A Study of LY3200882 and Pembrolizumab in Participants With Advanced Cancer

February 17, 2020 updated by: Eli Lilly and Company

Phase 1b/2 Study of LY3200882 and Pembrolizumab in Patients With Advanced Cancer

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besancon Cedex, France, 25030
        • CHU de Besancon Hopital Jean Minjoz
      • Villejuif Cedex, France, 94805
        • Gustave Roussy
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic I Provincial
      • Madrid, Spain, 28050
        • Hospital Madrid Norte Sanchinarro
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Institut Catala d'Oncologia
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: LY3200882 and Pembrolizumab (Dose Level 1)
Participants with urothelial carcinoma: LY3200882 administered orally with pembrolizumab administered intravenously (IV).
Drug: LY3200882
LY3200882 administered orally
Drug: Pembrolizumab
Pembrolizumab administered IV
EXPERIMENTAL: LY3200882 and Pembrolizumab (Dose Level 2)
Participants with urothelial carcinoma: LY3200882 administered orally with pembrolizumab administered IV.
Drug: LY3200882
LY3200882 administered orally
Drug: Pembrolizumab
Pembrolizumab administered IV
EXPERIMENTAL: LY3200882 and Pembrolizumab Expansion
Participants with urothelial carcinoma, non-small cell lung cancer, or hepatocellular carcinoma: LY3200882 administered orally twice in combination with pembrolizumab administered IV.
Drug: LY3200882
LY3200882 administered orally
Drug: Pembrolizumab
Pembrolizumab administered IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Dose Limiting Toxicity (DLT)
Time Frame: Up to 6 Weeks
Number of Participants with DLT
Up to 6 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR)
Time Frame: Baseline through Disease Progression or Death (Estimated at up to 12 Months)
ORR: Percentage of Participants with CR or 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
Time Frame: Baseline through Week 13
PK: Cmax of LY3200882 in Combination With Pembrolizumab
Baseline through Week 13
Duration of Response (DoR)
Time Frame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated at up to 12 Months)
DoR
Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated at up to 12 Months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Collaborators

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 5, 2019

Primary Completion (ANTICIPATED)

May 11, 2023

Study Completion (ANTICIPATED)

May 11, 2023

Study Registration Dates

First Submitted

November 7, 2019

First Submitted That Met QC Criteria

November 7, 2019

First Posted (ACTUAL)

November 12, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 19, 2020

Last Update Submitted That Met QC Criteria

February 17, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17387
  • I8X-MC-JECD (OTHER: Eli Lilly and Company)
  • 2019-001156-18 (EUDRACT_NUMBER)
  • KEYNOTE-961 (OTHER: Merck)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Advanced Cancer

Clinical Trials on LY3200882

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe