UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049997 |
|---|---|
| Receipt number | R000054531 |
| Scientific Title | An observational study to evaluate the safety and efficacy of lenvatinib plus pembrolizumab combination therapy for advanced or recurrent uterine cancer after use of platinum-based drugs(GOGO-EM4) |
| Date of disclosure of the study information | 2023/01/10 |
| Last modified on | 2023/01/11 06:16:56 |
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Basic information
Public title
An observational study to evaluate the safety and efficacy of lenvatinib plus pembrolizumab combination therapy for advanced or recurrent uterine cancer after use of platinum-based drugs(GOGO-EM4)
Acronym
GOGO-EM4
Scientific Title
An observational study to evaluate the safety and efficacy of lenvatinib plus pembrolizumab combination therapy for advanced or recurrent uterine cancer after use of platinum-based drugs(GOGO-EM4)
Scientific Title:Acronym
GOGO-EM4
Region
| Japan |
Condition
Condition
Advanced or recurrent uterine cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of Lenvatinib (LEN) + Pembrolizumab (PEM) combination therapy for advanced or recurrent endometrial cancer after platinum therapy in Japan.
Basic objectives2
Others
Basic objectives -Others
safety and efficacy
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Progression free survival; PFS
Key secondary outcomes
adverse event
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Cases with histopathological diagnosis of endometrial cancer(Includes carcinosarcoma, excludes sarcoma-only cases, regardless of MSI status)
2. Patients with exacerbation or relapse during or after chemotherapy including platinum-based antineoplastic agents
3. Cases in which LEN + PEM combination therapy was initiated between January 2022 and December 2024
4. Be at least 18 years of age at the time of registration(No upper limit specified)
5. Patients receiving at least 1 regimen of chemotherapy including platinum-based antineoplastic agents(Include preoperative chemotherapy and postoperative adjuvant chemotherapy for prevention of recurrence)
6. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of 0-1 at the start of LEN+PEM combination therapy
Key exclusion criteria
1. Patients with recurrent endometrial cancer who have not received any chemotherapy, including platinum-based antineoplastic agents
2. Cases with obvious infection
3. Cases with active multiple cancers
4. Patients with persistent adverse events (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0 Grade 2 or higher) from prior chemotherapy(Excluding epilation and peripheral neuropathy)
5. Cases with hematologic complications
6. Cases with a history of bone marrow transplantation
7. Cases with uncontrolled brain metastases
8. Patients with serious complications (cardiac disease, uncontrolled diabetes, malignant hypertension, bleeding tendency, etc.)
9. Pregnant or lactating patients and patients of childbearing potential (will) (except for patients using appropriate contraceptive methods)
10. Any other cases other than those listed above that the principal investigator deems inappropriate for enrollment of the case in the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Kimura |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
565-0871
Address
2-2 Yamadaoka Suitashi, Osaka
TEL
06-6879-3351
tadashi@gyne.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Nakagawa |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
565-0871
Address
2-2 Yamadaoka Suitashi, Osaka
TEL
06-6879-3351
Homepage URL
s.nakagawa@gyne.med.osaka-u.ac.jp
Sponsor or person
Institute
Gynecologic Oncology Group of Osaka(GOGO)
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Clinical Research Review Committee
Address
2-2 Yamadaoka Suitashi, Osaka
Tel
0662108296
rinri-jim@dmi.med.osaka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2022 | Year | 05 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 01 | Month | 10 | Day |
Last modified on
| 2023 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054531
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
