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| Name | Class |
|---|---|
| Jiangsu Cancer Institute & Hospital | OTHER |
| Fuzhou University Affiliated Provincial Hospital | OTHER |
| First Affiliated Hospital of Fujian Medical University | OTHER |
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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.
A total of 43 patients with FIGO 2018 stages IB3, IIA2, IIB, or IIIC1r will receive a combination treatment consisting of iparomlimab and tuvonralimab (5 mg/kg administered intravenously), cisplatin (75-80 mg/m², intravenously), and nab-paclitaxel (260 mg/m², intravenously) for one cycle. Following this, patients will receive two additional cycles of iparomlimab and tuvonralimab at the same dosage of 5 mg/kg, administered at three-week intervals. After completing three cycles of neoadjuvant treatment, patients who show a complete response (CR) or partial response (PR) will undergo radical surgery. The decision regarding subsequent adjuvant therapy will be guided by the NCCN guidelines. In contrast, patients with stable or progressive disease will proceed to concurrent chemoradiotherapy (CCRT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group : iparomlimab and tuvonralimab plus nab-paclitaxel, cisplatin | Experimental | Participants will receive iparomlimab and tuvonralimab at a dose of 5 mg/kg, nab-paclitaxel at 260 mg/m², and cisplatin at 75-80 mg/m², all administered intravenously on day 1. After three weeks, participants will continue with only iparomlimab and tuvonralimab(5 mg/kg) for two additional cycles at an interval of 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neoadjuvant chemo-immunotherapy: Iparomlimab and tuvonralimab plus cisplatin,nab-paclitaxel for 1 cycle and Iparomlimab and tuvonralimab for 2 cycles | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response (pCR) | Pathological complete response（pCR） is defined as the absence of viable tumor cells by surgery | From enrollment to the end of surgery at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | ORR is defined as the proportion of patients who achieve either a complete or partial response, as assessed by two experienced medical oncologists according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. | From enrollment to the end of surgery at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Immunophenotyping of peripheral blood mononuclear cells will be performed by flow cytometry | Using flow cytometry to analyze the peripheral blood mononuclear cells to predict the efficacy of neoadjuvant chemo-immunotherapy. Results will be summarized by dose level | Samples taken prior/after to every cycle of treatment, or at progression, an average of 2 year |
Inclusion Criteria:
Hb≥90g/L:
ANC≥1.5x10^9/L; PLT≥100x10^9/L;
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Sun, PHD | Contact | 86-15959028989 | sunyang@fjzlhospital.com | |
| Jie Lin, MD | Contact | 86-15860818601 | linjie@fjzlhospital.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Cancer Hospital | Recruiting | Fuzhou | Fujian | 350014 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39426385 | Background | Wu X, Sun Y, Yang H, Wang J, Lou H, Li D, Wang K, Zhang H, Wu T, Li Y, Wang C, Li G, Wang Y, Li D, Tang Y, Pan M, Cai H, Wang W, Yang B, Qian H, Tian Q, Yao D, Cheng Y, Wei B, Li X, Wang T, Hao M, Wang X, Wang T, Ran J, Zhu H, Zhu L, Liu X, Li Y, Chen L, Li Q, Yan X, Wang F, Cai H, Zhang Y, Liang Z, Liu F, Huang Y, Xia B, Qu P, Zhu G, Chen Y, Song K, Sun M, Chen Z, Zhou Q, Hu L, Abulizi G, Guo H, Liao S, Ye Y, Yan P, Tang Q, Sun G, Liu T, Lu D, Hu M, Wang ZM, Li B, Xia M. Cadonilimab plus platinum-based chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer (COMPASSION-16): a randomised, double-blind, placebo-controlled phase 3 trial in China. Lancet. 2024 Oct 26;404(10463):1668-1676. doi: 10.1016/S0140-6736(24)02135-4. Epub 2024 Oct 16. | |
| 39284953 |
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The iparomlimab and tuvonralimab at a dosage of 5 mg/kg administered intravenously, along with cisplatin (75-80 mg/m², intravenously) and nab-paclitaxel (260 mg/m², intravenously) for one cycle. Then, two additional cycles (interval of 3 weeks) of iparomlimab and tuvonralimab (5 mg/kg, intravenously) were followed.
