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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04158700
Other study ID # 17387
Secondary ID I8X-MC-JECD2019-
Status Withdrawn
Phase Phase 1/Phase 2
First received
Last updated
Start date December 5, 2019
Est. completion date May 11, 2023

Study information

Verified date February 2020
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 11, 2023
Est. primary completion date May 11, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
LY3200882
LY3200882 administered orally
Pembrolizumab
Pembrolizumab administered IV

Locations

Country Name City State
France CHU de Besancon Hopital Jean Minjoz Besancon Cedex
France Gustave Roussy Villejuif Cedex
Spain Hospital Clinic I Provincial Barcelona
Spain Institut Catala d'Oncologia L'Hospitalet de Llobregat Barcelona
Spain Hospital Madrid Norte Sanchinarro Madrid
United States Dana Farber Cancer Institute Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Eli Lilly and Company Merck Sharp & Dohme Corp.

Countries where clinical trial is conducted

United States,  France,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with Dose Limiting Toxicity (DLT) Number of Participants with DLT Up to 6 Weeks
Secondary Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR) ORR: Percentage of Participants with CR or PR Baseline through Disease Progression or Death (Estimated at up to 12 Months)
Secondary Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3200882 in Combination With Pembrolizumab PK: Cmax of LY3200882 in Combination With Pembrolizumab Baseline through Week 13
Secondary Duration of Response (DoR) DoR Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated at up to 12 Months)
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