Menu
Not yet recruiting NCT07617818

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

Phase II Interventional Cervical Cancer Neoadjuvant Therapy Immunotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: QL1706 + Cisplatin/Paclitaxel Neoadjuvant Therapy.
Who it may be relevant to
Registry conditions: Cervical Cancer, Neoadjuvant Therapy, Immunotherapy. Basic parameters: 18 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Pathological Complete Response (pCR) [Time frame: At surgery following completion of neoadjuvant therapy]
Secondary outcome measures (5)
  • Objective Response Rate (ORR) [Time frame: During neoadjuvant treatment period]
  • Progression-Free Survival (PFS) [Time frame: Up to 3 years]
  • 3-Year Pelvic Recurrence Rate [Time frame: 3 years]
  • Adverse Events [Time frame: From informed consent through 30 days after last treatment dose]
  • Overall Survival (OS) [Time frame: Up to 3 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07617818 · CERVINA Study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