UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025560 |
|---|---|
| Receipt number | R000029360 |
| Scientific Title | A multicenter, phase 1/2 study of Ramucirumab plus Nivolumab as second-line therapy in participants with gastric or GEJ cancer |
| Date of disclosure of the study information | 2017/01/06 |
| Last modified on | 2022/11/28 17:30:30 |
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Basic information
Public title
A multicenter, phase 1/2 study of Ramucirumab plus Nivolumab as second-line therapy in participants with gastric or GEJ cancer
Acronym
A multicenter, phase 1/2 study of Ramucirumab plus Nivolumab as second-line therapy in participants with gastric or GEJ cancer
Scientific Title
A multicenter, phase 1/2 study of Ramucirumab plus Nivolumab as second-line therapy in participants with gastric or GEJ cancer
Scientific Title:Acronym
A multicenter, phase 1/2 study of Ramucirumab plus Nivolumab as second-line therapy in participants with gastric or GEJ cancer
Region
| Japan |
Condition
Condition
Advanced or recurrent unresectable gastric or GEJ cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Phase 1
To estimate maximum tolerated dose (MTD) and dose limiting toxicity (DLT) and to determine of combination therapy of Ramucirumab and Nivolumab and to determine recommended dose (RD) of the therapy.
Phase 2
To assess safety and efficacy of the combination therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Phase 1
Number of participants with dose limiting toxicities (DLTs) for 28 days from first administration
Phase 2
Progression free survival rate after 6 months
Key secondary outcomes
Phase 1
Number of participants with adverse events
Phase 2
Overall response rate (ORR)
Disease control rate (DCR)
Progression-free survival (PFS)
Overall survival (OS)
Number of participants with adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Phase 1 (Level 1)
Ramucirumab: 8 mg/kg, every 2 weeks
Nivolumab: 3 mg/kg, every 2 weeks
Interventions/Control_2
Phase 1 (Level 0)
Ramucirumab: 8 mg/kg, every 2 weeks
Nivolumab: 1 mg/kg, every 2 weeks
Interventions/Control_3
Phase 2
Ramucirumab: 8 mg/kg, every 2 weeks
Nivolumab: recommended dose established in the phase 1 (3 mg/kg or 1 mg/kg), every 2 weeks
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- 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
- Patients with no pretreatment history including ramucirumab, nivolumab or other therapies targeting control of T cells
- Patients with written informed consent
Key exclusion criteria
- Patients have double cancer
- Patients have infection required systemic therapy
- Known central nervous 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
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Kato |
Organization
National Cancer Center Japan Hospital
Division name
Department of Head and Neck, Esophageal Medical Oncology
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
kenkato@ncc.go.jp
Public contact
Name of contact person
| 1st name | Hirokazu |
| Middle name | |
| Last name | Shoji |
Organization
National Cancer Center Japan Hospital
Division name
Department of Gastrointestinal Medical Oncology
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
Homepage URL
hshouji@ncc.go.jp
Sponsor or person
Institute
Department of Head and Neck Oncology, National Cancer Center Japan Hospital
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of National Cancer Center
Address
5-1-1, Thukiji, Chuo-ku, Tokyo, 104-0045, Japan
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT02999295
Org. issuing International ID_1
ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立研究開発法人国立がん研究センター中央病院（東京都）、公益財団法人 がん研究会有明病院（東京都）、埼玉県立がんセンター（埼玉県）、静岡県立静岡がんセンター（静岡県）、独立行政法人国立病院機構 九州がんセンター（福岡県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 06 | Day |
Related information
URL releasing protocol
https://ascopubs.org/doi/abs/10.1200/JCO.2019.37.4_suppl.129
Publication of results
Published
Result
URL related to results and publications
https://ascopubs.org/doi/abs/10.1200/JCO.2019.37.4_suppl.129
Number of participants that the trial has enrolled
46
Results
46 advanced gastric cancer patients (median age 66 years) were enrolled. No dose limiting toxicities were observed in the phase 1 part. With median follow up time of 10.2 month, 6-month progression free survival rate was 37.4% (90% confidential intervals: 25.7-49.2%), which met the primary endpoint of the phase 2 part. objective responce rate/disease responce rate were 26.7%/62.2%. Median progression free survival/overall survival were 2.9/9.0 months.
Results date posted
| 2022 | Year | 11 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Advanced gastric cancer patients with disease progression on first line chemotherapy containing platinum
Participant flow
Patients received Nivolumab (3mg/kg, Q2W) and Ramcirumab (8mg/kg, Q2W) until unacceptable toxicity or disease progression. After feasibility was evaluated in six patients (phase 1 part), additional 40 patients were required in a phase 2 part.
Adverse events
Grade 3 or 4 treatment related adverse events were hypertension (n=2), diarrhea (n=2), perforation at jejunum (n=1), hemorrhage (n=1), colitis (n=1), pancreatitis (n=1), liver dysfunction (n=1), cholangitis (n=1), hematoma (n=1), neutropenia (n=1) and proteinuria (n=1). There were no treatment-related deaths.
Outcome measures
Primary analysis: 6-months progression-free survival rate
Secondary endpoints: Objective response rate, Disease control rate, Progression free survival, Overall survival,
Safety
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 04 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 06 | Day |
Last modified on
| 2022 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029360
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