A Study of LY3200882 and Pembrolizumab in Participants With Advanced Cancer

Lilly

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Advanced Cancer

Treatments: Drug: Pembrolizumab; Drug: LY3200882

Study type: Interventional

Funder types: Industry

Identifiers

NCT04158700

2019-001156-18 (EudraCT Number)

17387

KEYNOTE-961 (Other Identifier)

I8X-MC-JECD (Other Identifier)

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

LY3200882 and Pembrolizumab (Dose Level 1)

Experimental group

Description:

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

Treatment:

Drug: Pembrolizumab

Drug: LY3200882

LY3200882 and Pembrolizumab (Dose Level 2)

Experimental group

Description:

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

Treatment:

Drug: Pembrolizumab

Drug: LY3200882

LY3200882 and Pembrolizumab Expansion

Experimental group

Description:

Participants with urothelial carcinoma, non-small cell lung cancer, or hepatocellular carcinoma: LY3200882 administered orally twice in combination with pembrolizumab administered IV.

Treatment:

Drug: Pembrolizumab

Drug: LY3200882