A Study of LY3381916 Alone or in Combination With LY3300054 in Participants With Solid Tumors
NCT ID: NCT03343613
Last Updated: 2020-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
60 participants
INTERVENTIONAL
2017-11-17
2020-05-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LY3381916 Escalation
LY3381916 administered orally.
LY3381916
IDO-1 inhibitor administered orally
LY3381916 + LY3300054 Escalation
LY3381916 administered orally and LY3300054 administered intravenously (IV).
LY3381916
IDO-1 inhibitor administered orally
LY3300054
PD-L1 inhibitor administered IV
LY3381916 Expansion
LY3381916 administered orally.
LY3381916
IDO-1 inhibitor administered orally
LY3381916 + LY3300054 Expansion B1
Metastatic triple negative breast cancer (TNBC)
LY3381916 administered orally and LY3300054 administered IV.
LY3381916
IDO-1 inhibitor administered orally
LY3300054
PD-L1 inhibitor administered IV
LY3381916 + LY3300054 Expansion B2
Metastatic non-small cell lung cancer (NSCLC)
LY3381916 administered orally and LY3300054 administered IV.
LY3381916
IDO-1 inhibitor administered orally
LY3300054
PD-L1 inhibitor administered IV
LY3381916 + LY3300054 Expansion B3
Metastatic clear cell carcinoma renal cell carcinoma (RCC)
LY3381916 administered orally and LY3300054 administered IV.
LY3381916
IDO-1 inhibitor administered orally
LY3300054
PD-L1 inhibitor administered IV
Interventions
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LY3381916
IDO-1 inhibitor administered orally
LY3300054
PD-L1 inhibitor administered IV
Eligibility Criteria
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Inclusion Criteria
* Dose expansion B1: Metastatic TNBC participants who have not received prior PD-1/L1 treatment.
* Dose expansion B2: Metastatic NSCLC participants who have progressed on prior PD-L1/L1 treatment.
* Dose expansion B3: Metastatic clear cell carcinoma RCC who have progressed on prior PD-L1/L1 treatment.
* Have adequate organ function.
* Have a performance status (PS) of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
* Are able and willing to provide required, newly acquired tumor biopsies.
* Have discontinued previous treatments for cancer.
* Are able to swallow capsules.
Exclusion Criteria
* Have known symptomatic central nervous system metastases or carcinomatous meningitis.
* Have a serious concomitant systemic disorder.
* Have a symptomatic human immunodeficiency virus infection or symptomatic activated/reactivated hepatitis B or C.
* Have a significant cardiac condition.
* Have previously received an indoleamine- 2,3-dioxygenase (IDO) inhibitor.
* Have an active autoimmune disease or currently require immunosuppression of \>10 milligrams of prednisone or equivalent per day.
* Have interstitial lung disease or (noninfectious) pneumonitis, participants with a history of (noninfectious) pneumonitis that required steroids to assist with management.
18 Years
ALL
No
Sponsors
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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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IU Simon Cancer Center
Indianapolis, Indiana, United States
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, United States
Tennessee Oncology PLLC
Nashville, Tennessee, United States
Institut Jules Bordet
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Finsen Institute
Copenhagen, , Denmark
Gustave Roussy
Villejuif, , France
Azienda Ospedaliera San Gerardo
Monza, Milano, Italy
Azienda Ospedaliera Umberto I
Ancona, , Italy
Hospital Clinico Universitario Virgen de la Victoria
Málaga, Andalusia, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Countries
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Related Links
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A Study of LY3381916 Alone or in Combination With LY3300054 in Participants With Solid Tumors
Other Identifiers
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I9L-MC-JZCA
Identifier Type: OTHER
Identifier Source: secondary_id
2017-002693-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16786
Identifier Type: -
Identifier Source: org_study_id
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