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Not yet recruiting NCT06602063

Surgery for Relapsed Ovarian Cancer in Precision

Phase I / Phase II Interventional Epithelial Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: surgery/chemotherapy, Iparomlimab/Tuvonralimab.
Who it may be relevant to
Registry conditions: Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma. Basic parameters: 18 years — 80 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Surgery With ICBs in BRCAwt, CD8+ TILs, 1st Relapsed Ovarian Cancer: A Pilot Study

Overview

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).

Detailed description

The immune phenotype of patients with relapsed ovarian cancer may correlate with their response to immunotherapy. 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). PD-L1 expression and CD8+ tumor-infiltrating T cell count (CD8+ TILs count) were evaluated as biomarkers using archived or fresh tumor tissue samples in patients with BRCA1/2 wild type.

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.

Interventions

  • Procedure surgery/chemotherapy
    secondary cytoreductive surgery followed by 6 cycles of post-operative chemotherapy
  • Drug 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.

Primary outcome measures

  • Progression-free survival in CF arm [Time frame: Up to 3 years]
  • 3-years Overall Survival Rate in CF arm [Time frame: Up to 3 years]
Secondary outcome measures (6)
  • Overall survival in CF arm [Time frame: Up to 3 years]
  • TFST in CF arm [Time frame: Up to 3 years]
  • TSST in CF arm [Time frame: Up to 3 years]
  • Post-operative complications in CF and CU arms [Time frame: Up to 1 months]
  • Quality of life assessments in CF arm using EORTC QLQ-C30 [Time frame: Up to 3 years]
  • Quality of life assessments in CF arm using FACT-O [Time frame: Up to 3 years]

Eligibility criteria

Inclusion criteria

  • 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.
  • Arm 3 (real word) Patients who meet the inclusion criteria but refuse to participate in the phase II CF and CU cohorts.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • Zhongshan Hospital Fudan University — Shanghai
  • Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology — Wuhan

Identifiers

NCT: NCT06602063 · SOC-P

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