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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03491345
Recruitment Status : Recruiting
First Posted : April 9, 2018
Last Update Posted : May 11, 2018
Sponsor:
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
Yonsei University

Brief 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.

Condition or disease Intervention/treatment Phase
PD-L1 Positive Mutation Tumor EBV Positive Mutation Tumor MSI-H Mutation Tumor POLE/POLD1 Mutation Tumor Drug: Avelumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Avelumab

Arm Intervention/treatment
Experimental: avelumab Drug: Avelumab
avelumab 10mg/kg, IV, q 2 weeks




Primary Outcome Measures :
  1. overall response rate [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. safety assessed by CTCAE v4.0 [ Time Frame: 2 weeks ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  2. disease control rate [ Time Frame: 6 weeks ]
  3. progression free survival [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491345


Locations
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Korea, Republic of
Division of Medical Oncology, Severance Breast Cancer Clinic, Yonsei Cancer Center, Severance Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 03722
Contact: GUN MIN KIM, MD    82-2-2228-4321    GMKIM77@yuhs.ac   
Sponsors and Collaborators
Yonsei University
Merck KGaA, Darmstadt, Germany

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03491345    
Other Study ID Numbers: 4-2016-1142
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs