None listed
Conditions
Interventions
Drug : The planned dose of pembrolizumab in this clinical trial is 200 mg administered every 3 weeks for a maximum of 35 administrations. Pembrolizumab 200 mg will be administered as an intravenous in
however, due to potential variability in infusion pumps among study sites, a deviation of -5 to +10 minutes from the planned infusion time is permitted.
Sponsors
Ajou University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients in whom an appropriate proteomic expression profile (IFN-? signature) has been identified through screening under the master protocol. IFN-? signature positivity is defined as a quantitative value for at least one of the following proteins—PD-L1 (CD274), TAP2, IDO1, WARS1, or UBE2L6—that is at least one standard deviation above the population mean for the respective protein. 2.Patients with pathologically or cytologically confirmed non-small cell lung cancer, head and neck squamous cell carcinoma, triple-negative breast cancer, gastric cancer, esophageal cancer, hepatocellular carcinoma, bladder or ureteral cancer (urothelial carcinoma), renal cell carcinoma, cervical cancer, endometrial cancer, or skin cancer (malignant melanoma, Merkel cell carcinoma, or cutaneous squamous cell carcinoma) for which pembrolizumab monotherapy has been approved by the U.S. Food and Drug Administration (FDA) and the Korean Ministry of Food and Drug Safety (MFDS). 3.Patients who are intolerant of standard therapy, including immune checkpoint inhibitors, or who have experienced progressive disease and meet one of the following criteria: Initial pembrolizumab treatment: Disease progression has been confirmed during or following standard therapy, with or without an immune checkpoint inhibitor other than pembrolizumab. Pembrolizumab retreatment: Disease progression has been confirmed more than 6 months after completion of a pembrolizumab-containing treatment regimen; or previous pembrolizumab treatment was discontinued because of a pembrolizumab-related adverse event, the symptoms have subsequently resolved or stabilized to Grade 1 or lower, and the treating physician or principal investigator determines that the patient is expected to derive clinical benefit from pembrolizumab retreatment. 4.Aged 19 years or older on the date of signing the informed consent form. 5.Eastern Cooperative Oncology Group (ECOG) performance status of 0–2. 6.Life expectancy of more than 8 weeks. 7.Adequate organ function, as defined by all of the following: Absolute neutrophil count (ANC) = 1.0 × 10?/L (= 1,000/mm³) Platelet count = 100 × 10?/L (= 100,000/mm³) Serum bilirubin = 1.5 × the institutional upper limit of normal (ULN), except in patients with Gilbert syndrome AST (SGOT) and ALT (SGPT) = 2.5 × the institutional ULN; = 5 × ULN in patients with liver metastases 24-hour urinary creatinine clearance or estimated glomerular filtration rate (eGFR) > 50 mL/min 8.Female patients must have a negative pregnancy test or be considered women of non-childbearing potential, as defined by either of the following: Postmenopausal status documented in the medical history, defined as amenorrhea for at least 1 year without another medical cause Prior hysterectomy, bilateral tubal ligation, or bilateral oophorectomy 9.Women of childbearing potential must agree to use an effective method of contraception (Appendix 1) throughout the study participation period and for at least 6 months after the final dose of the investigational product. They must also have a negative urine or serum pregnancy test performed within 14 days before the first dose of the investigational product. 10.Presence of at least one measurable lesion according to RECIST.
Exclusion criteria
Exclusion criteria: 1.Receipt of the last dose of anticancer therapy, including chemotherapy, immunotherapy, endocrine therapy, or targeted therapy (including tumor embolization and other investigational medicinal products), within 14 days before the first dose of the investigational product (IP); within 28 days for patients who previously received monoclonal antibodies or other biological therapies; or within 42 days for nitrosoureas or mitomycin C. 2.Any unresolved toxicity of NCI CTCAE Grade =2 from prior anticancer therapy, except for alopecia, vitiligo, and laboratory abnormalities defined in the inclusion criteria. a. Patients with Grade =2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician. b. Patients with irreversible toxicity that is not reasonably expected to be exacerbated by IP administration may be excluded only after consultation with the study physician. 3.Concurrent use of chemotherapy, an investigational product, a biological agent, or hormonal therapy for the treatment of cancer. Concurrent hormonal therapy for a non-cancer-related condition, such as hormone replacement therapy, is permitted. 4.Radiotherapy involving more than 30% of the bone marrow or wide-field radiotherapy within 4 weeks before the first dose of the IP. 5.Major surgery, as defined by the investigator, within 28 days before the first dose of the IP. Note: Local surgery for an isolated lesion for palliative purposes is permitted. 6.History of allogeneic organ transplantation. 7.Active or previously documented autoimmune or inflammatory disorders, including inflammatory bowel disease (e.g., colitis or Crohn’s disease), diverticulitis (except diverticulosis), systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis), Graves’ disease, rheumatoid arthritis, hypophysitis, or uveitis. The following are exceptions to this criterion: a. Patients with vitiligo or alopecia b. Patients with hypothyroidism, such as hypothyroidism following Hashimoto syndrome, who are stable on hormone replacement therapy c. Patients with chronic skin conditions that do not require systemic therapy d. Patients without active disease during the preceding 5 years may be eligible only after consultation with the study physician e. Patients with celiac disease controlled by diet alone 8.Uncontrolled intercurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness or social circumstances that would limit compliance with study requirements, substantially increase the risk of adverse events, or impair the patient’s ability to provide written informed consent. 9.History of another primary malignancy, except for the following: a. A malignancy treated with curative intent, with no known active disease within 3 years before the first dose of the IP and with a potentially low risk of recurrence b. Adequately treated non-melanoma skin cancer or malignant melanoma with no evidence of disease c. Adequately treated carcinoma in situ with no evidence of disease 10.History of leptomeningeal carcinomatosis. 11.Patients with treated brain metastases may participate if they demonstrate radiographic stability, defined as stability on two brain imaging studies obtained after tre
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| duration of response;Evaluation of Progression-Free Survival (PFS) and Overall Survival (OS) | — |
Countries
Korea, Republic of
Contacts
Public ContactYong Won Choi
Ajou University Hospital
Outcome results
None listed