Iparomlimab and Tuvonralimab Plus Paclitaxel and Platinum as Neoadjuvant Therapy for Locally Advanced Cervical Cancer

Summary

Purpose: To evaluate the efficacy and safety of neoadjuvant treatment with iparomlimab and tuvonralimab (QL1706), a dual PD1and CTLA4 bispecific antibody, in combination with paclitaxel and either cisplatin or carboplatin (TP/TC regimen) for patients with locally advanced cervical cancer. Eligibility Criteria: Women aged 18 to 70 years with newly diagnosed, histologically confirmed cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma), FIGO stage IB3 or IIA2, with no evidence of significant lymph node involvement (pelvic and paraaortic lymph nodes \<1.5 cm in short diameter), and who have not received any prior anticancer therapy. Study Procedures: Participants will receive up to 4 cycles of QL1706 plus TP/TC chemotherapy (once every 3 weeks) prior to surgery. After 2 cycles, clinical assessment will be performed to evaluate tumor response. If tumor shrinkage is observed, treatment may continue for 2 additional cycles, followed by imaging evaluation. Depending on the response, participants with complete or partial response may undergo less extensive surgery (cervical conization plus sentinel lymph node biopsy) rather than standard radical hysterectomy. After surgery, participants who achieve a major pathological response will receive QL1706 maintenance therapy as a single agent for up to 8 additional cycles (once every 3 weeks). For participants with insufficient tumor response, standard radical hysterectomy will be performed. Postoperative adjuvant therapy (radiation or chemotherapy) will follow standard clinical guidelines. Primary and Secondary Objectives: The primary endpoint is the pathological complete response (pCR) rate in the resected tissue following neoadjuvant treatment. Secondary endpoints include safety (treatment related adverse events), objective response rate (ORR), 3 years overall survival, 3 years disease free survival, and quality of life. Study Duration: Total participation time depends on treatment response and surgical scheduling, with an expected duration of approximately 9 to 12 months (including neoadjuvant treatment, surgery, and potential maintenance therapy).

Timeline

Start

2026-07-01

Primary completion

2028-12-01

Completion

2029-07-01

Publications

• Results Lou H, Zhou Y, Li D, et al. 251 Efficacy and safety of iparomlimab and tuvonralimab in previously treated patients with recurrent or metastatic cervical cancer: a multicenter, open-label, single-arm, phase 2 clinical trial (DUBHE-C- 206). Int J Gynecol Cancer. 2024;34(Suppl 1):A5.1.
• Results Pan YC, Dai Z, Ma H, Zheng J, Leng J, Xie C, Yuan Y, Yang W, Yalikun Y, Song X, Han CB, Shang C, Yang Y. Self-powered and speed-adjustable sensor for abyssal ocean current measurements based on triboelectric nanogenerators. Nat Commun. 2024 Jul 20;15(1):6133. doi: 10.1038/s41467-024-50581-w.
• Results Cui B, Xian C, Han B, Shu C, Qian Y, Ouyang Z, Wang X. High-resolution emission inventory of biogenic volatile organic compounds for rapidly urbanizing areas: A case of Shenzhen megacity, China. J Environ Manage. 2024 Feb;351:119754. doi: 10.1016/j.jenvman.2023.119754. Epub 2023 Dec 10.
• Results Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10. doi: 10.1016/0197-2456(89)90015-9.

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