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A Study of LY3200882 and Pembrolizumab in Participants With Advanced Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04158700
Recruitment Status : Withdrawn (The withdrawal is due to a strategic realignment and is not related to any particular safety or efficacy concern.)
First Posted : November 12, 2019
Last Update Posted : February 19, 2020
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: LY3200882 Drug: Pembrolizumab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1b/2 Study of LY3200882 and Pembrolizumab in Patients With Advanced Cancer
Estimated Study Start Date : December 5, 2019
Estimated Primary Completion Date : May 11, 2023
Estimated Study Completion Date : May 11, 2023


Arm Intervention/treatment
Experimental: LY3200882 and Pembrolizumab (Dose Level 1)
Participants with urothelial carcinoma: LY3200882 administered orally with pembrolizumab administered intravenously (IV).
Drug: LY3200882
LY3200882 administered orally

Drug: Pembrolizumab
Pembrolizumab administered IV

Experimental: LY3200882 and Pembrolizumab (Dose Level 2)
Participants with urothelial carcinoma: LY3200882 administered orally with pembrolizumab administered IV.
Drug: LY3200882
LY3200882 administered orally

Drug: Pembrolizumab
Pembrolizumab administered IV

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

Drug: Pembrolizumab
Pembrolizumab administered IV




Primary Outcome Measures :
  1. Number of Participants with Dose Limiting Toxicity (DLT) [ Time Frame: Up to 6 Weeks ]
    Number of Participants with DLT


Secondary Outcome Measures :
  1. 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) ]
    ORR: Percentage of Participants with CR or PR

  2. Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3200882 in Combination With Pembrolizumab [ Time Frame: Baseline through Week 13 ]
    PK: Cmax of LY3200882 in Combination With Pembrolizumab

  3. 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) ]
    DoR



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158700


Locations
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United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
France
CHU de Besancon Hopital Jean Minjoz
Besancon Cedex, France, 25030
Gustave Roussy
Villejuif Cedex, France, 94805
Spain
Institut Catala d'Oncologia
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Clinic I Provincial
Barcelona, Spain, 08036
Hospital Madrid Norte Sanchinarro
Madrid, Spain, 28050
Sponsors and Collaborators
Eli Lilly and Company
Merck Sharp & Dohme Corp.
Investigators
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Study Director: 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) Eli Lilly and Company
Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04158700    
Other Study ID Numbers: 17387
I8X-MC-JECD ( Other Identifier: Eli Lilly and Company )
2019-001156-18 ( EudraCT Number )
KEYNOTE-961 ( Other Identifier: Merck )
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
TGF-beta
Urothelial carcinoma
Hepatocellular carcinoma
Non-small cell lung cancer
TGF- beta receptor type I inhibitor
Additional relevant MeSH terms:
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Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents