Study Stopped
The withdrawal is due to a strategic realignment and is not related to any particular safety or efficacy concern.
A Study of LY3200882 and Pembrolizumab in Participants With Advanced Cancer
Phase 1b/2 Study of LY3200882 and Pembrolizumab in Patients With Advanced Cancer
4 other identifiers
interventional
N/A
3 countries
6
Brief Summary
The main purpose of this study is to see if the drug LY3200882 which is an inhibitor of transforming growth factor-β (TGFβ) receptor 1 in combination with pembrolizumab is safe and effective in participants with cancer that has spread to other parts of the body.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2019
Typical duration for phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2019
CompletedFirst Posted
Study publicly available on registry
November 12, 2019
CompletedStudy Start
First participant enrolled
December 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 11, 2023
CompletedFebruary 19, 2020
February 1, 2020
3.4 years
November 7, 2019
February 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants with Dose Limiting Toxicity (DLT)
Number of Participants with DLT
Up to 6 Weeks
Secondary Outcomes (3)
Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR)
Baseline through Disease Progression or Death (Estimated at up to 12 Months)
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3200882 in Combination With Pembrolizumab
Baseline through Week 13
Duration of Response (DoR)
Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated at up to 12 Months)
Study Arms (3)
LY3200882 and Pembrolizumab (Dose Level 1)
EXPERIMENTALParticipants with urothelial carcinoma: LY3200882 administered orally with pembrolizumab administered intravenously (IV).
LY3200882 and Pembrolizumab (Dose Level 2)
EXPERIMENTALParticipants with urothelial carcinoma: LY3200882 administered orally with pembrolizumab administered IV.
LY3200882 and Pembrolizumab Expansion
EXPERIMENTALParticipants with urothelial carcinoma, non-small cell lung cancer, or hepatocellular carcinoma: LY3200882 administered orally twice in combination with pembrolizumab administered IV.
Interventions
LY3200882 administered orally
Pembrolizumab administered IV
Eligibility Criteria
You may qualify if:
- Participants must have received a PD-1 PDLI therapy within 9 weeks of starting dosing on this study \[for example, nivolumab, pembrolizumab, atezolizumab\]
- Participants must be willing to have tumor biopsies
- Participants must have adequate organ function
- Participants must have Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
- Participants must be able to swallow tablets
- Participants with stable, previously treated brain metastases may participate if neurologic symptoms have resolved and participants have been off steroids for at least 14 days
You may not qualify if:
- Participants must not have moderate or severe cardiovascular disease
- Participants must not have active autoimmune disease (for example Crohn's disease, Hashimotos disease, etc)
- Participants must not have an active infection requiring treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (6)
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
CHU de Besancon Hopital Jean Minjoz
Besançon, 25030, France
Gustave Roussy
Villejuif, 94805, France
Institut Catala d'Oncologia
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Clinic I Provincial
Barcelona, 08036, Spain
Hospital Madrid Norte Sanchinarro
Madrid, 28050, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2019
First Posted
November 12, 2019
Study Start
December 5, 2019
Primary Completion
May 11, 2023
Study Completion
May 11, 2023
Last Updated
February 19, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.