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

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study ID
NCT07186868
Status
Not Yet Recruiting

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Conditions

  • Metastatic Cervical Cancer
  • Recurrent Cervical Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Sep 22, 2025
Start date
Oct 15, 2025
Status verified
Aug 2025
Primary completion
Aug 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
25 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

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) ]

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