Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
33 participants
INTERVENTIONAL
2025-07-31
2030-06-30
Brief Summary
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Detailed Description
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This study would be proceeded in two phases. The phase 1b single-arm study aimed to evaluate the efficacy of Iparomlimab/tuvonralimab in the treatment of BRCA wild type, PD-L1-positive, CD8+ TILs-positive, patients with PSROC. The patent-centric phase II study with three arms aimed to evaluate the efficacy of secondary cytoreduction followed by platinum-based chemotherapy in combination with Iparomlimab/tuvonralimab in these patients. In arm 1 and 2, patients received secondary cytoreduction followed by platinum-based chemotherapy in combination with Iparomlimab/tuvonralimab. In arm 3, patients received physician's therapy of choice.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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criteria-fulfilled arm
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.
surgery/chemotherapy
secondary cytoreductive surgery followed by 6 cycles of post-operative chemotherapy
Iparomlimab/Tuvonralimab
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
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.
surgery/chemotherapy
secondary cytoreductive surgery followed by 6 cycles of post-operative chemotherapy
Iparomlimab/Tuvonralimab
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.
real world arm
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.
No interventions assigned to this group
Interventions
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surgery/chemotherapy
secondary cytoreductive surgery followed by 6 cycles of post-operative chemotherapy
Iparomlimab/Tuvonralimab
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.
Eligibility Criteria
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Inclusion Criteria
1. Age at recurrence ≥ 18 years, \<80 years.
2. 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.
3. If the patient had previous PARPi maintenance therapy, disease progression should occurring at lease 3 months after the prior PARPi withdrawal.
4. BRCA1/2 wild type (both germline and somatic)
5. Homologous Recombination Deficiency (HRD) is available
6. Patients must provide archived or fresh tumor tissue samples for biomarker detection.
7. 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.
8. Assessed by the experienced surgeons, complete resection of all recurrent disease is possible (predicted by iMODEL score or by PET/CT).
9. ECOG performance status of 0 to 2
10. Adequate bone marrow, liver, and renal function to receive combined immunotherapy
11. Written informed consent
* Arm 2 (compassionate use, CU), Similar to cohort 1, except for:
1. 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.
2. PD-L1 positive or number of intraepithelial CD8+ TILs per high-powered field ≥ 6.
Exclusion Criteria
2. Patients with platinum-resistant or refractory diseases.
3. Lack of tumor samples (archived and/or recently obtained) for biomarker detection.
4. Previous administration of immunotherapy
5. Patients have been vaccinated with the live vaccine or received anti-tumor treatment within 4 weeks before the first administration.
6. 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).
7. Patients with parenchymal metastases and life-threatening complications in short term.
8. Any other concurrent medical conditions contraindicating surgery, chemotherapy, or immunotherapy that could compromise the adherence to the protocol.
9. Patients are known to be allergic to the active ingredients or excipients of Sintilimab.
10. HRD status is not available.
11. Any medication induced considerable risk of surgery, e.g. estimated bleeding due to oral anticoagulating agents or bevacizumab.
12. Patients for interval-debulking, or for second-look surgery, or palliative surgery planned.
13. Impossible to assess the resectability of recurrent disease or evaluate the score. Radiological signs suggesting complete resection is impossible.
18 Years
80 Years
FEMALE
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Tongji Hospital
OTHER
Shanghai Gynecologic Oncology Group
OTHER_GOV
Responsible Party
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Locations
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Zhongshan Hospital Fudan University
Shanghai, , China
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SOC-P
Identifier Type: -
Identifier Source: org_study_id
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