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 :
Completed
First Posted : October 9, 2015
Last Update Posted : January 20, 2021
|
Sponsor:
Eli Lilly and Company
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Eli Lilly and Company
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 : | 85 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 |
| Actual Study Start Date : | February 19, 2016 |
| Actual Primary Completion Date : | March 27, 2018 |
| Actual Study Completion Date : | January 13, 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
| 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:
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:
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:
Drug: MEDI4736 Administered IV |
Primary Outcome Measures :
- Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (up to 28 days) ]
Secondary Outcome Measures :
- 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) ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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
Locations
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 |
| 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: | January 20, 2021 |
| Last Verified: | January 2021 |
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:
|
Adenocarcinoma Carcinoma, Hepatocellular Neoplasms by Site Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Liver Neoplasms Digestive System Neoplasms Digestive System Diseases |
Liver Diseases Durvalumab Ramucirumab Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |