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.
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
Interventions
| Drug | Synonyms | Arms |
|---|
| LY3200882 | | LY3200882 and Pembrolizumab (Dose Level 1) |
| Pembrolizumab | | LY3200882 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
| Name | Type | Description | Interventions |
|---|
| LY3200882 and Pembrolizumab (Dose Level 1) | Experimental | Participants with urothelial carcinoma: LY3200882 administered orally with pembrolizumab administered intravenously (IV). | |
| LY3200882 and Pembrolizumab (Dose Level 2) | Experimental | Participants with urothelial carcinoma: LY3200882 administered orally with pembrolizumab administered IV. | |
| LY3200882 and Pembrolizumab Expansion | Experimental | Participants with urothelial carcinoma, non-small cell lung cancer, or hepatocellular carcinoma: LY3200882 administered orally twice in combination with pembrolizumab administered IV. | |
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: | Withdrawn |
| 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
February 19, 2020
