Advanced Cancer Clinical Trial
Official title:
Phase 1b/2 Study of LY3200882 and Pembrolizumab in Patients With Advanced Cancer
| Verified date | February 2020 |
| Source | Eli Lilly and Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | May 11, 2023 |
| Est. primary completion date | May 11, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU de Besancon Hopital Jean Minjoz | Besancon Cedex | |
| France | Gustave Roussy | Villejuif Cedex | |
| Spain | Hospital Clinic I Provincial | Barcelona | |
| Spain | Institut Catala d'Oncologia | L'Hospitalet de Llobregat | Barcelona |
| Spain | Hospital Madrid Norte Sanchinarro | Madrid | |
| United States | Dana Farber Cancer Institute | Boston | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company | Merck Sharp & Dohme Corp. |
United States, France, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants with Dose Limiting Toxicity (DLT) | Number of Participants with DLT | Up to 6 Weeks | |
| Secondary | Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR) | ORR: Percentage of Participants with CR or PR | Baseline through Disease Progression or Death (Estimated at up to 12 Months) | |
| Secondary | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3200882 in Combination With Pembrolizumab | PK: Cmax of LY3200882 in Combination With Pembrolizumab | Baseline through Week 13 | |
| Secondary | Duration of Response (DoR) | DoR | Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated at up to 12 Months) |
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