Gastric CancerPhase 1/2NCT02999295
A Phase 1/2 Study of Ramucirumab Plus Nivolumab in Participants With Gastric or GEJ Cancer
A Phase 1/2 study testing Ramucirumab and Nivolumab in people with Gastric Cancer and Gastroesophageal Junction Region (GEJ) Cancer, run by National Cancer Center, Japan at 1 site in Japan.
Trial summary
The main purpose of this study is to evaluate the safety and efficacy of the combination therapy of ramucirumab and nivolumab in participants with advanced or recurrent unresectable gastric or GEJ cancer. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastric Cancer, Gastroesophageal Junction Region (GEJ) Cancer
- What is being tested?
- Ramucirumab and Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2017to Aug 2019
- Phase
- Phase 1/2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced or recurrent unresectable gastric or GEJ cancer
- Histologically confirmed adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma or poorly differentiated adenocarcinoma), signet-ring cell carcinoma, mucinous adenocarcinoma or hepatoid adnocarcinoma
- Patients with normal oral intake
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Patients who have measurable target lesion
- Patients has a refractory or intolerant pretreatment by pyrimidine fluoride anticancer agent and platinum-based anticancer agent
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- Patients with adequate organ function
- Patients with no pretreatment history including ramucirumab, nivolumab or other therapies targeting control of T cells
- Patients with written informed consent
Who cannot join
- Patients have double cancer
- Patients have infection required systemic therapy
- Known central vervous system (CNS) metastasis
- Patients with history of pneumonitis or pulmonary fibrosis
- Patients with history of serious anaphylaxis induced by antibody preparation
- Patients who have known active autoimmune disease or history of chronic recurrent autoimmune disease
- Female who is pregnant, lactating or suspected pregnancy
- Patients with psychosis or dementia to interfere to obtain informed consent appropriately
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Phase 1/2 Study of Ramucirumab Plus Nivolumab as Second-line Therapy in Participants With Gastric or GEJ Cancer
The main purpose of this study is to evaluate the safety and efficacy of the combination therapy of ramucirumab and nivolumab in participants with advanced or recurrent unresectable gastric or GEJ cancer.
- Being tested
- Ramucirumab, Nivolumab
- Medical subject headings
- Stomach Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamucirumabBiological
Also called LY3009806
Ramucirumab (8 mg/kg) is administered.
NivolumabBiological
Also called ONO-4538
Nivolumab (3.0 mg/kg or 1.0 mg/kg) is administered.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 | Experimental | Ramucirumab: 8 mg/kg, every two week Nivolumab: 3.0 mg/kg or 1.0 mg/kg (optional), every two weeks Receives: Biological: Ramucirumab; Biological: Nivolumab |
| Phase 2 | Experimental | Ramucirumab: 8 mg/kg, every two week Nivolumab: recommended dose established in the phase 1, every two weeks Receives: Biological: Ramucirumab; Biological: Nivolumab |
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)
Number of participants with dose limiting toxicities (DLTs)
Measured: Phase 1, course 1 (up to 28 days)
Progression free survival rate after 6 months
Progression free survival rate after 6 months
Measured: from baseline to 6 months
Secondary outcomes (5)
Number of participants with adverse events
Number of participants with adverse events
Measured: from baseline to date of treatment cessation, approximately 24 months
Objective response rate (ORR)
percentage of participants with with a best response of complete response (CR) or partial response (PR)
Measured: from baseline to date of disease progression, approximately 24 months
Disease control rate (DCR)
percentage of participants with with a best response of CR, PR or stable disease (SD)
Measured: from baseline to date of disease progression, approximately 24 months
Overall survival (OS)
Overall survival (OS)
Measured: from baseline to date of death, approximately 24 months
Progression free survival (PFS)
Progression free survival (PFS)
Measured: from baseline to date of disease progression or death, approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionNov 2017
- Study completionAug 2019
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Japan
- Sponsor type
- Other government
- Collaborators
- Ono Pharmaceutical Co., Ltd., Fiverings Co., Ltd.
- Responsible party
- Principal investigator, Ken Kato, National Cancer Center, Japan
- Investigators
- Ken Kato, M.D. / Ph.D., Principal investigator, Department of Gastrointestinal Medical Oncology, National cancer center hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999295
- Sponsor's protocol ID
- NCCH-1611
- Status last verified
- Aug 2019
- First submitted
- 19 Dec 2016
- Last updated
- 21 Aug 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase 1/2 Study of Ramucirumab Plus Nivolumab as Second-line Therapy in Participants With Gastric or GEJ Cancer
- ClinicalTrials.gov ID
- NCT02999295
- Acronym / sponsor ID
- NCCH-1611
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- National Cancer Center, JapanOther government
- Collaborators
- Ono Pharmaceutical Co., Ltd., Fiverings Co., Ltd.
- Study start
- Jan 2017 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 21 Dec 2016 (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 and efficacy of the combination therapy of ramucirumab and nivolumab in participants with advanced or recurrent unresectable gastric or GEJ cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | Experimental | Biological: Ramucirumab, Biological: NivolumabRamucirumab: 8 mg/kg, every two week Nivolumab: 3.0 mg/kg or 1.0 mg/kg (optional), every two weeks |
| Phase 2 | Experimental | Biological: Ramucirumab, Biological: NivolumabRamucirumab: 8 mg/kg, every two week Nivolumab: recommended dose established in the phase 1, every two weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Advanced or recurrent unresectable gastric or GEJ cancer
- Histologically confirmed adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma or poorly differentiated adenocarcinoma), signet-ring cell carcinoma, mucinous adenocarcinoma or hepatoid adnocarcinoma
- Patients with normal oral intake
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Patients who have measurable target lesion
Key exclusion criteria (8 listed)
- Patients have double cancer
- Patients have infection required systemic therapy
- Known central vervous system (CNS) metastasis
- Patients with history of pneumonitis or pulmonary fibrosis
- Patients with history of serious anaphylaxis induced by antibody preparation
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: LY3009806Ramucirumab (8 mg/kg) is administered. | Biological | Phase 1, Phase 2 |
| NivolumabAlso: ONO-4538Nivolumab (3.0 mg/kg or 1.0 mg/kg) is administered. | Biological | Phase 1, Phase 2 |
Primary outcome
Number of participants with dose limiting toxicities (DLTs)
Time frame: Phase 1, course 1 (up to 28 days)
Number of participants with dose limiting toxicities (DLTs)
Progression free survival rate after 6 months
Time frame: from baseline to 6 months
Progression free survival rate after 6 months
5 secondary outcomes
Number of participants with adverse events
Time frame: from baseline to date of treatment cessation, approximately 24 months
Objective response rate (ORR)
Time frame: from baseline to date of disease progression, approximately 24 months
Disease control rate (DCR)
Time frame: from baseline to date of disease progression, approximately 24 months
Overall survival (OS)
Time frame: from baseline to date of death, approximately 24 months
Progression free survival (PFS)
Time frame: from baseline to date of disease progression or death, approximately 24 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 21 Aug 2019.
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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.
Ken Kato, M.D. / Ph.D. principal investigator
Department of Gastrointestinal Medical Oncology, National cancer center hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ramucirumab and Nivolumab in people with Gastric Cancer and Gastroesophageal Junction Region (GEJ) Cancer, run by National Cancer Center, Japan at 1 site in Japan.
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 9 inclusion and 8 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 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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 combined 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.
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?
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: Phase 1, course 1 (up to 28 days)). The study lists 2 primary outcomes in all. 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 21 Aug 2019.