UnknownPhase 2

K-Basket, Avelumab, Biomarker-driven, Advanced Solid Tumor

South Korea60 participantsStarted 2017-08-01

Plain-language summary

Investigators have conducted K-BASKET trial (Korea-Biomarker-driven multi-arm drug-screening, knowledge and evidence-generating targeted trial), which was based on the specific genetic aberration, not the cancer type, which could accelerate matching the right drug to the right target so that every cancer patient could get the right specific drug based on the specific genetic biomarker, like NCI-MATCH trial. Next generation sequencing (NGS) focusing panel has the mutation and copy number variation of MET, PIK3CA and AKT. Investigators will open new treatment arms during the progress of K-BASKET trial. Patient with PD-L1 positive or EBV positive or MSI-H or POLE/POLD1 mutation tumor will be assigned to Avelumab monotherapy.

Who can participate

Age range20 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Provided written informed consent for treatment. * Age ≥ 20 years old * Meet at least one of the following requirements; A. PD-L1 positive by IHC or B. EBV positive by ISH or C. MSI-H by IHC or D. POLE mutation E. POLD1 mutation * Progressive disease who failed to previous standard treatment * At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 on time of patient's allocation. * Adequate organ function as defined by the following criteria: A. Adequate hematological function defined by absolute neutrophil count (ANC) ≥ 1500/mm3, platelet count ≥ 100,000/mm3 , hemoglobin ≥ 9.0 g/dL B. Adequate hepatic function defined by AST and ALT levels ≤ 2.5 × upper limit of normal (ULN) and total bilirubin level ≤ 1.5 × ULN C. Adequate renal function defined by and estimated creatinine clearance (CrCl) ≥ 30 mL/min (MDRD) * A life expectancy of at least 90 days * Negative serum pregnancy test at screening for women of childbearing potential * Highly effective contraception for both male and female subjects if the risk of conception exists. Exclusion Criteria: * Previous treatment with immune checkpoint inhibitor (Anti-PD1, Anti-PDL1, Anti-CTLA4 etc.) * Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3 NCI CTCAE v 4.03), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of pa…

What they're measuring

overall response rate

Timeframe: 6 weeks

Trial details

NCT IDNCT03491345

SponsorYonsei University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08