Etoposide Capsules Combined With Bevacizumab and Iparomlimab and Tuvonralimab in the Treatment of Platinum Resistant or Platinum Refractory Ovarian Cancer

NCT07117877 | Not Yet Recruiting Phase 2

• 1 other identifier: OCR-EBQ-2025
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a Prospective, Single-arm, Phase II clinical trial. The purpose of this study is to find out if taking Etoposide Capsules combined With Bevacizumab and Iparomlimab and Tuvonralimab is safe and works well for people with platinum-resistant or platinum refractory ovarian cancer . Researchers will look at the Progression-Free Survival, Objective Response Rate, Overall Survival, safety, and any side effects.

Conditions

Platinum Resistant Ovarian Cancer; Platinum Refractory Epithelial Ovarian Cancer; Ovarian Cancer (OvCa)

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression-free survival, according to RECIST v1.1

  approximately 2 years

Secondary Outcomes (3)

• ORR

  Up to 24 months

• OS

  Up to 2 years

• AEs

  From the first drug administration to within 30 days for the last treatment dose

Study Arms (1)

Etoposide+Bevacizumab+Iparomlimab and Tuvonralimab

EXPERIMENTAL

Participants will receive Etoposide Capsules, Bevacizumab and Iparomlimab and Tuvonralimab in combination. 21 days as a cycle.

Drug: Etoposide Capsules; Drug: Bevacizumab; Drug: Iparomlimab and Tuvonralimab (QL1706)

Interventions

Etoposide Capsules DRUG

50 mg(25mg/pill, 2 pills at a time) orally, qd, days 1 to 14, per cycle

Etoposide+Bevacizumab+Iparomlimab and Tuvonralimab

Bevacizumab DRUG

7.5mg/kg, i.v, q3w

Etoposide+Bevacizumab+Iparomlimab and Tuvonralimab

Iparomlimab and Tuvonralimab (QL1706) DRUG

5mg/kg, i.v., q3w

Etoposide+Bevacizumab+Iparomlimab and Tuvonralimab

Eligibility Criteria

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

You may qualify if:

• Age: 18-75, female;
• According to RECIST 1.1 criteria, there are measurable lesions at baseline;
• ECOG PS： 0-1；
• Epithelial ovarian, fallopian tube, and primary peritoneal cancer with platinum resistance or platinum refractory recurrence; Provide 10 white films for pathological type confirmation and efficacy marker exploration, and meet all of the following conditions.
• ① Received systemic treatment with ≥ 1 line and ≤ 6 lines, among which only received systemic treatment with ≤ 4 lines after platinum resistance relapse.
• ② Previous treatments should include at least one platinum based chemotherapy regimen. There are two specific situations:
• For patients who have only received 1-line platinum based chemotherapy in the past, disease remission (CR or PR) must be achieved, and disease progression must occur within a period of ≥ 4 weeks and\<6 months after the last platinum based chemotherapy.
• For patients who have received systemic treatment from line 2 to line 5 in the past, it is required that disease progression must occur within a period of less than 6 months after the last platinum based chemotherapy.
• Note: When determining the number of lines, the following requirements should be noted:
• The overall count of neoadjuvant ± adjuvant systemic therapy is one line. Maintenance treatment does not calculate the number of lines separately. Simple endocrine therapy is counted as a baseline, but the use of endocrine therapy due to non disease progression (such as only elevated CA-125) is not counted as a baseline.
• Changing the treatment plan due to intolerance without disease progression is not considered as changing the line.
• The subject needs to experience disease progression after the final systemic treatment.
• The main organ functions well and meets the following criteria:
• Blood routine examination (without blood transfusion or correction with hematopoietic stimulating factor drugs within 14 days): hemoglobin (Hb) ≥ 90g/L; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; platelet count (PLT) ≥ 90 × 109/L;
• Biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN for tumor liver metastases); Serum total bilirubin (TBIL) ≤ 1.5 × ULN (Gilbert syndrome subjects, ≤ 3 × ULN); Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance rate ≥ 60mL/min;

You may not qualify if:

• Patients who participate in other clinical trials simultaneously;
• Allergic constitution, including a history of severe drug allergies or drug allergic reactions; Known to be allergic or intolerant to the investigational drug;
• No measurable lesions or lesions that cannot be evaluated;
• Patients with untreated central nervous system metastases, who have previously received systemic or curative treatment for brain or meningeal metastases (radiotherapy or surgery), have been confirmed stable for at least one month by imaging, and have stopped systemic hormone therapy (dose\>10mg/day prednisone or other therapeutic hormones) for more than two weeks without clinical symptoms can be included;
• Those who are unable to swallow pills normally or have gastrointestinal dysfunction, as determined by researchers, may affect drug absorption;
• Individuals who have experienced intestinal obstruction within the past 3 months;
• At present, there are uncontrollable malignant pleural effusion, ascites, or pericardial effusion (defined as those that cannot be effectively controlled by diuretics or puncture methods as determined by researchers);
• Suffering from uncontrolled comorbidities, including but not limited to: active HBV or HCV infection; Known history of HIV infection or AIDS; Active syphilis; Active tuberculosis; Active infection; Uncontrolled hypertension and symptomatic heart failure; Active bleeding;
• History of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or other malignant tumors within 5 years prior to the initial administration of the study (excluding completely relieved carcinoma in situ and malignant tumors with slow progression determined by the investigator)
• Other incurable malignant tumors in the past (within 5 years) or at the same time, except for cured skin basal cell carcinoma, cervical carcinoma in situ and breast cancer with no recurrence after radical surgery\>3 years;
• Pregnant or lactating women;
• According to the researchers' assessment, there may be other factors that could lead to the forced termination of this study, such as other serious illnesses (including mental illnesses) requiring concurrent treatment, serious laboratory abnormalities, and family or social factors that could affect the safety of the subjects or the collection of data and samples.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Etoposide; Bevacizumab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Xingzhu Ju, PhD

CONTACT

021-64175590; lizfeng1231@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of Gynecologic Oncology

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: August 28, 2025

Record last verified: 2025-08

Locations

CN (1)