Clinical Trials /

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

NCT03491345

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: K-Basket, Avelumab, Biomarker-driven, Advanced Solid Tumor
  • Official Title: A Phase II Study of Avelumab Monotherapy in PD-L1 Positive or EBV Positive or MSI-H or POLE/POLD1 Mutated Advanced Solid Tumor (Part of K-BASKET Trial; Korea-Biomarker-driven Multi-arm Drug-screening, Knowledge and Evidence-generating Targeted Trial)

Clinical Trial IDs

  • ORG STUDY ID: 4-2016-1142
  • NCT ID: NCT03491345

Conditions

  • PD-L1 Positive Mutation Tumor
  • EBV Positive Mutation Tumor
  • MSI-H Mutation Tumor
  • POLE/POLD1 Mutation Tumor

Interventions

DrugSynonymsArms
Avelumabavelumab

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
avelumabExperimental
  • Avelumab

Eligibility Criteria

        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 partially controlled asthma)

          -  Prior organ transplantation, including allogeneic stem cell transplantation

          -  Significant acute or chronic infections

          -  Active autoimmune disease that might deteriorate when receiving an immunostimulatory
             agent:

          -  All subjects with brain metastases, except those meeting the following criteria:

          -  Subjects with clinically significant (i.e., active) cardiovascular medical history:
             cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial
             infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure
             (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia
             requiring medication

          -  Unresolved toxicity of Grade >1 attributed to any prior therapies (excluding alopecia,
             skin pigmentation and anemia).

          -  Pregnancy or lactation

          -  Interstitial lung disease

          -  Known alcohol or drug abuse

          -  All other significant diseases (for example, inflammatory bowel disease, uncontrolled
             asthma), which, in the opinion of the Investigator, might impair the subject's
             tolerance of trial treatment

          -  Any psychiatric condition that would prohibit the understanding or rendering of
             informed consent

          -  Vaccination within 4 weeks of the first dose of avelumab and while on trial is
             prohibited except for administration of inactivated vaccines
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:overall response rate
Time Frame:6 weeks
Safety Issue:
Description:

Secondary Outcome Measures

Measure:safety assessed by CTCAE v4.0
Time Frame:2 weeks
Safety Issue:
Description:Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measure:disease control rate
Time Frame:6 weeks
Safety Issue:
Description:
Measure:progression free survival
Time Frame:4 weeks
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Yonsei University

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