Statements (67)
| Predicate | Object |
|---|---|
| gptkbp:instance_of |
gptkb:legal_case
|
| gptkbp:bfsLayer |
6
|
| gptkbp:bfsParent |
gptkb:pembrolizumab
|
| gptkbp:advocates_for |
obtained prior to enrollment
|
| gptkbp:allows |
small sample size
|
| gptkbp:analysis |
performed by independent committee
|
| gptkbp:analyzes |
gptkb:pembrolizumab
|
| gptkbp:business_model |
obtained from institutional review boards
|
| gptkbp:clinical_trial |
gptkb:Clinical_Trials.gov
gptkb:KEYNOTE-006 Phase II defined prior to study initiation demonstrated efficacy in melanoma |
| gptkbp:collaborations |
with academic institutions
various oncology centers |
| gptkbp:collection |
prospective
|
| gptkbp:committee |
oversaw trial integrity
|
| gptkbp:criteria |
gptkb:healthcare_organization
adult patients |
| gptkbp:data_privacy |
maintained throughout the study
|
| gptkbp:duration |
up to 2 years
until disease progression |
| gptkbp:future_plans |
explore combination therapies
|
| gptkbp:has_impact_on |
advances immunotherapy research
|
| https://www.w3.org/2000/01/rdf-schema#label |
KEYNOTE-002
|
| gptkbp:impact |
influenced future melanoma treatments
|
| gptkbp:is_compared_to |
pembrolizumab vs chemotherapy
|
| gptkbp:is_studied_in |
open-label
adhered to strict guidelines marked by final data analysis |
| gptkbp:is_tested_for |
gptkb:II
PD-L1 expression |
| gptkbp:launch_date |
2014-01-01
|
| gptkbp:location |
multiple sites
|
| gptkbp:number |
NC T02227251
|
| gptkbp:objective |
evaluate safety and efficacy
|
| gptkbp:outcome |
assessed during the trial
|
| gptkbp:participants |
overall response rate
progression-free survival |
| gptkbp:population |
diverse population
|
| gptkbp:primary_source |
Dr. Roger M. Perlmutter
|
| gptkbp:products |
gptkb:pembrolizumab
|
| gptkbp:provides_information_on |
encouraged post-study
pembrolizumab every 3 weeks |
| gptkbp:publishes |
peer-reviewed journal
|
| gptkbp:receives_funding_from |
provided by Merck & Co.
|
| gptkbp:recorded_by |
non-randomized
|
| gptkbp:regulatory_compliance |
FDA approved pembrolizumab
|
| gptkbp:research |
presented at conferences
contributed to treatment guidelines follow-up studies planned pembrolizumab is effective in melanoma through scientific publications |
| gptkbp:research_areas |
oncology
|
| gptkbp:result |
gptkb:2017
pembrolizumab showed improved outcomes |
| gptkbp:safety_features |
acceptable
prioritized during the trial |
| gptkbp:side_effect |
monitored throughout the trial
|
| gptkbp:sponsor |
gptkb:Merck_&_Co.
|
| gptkbp:status |
completed
|
| gptkbp:student_enrollment |
approximately 300 patients
based on specific criteria |
| gptkbp:targets |
advanced melanoma
|
| gptkbp:treatment |
evaluated at regular intervals
|
| gptkbp:warranty |
planned for participants
|
| gptkbp:year |
2016-12-31
|