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

Yonsei University

Status and phase

Active, not recruiting

Phase 2

Conditions

PD-L1 Positive Mutation Tumor

POLE/POLD1 Mutation Tumor

MSI-H Mutation Tumor

EBV Positive Mutation Tumor

Treatments

Drug: Avelumab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03491345

4-2016-1142

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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