A Study of LY3200882 and Pembrolizumab in Participants With Advanced Cancer

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-05

Study Completion Date

2023-05-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Advanced Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LY3200882 and Pembrolizumab (Dose Level 1)

Participants with urothelial carcinoma: LY3200882 administered orally with pembrolizumab administered intravenously (IV).

Group Type EXPERIMENTAL

LY3200882

Intervention Type DRUG

LY3200882 administered orally

Pembrolizumab

Intervention Type DRUG

Pembrolizumab administered IV

LY3200882 and Pembrolizumab (Dose Level 2)

Participants with urothelial carcinoma: LY3200882 administered orally with pembrolizumab administered IV.

Group Type EXPERIMENTAL

LY3200882

Intervention Type DRUG

LY3200882 administered orally

Pembrolizumab

Intervention Type DRUG

Pembrolizumab administered IV

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.

Group Type EXPERIMENTAL

LY3200882

Intervention Type DRUG

LY3200882 administered orally

Pembrolizumab

Intervention Type DRUG

Pembrolizumab administered IV

Interventions

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LY3200882

LY3200882 administered orally

Intervention Type DRUG

Pembrolizumab

Pembrolizumab administered IV

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No