of biomarker analysis between newly collected and stored samples
Collection of stored samples will also be requested (if present). However, the Or if the specimen is not appropriate for the assay in any way, the patient have.
(6) ECOG activity state 0 or 1
(7) Patients who exhibit appropriate organ function as defined in Table 1 in a screening test conducted within 10 days prior to the
The subject must be excluded from participating in the trial if the subject:
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.
2.Has squamous cell or undifferentiated gastric cancer.
3.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.
4.Has a known history of active TB (Bacillus Tuberculosis)
5.Hypersensitivity to pembrolizumab or any of its excipients.
6.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.
7.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.
-Note: Subjects with = Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
-Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
8.Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
9.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.
10.Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
11.Has known history of, or any evidence of active, non-infectious pneumonitis.
12.Has an active infection requiring systemic therapy.
13.Has a history or current evidence of any condition, 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.
14.Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
15.Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
16.Has received prior therapy with an anti-PD-1, anti-PD-L1, or
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method objective response rate, ORR;Integrative genomic analysis
- Secondary Outcome Measures
Name Time Method Safety(adverse events (AEs), laboratory tests, vital signs, etc);Genomic analysis (Whole Exome Sequencing at baseline, RNA-seq pre and post)