Advanced Cancer
Conditions
Keywords
TGF-beta, Urothelial carcinoma, Hepatocellular carcinoma, Non-small cell lung cancer, TGF- beta receptor type I inhibitor
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.
Interventions
DRUGLY3200882
LY3200882 administered orally
DRUGPembrolizumab
Pembrolizumab administered IV
Sponsors
Merck Sharp & Dohme LLC
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Dose Limiting Toxicity (DLT) | Up to 6 Weeks | Number of Participants with DLT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
France, Spain, United States
Outcome results
None listed