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Epithelial Ovarian CancerPhase 1/2NCT06602063

Surgery for Relapsed Ovarian Cancer in Precision

A Phase 1/2 study testing surgery/chemotherapy and Iparomlimab/Tuvonralimab in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Shanghai Gynecologic Oncology Group at 2 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 years, women only
What is being tested?
surgery/chemotherapy and Iparomlimab/Tuvonralimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
2 sitesChina
Study dates
Jul 2025to Jun 2030
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

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

China2 sites

  • Zhongshan Hospital Fudan University

    Shanghai

    Tingyan Shi, MD, PHD, shi.tingyan@zs-hospital.sh.cn

    Rongyu Zang, MD, PHD

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

    Wuhan

    Qinglei Gao, MD, PHD, gingleigao@hotmiail.com

    Qinglei Gao, MD,PHD

Other trials in China

About this study

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

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).

Read the 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.

Being tested
surgery/chemotherapy, Iparomlimab/Tuvonralimab
Keywords
Ovarian cancer, Immune checkpoint inhibitor, Secondary cytoreduction, Biomarker-driven
Medical subject headings
Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • surgery/chemotherapyProcedure or surgery

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

  • Iparomlimab/TuvonralimabDrug

    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.

Study groups in NCT06602063
Study groupRoleWhat they receive
criteria-fulfilled armExperimentalPatients 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.
Receives: Procedure: surgery/chemotherapy; Drug: Iparomlimab/Tuvonralimab
compassionate use armExperimentalPatients 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.
Receives: Procedure: surgery/chemotherapy; Drug: Iparomlimab/Tuvonralimab
real world armNo interventionPatients 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to 3 years

  2. 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

    Measured: Up to 3 years

Secondary outcomes (6)

  1. Overall survival in CF arm

    The time from entry into the study to the date of death from any cause or last follow-up in CF arm

    Measured: Up to 3 years

  2. TFST in CF arm

    Time from entry into the study until the starting date of the first subsequent anticancer therapy or death, whichever occurred first, whichever occurred first, in CF arm

    Measured: Up to 3 years

  3. TSST in CF arm

    Time from entry into the study until the starting date of the second subsequent anticancer therapy or death, whichever occurred first, in CF arm

    Measured: Up to 3 years

  4. Post-operative complications in CF and CU arms

    The surgical complications will be evaluated at 30-day after secondary cytoreductive surgery in CF and CU arms

    Measured: Up to 1 months

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

    Changes in EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) scores in CF arm (baseline; 6 months, 12 months, 24 months and 36 months after entry into the study; score range 0-126; higher score = worse outcome)

    Measured: Up to 3 years

  6. Quality of life assessments in CF arm using FACT-O

    Changes in FACT-O (Functional Assessment of Cancer Therapy-Ovarian cancer) scores in CF arm (baseline; 6 months, 12 months, 24 months and 36 months after entry into the study; score range 0-156; higher score = worse outcome)

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study startJul 2025 (estimated)
  3. Primary completionJun 2030 (estimated)
  4. Study completionJun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06602063
Sponsor's protocol ID
SOC-P
Status last verified
Jun 2025
First submitted
9 Sep 2024
Last updated
27 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing surgery/chemotherapy and Iparomlimab/Tuvonralimab in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Shanghai Gynecologic Oncology Group at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tingyan Shi, MD, PHD (86-21-64041990, shi.tingyan@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival in CF arm (time frame: Up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06602063.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.

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