Actively Recruiting
Iparomlimab and Tuvonralimab Combined With Paclitaxel and Cisplatin as Neoadjuvant Therapy for Cervical Cancer: a Phase 2 Umbrella Trial
Led by Obstetrics & Gynecology Hospital of Fudan University · Updated on 2025-04-01
35
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring new treatment options for locally advanced cervical cancer, a condition with a low survival rate despite standard radical chemoradiotherapy. This study focuses on evaluating the combination of Iparomlimab and Tuvonralimab, two engineered monoclonal antibodies targeting PD-1 and CTLA-4, together with paclitaxel and cisplatin as neoadjuvant therapy. The study includes patients with various stages of cervical cancer, including those desiring fertility-preserving treatment, aiming to improve tumor response and reduce recurrence risks. Participants will receive three cycles of neoadjuvant therapy with Iparomlimab and Tuvonralimab at 5 mg/kg every three weeks, plus paclitaxel (135-175 mg/m2) and cisplatin (75-80 mg/m2) administered every three weeks. After completing therapy, patients who achieve complete or partial response will undergo surgery: radical hysterectomy plus lymphadenectomy for locally advanced cases, or fertility-preserving surgery such as conization, simple or radical trachelectomy plus lymphadenectomy for those aiming to preserve fertility. This approach seeks to optimize treatment effectiveness while considering fertility outcomes. During the study, participants will be closely monitored through imaging, biomarker analyses, and pathological assessments to evaluate tumor response and safety. Primary outcomes include objective response rate and pathological complete response measured at 9 weeks and 3 months, respectively, alongside changes in tumor-related biomarkers. Secondary outcomes assess overall survival, disease-free survival, and adverse events over two years. Participants must comply with study procedures and follow-up visits for up to two years to ensure thorough evaluation of treatment effects and safety.
CONDITIONS
Brief Title
Iparomlimab and Tuvonralimab Combined With Paclitaxel and Cisplatin as Neoadjuvant Therapy for CC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed cervical squamous cell carcinoma, cervical adenocarcinoma, or cervical adenosquamous carcinoma.
- Arm 1: Locally advanced cervical cancer classified as FIGO 2018 stages IB3, IIA2, IIB, or IIICr with lesion size 4 cm or larger confirmed by MRI.
- Arm 2: Cervical cancer classified as FIGO 2018 stages IB2, IB3 (lesion 6 cm or smaller), IIA1, or IIA2 (lesion 6 cm or smaller) with strong desire to preserve fertility.
- Planned to undergo surgical treatments of cervical cancer.
- Age 18 to 75 years for Arm 1; age 18 to 45 years for Arm 2.
- ECOG performance status score 0-1.
- No prior immunotherapy.
- Expected survival of at least 6 months.
- Women of childbearing potential must use contraception during the study and for 6 months after, with a negative pregnancy test and not breastfeeding.
- Adequate organ function within 7 days before treatment.
- Voluntary participation with informed consent and good compliance.
You will not qualify if you...
- Histological subtypes or disease stages not included in the inclusion criteria.
- Severe hypersensitivity (grade 3 or higher) to study drugs or their components.
- Participation in another clinical trial within 4 weeks before enrollment.
- Recent or planned vaccination with inactivated vaccines within 30 days before treatment.
- Recent treatment with immunostimulants or related agents within 6 weeks before first dose.
- Immunodeficiency, chronic systemic steroid therapy, or other immunosuppressive treatments within 7 days before first dose.
- Active autoimmune disease requiring systemic treatment within past 2 years.
- History or presence of pneumonitis requiring steroid treatment.
- Active infection requiring systemic treatment.
- Known history of HIV, hepatitis B or C, or active tuberculosis.
- Prior allogeneic tissue or organ transplantation.
- Central nervous system metastases.
- Uncontrolled pleural or peritoneal effusion.
- Impaired mobility from bone metastases.
- Insufficient bone marrow function without recent transfusion.
- Significant liver or kidney abnormalities.
- Bleeding risks including coagulation abnormalities or recent serious bleeding events.
- Cardiovascular or cerebrovascular abnormalities within specified timeframes.
- Other conditions judged by investigators to affect study results or safety.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 9 weeks
Participants receive neoadjuvant therapy consisting of Iparomlimab and Tuvonralimab combined with paclitaxel and cisplatin administered every 3 weeks for 3 cycles.
3 visits (in-person, every 3 weeks)
Duration - Single surgical procedure after neoadjuvant therapy
Participants who achieve complete or partial response after neoadjuvant therapy undergo surgery. This includes either radical hysterectomy plus lymphadenectomy or fertility-preserving surgery depending on cancer stage and participant preference.
1 visit (in-person, surgical)
Duration - Up to 2 years
Participants are followed after surgery to monitor safety, disease status, and collect biomarker data.
Regular visits during follow-up period
Trial Site Locations
Total: 1 location
1
The Obstetrics & Gynecology Hospital of Fudan University
Shanghai, China
Actively Recruiting
Research Team
J
Junjun Qiu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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