Combining Cadonilimab with Radiotherapy for Advanced Cervical Cancer

A Single-arm, Multicenter, Phase II Study to Evaluate Cadonilimab（AK104） Combined With Radiotherapy For The Treatment of Locally Advanced Cervical Cancer

This study is testing if a new treatment combining Cadonilimab with radiation therapy can help women with advanced cervical cancer who can't handle chemotherapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Chongqing University Cancer Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, prednisone, Cadonilimab
• Locations: 1 site (Chongqing, CHN)
• Trial ID: NCT05687851 on ClinicalTrials.gov

What this trial studies

This phase II clinical trial evaluates the safety and efficacy of Cadonilimab, a bispecific antibody targeting PD-1 and CTLA-4, in conjunction with radiotherapy for women with locally advanced cervical cancer who cannot tolerate chemotherapy. The study is single-arm and multicenter, focusing on patients with specific histologically confirmed types of cervical cancer. Participants will receive Cadonilimab along with external beam radiotherapy and brachytherapy, with the aim of assessing treatment outcomes and safety profiles.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18 and older with histologically confirmed locally advanced cervical cancer and an ECOG performance status of 0-2.

Not a fit: Patients who are currently receiving systemic anti-tumor therapy or those with early-stage cervical cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with locally advanced cervical cancer who are unable to undergo chemotherapy.

How similar studies have performed: While the combination of immunotherapy and radiotherapy is being explored in various cancers, this specific approach for locally advanced cervical cancer is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Able to understand and voluntarily sign written informed consent.
2. Women aged ≥18 years at the time of study entry.
3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2.
4. Life expectancy ≥12 weeks.
5. Intolerance to chemotherapy regimens.
6. Histologically confirmed cervical cancer.

   1. Histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix;
   2. Not receiving systemic anti-tumour therapy (including but not limited to radiotherapy, targeted therapy and immunotherapy, etc; concurrent chemotherapy is not included. Note: Removal or biopsy of pelvic lymph nodes or para-aortic lymph nodes for the purpose of clinical staging is allowed).
   3. Locally advanced cervical cancer（LACC）: The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stage IB3/IIA2, IIB-IVA.
7. At least one measurable tumor lesion according to RECIST v1.1 criteria.
8. Available archived tumor tissue samples or recent biopsies.
9. Adequate organ function.
10. For fertile women with negative serum pregnancy and effective contraception within 7 days before administration (until 120 days after the last administration of the study drug and at least 180 days after radiotherapy)

Exclusion Criteria:

1. Other histological types of cervical cancer (eg, neuroendocrine carcinoma, small cell carcinoma, sarcoma, etc).
2. Evidence of distant metastases.
3. Have received total hysterectomy.
4. Subject with other active malignancies within 2 years prior enter the study.
5. Subject who cannot receive brachytherapy.
6. Active or prior documented autoimmune disease that may relapse.
7. History of interstitial lung disease or noninfectious pneumonitis.
8. Subject with the clinically significant cardio-cerebrovascular disease.
9. History of severe hypersensitivity reactions to other mAbs.
10. Prior allogeneic stem cell transplantation or organ transplantation.
11. Subjects who require systemic treatment with glucocorticoid (\>10 mg/day of prednisone or equivalent glucocorticoid) or other immunosuppressive agents within 14 days prior enter the study.
12. Receipt of live attenuated vaccines within 30 days prior to the first dose of the study drug.
13. Prior exposure to any experimental antitumor vaccines, or any agent targeting T-cell costimulation or immune checkpoint pathways (eg, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, anti-CD137 or anti-OX40 antibody, etc).
14. Any condition that, in the opinion of the Investigator, would interfere with the evaluation of the study drug or interpretation of subject safety or study results.

Where this trial is running

Chongqing, CHN

• Chongqing university Cancer Hospital — Chongqing, Chn, China (Recruiting)

Study contacts

• Principal investigator: Qi Zhou, MD — Chongqing University Cancer Hospital
• Study coordinator: Xingtao Long, MD

Conditions Locally Advanced Cervical Cancer; Local advanced cervical cancer; Concurrent chemoradiotherapy