New Immunotherapy-Chemo cocktail aims to boost cervical cancer survival
NCT ID NCT07244965
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether adding the immunotherapy drug ivonescimab to chemotherapy before standard chemoradiation can improve outcomes for women with high-risk, locally advanced cervical cancer. About 42 participants will receive two cycles of the combination, then proceed to standard chemoradiation. The study measures how long the cancer stays under control and how well the tumors shrink.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ivonescimab (an immunotherapy drug) combined with paclitaxel and cisplatin (chemotherapy)
- What this could lead to
- If it works, this could offer a new treatment approach to shrink tumors before standard chemoradiation, potentially improving survival for women with advanced cervical cancer.
- What could go wrong
- This is a small, early-phase trial with only 42 participants and no comparison group. The combination may cause significant side effects, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Able to understand and voluntarily sign the written informed consent form before any study-specific procedures. * Female participants aged ≥18 years on the day of signing informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Expected survival time ≥3 months. * Histologically confirmed diagnosis of cervical cancer. * Histological types limited to squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. * No prior anti-tumor treatments (including but not limited to radiotherapy, chemotherapy, surgery, targeted therapy, and immunotherapy). Note: Lymph node dissection or biopsy for clinical staging is allowed. * FIGO 2018 stage III-IVA cervical cancer unsuitable for curative surgery. Lymph node metastasis may be confirmed by biopsy or imaging. Imaging-based lymph node metastasis must meet: MRI/CT showing positive lymph node with short-axis diameter ≥10 mm, and ≥15 mm to be used as target lesion. * At least one measurable lesion per RECIST v1.1 criteria. * PD-L1 CPS score ≥1 in tumor tissue. * Must provide tumor tissue sample before treatment (FFPE blocks or ≥5 unstained slides, preferably freshly obtained). * Adequate organ function as per screening labs: * Hematological (without transfusion or growth factors within 2 weeks): * ANC ≥1.5×10⁹/L * Platelets ≥90×10⁹/L * Hemoglobin ≥9.0 g/dL * Renal: * Creatinine ≤1.5×ULN or CrCl ≥50 mL/min (≥60 mL/min if cisplatin is planned), calculated by Cockcroft-Gault: CrCl (mL/min) = \[(140 - age) × weight (kg) × 0.85\] / \[serum creatinine (mg/dL) × 72\] * Hepatic: * Total bilirubin ≤1.5×ULN (≤3×ULN if Gilbert's syndrome suspected) * AST and ALT ≤2.5×ULN * Coagulation: * INR ≤1.5×ULN and APTT ≤1.5×ULN (unless on anticoagulants with stable dosing) * Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to first dose, and agree to use effective contraception during treatment and for at least 120 days after last dose of study drug and 180 days after chemoradiotherapy. * Effective contraception includes hormonal contraception, IUDs, or double barrier methods. Periodic abstinence and rhythm methods are not acceptable. Exclusion Criteria: * Cervical cancer of non-eligible histology (e.g., neuroendocrine carcinoma, sarcoma). * Evidence of distant metastasis, including inguinal lymph node metastasis or lymph node involvement above L1 vertebral level. * History of total hysterectomy (removal of uterus and cervix). Subtotal hysterectomy or cornuostomy preserving the cervix is acceptable. * Anatomical or geometric contraindications to brachytherapy. * Active malignancies within 2 years, except for treated non-melanoma skin cancer, superficial bladder cancer, in-situ breast cancer (note: cervical carcinoma in situ history is exclusionary). * Bilateral hydronephrosis deemed non-relievable by nephrostomy or ureteral stenting. * Anti-tumor therapy within 2 weeks before treatment initiation (including but not limited to radiotherapy, chemotherapy, surgery, targeted therapy, immunotherapy, or immuno-co-stimulatory agents like ICOS, CD40, CD137, GITR, OX40 antibodies). * Immunomodulatory drugs (e.g., thymosin, interferon, IL-2) within 2 weeks before treatment. * Systemic corticosteroids (\>10 mg/day prednisone or equivalent) or other immunosuppressants within 2 weeks, except: * Inhaled, ophthalmic, or topical steroids ≤10 mg/day prednisone or equivalent * Physiologic hormone replacement ≤10 mg/day prednisone or equivalent * Prophylactic corticosteroids for hypersensitivity (e.g., CT contrast) * Active infections requiring systemic treatment (e.g., active TB, syphilis, systemic fungal infections), except HBV antiviral therapy. * Severe infection within 4 weeks prior to treatment (e.g., hospitalization, sepsis, severe pneumonia). * Major surgery or significant trauma (e.g., fractures) within 4 weeks, or planned elective major surgery. Pelvic/para-aortic lymph node dissection not exclusionary. * Live vaccines within 4 weeks. * Active or history of autoimmune diseases except for: * Vitiligo, alopecia, psoriasis, or eczema not requiring systemic therapy * Autoimmune thyroiditis requiring only stable hormone therapy * Type I diabetes requiring only stable insulin replacement * Any of the following cardiovascular/cerebrovascular diseases: * MI, unstable angina, PE, aortic dissection, DVT, or arterial embolism within 6 months * NYHA Class II or greater heart failure * Significant arrhythmias needing long-term treatment (stable asymptomatic Afib allowed) * Stroke (CVA) within 6 months * LVEF \<50% * History of myocarditis or cardiomyopathy * Known primary or secondary immunodeficiency, including HIV antibody positivity. * Active HBV infection: HBsAg positive with HBV DNA \>1000 IU/mL or \>5000 copies/mL; active HCV infection. * Exception: treated and stable HBV patients with HBV DNA ≤500 IU/mL (or ≤2500 copies/mL); cured HCV patients (HCVAb+ but HCV RNA-) allowed. * History of or active inflammatory bowel disease (Crohn's, ulcerative colitis), diverticulitis. * Known history of allogeneic organ or stem cell transplantation. * Interstitial lung disease or history of non-infectious pneumonitis. * History of severe hypersensitivity to monoclonal antibodies. * Known contraindications to cisplatin/carboplatin or paclitaxel. * Pregnant or breastfeeding women. * Any condition that may interfere with the study drug's safety or efficacy evaluation as judged by the investigator (e.g., other serious illness, psychiatric disorders).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Women's Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000, China
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Other studies related to the condition(s) this trial covers.