A Study of LY3200882 and Pembrolizumab in Participants With Advanced Cancer

Phase 1

Withdrawn

• Conditions: Advanced Cancer
• Interventions: Drug: LY3200882; Drug: Pembrolizumab

• Registration Number: NCT04158700
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-11-07
• Study First Submitted QC: 2019-11-07
• Study First Posted: 2019-11-12
• Study Start: 2019-12-05
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-17
• Last Update Posted: 2020-02-19
• Primary Completion: 2023-05-11
• Study Completion: 2023-05-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Participants with Dose Limiting Toxicity (DLT)	Up to 6 Weeks	Number of Participants with DLT

Secondary Outcome Measures

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

Trial Locations

Locations (6)

Institut Catala d'Oncologia; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Madrid Norte Sanchinarro; 🇪🇸 Madrid, Spain

Hospital Clinic I Provincial; 🇪🇸 Barcelona, Spain

CHU de Besancon Hopital Jean Minjoz; 🇫🇷 Besancon Cedex, France

Gustave Roussy; 🇫🇷 Villejuif Cedex, France

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States