NCT07186868Not yet recruiting
QL706 + Chemo ± Bevacizumab in Anti-PD-(L)1-Resistant R/M Cervical Cancer
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
Source: ClinicalTrials.gov · Last updated 22 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 25 (estimated)
- First submitted
- 16 Sept 2025
- Start date
- 15 Oct 2025
- Primary completion date
- 30 Aug 2027
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Cervical cancer
- NCT number
- NCT07186868
What you commit to
- Study type: Observational
- Planned participants: 25
- From 15 Oct 2025 to the primary completion date, 30 Aug 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- Known allergy to any component of the study drugs.
- 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.
- Any other condition deemed by the investigator as unsuitable for participation in this study.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.