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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02572687
Recruitment Status : Active, not recruiting
First Posted : October 9, 2015
Last Update Posted : June 17, 2020
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE October 7, 2015
First Posted Date  ICMJE October 9, 2015
Last Update Posted Date June 17, 2020
Actual Study Start Date  ICMJE February 19, 2016
Actual Primary Completion Date March 27, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2015)
Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (up to 28 days) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2015)
  • 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) ]
  • 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) ]
  • 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) ]
  • Time to First Response (TTR) [ Time Frame: Baseline to Date of CR or PR (Approximately 22 Months) ]
  • Progression Free Survival (PFS) [ Time Frame: Baseline to Progressive Disease or Death from Any Cause (Approximately 22 Months) ]
  • Overall Survival (OS) [ Time Frame: Baseline to Progressive Disease or Death from Any Cause (Approximately 32 Months) ]
  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ramucirumab and MEDI4736 [ Time Frame: Predose Cycle 1 Day 1 through Follow Up (Approximately 22 Months) ]
  • PK: Minimum Concentration (Cmin) of Ramucirumab and MEDI4736 [ Time Frame: Predose Cycle 1 Day 1 through Follow up (Approximately 22 Months) ]
  • Number of Participants with Treatment Emergent Anti Ramucirumab Antibodies [ Time Frame: Predose Cycle 1 Day 1 through Follow Up (Approximately 22 Months) ]
  • Number of Participants with Treatment Emergent Anti MEDI4736 Antibodies [ Time Frame: Predose Cycle 1 Day 1 through Follow Up (Approximately 22 Months) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Ramucirumab (LY3009806) Plus MEDI4736 in Participants With Advanced Gastrointestinal or Thoracic Malignancies
Official Title  ICMJE An Open-Label, Multicenter, Phase 1 Study of Ramucirumab Plus MEDI4736 in Patients With Locally Advanced and Unresectable or Metastatic Gastrointestinal or Thoracic Malignancies
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Gastric Cancer
  • Gastroesophageal Junction Adenocarcinoma
  • Non-Small Cell Lung Cancer
  • Hepatocellular Carcinoma
Intervention  ICMJE
  • Drug: Ramucirumab
    Administered IV
    Other Names:
    • LY3009806
    • IMC-11121B
    • Cyramza
  • Drug: MEDI4736
    Administered IV
Study Arms  ICMJE
  • 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.

    Interventions:
    • Drug: Ramucirumab
    • Drug: MEDI4736
  • 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.

    Interventions:
    • Drug: Ramucirumab
    • Drug: MEDI4736
  • 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.

    Interventions:
    • Drug: Ramucirumab
    • Drug: MEDI4736
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 8, 2015)
114
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 30, 2021
Actual Primary Completion Date March 27, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   Israel,   Italy,   Korea, Republic of,   Spain,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02572687
Other Study ID Numbers  ICMJE 16116
I4T-MC-JVDJ ( Other Identifier: Eli Lilly and Company )
2015-003013-14 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE AstraZeneca
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date June 15, 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP