Surgery for Relapsed Ovarian Cancer in Precision

NCT06602063 | Not Yet Recruiting Phase 1

• 1 other identifier: SOC-P
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

Brief Summary

This multicenter, biomarker-driven, patient-centric study aimed to evaluate the efficacy of secondary cytoreduction followed by platinum-based chemotherapy in combination with anti-PD1/CTLA-4 bispecifics therapy in patients with platinum-sensitive relapsed ovarian cancer (PSROC).

Conditions

Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma

Keywords

Ovarian cancer; Immune checkpoint inhibitor; Secondary cytoreduction; Biomarker-driven

Outcome Measures

Primary Outcomes (2)

• Progression-free survival in CF arm

  The time from entry into the study to the diagnosis of the first progression or recurrence or death in CF arm, whichever occurs first

  Up to 3 years

• 3-years Overall Survival Rate in CF arm

  The proportion of patients without death at 3 years after entry into the study in CF arm

  Up to 3 years

Secondary Outcomes (6)

• Overall survival in CF arm

  Up to 3 years

• TFST in CF arm

  Up to 3 years

• TSST in CF arm

  Up to 3 years

• Post-operative complications in CF and CU arms

  Up to 1 months

• Quality of life assessments in CF arm using EORTC QLQ-C30

  Up to 3 years

Study Arms (3)

criteria-fulfilled arm

EXPERIMENTAL

Patients who meet the inclusion and exclusion criteria will receive secondary cytoreductive surgery followed by 6 cycles of post-operative chemotherapy with Iparomlimab/tuvonralimab maintenance therapy.

Procedure: surgery/chemotherapy; Drug: Iparomlimab/Tuvonralimab

compassionate use arm

EXPERIMENTAL

Patients who are enrolled under expanded eligibility criteria will receive secondary cytoreductive surgery followed by 6 cycles of post-operative chemotherapy with Iparomlimab/tuvonralimab maintenance therapy.

Procedure: surgery/chemotherapy; Drug: Iparomlimab/Tuvonralimab

real world arm

NO INTERVENTION

Patients who meet the inclusion and exclusion criteria but refuse to participate in the CF and CU arms will receive the physician's therapy of choice.

Interventions

surgery/chemotherapy PROCEDURE

secondary cytoreductive surgery followed by 6 cycles of post-operative chemotherapy

compassionate use arm; criteria-fulfilled arm

Iparomlimab/Tuvonralimab DRUG

Iparomlimab/tuvonralimab will be administered at a dose of 5 mg per kilogram IV every 21 days. Treatment will continue until disease progression confirmed by RECIST criteria v1.1, intolerable toxicity or withdrawal of consent.

compassionate use arm; criteria-fulfilled arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: participant eligibility is based on self-representation of gender identity
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Arm 1 (criteria-fulfilled, CF)
• Age at recurrence ≥ 18 years, \<80 years.
• Patients with platinum-sensitive, first relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer (EOC, PPC, FTC), which is defined as those with treatment -free interval of 6 months or more.
• If the patient had previous PARPi maintenance therapy, disease progression should occurring at lease 3 months after the prior PARPi withdrawal.
• BRCA1/2 wild type (both germline and somatic)
• Homologous Recombination Deficiency (HRD) is available
• Patients must provide archived or fresh tumor tissue samples for biomarker detection.
• PD-L1 positive (if either at least 1% of assessed tumour cells expressed membranous PD-L1, at least 5% of immune cells within the tumour area expressed PD-L1, or both) and number of intraepithelial CD8+ tumor-infiltrating lymphocytes (TILs) per high-powered field ≥ 6.
• Assessed by the experienced surgeons, complete resection of all recurrent disease is possible (predicted by iMODEL score or by PET/CT).
• ECOG performance status of 0 to 2
• Adequate bone marrow, liver, and renal function to receive combined immunotherapy
• Written informed consent
• Arm 2 (compassionate use, CU), Similar to cohort 1, except for:
• If the patient had previous PARPi maintenance therapy, disease progression should occurring within 3 months after the prior PARPi withdrawal or during the PARPi maintenance therapy.
• PD-L1 positive or number of intraepithelial CD8+ TILs per high-powered field ≥ 6.

You may not qualify if:

• Patients with borderline, low-grade tumors, clear cell carcinoma, as well as non-epithelial tumors.
• Patients with platinum-resistant or refractory diseases.
• Lack of tumor samples (archived and/or recently obtained) for biomarker detection.
• Previous administration of immunotherapy
• Patients have been vaccinated with the live vaccine or received anti-tumor treatment within 4 weeks before the first administration.
• Synchronous or metachronous (within 5 years) malignancy, symptomatic or uncontrolled visceral metastases that require simultaneous treatment, other than carcinoma in situ or breast cancer (without any signs of relapse or activity).
• Patients with parenchymal metastases and life-threatening complications in short term.
• Any other concurrent medical conditions contraindicating surgery, chemotherapy, or immunotherapy that could compromise the adherence to the protocol.
• Patients are known to be allergic to the active ingredients or excipients of Sintilimab.
• HRD status is not available.
• Any medication induced considerable risk of surgery, e.g. estimated bleeding due to oral anticoagulating agents or bevacizumab.
• Patients for interval-debulking, or for second-look surgery, or palliative surgery planned.
• Impossible to assess the resectability of recurrent disease or evaluate the score. Radiological signs suggesting complete resection is impossible.

Sponsors & Collaborators

• Shanghai Gynecologic Oncology Group: lead
• Shanghai Zhongshan Hospital: collaborator
• Tongji Hospital: collaborator

Study Sites (2)

Zhongshan Hospital Fudan University

Shanghai, China

Location

Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Ovarian Neoplasms

Interventions

Surgical Procedures, Operative; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; 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; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Tingyan Shi, MD, PHD

CONTACT

86-21-64041990; shi.tingyan@zs-hospital.sh.cn

Yulian Chen, MD

CONTACT

86-21-64041990; emma_serendipity@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)