PD-L1 Positive Mutation TumorPhase 2NCT03491345
K-Basket, Avelumab, Biomarker-driven, Advanced Solid Tumor
A Phase 2 study testing Avelumab in people with PD-L1 Positive Mutation Tumor and EBV Positive Mutation Tumor, run by Yonsei University at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- PD-L1 Positive Mutation Tumor, EBV Positive Mutation Tumor, MSI-H Mutation Tumor
- What is being tested?
- Avelumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2017to Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Adequate organ function as defined by the following criteria:
- 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.
Who cannot join
- 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:
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Medical Oncology, Severance Breast Cancer Clinic, Yonsei Cancer Center, Severance Hospital, Yonsei University Health System
Seoul, 03722
About this study
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)
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.
- Conditions
- PD-L1 Positive Mutation Tumor, EBV Positive Mutation Tumor, MSI-H Mutation Tumor, POLE/POLD1 Mutation Tumor
- Being tested
- Avelumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvelumabDrug
avelumab 10mg/kg, IV, q 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| avelumab | Experimental | Not described Receives: Drug: Avelumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate
Measured: 6 weeks
Secondary outcomes (3)
safety assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 2 weeks
disease control rate
Measured: 6 weeks
progression free survival
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start1 Aug 2017
- Primary completionAug 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PD-L1 Positive Mutation TumorStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491345
- Sponsor's protocol ID
- 4-2016-1142
- Status last verified
- Aug 2022
- First submitted
- 30 Mar 2018
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03491345
- Acronym / sponsor ID
- 4-2016-1142
- Conditions
- PD-L1 Positive Mutation Tumor, EBV Positive Mutation Tumor, MSI-H Mutation Tumor, POLE/POLD1 Mutation Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 9 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| avelumab | Experimental | Drug: Avelumab |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (14 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avelumabavelumab 10mg/kg, IV, q 2 weeks | Drug | avelumab |
Primary outcome
overall response rate
Time frame: 6 weeks
3 secondary outcomes
safety assessed by CTCAE v4.0
Time frame: 2 weeks
disease control rate
Time frame: 6 weeks
progression free survival
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Avelumab in people with PD-L1 Positive Mutation Tumor and EBV Positive Mutation Tumor, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.