RecruitingPhase 2NCT07055399

Neoadjuvant Iparomlimab and Tuvonralimab Plus Chemotherapy-eclipse for Locally Advanced Cervical Cancer (NICE-CC)

Neoadjuvant Therapy of Iparomlimab and Tuvonralimab Combined With Chemotherapy-eclipse for Locally Advanced Cervical Cancer:A Single-arm, Open-label, Phase II Trial


Sponsor

Fujian Cancer Hospital

Enrollment

43 participants

Start Date

Aug 21, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Locally advanced cervical cancer (LACC) remains a significant global health concern with limited treatment options. Recent advancements suggest that using neoadjuvant anti-PD-1 inhibitors in combination with chemotherapy, followed by radical surgery, may be an effective treatment strategy for patients with PD-L1-positive LACC. This study aims to evaluate the efficacy and safety of preoperative treatment with iparomlimab and tuvonralimab-a bifunctional PD-1/CTLA-4 dual blocker-combined with chemotherapy for LACC.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial (NICE-CC) tests a combination of two immunotherapy drugs — iparomlimab and tuvonralimab — along with chemotherapy as a treatment given before surgery for women with locally advanced cervical cancer. The goal is to shrink the tumor before the operation and improve long-term outcomes. **You may be eligible if...** - You are 18–70 years old with locally advanced cervical cancer (stages IB3, IIA2, or IIIC1r) - Your cancer is squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma confirmed by biopsy - You have not received any prior cancer treatment for this condition - Your blood counts and organ function meet the required levels - You have a measurable tumor **You may NOT be eligible if...** - You have previously had any cancer treatment - You have an active autoimmune condition requiring systemic therapy - You are currently enrolled in another clinical trial - You have had another cancer in the last 3 years - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGneoadjuvant chemo-immunotherapy: Iparomlimab and tuvonralimab plus cisplatin,nab-paclitaxel for 1 cycle and Iparomlimab and tuvonralimab for 2 cycles

Neoadjuvant chemo-immunotherapy: Iparomlimab and tuvonralimab, cisplatin, and nab-paclitaxel for 1 cycle, then Iparomlimab and tuvonralimab continued for 2 cycles at 3-week intervals. Details: Iparomlimab and tuvonralimab 5 mg/kg, IV infusion, Q3W for 3 cycles Cisplatin:75-80 mg/m2, IV infusion, (cycle 1) Nab-paclitaxel 260 mg/m2,30min,IV infusion,(cycle 1)


Locations(1)

Fujian Cancer Hospital

Fuzhou, Fujian, China

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NCT07055399


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