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NCT Number: NCT07617818

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

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.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Immunotherapy Neoadjuvant Therapy Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

QL1706 + Cisplatin/Paclitaxel Neoadjuvant Therapy

Drug

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 outcomes

  1. Pathological Complete Response (pCR)

    Time frame: At surgery following completion of neoadjuvant therapy

    Proportion of patients achieving pathological complete response after neoadjuvant therapy.

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: During neoadjuvant treatment period

    Proportion of patients achieving complete or partial response according to RECIST v1.1.

  2. Progression-Free Survival (PFS)

    Time frame: Up to 3 years

    Time from treatment initiation to disease progression or death.

  3. 3-Year Pelvic Recurrence Rate

    Time frame: 3 years

    Proportion of patients with pelvic recurrence within 3 years.

  4. Adverse Events

    Time frame: From informed consent through 30 days after last treatment dose

    Incidence and severity of adverse events graded according to CTCAE v5.0.

  5. Overall Survival (OS)

    Time frame: Up to 3 years

    Time from treatment initiation to death from any cause

Study contacts

Contact information is provided by the study sponsor or research team.

Zhigang Zhang, MD

CONTACT

[email protected]

86057189713631

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study 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)

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jun 1, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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