309 Participants Needed

Ramucirumab/Merestinib + Chemotherapy for Biliary Tract Cancer

Recruiting at 161 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Eli Lilly and Company
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The main purpose of this study is to evaluate the efficacy and safety of ramucirumab or merestinib or placebo plus cisplatin and gemcitabine in participants with advanced or metastatic biliary tract cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since previous systemic therapy for advanced or metastatic disease is not allowed, you may need to discuss your current medications with the trial team.

Is the combination of Ramucirumab/Merestinib with chemotherapy safe for humans?

The combination of Ramucirumab with chemotherapy has been studied in patients with advanced biliary tract cancer and showed no unexpected safety issues, aligning with previous safety reports for other conditions.12345

How is the drug combination of Ramucirumab and Merestinib with chemotherapy unique for treating biliary tract cancer?

This treatment is unique because it combines Ramucirumab, which targets VEGFR-2 to block blood vessel growth in tumors, with Merestinib and standard chemotherapy, potentially offering a new approach for advanced biliary tract cancer, which has limited treatment options.13467

What data supports the effectiveness of the drug combination Ramucirumab/Merestinib with chemotherapy for biliary tract cancer?

A study evaluated the addition of ramucirumab or merestinib to standard chemotherapy for advanced biliary tract cancer, aiming to assess their effectiveness and safety. Another study found that ramucirumab, which targets a protein involved in blood vessel growth in tumors, was investigated for its potential benefits in advanced biliary tract cancer previously treated with chemotherapy.12367

Who Is on the Research Team?

C1

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Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic biliary tract cancer who haven't had previous systemic therapy for their condition. They must be relatively healthy and active (with good performance status), have measurable disease, provide tissue samples, have proper organ function and biliary drainage, and use effective contraception if of childbearing potential.

Inclusion Criteria

My cancer is a type of biliary tract cancer that cannot be surgically removed.
Have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST)
My organs are functioning well.
See 5 more

Exclusion Criteria

I have had cancer or have another cancer besides the one being studied.
I expect to undergo a major surgery during the study.
I do not have severe health issues unrelated to my cancer that could risk my life.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ramucirumab or merestinib or placebo plus cisplatin and gemcitabine for up to 8 cycles

24 weeks
Visits every 21 days (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 months

What Are the Treatments Tested in This Trial?

Interventions

  • Merestinib
  • Ramucirumab
Trial Overview The study tests the effectiveness and safety of two drugs: Ramucirumab or Merestinib, each combined with Cisplatin and Gemcitabine chemotherapy. Participants will also receive either a placebo pill or IV to compare against these treatments.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Placebo Group
Group I: 80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² GemcitabineExperimental Treatment3 Interventions
Group II: 8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² GemcitabineExperimental Treatment3 Interventions
Group III: Placebo Oral + 25 mg/m² Cisplatin + 1000 mg/m² GemcitabinePlacebo Group3 Interventions
Group IV: Placebo IV + 25 mg/m² Cisplatin + 1000 mg/m² GemcitabinePlacebo Group3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Published Research Related to This Trial

In a study involving 117 patients with advanced biliary tract cancer, rising levels of circulating VEGFA were linked to worse progression-free survival (PFS) and overall survival (OS) in those treated with cisplatin/gemcitabine, but this negative effect was reduced in patients receiving cediranib.
The study found that increases in circulating CK18 and VEGFR2 levels were associated with poorer outcomes, suggesting these markers could help predict patient prognosis and treatment response, highlighting the potential for using minimally invasive biomarkers in managing advanced biliary tract cancer.
Circulating biomarkers during treatment in patients with advanced biliary tract cancer receiving cediranib in the UK ABC-03 trial.Backen, AC., Lopes, A., Wasan, H., et al.[2022]
In a phase I/II trial involving 41 patients with untreated advanced biliary tract cancer, the maximum tolerated dose (MTD) of binimetinib was established at 45 mg twice daily when combined with gemcitabine and cisplatin, showing a median overall survival of 13.3 months.
Despite the treatment regimen, the combination of binimetinib with chemotherapy did not improve progression-free survival (PFS) or response rate (RR), suggesting that molecular profiling may be necessary to identify patients who could benefit from this therapy.
Binimetinib plus Gemcitabine and Cisplatin Phase I/II Trial in Patients with Advanced Biliary Cancers.Lowery, MA., Bradley, M., Chou, JF., et al.[2022]

Citations

Addition of ramucirumab or merestinib to standard first-line chemotherapy for locally advanced or metastatic biliary tract cancer: a randomised, double-blind, multicentre, phase 2 study. [2023]
Circulating biomarkers during treatment in patients with advanced biliary tract cancer receiving cediranib in the UK ABC-03 trial. [2022]
Binimetinib plus Gemcitabine and Cisplatin Phase I/II Trial in Patients with Advanced Biliary Cancers. [2022]
New Treatment Options for Advanced Biliary Tract Cancer. [2021]
Phase II Study of Ramucirumab in Advanced Biliary Tract Cancer Previously Treated By Gemcitabine-Based Chemotherapy. [2023]
Cediranib or placebo in combination with cisplatin and gemcitabine chemotherapy for patients with advanced biliary tract cancer (ABC-03): a randomised phase 2 trial. [2022]
Ramucirumab Plus Pembrolizumab in Patients with Previously Treated Advanced or Metastatic Biliary Tract Cancer: Nonrandomized, Open-Label, Phase I Trial (JVDF). [2023]
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