Completed

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

H9H-MC-JBEF - ClinicalTrials.gov - NCT02423343

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), hepatocellular carcinoma (HCC) or glioblastoma.
How long will I be in the trial?
Your participation in this trial could last up to 4 months depending on how you and your tumor respond.
Email
Completed

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

H9H-MC-JBEF - ClinicalTrials.gov - NCT02423343

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), hepatocellular carcinoma (HCC) or glioblastoma.
How long will I be in the trial?
Your participation in this trial could last up to 4 months depending on how you and your tumor respond.
Email

Key Requirements

Age :

18+

Sex:

All

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18+

Sex

All

Participants must

For the Phase 1b part of the trial, participants must have advanced refractory solid tumors in any line of therapy. For the Phase 2 part of the trial, participants must have recurrent or refractory NSCLC or HCC with elevated alpha-fetoprotein (AFP), or glioblastoma tumor type

Participants with NSCLC prior lines of therapy must include a platinum-based therapy

Participants with NSCLC must have completed neo-adjuvant or adjuvant therapy with a platinum doublet and have experienced disease recurrence within 6 months of completing the platinum doublet

Participants with HCC must have Child-Pugh A only

Participants with HCC must have had: one prior line of therapy which included sorafenib or have progressed or if not eligible for transarterial chemoembolization, were intolerant to sorafenib

Participants with HCC may have had sorafenib for locally advanced disease or are intolerant to sorafenib. Participants may have had clinical progression only following sorafenib or local therapy

Participants with Glioblastoma (GB) must have had previous first line of therapy with at least radiotherapy and temozolomide except for participants with O6-methylguanine-DNA methyltransferase (MGMT) unmethylated newly diagnosed GB. Participants with MGMT unmethylated newly diagnosed GB may have received radiation therapy only

Any participant must have adequate organ function

Any participant must use an approved contraceptive method

Participants must NOT

Any participant must not have moderate or severe cardiovascular disease

Trial Summary

Conditions the trial is for

Solid Tumor, Non-small Cell Lung Cancer, Glioblastoma

What the trial is testing?

Galunisertib, Nivolumab

Could I receive a Placebo?

no

Enrollment Goal

100

Trial Dates

January 2015 - July 2020

Trial Phase

1

Enter your postal code to find the nearest site

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18+

Sex

All

Participants must

For the Phase 1b part of the trial, participants must have advanced refractory solid tumors in any line of therapy. For the Phase 2 part of the trial, participants must have recurrent or refractory NSCLC or HCC with elevated alpha-fetoprotein (AFP), or glioblastoma tumor type

Participants with NSCLC prior lines of therapy must include a platinum-based therapy

Participants with NSCLC must have completed neo-adjuvant or adjuvant therapy with a platinum doublet and have experienced disease recurrence within 6 months of completing the platinum doublet

Participants with HCC must have Child-Pugh A only

Participants with HCC must have had: one prior line of therapy which included sorafenib or have progressed or if not eligible for transarterial chemoembolization, were intolerant to sorafenib

Participants with HCC may have had sorafenib for locally advanced disease or are intolerant to sorafenib. Participants may have had clinical progression only following sorafenib or local therapy

Participants with Glioblastoma (GB) must have had previous first line of therapy with at least radiotherapy and temozolomide except for participants with O6-methylguanine-DNA methyltransferase (MGMT) unmethylated newly diagnosed GB. Participants with MGMT unmethylated newly diagnosed GB may have received radiation therapy only

Any participant must have adequate organ function

Any participant must use an approved contraceptive method

Participants must NOT

Any participant must not have moderate or severe cardiovascular disease

Trial Summary

Conditions the trial is for

Solid Tumor, Non-small Cell Lung Cancer, Glioblastoma

What the trial is testing?

Galunisertib, Nivolumab

Could I receive a Placebo?

no

Enrollment Goal

100

Trial Dates

January 2015 - July 2020

Trial Phase

1

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Trial Locations

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Resources

Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?