Study of Fruquintinib Plus Sintilimab for Treatment of Advanced Endometrial Cancer

NCT06584032 | Recruiting Phase 3 DMC

• 1 other identifier: 2024-013-00CH1
• Study Type: interventional
• Target: 412
• Locations: 1 country
• Sites: 17

Brief Summary

The goal of this study is to evaluate whether fruquintinib(HMPL-013) plus sintilimab(IBI308) is safe and effective in the treatment of advanced endometrial cancer(EMC).

Conditions

Advanced Endometrial Cancer

Keywords

fruquintinib; sintilimab; endometrial cancer

Outcome Measures

Primary Outcomes (2)

• Progression-Free Survival (PFS) as assessed by IRC

  Progression-free survival (PFS) is defined as the time from randomization to disease progression assessed by IRC or death due to any cause, whichever occurs first.

  Up to approximately 4 years

• Overall Survival (OS)

  Overall Survival (OS) is defined as the time from randomization to death due to any cause.

  Up to approximately 4 years

Secondary Outcomes (9)

• Objective Response Rate (ORR)

  Up to approximately 4 years

• Duration of Response (DoR)

  Up to approximately 4 years

• Disease Control Rate (DCR)

  Up to approximately 4 years

• Time To Response (TTR)

  Up to approximately 4 years

• Progression-Free Survival (PFS) as assessed by investigator

  Up to approximately 4 years

Study Arms (2)

Experimental group

EXPERIMENTAL

Patients will be treated with a planned dose of fruquintinib and sintilimab every three weeks until an IRC (independent review committee)-confirmed PD(disease progression) or meeting other discontinuation criteria.

Drug: fruquintinib; Biological: sintilimab

Control group

ACTIVE COMPARATOR

Patients will be treated with TPC (chemotherapy of treating physician's choice, paclitaxel or doxorubicin) every three or four weeks until IRC-confirmed PD or meeting other discontinuation criteria.

Drug: paclitaxel; Drug: doxorubicin

Interventions

fruquintinib DRUG

Fruquintinib will be orally administrated once daily for 2 consecutive weeks followed by a 1-week break.

Also known as: HMPL-013

Experimental group

sintilimab BIOLOGICAL

Sintilimab will be intravenously administrated on Day 1 every three weeks.

Also known as: IBI308

Experimental group

paclitaxel DRUG

175 mg/m\^2 via IV infusion, once a week for 3 weeks followed by a 1-week break.

Control group

doxorubicin DRUG

60mg/m\^2 via IV infusion, on Day 1 every three weeks.

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have fully understood and voluntarily signed the informed consent form
• Age 18 to 75 years (inclusive) ; Body mass index (BMI) ≥ 18.5kg/m\^2;
• Histologically or cytologically confirmed advanced or recurrent endometrial cancer with measurable lesions
• Patients who previously failed first-line systemic platinum-based therapy
• ECOG PS (Eastern Cooperative Oncology Group performance status score) 0 or 1;
• Need to provide tumor samples for central lab testing of biomarkers such as MSI(microsatellite instability) status;
• Non-MSI-H(non-microsatellite instability-high) by central lab or previous test result indicating pMMR(proficient mismatch repair);
• Adequate function of the major organs;
• Expected survival ≥ 12 weeks;
• Female patients of childbearing potential must have a negative serum pregnancy test within 7 days before randomization.

You may not qualify if:

• Endometrial carcinosarcoma or sarcoma;
• Known MMR(mismatch repair)/MSI status with dMMR(deficient mismatch repair) or MSI-H(microsatellite instability-high);
• Toxicities related to prior anticancer therapy did not recover to ≤CTCAE Grade 1, except alopecia and oxaliplatin-induced peripheral neurotoxicity ≤CTCAE Grade 2;
• Received systemic anti-tumor therapy approved within 4 weeks before randomization;
• Other malignancies within the past 5 years;
• Previous or screening central nervous system (CNS) metastases;
• Radical radiotherapy within 4 weeks before randomization
• Previously received any anti-programmed cell death receptor-1 (PD-1) antibody, anti-PD-L1(programmed death ligand-1) antibody, anti-PD-L2(programmed death ligand-2) antibody, or anti cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody or any other antibody acting on T cell costimulation or checkpoint pathways (eg, OX40, CD137, etc) or small molecule vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors;
• Symptomatic or treatment-requiring thyroid dysfunction at screening;
• Use of immunosuppressive agents within 4 weeks before randomization
• Presence of any active autoimmune disease requiring systemic treatment or history of autoimmune disease within the past 2 years;
• Systemic immunostimulants within 4 weeks before randomization;
• Administration of any live or live-attenuated vaccine within 4 weeks before randomization or planned during the study;
• Major surgical procedures within 4 weeks before randomization;
• Uncontrolled malignant pleural effusion, ascites or pericardial effusion;

Sponsors & Collaborators

• Hutchmed: lead

Study Sites (17)

Beijing Obstetrics and Gynecology Hospital

Beijing, Beijing Municipality, 100026, China

NOT YET RECRUITING

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

NOT YET RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

NOT YET RECRUITING

SUN Yat-sen University Cancer Center

Guangzhou, Guangdong, 510050, China

NOT YET RECRUITING

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, 530012, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

NOT YET RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410031, China

NOT YET RECRUITING

Xijing Hospital of Air Force Military Medical University

Xi'an, Shaanxi, 710032, China

NOT YET RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

NOT YET RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Sencond Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

NOT YET RECRUITING

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

NOT YET RECRUITING

Yunnan Cancer Hospital

Kunming, Yunnan, 650118, China

NOT YET RECRUITING

Women's Hospital school of Medical Zhejiang University

Hangzhou, Zhejiang, 310003, China

NOT YET RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310005, China

NOT YET RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325015, China

NOT YET RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

HMPL-013; sintilimab; Paclitaxel; Doxorubicin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Xiaohua Wu

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Panfeng Tan

CONTACT

86-21-20671828; panfengt@hutch-med.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: September 4, 2024
• Study Start: December 12, 2024
• Primary Completion (Estimated): January 8, 2029
• Study Completion (Estimated): June 9, 2029
• Last Updated: January 7, 2025

Record last verified: 2025-01

Locations

CN (17)