Clinical Trials /

A Study of LY3200882 and Pembrolizumab in Participants With Advanced Cancer

NCT04158700

Description:

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.

Related Conditions:
  • Hepatocellular Carcinoma
  • Non-Small Cell Lung Carcinoma
  • Urothelial Carcinoma
Recruiting Status:

Withdrawn

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of LY3200882 and Pembrolizumab in Participants With Advanced Cancer
  • Official Title: Phase 1b/2 Study of LY3200882 and Pembrolizumab in Patients With Advanced Cancer

Clinical Trial IDs

  • ORG STUDY ID: 17387
  • SECONDARY ID: I8X-MC-JECD
  • SECONDARY ID: 2019-001156-18
  • SECONDARY ID: KEYNOTE-961
  • NCT ID: NCT04158700

Conditions

  • Advanced Cancer

Interventions

DrugSynonymsArms
LY3200882LY3200882 and Pembrolizumab (Dose Level 1)
PembrolizumabLY3200882 and Pembrolizumab (Dose Level 1)

Purpose

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 Arms

NameTypeDescriptionInterventions
LY3200882 and Pembrolizumab (Dose Level 1)ExperimentalParticipants with urothelial carcinoma: LY3200882 administered orally with pembrolizumab administered intravenously (IV).
  • LY3200882
  • Pembrolizumab
LY3200882 and Pembrolizumab (Dose Level 2)ExperimentalParticipants with urothelial carcinoma: LY3200882 administered orally with pembrolizumab administered IV.
  • LY3200882
  • Pembrolizumab
LY3200882 and Pembrolizumab ExpansionExperimentalParticipants with urothelial carcinoma, non-small cell lung cancer, or hepatocellular carcinoma: LY3200882 administered orally twice in combination with pembrolizumab administered IV.
  • LY3200882
  • Pembrolizumab

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

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

Secondary Outcome Measures

Measure: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)
Safety Issue:
Description:ORR: Percentage of Participants with CR or PR
Measure:Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3200882 in Combination With Pembrolizumab
Time Frame:Baseline through Week 13
Safety Issue:
Description:PK: Cmax of LY3200882 in Combination With Pembrolizumab
Measure: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)
Safety Issue:
Description:DoR

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Eli Lilly and Company

Trial Keywords

  • TGF-beta
  • Urothelial carcinoma
  • Hepatocellular carcinoma
  • Non-small cell lung cancer
  • TGF- beta receptor type I inhibitor

Last Updated

December 15, 2019