Skip to main content
OpenTrials
Completed

NCT Number: NCT02572687

A Study of Ramucirumab (LY3009806) Plus MEDI4736 in Participants With Advanced Gastrointestinal or Thoracic Malignancies

The main purpose of this study is to evaluate the safety of ramucirumab plus MEDI4736 in participants with locally advanced and unresectable or metastatic gastrointestinal or thoracic malignancies including gastric or gastroesophageal junction (GEJ) adenocarcinoma, non-small cell lung cancer (NSCLC), or hepatocellular carcinoma (HCC).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastric Cancer Adenocarcinoma Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Hepatocellular Carcinoma, Non-Small-Cell Lung Digestive System Diseases Digestive System Neoplasms Gastroesophageal Junction Adenocarcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Hepatocellular Carcinoma Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Processes Non-small Cell Lung Cancer Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Stomach Diseases Stomach Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Besançon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Measurable metastatic disease or locally advanced and unresectable disease
  • Has histopathologically confirmed gastric or GEJ adenocarcinoma with documented disease progression after 1-2 prior lines of systemic therapy
  • Has histopathologically confirmed nonsquamous or squamous NSCLC with documented disease progression after 1-3 prior lines of systemic therapy
  • Has histopathologically or cytologically confirmed HCC, Child-Pugh Class A, with documented disease progression during or after discontinuation of sorafenib therapy, or intolerance of sorafenib therapy, and an α-fetoprotein (AFP) ≥ 1.5x upper limit of normal
  • Availability of tumor tissue for biomarker analysis
  • Has an Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • Has adequate organ function

Exclusion criteria

  • Has known brain metastases
  • Has a history of prior cancers not included in this study that were either not treated with curative intent or have been active within the past 5 years
  • History of allogeneic organ transplant
  • Has active or prior documented autoimmune disease within the past 24 months
  • Has human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related illness, or a history of immunodeficiency
  • Has active hepatitis B or hepatitis C infection, or co-infection with both hepatitis B and C virus
  • For gastric/GEJ and NSCLC participants, has chronic hepatitis B or hepatitis C infection. (For HCC participants, those with chronic hepatitis B virus [HBV] infection with a negative HBV deoxyribonucleic acid [DNA] test and who are on antiviral therapy, and those with chronic hepatitis C virus [HCV] infection are eligible)
  • Has a history of interstitial lung disease, idiopathic pulmonary fibrosis, pneumoconiosis, non-infections pneumonitis, radiation-induced or drug-induced pneumonitis
  • Has received any previous systemic therapy targeting programmed death (PD) 1 or PD-ligand 1/2 signaling pathways, and other immune checkpoint inhibitors
  • Have received previous systemic therapy with ramucirumab

Treatment and study plan

Ramucirumab

Drug

Administered IV

Other names: LY3009806, IMC-11121B, Cyramza

MEDI4736

Drug

Administered IV

Primary outcomes

  1. Number of Participants with Dose Limiting Toxicities (DLTs)

    Time frame: Cycle 1 (up to 28 days)

Secondary outcomes

  1. Percentage of Participants with a Best Response of Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR)

    Time frame: Baseline to Disease Progression (Approximately 22 Months)

  2. Proportion of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR)

    Time frame: Baseline to Disease Progression (Approximately 22 Months)

  3. Duration of Response (DoR)

    Time frame: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Approximately 22 Months)

  4. Time to First Response (TTR)

    Time frame: Baseline to Date of CR or PR (Approximately 22 Months)

  5. Progression Free Survival (PFS)

    Time frame: Baseline to Progressive Disease or Death from Any Cause (Approximately 22 Months)

  6. Overall Survival (OS)

    Time frame: Baseline to Progressive Disease or Death from Any Cause (Approximately 32 Months)

  7. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ramucirumab and MEDI4736

    Time frame: Predose Cycle 1 Day 1 through Follow Up (Approximately 22 Months)

  8. PK: Minimum Concentration (Cmin) of Ramucirumab and MEDI4736

    Time frame: Predose Cycle 1 Day 1 through Follow up (Approximately 22 Months)

  9. Number of Participants with Treatment Emergent Anti Ramucirumab Antibodies

    Time frame: Predose Cycle 1 Day 1 through Follow Up (Approximately 22 Months)

  10. Number of Participants with Treatment Emergent Anti MEDI4736 Antibodies

    Time frame: Predose Cycle 1 Day 1 through Follow Up (Approximately 22 Months)

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • AstraZeneca

Registry information

Official study title

An Open-Label, Multicenter, Phase 1 Study of Ramucirumab Plus MEDI4736 in Patients With Locally Advanced and Unresectable or Metastatic Gastrointestinal or Thoracic Malignancies

Important dates

Study start
2016
Primary completion
2018
Study completion
2021
First posted
Oct 9, 2015
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.