QL1706 Combined With Cisplatin/Paclitaxel as Neoadjuvant Therapy for Cervical Cancer

A Phase II, Single-Arm Study of QL1706 Combined With Cisplatin/Paclitaxel as Neoadjuvant Therapy Prior to Conservative Surgery for FIGO 2018 Stage IB1-IB3 Cervical Cancer (CERVINA Study)

This is a prospective, single-arm, phase II clinical study designed to evaluate the efficacy and safety of QL1706 combined with cisplatin and paclitaxel as neoadjuvant therapy in patients with FIGO 2018 stage IB1-IB3 cervical cancer undergoing conservative surgery.

The primary endpoint is pathological complete response (pCR). Secondary endpoints include objective response rate (ORR), progression-free survival (PFS), overall survival (OS), 3-year pelvic recurrence rate, and safety profile.

Additionally, exploratory biomarker analyses will be conducted to investigate changes in immune status, genomic alterations, PD-L1 expression, tumor mutational burden, MSI-H/dMMR status, and vaginal microbiota before and after treatment.

Study Overview

• Status: Not yet recruiting
• Conditions: Cervical Cancer; Neoadjuvant Therapy; Immunotherapy
• Intervention / Treatment: Drug: QL1706 + Cisplatin/Paclitaxel Neoadjuvant Therapy

Detailed Description

Cervical cancer remains one of the most common gynecologic malignancies worldwide. Neoadjuvant chemotherapy (NACT) has demonstrated favorable response rates in locally advanced cervical cancer; however, pathological complete response (pCR) rates remain limited.

QL1706 is a novel bifunctional PD-1/CTLA-4 antibody combination developed using the MabPair® platform. It consists of the anti-PD-1 antibody iparomlimab and the anti-CTLA-4 antibody tuvonralimab. Previous studies have demonstrated promising antitumor activity in recurrent or metastatic cervical cancer.

This study aims to investigate whether the addition of QL1706 to cisplatin/paclitaxel neoadjuvant therapy can improve pathological response and clinical outcomes in patients with FIGO 2018 stage IB1-IB3 cervical cancer undergoing conservative surgery.

Approximately 50 patients will be enrolled. Eligible patients will receive neoadjuvant QL1706 combined with cisplatin and paclitaxel followed by radical surgery. Efficacy will be evaluated using RECIST v1.1 and pathological assessment. Safety will be assessed according to CTCAE v5.0.

Exploratory translational studies will evaluate immune microenvironment changes, molecular biomarkers, and vaginal microbiota alterations associated with treatment response.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhigang Zhang, MD; Phone Number: 86057189713631; Email: zzg2011@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Female patients aged 18-65 years.
• Histologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
• FIGO 2018 stage IB1, IB2, or IB3 cervical cancer.
• Pelvic MRI completed before enrollment.
• ECOG performance status of 0-2.
• Adequate organ and bone marrow function.
• No prior immunotherapy for malignant tumors.
• Ability to understand and willingness to sign written informed consent.

Exclusion Criteria:

• Presence of uncontrolled concomitant malignancies.
• Active autoimmune disease or history of autoimmune disease with potential recurrence.
• Interstitial lung disease or uncontrolled pneumonitis.
• Active hepatitis B or hepatitis C infection.
• Known HIV infection.
• Receipt of live vaccines within 30 days before first dose.
• Uncontrolled cardiovascular disease.
• Known hypersensitivity to study drugs.
• Any condition that, in the investigator's judgment, may interfere with study participation or interpretation of results.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Arm; QL1706 + Cisplatin/Paclitaxel Neoadjuvant Therapy	Drug: QL1706 + Cisplatin/Paclitaxel Neoadjuvant Therapy; QL1706 is a bifunctional PD-1/CTLA-4 antibody combination consisting of iparomlimab and tuvonralimab. Drug: Cisplatin Cisplatin administered as part of neoadjuvant chemotherapy. Drug: Paclitaxel Paclitaxel administered as part of neoadjuvant chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological Complete Response (pCR)	Proportion of patients achieving pathological complete response after neoadjuvant therapy.	At surgery following completion of neoadjuvant therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	Proportion of patients achieving complete or partial response according to RECIST v1.1.	During neoadjuvant treatment period
Progression-Free Survival (PFS)	Time from treatment initiation to disease progression or death.	Up to 3 years
3-Year Pelvic Recurrence Rate	Proportion of patients with pelvic recurrence within 3 years.	3 years
Adverse Events	Incidence and severity of adverse events graded according to CTCAE v5.0.	From informed consent through 30 days after last treatment dose
Overall Survival (OS)	Time from treatment initiation to death from any cause	Up to 3 years

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Jianwei Zhou, PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): December 15, 2029

Study Registration Dates

• First Submitted: May 26, 2026
• First Submitted That Met QC Criteria: May 26, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Platinum Compounds; Cisplatin
• Other Study ID Numbers: CERVINA Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No