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

NCT07186868 | Not Yet Recruiting

• 1 other identifier: NCC-01
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Recurrent Cervical Cancer; Metastatic Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  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 Outcomes (4)

• Progression-Free Survival (PFS)

  From enrollment until disease progression or death (assessed approximately every 8 weeks for up to 24 months).

• Duration of Response (DoR)

  From the first recorded response until disease progression or death (assessed approximately every 8 weeks for up to 24 months).

• Disease Control Rate (DCR)

  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)

  From enrollment until death from any cause (assessed every 12 weeks during follow-up for up to 24 months).

Study Arms (1)

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

Interventions

Iparomlimab and Tuvonralimab (QL1706) + Nab-Paclitaxelwith or without Bevacizumab BIOLOGICAL

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.

QL1706 + Nab-Paclitaxel ± Bevacizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 22, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-08