A Study of the CD73 Inhibitor LY3475070 Alone or in Combination With Pembrolizumab in Participants With Advanced Cancer
NCT ID: NCT04148937
Last Updated: 2024-04-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
52 participants
INTERVENTIONAL
2020-01-16
2022-06-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase 1a Cohort A LY3475070 (dose escalation)
Participants received 150 milligram (mg) once daily or 300 mg once daily or 300mg twice daily or 600mg once daily oral LY3475070 on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
LY3475070
Administered orally
Phase 1a Cohort B LY3475070 + Pembrolizumab (dose escalation)
Participants received 150 mg once daily or 150 mg twice daily or 300 mg once daily or 300mg twice daily oral LY3475070 on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
LY3475070
Administered orally
Pembrolizumab
Administered IV
Phase 1b Cohort C1 LY3475070 + Pembrolizumab (dose expansion)
LY3475070 administered orally and pembrolizumab administered IV.
Based on Sponsor decision, Phase 1b expansion cohorts were not initiated.
LY3475070
Administered orally
Pembrolizumab
Administered IV
Phase 1b Cohort C2 LY3475070 (dose expansion)
LY3475070 administered orally.
Based on Sponsor decision, Phase 1b expansion cohorts were not initiated.
LY3475070
Administered orally
Phase 1b Cohort D1 LY3475070 + Pembrolizumab (dose expansion)
LY3475070 administered orally and pembrolizumab administered IV.
Based on Sponsor decision, Phase 1b expansion cohorts were not initiated.
LY3475070
Administered orally
Pembrolizumab
Administered IV
Phase 1b Cohort D2 LY3475070 (dose expansion)
LY3475070 administered orally.
Based on Sponsor decision, Phase 1b expansion cohorts were not initiated.
LY3475070
Administered orally
Phase 1b Cohort E LY3475070 + Pembrolizumab (dose expansion)
LY3475070 administered orally and pembrolizumab administered IV.
Based on Sponsor decision, Phase 1b expansion cohorts were not initiated.
LY3475070
Administered orally
Pembrolizumab
Administered IV
Interventions
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LY3475070
Administered orally
Pembrolizumab
Administered IV
Eligibility Criteria
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Inclusion Criteria
* Participants must have stopped other forms of treatment for the cancer
* In the expansion cohorts participants must be able and willing to provide a sample of the tumor before beginning treatment and a sample during the treatment. For certain tumor types, the result of a test on the tumor sample may exclude the participant from the study
* Participants must not be pregnant, and must agree to use birth control
* Participants must have progressed through or be intolerant to therapies with known clinical benefit
Exclusion Criteria
* Participant must not have cancer that has spread to the brain
* Participant must not have received a vaccine within the last 30 days
* Participant must not have had bowel obstruction within the last 6 months, or intestinal surgery
* Participant must not have an infection that is currently being treated
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Sarah Cannon Research Institute at HealthOne
Denver, Colorado, United States
Florida Cancer Specialists ORLANDO/DDU
Lake Mary, Florida, United States
START Midwest
Grand Rapids, Michigan, United States
Washington University Medical School
St Louis, Missouri, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Addenbrookes Hospital
Cambridge, Cambridgeshire, United Kingdom
Beatson West of Scotland Cancer Center
Glasgow, Scotland, United Kingdom
Christie NHS Foundation Trust
Manchester, , United Kingdom
Royal Marsden NHS Trust
Sutton, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of the CD73 Inhibitor LY3475070 Alone or in Combination With Pembrolizumab in Participants With Advanced Cancer
Other Identifiers
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J2I-MC-JZMA
Identifier Type: OTHER
Identifier Source: secondary_id
2019-003270-64
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Keynote A57
Identifier Type: OTHER
Identifier Source: secondary_id
17504
Identifier Type: -
Identifier Source: org_study_id
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