QL706 + Chemo ± Bevacizumab in Anti-PD-(L)1-Resistant R/M Cervical Cancer

September 16, 2025 updated by: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

A Prospective, Open-Label, Single-Arm Study of Iparomlimab and Toripalimab Plus Nab-Paclitaxel With or Without Bevacizumab in Recurrent/Metastatic Cervical Cancer Progressed on Anti-PD-(L)1 Therapy

This is a clinical research study for women with recurrent or metastatic cervical cancer whose disease has progressed after prior treatment with a PD-1/PD-L1 inhibitor immunotherapy.

The study will evaluate the effectiveness and safety of a new combination treatment consisting of iparvolimab and tuvonralimab (QL1706)-a dual-targeting immunotherapy drug-along with chemotherapy (nab-paclitaxel) with or without bevacizumab, an anti-angiogenic drug that may help prevent tumor growth.

Approximately 25 participants will be enrolled in this open-label, single-arm study. All participants will receive the study treatment for up to 6 cycles, followed by maintenance therapy until disease progression, unacceptable side effects, or other reasons for stopping treatment.

The main goal of the study is to see how many patients respond to the treatment (Objective Response Rate, ORR). Other goals include measuring how long the response lasts, how long patients live without the cancer getting worse, and overall survival. Safety and quality of life will also be closely monitored.

This study is for women aged 18-75 who have previously received PD-1/PD-L1 treatment and whose cancer has worsened. Participants must be in generally good health with adequate organ function and no other active cancers.

The study will be conducted at a single center in China. All participants will provide written informed consent before joining the study.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, open-label, single-arm, single-center phase II clinical trial investigating the efficacy and safety of a combination therapy in patients with recurrent or metastatic cervical cancer who have experienced disease progression following prior anti-PD-1/PD-L1 therapy.

The study aims to address the high unmet medical need in this patient population where treatment options are limited after failure of immunotherapy. The investigational regimen consists of iparomlimab and tuvonralimab (QL1706), a novel bifunctional antibody targeting both PD-1 and CTLA-4, combined with nab-paclitaxel chemotherapy, with the optional addition of bevacizumab at the investigator's discretion.

Approximately 25 participants will receive the combination treatment for 6 cycles (3-week cycles), followed by maintenance therapy with QL1706 ± bevacizumab until disease progression, unacceptable toxicity, or other discontinuation criteria are met. The primary endpoint is Objective Response Rate (ORR) per RECIST 1.1. Secondary endpoints include Progression-Free Survival (PFS), Duration of Response (DoR), Disease Control Rate (DCR), Overall Survival (OS), and safety profile. An exploratory objective will analyze the correlation between PD-L1 expression status and treatment outcomes.

The study will include rigorous safety monitoring per NCI CTCAE v5.0 guidelines and regular tumor assessments. The sample size was calculated based on the assumption of improving the ORR from a historical control of 15% to 40% with the new combination.

Study Type

Observational

Enrollment (Estimated)

25

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This study will enroll adult female patients (aged 18-75) with recurrent or metastatic cervical cancer whose disease has progressed after prior treatment with a PD-1 or PD-L1 inhibitor. Participants must have at least one measurable lesion, an ECOG performance status of 0 or 1, and adequate organ function.

Description

Inclusion Criteria:

  • Female patients aged 18 to 75 years.
  • Histologically, pathologically, or radiologically confirmed recurrent or metastatic cervical cancer.
  • At least one measurable lesion as defined by RECIST 1.1 (non-nodal lesion longest diameter ≥10 mm or lymph node short axis ≥15 mm).
  • ECOG performance status of 0 or 1.
  • Life expectancy ≥12 weeks.
  • Disease progression after receiving at least one prior anti-PD-1/PD-L1 monoclonal antibody therapy (alone or in combination).
  • Adequate organ function within 14 days before enrollment:

Absolute neutrophil count (ANC) >1.5 × 10⁹/L Platelets >100 × 10⁹/L Hemoglobin >100 g/L Serum total bilirubin <1.5 × ULN ALT and AST <3 × ULN Creatinine clearance (CCr) >60 mL/min

  • Voluntarily sign the informed consent form, able to understand and comply with study requirements.

