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)

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) - GOGO-EM4

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000049997

Enrollment

100

Registered

2023-01-10

Start date

2022-07-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced or recurrent uterine cancer

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Progression free survival; PFS	—

Secondary

Measure	Time frame
adverse event	—

Countries

Japan

Contacts

Public ContactSatoshi Nakagawa

Osaka University Graduate School of Medicine Department of Obstetrics and Gynecology

s.nakagawa@gyne.med.osaka-u.ac.jp06-6879-3351

Outcome results