Iparomlimab and Tuvonralimab Plus Chemotherapy as Neoadjuvant Therapy for Ovarian Cancer（Phase II）

NCT07673835 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: FUOBGY-2026-56
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-arm, single-center prospective clinical study that will evaluate the clinical feasibility and efficacy of immunotherapy combined with chemotherapy in the neoadjuvant treatment of ovarian cancer, in order to explore the progression-free survival of the study population.

Conditions

Ovarian Cancer

Keywords

Ovarian Cancer; Neoadjuvant Therapy; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• median progression-free survival (PFS)

  Progression-free survival (PFS) is defined as the time from randomization to the first documented disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first. Median PFS will be estimated using the Kaplan-Meier method.

  From first dose of study treatment to disease progression or death from any cause, with patients followed until disease progression, death, or last disease, assessment assessed up to 60 months.

Study Arms (1)

Experimental Arm

EXPERIMENTAL

Participants will receive immunotherapy combined with platinum-based chemotherapy administered every 3 weeks for 3-4 cycles, followed by interval cytoreductive surgery. Adjuvant chemotherapy will be given postoperatively according to pathological results.

Procedure: Neoadjuvant Therapy Plus Surgery

Interventions

Neoadjuvant Therapy Plus Surgery PROCEDURE

Participants will receive immunotherapy (iparomlimab plus tuvonralimab) combined with platinum-based chemotherapy administered every 3 weeks for 3-4 cycles, followed by cytoreductive surgery. Adjuvant chemotherapy will be given postoperatively based on pathological results.

Experimental Arm

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma, FIGO 2014 stage III-IV disease;
• Female patients aged 18 to 75 years;
• Willing and able to provide written informed consent and comply with study visits and protocol-specified procedures;
• Candidates for cytoreductive surgery (debulking surgery);
• At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
• Estimated life expectancy of at least 6 months;
• Women of childbearing potential must agree to use effective contraception during the study period, and a negative serum or urine pregnancy test is required prior to enrollment;
• Adequate organ function.

You may not qualify if:

• Histological subtypes other than epithelial ovarian carcinoma, including mucinous carcinoma and clear cell carcinoma.
• Pregnant women or patients whose most recent pregnancy was terminated within 2 weeks prior to screening.
• Clinically significant hydronephrosis not amenable to stenting or nephrostomy, or presence of CNS metastases or carcinomatous meningitis.
• History of other malignancies within 3 years, except for adequately treated curable cancers (e.g., skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, or carcinoma in situ of the breast).
• Prior treatment with immune checkpoint inhibitors or other immunomodulatory anticancer therapies.
• Major surgery within 4 weeks before study treatment, or planned major surgery during the study period.
• Severe cardiovascular or cerebrovascular disease.
• Unresolved ≥ Grade 2 toxicity (CTCAE v5.0) from prior anticancer therapy, excluding alopecia.
• Known hypersensitivity to study drugs or their components.
• Any condition that may compromise patient safety or interfere with study evaluation, as judged by the investigator.

Sponsors & Collaborators

• Obstetrics & Gynecology Hospital of Fudan University: lead

Study Sites (1)

Obstetrics and Gynecology Hospital of Fudan University

Shanghai, 201101, China

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Neoadjuvant Therapy; Surgical Procedures, Operative

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)

Combined Modality Therapy; Therapeutics

Central Study Contacts

Xin Wu, Dr

CONTACT

86 21 33189900; wuxin_fc@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2026
• First Posted: June 29, 2026
• Study Start: June 6, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)