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

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ClinicalTrials.gov Identifier: NCT02572687
Recruitment Status : Active, not recruiting
First Posted : October 9, 2015
Last Update Posted : April 18, 2018
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Gastric Cancer Gastroesophageal Junction Adenocarcinoma Non-Small Cell Lung Cancer Hepatocellular Carcinoma Drug: Ramucirumab Drug: MEDI4736 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : February 2016
Actual Primary Completion Date : March 27, 2018
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ramucirumab + MEDI4736 (NSCLC)

In phase 1a (DLT phase), ramucirumab plus MEDI4736 given intravenously (IV) every 3 weeks (q3w) of a 21 day treatment cycle. Participants may continue to receive study treatment until discontinuation criteria are met.

In phase 1b (expansion phase), ramucirumab plus MEDI4736 given IV q3w. Participants may continue to receive study treatment until discontinuation criteria are met.

Drug: Ramucirumab
Administered IV
Other Names:
  • LY3009806
  • IMC-11121B
  • Cyramza

Drug: MEDI4736
Administered IV

Experimental: Ramucirumab + MEDI4736 (Gastric/GEJ)

In phase 1a (DLT phase), ramucirumab plus MEDI4736 given IV every 2 weeks (q2w) of a 28 day treatment cycle. Participants may continue to receive study treatment until discontinuation criteria are met.

In phase 1b (expansion phase), ramucirumab plus MEDI4736 given IV q2w. Participants may continue to receive study treatment until discontinuation criteria are met.

Drug: Ramucirumab
Administered IV
Other Names:
  • LY3009806
  • IMC-11121B
  • Cyramza

Drug: MEDI4736
Administered IV

Experimental: Ramucirumab + MEDI4736 (HCC)

In phase 1a (DLT phase), ramucirumab plus MEDI4736 given IV q2w of a 28 day treatment cycle. Participants may continue to receive study treatment until discontinuation criteria are met.

In phase 1b (expansion phase), ramucirumab plus MEDI4736 given IV q2w. Participants may continue to receive study treatment until discontinuation criteria are met.

Drug: Ramucirumab
Administered IV
Other Names:
  • LY3009806
  • IMC-11121B
  • Cyramza

Drug: MEDI4736
Administered IV




Primary Outcome Measures :
  1. Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (up to 28 days) ]

Secondary Outcome Measures :
  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) ]


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:

  • 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

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): NCT02572687


  Show 28 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
AstraZeneca
Investigators
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:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02572687     History of Changes
Other Study ID Numbers: 16116
I4T-MC-JVDJ ( Other Identifier: Eli Lilly and Company )
2015-003013-14 ( EudraCT Number )
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

Keywords provided by Eli Lilly and Company:
metastatic
advanced
immuno-oncology
vascular endothelial growth factor (VEGF)
angiogenesis
PD-1
PD-L1

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Carcinoma, Hepatocellular
Stomach Neoplasms
Esophageal Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Antibodies, Monoclonal
Ramucirumab
Immunologic Factors
Physiological Effects of Drugs