Clinical trial NCT04158700: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Advanced Cancer
Keywords: TGF-beta
Urothelial carcinoma
Hepatocellular carcinoma
Non-small cell lung cancer
TGF- beta receptor type I inhibitor
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2019-11-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants with Dose Limiting Toxicity (DLT)
timeFrame: Up to 6 Weeks
Secondary outcomes:
measure: Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR)
timeFrame: Baseline through Disease Progression or Death (Estimated at up to 12 Months)
measure: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3200882 in Combination With Pembrolizumab
timeFrame: Baseline through Week 13
measure: Duration of Response (DoR)
timeFrame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated at up to 12 Months)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Besancon Cedex
country: France
facility: CHU de Besancon Hopital Jean Minjoz
city: Villejuif Cedex
country: France
facility: Gustave Roussy
city: L'Hospitalet de Llobregat
country: Spain
facility: Institut Catala d'Oncologia
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial
city: Madrid
country: Spain
facility: Hospital Madrid Norte Sanchinarro
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: