Gastric CancerPhase 1NCT02572687
A Study of Ramucirumab (LY3009806) Plus MEDI4736 in Participants With Advanced Gastrointestinal or Thoracic Malignancies
A Phase 1 study testing Ramucirumab and MEDI4736 in people with Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by Eli Lilly and Company at 28 sites in 8 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Non-Small Cell Lung Cancer
- What is being tested?
- Ramucirumab and MEDI4736
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 28 sitesin 8 countries
- Study dates
- 19 Feb 2016to 13 Jan 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
28 sites in 8 countries.
28 sites in 8 countries
United States7 sites
Johns Hopkins University
Baltimore, Maryland, 21231
Carolinas Medical Center
Charlotte, North Carolina, 28204
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-6307
The Miriam Hospital
Providence, Rhode Island, 02906
UCLA Medical Center
Santa Monica, California, 90404
Washington University Medical Center
St Louis, Missouri, 63110
France4 sites
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, 25030
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Marseille, 13385
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Montpellier, 34298
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Saint-Etienne, 42055
South Korea4 sites
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Seoul, 03080
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Seoul, 03722
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Seoul, 05505
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Seoul, 06351
Taiwan4 sites
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Tainan, 70403
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Tainan, 704
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Tainan, 73657
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Taipei, 10048
Israel3 sites
Hadassah Medical Center - Ein Karem
Jerusalem, 9112001
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.
Ramat Gan, 5266202
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Tel Aviv, 6423906
Spain3 sites
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Madrid, 28040
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Málaga, 29010
Hospital Virgen del Rocío
Seville, 41013
Italy2 sites
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.
Milan, 20133
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Rozzano, 20089
Germany1 site
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.
Großhansdorf, 22927
About this study
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
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).
- Conditions
- Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Non-Small Cell Lung Cancer, Hepatocellular Carcinoma
- Being tested
- Ramucirumab, MEDI4736
- Keywords
- metastatic, advanced, immuno-oncology, vascular endothelial growth factor (VEGF), angiogenesis, PD-1, PD-L1
- Medical subject headings
- Stomach Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Hepatocellular, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamucirumabDrug
Also called LY3009806, IMC-11121B, Cyramza
Administered IV
MEDI4736Drug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| Ramucirumab + MEDI4736 (NSCLC) | Experimental | 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. Receives: Drug: Ramucirumab; Drug: MEDI4736 |
| Ramucirumab + MEDI4736 (Gastric/GEJ) | Experimental | 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. Receives: Drug: Ramucirumab; Drug: MEDI4736 |
| Ramucirumab + MEDI4736 (HCC) | Experimental | 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. Receives: Drug: Ramucirumab; Drug: MEDI4736 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Dose Limiting Toxicities (DLTs)
Measured: Cycle 1 (up to 28 days)
Secondary outcomes (10)
Percentage of Participants with a Best Response of Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR)
Measured: 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)
Measured: Baseline to Disease Progression (Approximately 22 Months)
Duration of Response (DoR)
Measured: 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)
Measured: Baseline to Date of CR or PR (Approximately 22 Months)
Progression Free Survival (PFS)
Measured: Baseline to Progressive Disease or Death from Any Cause (Approximately 22 Months)
Overall Survival (OS)
Measured: Baseline to Progressive Disease or Death from Any Cause (Approximately 32 Months)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ramucirumab and MEDI4736
Measured: Predose Cycle 1 Day 1 through Follow Up (Approximately 22 Months)
PK: Minimum Concentration (Cmin) of Ramucirumab and MEDI4736
Measured: Predose Cycle 1 Day 1 through Follow up (Approximately 22 Months)
Number of Participants with Treatment Emergent Anti Ramucirumab Antibodies
Measured: Predose Cycle 1 Day 1 through Follow Up (Approximately 22 Months)
Number of Participants with Treatment Emergent Anti MEDI4736 Antibodies
Measured: Predose Cycle 1 Day 1 through Follow Up (Approximately 22 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study start19 Feb 2016
- Primary completion27 Mar 2018
- Study completion13 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572687
- Sponsor's protocol ID
- 16116
- Other IDs
- I4T-MC-JVDJ, 2015-003013-14, 2015
- Status last verified
- Jan 2021
- First submitted
- 7 Oct 2015
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02572687
- Acronym / sponsor ID
- 16116
- Conditions
- Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Non-Small Cell Lung Cancer, Hepatocellular Carcinoma
- Keywords
- metastatic, advanced, immuno-oncology, vascular endothelial growth factor (VEGF), angiogenesis, PD-1, PD-L1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Study start
- 19 Feb 2016 (actual)
- Primary completion
- 27 Mar 2018 (actual)
- Study completion
- 13 Jan 2021 (actual)
- First posted
- 9 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ramucirumab + MEDI4736 (NSCLC) | Experimental | Drug: Ramucirumab, Drug: MEDI4736In 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. |
| Ramucirumab + MEDI4736 (Gastric/GEJ) | Experimental | Drug: Ramucirumab, Drug: MEDI4736In 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. |
| Ramucirumab + MEDI4736 (HCC) | Experimental | Drug: Ramucirumab, Drug: MEDI4736In 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Measurable metastatic disease or locally advanced and unresectable disease
- Availability of tumor tissue for biomarker analysis
- Has an Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Has adequate organ function
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RamucirumabAlso: LY3009806, IMC-11121B, CyramzaAdministered IV | Drug | Ramucirumab + MEDI4736 (Gastric/GEJ), Ramucirumab + MEDI4736 (HCC), Ramucirumab + MEDI4736 (NSCLC) |
| MEDI4736Administered IV | Drug | Ramucirumab + MEDI4736 (Gastric/GEJ), Ramucirumab + MEDI4736 (HCC), Ramucirumab + MEDI4736 (NSCLC) |
Primary outcome
Number of Participants with Dose Limiting Toxicities (DLTs)
Time frame: Cycle 1 (up to 28 days)
10 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- A Study of Ramucirumab (LY3009806) Plus MEDI4736 in Participants With Advanced Gastrointestinal or Thoracic MalignanciesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
28 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ramucirumab and MEDI4736 in people with Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by Eli Lilly and Company at 28 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, France, South Korea, Taiwan, Israel and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Dose Limiting Toxicities (DLTs) (time frame: Cycle 1 (up to 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.