Exclusion Criteria:

  • Known allergy to any component of the study drugs.
  • Prior treatment with any CTLA-4 targeting medication.
  • Adverse reactions from previous anti-cancer therapy have not recovered to ≤ Grade 1 (per CTCAE v5.0) (except for toxicities without safety risk per investigator's judgment, e.g., alopecia).
  • History of other malignancies within the past 5 years, except for cured malignancies.
  • Severe comorbid conditions, including but not limited to:

Extensive interstitial lung disease requiring medication. Active or uncontrolled infections (e.g., tuberculosis, HIV). Decompensated liver disease, active hepatitis, or active bleeding. History of cerebrovascular accident or pulmonary embolism. Active, known, or suspected autoimmune diseases. Active infection requiring systemic anti-infective therapy.

  • Ascites with depth >5 cm measured by ultrasound or CT, OR ascites causing severe symptoms (e.g., abdominal distension, dyspnea, circulatory dysfunction) significantly impacting physical function or study safety.
  • Pregnant, planning pregnancy, or lactating women.
  • Any other condition deemed by the investigator as unsuitable for participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
QL1706 + Nab-Paclitaxel ± Bevacizumab
All participants will receive the study intervention: Iparomlimab and Tuvonralimab (QL1706) at 5.0 mg/kg IV Q3W + Nab-Paclitaxel at 260 mg/m² IV Q3W, with or without Bevacizumab (7.5-15 mg/kg IV Q3W) per investigator's choice, for 6 cycles. This is followed by maintenance therapy with QL1706 ± Bevacizumab until disease progression, unacceptable toxicity, or other discontinuation criteria are met.
Biological: Iparomlimab and Tuvonralimab (QL1706) + Nab-Paclitaxelwith or without Bevacizumab
All participants will receive the study intervention: Iparomlimab and Tuvonralimab (QL1706) at 5.0 mg/kg IV Q3W + Nab-Paclitaxel at 260 mg/m² IV Q3W, with or without Bevacizumab (7.5-15 mg/kg IV Q3W) per investigator's choice, for 6 cycles. This is followed by maintenance therapy with QL1706 ± Bevacizumab until disease progression, unacceptable toxicity, or other discontinuation criteria are met.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: From enrollment until disease progression, unacceptable toxicity, or any other discontinuation criterion is met (assessed approximately every 8 weeks for up to 24 months)
The proportion of participants achieving a best overall response of Complete Response (CR) or Partial Response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Tumor assessments are performed by the investigators via computed tomography (CT) or magnetic resonance imaging (MRI) scans.
From enrollment until disease progression, unacceptable toxicity, or any other discontinuation criterion is met (assessed approximately every 8 weeks for up to 24 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: From enrollment until disease progression or death (assessed approximately every 8 weeks for up to 24 months).
The time from the start of study treatment until the first documentation of disease progression as per RECIST 1.1, or death from any cause, whichever occurs first.
From enrollment until disease progression or death (assessed approximately every 8 weeks for up to 24 months).
Duration of Response (DoR)
Time Frame: From the first recorded response until disease progression or death (assessed approximately every 8 weeks for up to 24 months).
The time from the first documentation of objective response (CR or PR) per RECIST 1.1 until the first documentation of disease progression or death from any cause.
From the first recorded response until disease progression or death (assessed approximately every 8 weeks for up to 24 months).
Disease Control Rate (DCR)
Time Frame: From enrollment until disease progression, unacceptable toxicity, or any other discontinuation criterion is met (assessed approximately every 8 weeks for up to 24 months).
The proportion of participants who achieve a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) per RECIST 1.1, maintained for at least 4 weeks.
From enrollment until disease progression, unacceptable toxicity, or any other discontinuation criterion is met (assessed approximately every 8 weeks for up to 24 months).
Overall Survival (OS)
Time Frame: From enrollment until death from any cause (assessed every 12 weeks during follow-up for up to 24 months).
The time from the start of study treatment until death from any cause.
From enrollment until death from any cause (assessed every 12 weeks during follow-up for up to 24 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 15, 2025

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

September 16, 2025

First Submitted That Met QC Criteria

September 16, 2025

First Posted (Actual)

September 22, 2025

Study Record Updates

Last Update Posted (Actual)

September 22, 2025

Last Update Submitted That Met QC Criteria

September 16, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Cervical Cancer

Clinical Trials on Iparomlimab and Tuvonralimab (QL1706) + Nab-Paclitaxelwith or without Bevacizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe