Locally Advanced (Unresectable) or Metastatic Adenocarcinoma of the Gastric and Gastro-esophageal JunctionPhase 2NCT01585987
An Efficacy Study in Gastric and Gastroesophageal Junction Cancer Comparing Ipilimumab Versus Standard of Care Immediately Following First Line Chemotherapy
A Phase 2 study testing Ipilimumab in people with Locally Advanced (Unresectable) or Metastatic Adenocarcinoma of the Gastric and Gastro-esophageal Junction, run by Bristol-Myers Squibb at 36 sites in 12 countries.
Trial summary
The purpose of the study is to compare the efficacy of Ipilimumab and standard of care as sequential or maintenance treatment immediately after first-line chemotherapy in the treatment of unresectable or metastatic gastric and gastro-esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced (Unresectable) or Metastatic Adenocarcinoma of the Gastric and Gastro-esophageal Junction
- What is being tested?
- Ipilimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 36 sitesin 12 countries
- Study dates
- Jul 2012to Apr 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologically confirmed, unresectable locally advanced or metastatic adenocarcinoma of the gastric and gastro-esophageal junction
- Received first-line chemotherapy using fluoropyrimidine and platinum combination without disease progression
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Measurable disease by modified WHO criteria (unless complete response from previous chemotherapy)
Who cannot join
- Known Human Epidermal growth factor Receptor2 (HER2) positive status
- Radiological evidence of brain metastases
- History of severe autoimmune or immune mediated disease requiring prolonged immunosuppressive treatment
- Inadequate hematologic, renal and hepatic function
Trial locations and contacts
36 sites in 12 countries.
36 sites in 12 countries
Italy5 sites
Local Institution
Florence, 50134
Local Institution
Milan, 20133
Local Institution
Padova, 35128
Local Institution
Pisa, 56126
Local Institution
Roma, 00189
South Korea5 sites
Local Institution
Gyeonggi-do, 431-796
Local Institution
Gyeonggi-do, 463-707
Local Institution
Seoul, 110-774
Local Institution
Seoul, 135-705
Local Institution
Seoul, 135-720
United States4 sites
The University Of Texas Md Anderson Cancer Center
Houston, Texas, 77030
Mount Sinai Medical Center
Miami Beach, Florida, 33140
Nyu Clinical Cancer Center
New York, New York, 10016
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
France4 sites
Local Institution
Montpellier, 34295
Local Institution
Nice, 06202
Local Institution
Rennes, 35042
Local Institution
Toulouse, 31059
Japan4 sites
Local Institution
Kitaadachi-gun, Saitama, 3620806
Local Institution
Nagoya, Aichi-ken, 4648681
Local Institution
Osaka-sayama-shi, Osaka, 5898511
Local Institution
Saku-shi, Nagano, 3840301
Poland4 sites
Local Institution
Katowice, Ochojec, 40-635
Local Institution
Krakow, 31-501
Local Institution
Lodz, 93-513
Local Institution
Olsztyn, 10-513
Spain3 sites
Local Institution
Barcelona, 08035
Local Institution
Madrid, 28040
Local Institution
Madrid, 28050
Singapore2 sites
Local Institution
Singapore, 169610
Local Institution
Singapore, 308433
About this study
Official title: A Randomized, Open-label, Two-arm Phase II Trial Comparing the Efficacy of Sequential Ipilimumab Versus Best Supportive Care Following First-line Chemotherapy in Subjects With Unresectable Locally Advanced/Metastatic Gastric or Gastro-esophageal Junction Cancer
The purpose of the study is to compare the efficacy of Ipilimumab and standard of care as sequential or maintenance treatment immediately after first-line chemotherapy in the treatment of unresectable or metastatic gastric and gastro-esophageal cancer.
- Being tested
- Ipilimumab, Best Supportive care (BSC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpilimumabBiological
Also called BMS-734016
Best Supportive care (BSC)Other
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Ipilimumab | Experimental | Ipilimumab 10 mg/kg solution intravenously, 90 minute infusion, once every 3 weeks for 4 doses, then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Receives: Biological: Ipilimumab |
| Arm B: Best Supportive care (BSC) | Other | BSC may include the continuation of the Fluoropyrimidine that was used during the lead-in chemotherapy, but no other systemic anti cancer therapy Receives: Other: Best Supportive care (BSC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune-related Progression Free Survival (irPFS) as Per Assessment of a Blinded Independent Review Committee (IRC) According to Immune Related Response Criteria (irRC) Guidelines
irPFS is defined as the time between the randomization date and the time of disease progression per irRC or death, whichever occurs first. irRC criteria=Measurable new lesions: incorporated into the tumor burden (eg, added to the index lesions); do not define progression unless the total measurable tumor burden increases by the required amount (25%). New non-measurable lesions: not considered progression if the total measurable tumor burden is stable or shrinking. irPFS was measured in months.
Measured: Randomization up to 91 irPFS events (Approximately 19 months )
Secondary outcomes (4)
Progression Free Survival (PFS) Per Modified World Health Organization (mWHO) Criteria
PFS per mWHO was defined as the time between the randomization date and the time of disease progression per mWHO criteria or death, whichever occurred first and was measured in months. mWHO criteria: New lesions always mean progression; Changes in non-measurable lesions contribute in the definitions of Complete Response (CR), Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD).
Measured: Randomization up to 91 irPFS events (Approximately 19 months )
Overall Survival (OS) at Primary Endpoint
OS was defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive.
Measured: Randomization up to 91 irPFS events (Approximately 19 months)
Overall Survival (OS) at Study Completion
OS was defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive.
Measured: Randomization up to end of study, April 2015 (Approximately 28 months)
Percentage of Participants With Immune-Related Best Overall Response (irBOR)
IrBOR rate was defined as the number of participants whose Immune-related Best Overall Response (irBOR) criteria was Immune-related Complete Response (irCR) or Immune-related Partial Response (irPR), divided by the total number of participants. The immune-related sum of products of diameters (irSPD) incorporates - in addition to the index lesions - measurable new lesions that may have developed on-study, providing an assessment that includes both index and new lesions. irCR=Complete disappearance of all tumor lesions (both index and non-index lesions with no new measurable/unmeasurable lesions). irPR=A 50% or greater decrease, relative to baseline of the irSPD, (based on irSPD of all index lesions and any measurable new lesions).
Measured: Randomization up to 91 irPFS events (Approximately 19 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced (Unresectable) or Metastatic Adenocarcinoma of the Gastric and Gastro-esophageal JunctionStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01585987
- Sponsor's protocol ID
- CA184-162
- Other IDs
- 2011-000853-22
- Status last verified
- Apr 2016
- First submitted
- 25 Apr 2012
- Last updated
- 17 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.
PubMed 35623069
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Two-arm Phase II Trial Comparing the Efficacy of Sequential Ipilimumab Versus Best Supportive Care Following First-line Chemotherapy in Subjects With Unresectable Locally Advanced/Metastatic Gastric or Gastro-esophageal Junction Cancer
- ClinicalTrials.gov ID
- NCT01585987
- Acronym / sponsor ID
- CA184-162
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 26 Apr 2012 (estimated)
- Results
- Posted 18 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare the efficacy of Ipilimumab and standard of care as sequential or maintenance treatment immediately after first-line chemotherapy in the treatment of unresectable or metastatic gastric and gastro-esophageal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Ipilimumab | Experimental | Biological: IpilimumabIpilimumab 10 mg/kg solution intravenously, 90 minute infusion, once every 3 weeks for 4 doses, then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) |
| Arm B: Best Supportive care (BSC) | Other | Other: Best Supportive care (BSC)BSC may include the continuation of the Fluoropyrimidine that was used during the lead-in chemotherapy, but no other systemic anti cancer therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed, unresectable locally advanced or metastatic adenocarcinoma of the gastric and gastro-esophageal junction
- Received first-line chemotherapy using fluoropyrimidine and platinum combination without disease progression
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Measurable disease by modified WHO criteria (unless complete response from previous chemotherapy)
Key exclusion criteria (4 listed)
- Known Human Epidermal growth factor Receptor2 (HER2) positive status
- Radiological evidence of brain metastases
- History of severe autoimmune or immune mediated disease requiring prolonged immunosuppressive treatment
- Inadequate hematologic, renal and hepatic function
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 |
|---|---|---|
| IpilimumabAlso: BMS-734016 | Biological | Arm A: Ipilimumab |
| Best Supportive care (BSC) | Other | Arm B: Best Supportive care (BSC) |
Primary outcome
Immune-related Progression Free Survival (irPFS) as Per Assessment of a Blinded Independent Review Committee (IRC) According to Immune Related Response Criteria (irRC) Guidelines
Time frame: Randomization up to 91 irPFS events (Approximately 19 months )
irPFS is defined as the time between the randomization date and the time of disease progression per irRC or death, whichever occurs first. irRC criteria=Measurable new lesions: incorporated into the tumor burden (eg, added to the index lesions); do not define progression unless the total measurable tumor burden increases by the required amount (25%). New non-measurable lesions: not considered progression if the total measurable tumor burden is stable or shrinking. irPFS was measured in months.
4 secondary outcomes
Progression Free Survival (PFS) Per Modified World Health Organization (mWHO) Criteria
Time frame: Randomization up to 91 irPFS events (Approximately 19 months )
Overall Survival (OS) at Primary Endpoint
Time frame: Randomization up to 91 irPFS events (Approximately 19 months)
Overall Survival (OS) at Study Completion
Time frame: Randomization up to end of study, April 2015 (Approximately 28 months)
Percentage of Participants With Immune-Related Best Overall Response (irBOR)
Time frame: Randomization up to 91 irPFS events (Approximately 19 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35623069Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
36 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ipilimumab in people with Locally Advanced (Unresectable) or Metastatic Adenocarcinoma of the Gastric and Gastro-esophageal Junction, run by Bristol-Myers Squibb at 36 sites in 12 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 4 inclusion and 4 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 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Italy, South Korea, United States, France, Japan and 7 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Immune-related Progression Free Survival (irPFS) as Per Assessment of a Blinded Independent Review Committee (IRC) According to Immune Related Response Criteria (irRC) Guidelines (time frame: Randomization up to 91 irPFS events (Approximately 19 months )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01585987, which also lists 1 linked publication.
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 17 May 2016.