Study Of Cadonilimab Combined With Radiotherapy In The Treatment of Locally Advanced Cervical Cancer

Chongqing University Cancer Hospital

Status and phase: Enrolling; Phase 2

Conditions: Locally Advanced Cervical Cancer

Treatments: Drug: Cadonilimab（AK104）; Radiation: EBRT; Radiation: BT

Study type: Interventional

Funder types: Other

Identifiers

NCT05687851

CQGOG010

Details and patient eligibility

About

Cadonilimab（AK104）is a humanized IgG1 bispecific antibody that targets PD-1 and CTLA-4.

This is a single-arm, multicenter, open-label, phase II study, the purpose of this study is to evaluate the efficacy and safety of Cadonilimab plus radiotherapy in participants with locally advanced cervical cancer who do not tolerate chemotherapy.

Enrollment: 33 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

treatment arm

Experimental group

Description:

Participants receive Cadonilimab at a dose of 10 mg/kg, Q3W (Day 1 of each 21 day treatment cycle) via IV infusion, until disease progression, intolerable toxicity, investigator determines that the participant cannot continue to benefit, withdraw informed consent, or Cadonilimab treatment over 2 years. During the q3w dosing period of Cadonilimab, participants receive radiotherapy including external beam radiotherapy (EBRT) and followed by brachytherapy.

Treatment:

Radiation: BT

Radiation: EBRT

Drug: Cadonilimab（AK104）