Pre-surgery iparomlimab and tuvonralimab with chemotherapy for locally advanced cervical cancer

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

This phase 2 trial tests whether giving iparomlimab and tuvonralimab with chemotherapy before surgery helps people with locally advanced cervical cancer shrink their tumors and improve outcomes.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Fujian Cancer Hospital (other gov)
• Drugs / interventions: iparomlimab, tuvonralimab, chemotherapy
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT07055399 on ClinicalTrials.gov

What this trial studies

In this single-arm phase 2 trial, 43 patients with FIGO 2018 stages IB3, IIA2, IIB, or IIIC1r locally advanced cervical cancer receive one cycle of iparomlimab and tuvonralimab plus cisplatin and nab‑paclitaxel followed by two additional cycles of iparomlimab and tuvonralimab at three‑week intervals. Tumor response is assessed after three cycles using RECIST v1.1, with patients achieving complete or partial responses proceeding to radical surgery and others moving to concurrent chemoradiotherapy. The trial collects safety and efficacy data, including pathological response rates, and includes blood and tumor sampling for biomarker analyses. Treatments and follow-up are conducted at the lead site with standardized criteria for subsequent adjuvant therapy per guidelines.

Who should consider this trial

Good fit: Adults 18–70 years old with histologically confirmed squamous cell, adenocarcinoma, or adenosquamous cervical cancer at FIGO 2018 stages IB3, IIA2, IIB, or IIIC1r, ECOG 0–1, adequate organ function, measurable disease, and willingness to provide blood and tumor samples.

Not a fit: Patients with poor organ function, ECOG >1, prior systemic therapy, metastatic disease beyond the included stages, or those whose tumors progress during neoadjuvant treatment are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this preoperative chemo‑immunotherapy approach could increase tumor shrinkage before surgery, raise the chance of complete resection, and improve longer‑term disease control.

How similar studies have performed: Early neoadjuvant trials combining PD‑1 inhibitors with chemotherapy in cervical cancer have shown promising tumor responses, but the specific dual PD‑1/CTLA‑4 bifunctional antibody regimen used here is novel and less extensively tested.

Eligibility criteria

Inclusion Criteria:

* 1、Written informed consent
* 2、18-70 years old
* 3、Adequate organ function and ECOG of 0 \~1
* 4、Without systemic therapy at the time of enrollment
* 5、FIGO 2018 stage IB3, IIA2, or IIIC1r
* 6、Histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
* 7、Measurable lesions could be defined by RECIST v1.1
* 8、Willing to get blood/ tumor tissue tested
* 9、Patients who observed the rules about the scheduled visit, study schedule, and medical examination
* 10、The function of major organs is normal, and the following criteria are met:
* 10.1 Blood routine examination must meet: (no blood transfusion within 14 days)

Hb≥90g/L:

ANC≥1.5x10\^9/L; PLT≥100x10\^9/L;

* 10.2 The biochemical examination must meet the following standards BIL \< 1.5 × ULN; ALT and AST \< 2.5xULN; ALB≥ 28 g/L
* 11、Patients who are willing and able to comply with visiting arrangements, treatment plans, laboratory tests, and other research procedures.

Exclusion Criteria:

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

Where this trial is running

Fuzhou, Fujian

• Fujian Cancer Hospital — Fuzhou, Fujian, China (RECRUITING)

Study contacts

• Study coordinator: Yang Sun, PHD

Conditions: Locally Advanced Cervical Cancer, Cervical Cancer, neoadjuvant, chemo-immunotherapy, iparomlimab and tuvonralimab