Zimberelimab with radiotherapy and chemotherapy for advanced cervical cancer

A Prospective, Single Arm, Phase II Clinical Study on the Treatment of Locally Advanced Cervical Cancer (Ⅱ B to Ⅳ a) With Zimberelimab Combined With Concurrent Radiotherapy and Chemotherapy

This study is testing if the immunotherapy drug Zimberelimab, when used with radiation and chemotherapy, can help people with advanced cervical cancer feel better and improve their treatment outcomes.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Shanghai Zhongshan Hospital (Academic / other)
• Drugs / interventions: cepalimumab, immunotherapy, prednisone, Zimberelimab, chemotherapy
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05437692 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of Zimberelimab, an immunotherapy drug, when combined with concurrent radiotherapy and chemotherapy in patients with locally advanced cervical cancer. The study aims to enroll 19 patients with FIGO stage IIB to IVA cervical cancer, specifically those with cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. Participants will be monitored for treatment outcomes and potential side effects throughout the trial period.

Who should consider this trial

Good fit: Ideal candidates include women aged 18 to 75 with stage IIB to IVA cervical cancer who have not previously received radiotherapy or immunotherapy.

Not a fit: Patients with earlier stages of cervical cancer or those who have received prior treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could improve outcomes for patients with locally advanced cervical cancer.

How similar studies have performed: While there have been studies on immunotherapy for cervical cancer, the specific combination of Zimberelimab with concurrent radiotherapy and chemotherapy is relatively novel.

Eligibility criteria

Inclusion Criteria:

* FIGO 2018 stage IIB to IVA cervical cancer;
* Cervical squamous cell carcinoma, cervical adenocarcinoma or cervical adenosquamous carcinoma confirmed by histology;
* Have not received any radiotherapy for cervical cancer in the past, and have not received immunotherapy;
* Have measurable lesions (according to RECIST v1.1 standard);
* ECOG score: 0 \~ 1;
* 18\~75 years old (calculated on the day of signing the informed consent);
* The estimated survival period exceeds 6 months;
* Before enrollment, try to provide enough tumor tissue samples (archived or fresh biopsy samples) to evaluate and confirm the expression of PD-L1 and to detect other biomarkers; Considering the accessibility of clinical specimens, there is no mandatory requirement for specimens;
* Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within ● months after the end of the study; Within 7 days before the study was enrolled, the serum or urine pregnancy test was negative, and must be non lactating patients;
* For the full organ function defined in the protocol, the test samples must be collected within 7 days before the start of the study treatment;
* The patients volunteered to join the study and signed the informed consent form.

Exclusion Criteria:

* The subjects have other histological subtypes except those permitted by inclusion criteria 2;
* Bilateral hydronephrosis, unless at least one side has been implanted with a stent or solved by a positioned nephrostomy;
* Those who are allergic to gadolinium, a common non-ionic CT contrast agent and a magnetic resonance contrast agent
* Have anatomical structure or tumor geometry or any other reasons or contraindications that cannot be treated with intracavitary brachytherapy or intracavitary and implantable brachytherapy;
* Severe hypersensitivity (≥ grade 3) to cepalimumab and / or any of its excipients;
* Participated in or had participated in clinical trials within 4 weeks before randomization;
* Have been vaccinated or will be vaccinated with live vaccine within 30 days before the first study treatment;
* Have received systemic immune stimulant, colony stimulating factor, interferon, interleukin and vaccine combination treatment within 6 weeks or 5 half lives (whichever is shorter) before the first administration;
* Within 7 days before the first administration, the patient has been diagnosed with immune deficiency or is receiving chronic systemic steroid therapy (the dose exceeds 10mg prednisone equivalent per day) or any other form of immunosuppressive therapy;
* Active autoimmune diseases requiring systemic treatment during the past two years (such as the use of disease regulating drugs, corticosteroids or immunosuppressive drugs);
* Have a history of (non infectious) pneumonia requiring steroid treatment or currently have (non infectious) pneumonia;
* Active infection requiring systematic treatment;
* Known HIV infection history;
* Known hepatitis B (defined as HBsAg reactivity) or known active hepatitis C virus (defined as detection of HCV RNA \[qualitative\]) infection history;
* Known history of active tuberculosis (TB; Mycobacterium tuberculosis);
* Received allogeneic tissue / solid organ transplantation;
* Central nervous system metastasis such as tumor brain metastasis;
* Patients with uncontrolled hydrothorax and ascites;
* Patients with movement disorders such as pathological fractures caused by tumor bone metastasis;
* Insufficient hematopoietic function of bone marrow (without blood transfusion within 14 days):
* Abnormal liver:
* Abnormal kidney:
* Risk of bleeding:
* Cardiovascular and cerebrovascular abnormalities:

Where this trial is running

Shanghai, Shanghai

• Shanghai Zhongshan hospital — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Lin Genlai, MD — Shanghai Zhongshan Hospital
• Study coordinator: Lin Genlai, MD

Conditions Locally Advanced Cervical Cancer