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.
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.
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.
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.
Cohort
Prospective
Iparomlimab and Tuvonralimab (QL1706) + Nab-Paclitaxelwith or without Bevacizumab
Biological/VaccineAll 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.
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.
Progression-Free Survival (PFS)
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.
Duration of Response (DoR)
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.
Disease Control Rate (DCR)
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.
Overall Survival (OS)
The time from the start of study treatment until death from any cause.
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