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NCT07186868

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

Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

Start Date

2025-10-15

Completion Date

2027-12-30

Last Updated

2025-09-22

Healthy Volunteers

Conditions

Recurrent Cervical Cancer Metastatic Cervical Cancer

Interventions

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.

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.