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May 30, 2026

Iparomlimab and tuvonralimab combined with paclitaxel and cisplatin as neoadjuvant therapy for cervical cancer: A phase II umbrella trial.

Key Points

To evaluate the efficacy and safety of QL1706 combined with paclitaxel and cisplatin as neoadjuvant therapy for locally advanced and early-stage cervical cancer.
Phase II umbrella trial design with two arms for patients with locally advanced cervical cancer (Arm 1) and fertility preservation (Arm 2).
Patients to receive 3 cycles of QL1706, paclitaxel, and cisplatin.
Endpoints include objective response rate, pathological complete response, adverse events, and survival rates.
Primary endpoints are the objective response rate and pathological complete response, with results expected significantly impacting treatment decisions.
Secondary endpoints include 2-year overall survival and disease-free survival rates alongside pregnancy outcomes for Arm 2.

Abstract

TPS5629 Background: There is an urgent need to improve neoadjuvant therapy for locally advanced cervical cancer (LACC) and fertility-preserving neoadjuvant therapy for early-stage cervical cancer patients. However, there is no study evaluating the efficacy and safety of PD-1 and CTLA-4 dual blockade-based therapy for above clinical scenarios. The present study aims to assess QL1706 combined with paclitaxel and cisplatin as neoadjuvant therapy for LACC and early-stage cervical cancer patients for fertility-preservation respectively. Methods: Trial design: For Arm 1 (LACC), patients aged 18-75 years, with FIGO 2018 stages IB3, IIA2, IIB, or IIICr (lesion ≥4 cm, confirmed by MRI), histologically confirmed as cervical squamous cell carcinoma, cervical adenocarcinoma, or cervical adenosquamous carcinoma will be included. For Arm 2 (fertility preservation), patients aged 18-45 years old, who have a strong desire to preserve fertility, with FIGO 2018 stages IB2, IB3 (lesion ≤6 cm), IIA1, or IIA2 (lesion ≤6 cm) and histologically confirmed as cervical squamous cell carcinoma, cervical adenocarcinoma, or cervical adenosquamous carcinoma, will be included. All participants will be given 3 cycles of neoadjuvant treatment with QL1706 (5 mg/kg), paclitaxel (135-175 mg/m 2 ) and cisplatin (75-80 mg/m 2 ) per 21 days. Patients in Arm 1 (LACC) who achieve CR/PR will undergo radical hysterectomy plus lymphadenectomy after 3 cycles of neoadjuvant therapy whereas patients in Arm 2 (fertility preservation) who achieve CR/PR will undergo fertility-preserving surgery. For IB1/IB2 patients, conization or simple trachelectomy plus lymphadenectomy will be performed. For IIA1/IIA2 patients, radical trachelectomy plus lymphadenectomy will be performed. Patients achieve PD/SD will be given standard treatment according to the current NCCN guideline. The primary endpoints consist of objective response rate (ORR), pathological complete response (pCR) and changes in tumor-related biomarkers (ctDNA, etc). Secondary endpoints include 2-year overall survival (OS), 2-year disease-free survival (DFS) and adverse events. Other endpoints are 2-year pregnancy rate and infant survival rate for Arm 2. Sample size is 20 for Arm 1 and 15 for Arm 2. Clinical trial identification: NCT06878222. Clinical trial information: NCT06878222 .

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