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

NCT07055399 | Recruiting Phase 2

• 1 other identifier: NICE-CC trial
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Locally Advanced Cervical Cancer

Keywords

Cervical Cancer; neoadjuvant; chemo-immunotherapy; iparomlimab and tuvonralimab;

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Objective response rate (ORR)

  From enrollment to the end of surgery at 3 months

• Event-free survival (EFS)

  Through the study completion, an average of 2 year

• Primary pathological response (MPR)

  From enrollment to the end of surgery at 3 months

• Disease-free survival (DFS)

  Through the study completion, an average of 2 year

• Adverse events

  During the treatment（12months）

Other Outcomes (2)

• Immunophenotyping of peripheral blood mononuclear cells will be performed by flow cytometry

  Samples taken prior/after to every cycle of treatment, or at progression, an average of 2 year

• Tumor micrioenviroment assessment

  Samples taken prior/after to every cycle of treatment, or at progression, an average of 2 year

Study Arms (1)

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.

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

Interventions

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)

Study group : iparomlimab and tuvonralimab plus nab-paclitaxel, cisplatin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 、Written informed consent
• 、18-70 years old
• 、Adequate organ function and ECOG of 0 \~1
• 、Without systemic therapy at the time of enrollment
• 、FIGO 2018 stage IB3, IIA2, or IIIC1r
• 、Histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
• 、Measurable lesions could be defined by RECIST v1.1
• 、Willing to get blood/ tumor tissue tested
• 、Patients who observed the rules about the scheduled visit, study schedule, and medical examination
• 、The function of major organs is normal, and the following criteria are met:
• Blood routine examination must meet: (no blood transfusion within 14 days)
• Hb≥90g/L:
• ANC≥1.5x10\^9/L; PLT≥100x10\^9/L;
• The biochemical examination must meet the following standards BIL \< 1.5 × ULN; ALT and AST \< 2.5xULN; ALB≥ 28 g/L
• 、Patients who are willing and able to comply with visiting arrangements, treatment plans, laboratory tests, and other research procedures.

You may not qualify if:

• 、History of other malignancies within 3 years
• 、Participate in other clinical trials at the same time
• 、Active autoimmune disease, which needs systemic therapy
• 、Uncontrolled infection, which needs systemic therapy
• 、History of allogeneic tissue/solid organ transplant
• 、Serious illness, such as severe mental disorders, cardiac disease, coagulation disorders, digestive system disease, etc
• 、Active HBV, HCV, or HIV infection
• 、Pregnant or lactating female patients
• 、Drug or alcohol abuse
• 、 Unable or unwilling to sign the informed consent

Sponsors & Collaborators

• Fujian Cancer Hospital: lead
• Jiangsu Cancer Institute & Hospital: collaborator
• Fuzhou University Affiliated Provincial Hospital: collaborator
• First Affiliated Hospital of Fujian Medical University: collaborator

Study Sites (1)

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

RECRUITING

Related Publications (7)

• 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.

  PMID: 39426385 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.

  PMID: 39284953 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.

  PMID: 40167968 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.

  PMID: 38048802 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.

  PMID: 35256411 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.

  PMID: 38081139 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.

  PMID: 38572751 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Yang Sun, PHD

CONTACT

86-15959028989; sunyang@fjzlhospital.com

Jie Lin, MD

CONTACT

86-15860818601; linjie@fjzlhospital.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: July 8, 2025
• Study Start: August 21, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2029
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)