A Study of Galunisertib (LY2157299) in Combination With Nivolumab in Advanced Refractory Solid Tumors and in Recurrent or Refractory NSCLC, or Hepatocellular Carcinoma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Eli Lilly and Company
Study ID
NCT02423343
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Hepatocellular Carcinoma Recurrent
  • Non-Small Cell Lung Cancer Recurrent
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Galunisertib — DRUG
    Administered orally
  • Nivolumab — DRUG
    Administered IV

Study Details

The main purpose of this study is to evaluate the safety, tolerability, and efficacy of the study drug known as galunisertib in combination with nivolumab in participants with advanced refractory solid tumors and in recurrent or refractory non-small cell lung cancer (NSCLC) or hepatocellular carcinoma (HCC).

Key Dates

Start date
Jan 1, 2015
Status verified
Aug 2021
Primary completion
Dec 13, 2018
Completion
Jul 8, 2020

Study Design

Enrollment
41 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Galunisertib + Nivolumab (Cohort 1) Phase 1b
    50 milligrams (mg) Galunisertib administered orally once daily (QD) on Day 1 through Day 14 of each 4-week cycle in combination with 3 milligrams per kilogram (3 mg/kg) nivolumab given intravenously (IV), every 2 weeks (Q2W), (Day 1 and Day 15). Participants may continue to receive study drug until discontinuation criteria are met.
  • Experimental: Galunisertib + Nivolumab (Cohort 2) Phase 1b
    50 mg Galunisertib administered orally twice daily (BID) on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV, Q2W,(Day 1 and Day 15). Participants may continue to receive study drug until discontinuation criteria are met.
  • Experimental: Galunisertib + Nivolumab (Cohort 3) Phase 1b
    80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV, Q2W, (Day 1 and Day 15). Participants may continue to receive study drug until discontinuation criteria are met.
  • Experimental: Galunisertib + Nivolumab (Cohort 4) Phase 1b
    150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV, Q2W,(Day 1 and Day 15). Participants may continue to receive study drug until discontinuation criteria are met.
  • Experimental: Galunisertib + Nivolumab - Non-small Cell Lung Cancer (NSCLC) Phase 2
    150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV, Q2W, (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
  • Experimental: Galunisertib + Nivolumab - Hepatocellular Carcinoma (HCC) Phase 2
    150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV, Q2W, (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.

Primary Outcome Measure

Phase 1b: Maximum Tolerated Dose (MTD) of Galunisertib in Combination With Nivolumab [ Time Frame: Cycle 1 through Cycle 2 (Up to 2 Months) ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham Medical CenterBirminghamAlabama35294-
University of California - San DiegoLa JollaCalifornia92093-
H Lee Moffitt Cancer CenterTampaFlorida33612-9497-
Dana Farber Cancer InstituteBostonMassachusetts02215-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham Medical Center· Birmingham, ALUniversity of California - San Diego· La Jolla, CAH Lee Moffitt Cancer Center· Tampa, FLDana Farber Cancer Institute· Boston, MAUniversity of Texas MD Anderson Cancer Center· Houston, TX

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