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|
| Event-free survival (EFS) |
EFS is defined as the time from initial treatment to the date of disease progression that prevents definitive surgery, local or distant recurrence, occurrence of a second primary cancer, or death from any cause, whichever occurs first. |
| Through the study completion, an average of 2 year |
| Primary pathological response (MPR) | MPR is defined as having no more than 10% viable tumor by surgery. | From enrollment to the end of surgery at 3 months |
| Disease-free survival (DFS) | DFS is the interval from the initial treatment to the first occurrence of locoregional failure, distant metastasis, or death from any cause. | Through the study completion, an average of 2 year |
| Adverse events | Incidence of Treatment-Emergent Adverse Events, Including adverse events and complications. Incidence of adverse events using CTCAE 5.0; grade 3 treatment-related adverse events and higher-grade will be reported | During the treatment（12months） |
| Tumor micrioenviroment assessment | using tumor tissue (multiple immunofluorescence) to assess immune cells before and after 3 cycles of neoadjuvant chemo-immunotherapy | Samples taken prior/after to every cycle of treatment, or at progression, an average of 2 year |
| Background |
| Nederlof I, Isaeva OI, de Graaf M, Gielen RCAM, Bakker NAM, Rolfes AL, Garner H, Boeckx B, Traets JJH, Mandjes IAM, de Maaker M, van Brussel T, Chelushkin M, Champanhet E, Lopez-Yurda M, van de Vijver K, van den Berg JG, Hofland I, Klioueva N, Mann RM, Loo CE, van Duijnhoven FH, Skinner V, Luykx S, Kerver E, Kalashnikova E, van Dongen MGJ, Sonke GS, Linn SC, Blank CU, de Visser KE, Salgado R, Wessels LFA, Drukker CA, Schumacher TN, Horlings HM, Lambrechts D, Kok M. Neoadjuvant nivolumab or nivolumab plus ipilimumab in early-stage triple-negative breast cancer: a phase 2 adaptive trial. Nat Med. 2024 Nov;30(11):3223-3235. doi: 10.1038/s41591-024-03249-3. Epub 2024 Sep 16. |
| 40167968 | Background | Keam SJ. Iparomlimab and Tuvonralimab: First Approval. Drugs. 2025 May;85(5):699-706. doi: 10.1007/s40265-025-02160-6. Epub 2025 Apr 1. |
| 38048802 | Background | Li K, Chen J, Hu Y, Wang YZ, Shen Y, Chen G, Peng W, Fang Z, Xia B, Chen X, Song K, Wang Y, Zou D, Wang YC, Han Y, Feng X, Yuan J, Guo S, Meng X, Feng C, Chen Y, Yang J, Fan J, Wang J, Ai J, Ma D, Sun C. Neoadjuvant chemotherapy plus camrelizumab for locally advanced cervical cancer (NACI study): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2024 Jan;25(1):76-85. doi: 10.1016/S1470-2045(23)00531-4. Epub 2023 Dec 1. |
| 35256411 | Background | Miriyala R, Mahantshetty U, Maheshwari A, Gupta S. Neoadjuvant chemotherapy followed by surgery in cervical cancer: past, present and future. Int J Gynecol Cancer. 2022 Mar;32(3):260-265. doi: 10.1136/ijgc-2021-002531. |
| 38081139 | Background | Abu-Rustum NR, Yashar CM, Arend R, Barber E, Bradley K, Brooks R, Campos SM, Chino J, Chon HS, Crispens MA, Damast S, Fisher CM, Frederick P, Gaffney DK, Gaillard S, Giuntoli R, Glaser S, Holmes J, Howitt BE, Lea J, Mantia-Smaldone G, Mariani A, Mutch D, Nagel C, Nekhlyudov L, Podoll M, Rodabaugh K, Salani R, Schorge J, Siedel J, Sisodia R, Soliman P, Ueda S, Urban R, Wyse E, McMillian NR, Aggarwal S, Espinosa S. NCCN Guidelines(R) Insights: Cervical Cancer, Version 1.2024. J Natl Compr Canc Netw. 2023 Dec;21(12):1224-1233. doi: 10.6004/jnccn.2023.0062. |
| 38572751 | Background | Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4. |
| 41775252 | Derived | Lin J, Wu Q, Liu B, He H, Guo X, Li L, Jiang Y, Huang Y, Lin Y, He T, Zheng X, Li S, Chen L, Lin C, Li E, Zhou S, Sun Y. Neoadjuvant therapy of iparomlimab and tuvonralimab combined with chemotherapy-extenuated for locally advanced cervical cancer (NICE-CC): an investigator-initiated, multicentre, open-label, phase II trial. J Gynecol Oncol. 2026 Feb 9. doi: 10.3802/jgo.2026.37.e70. Online ahead of print. |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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