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

NCT05687851 | Recruiting Phase 2

• 1 other identifier: CQGOG010
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Locally Advanced Cervical Cancer

Keywords

Local advanced cervical cancer; Concurrent chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• ORR assessed by Investigator

  The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR per RECIST v1.1.

  Up to 2 years

Secondary Outcomes (5)

• DCR

  Up to 2 years

• PFS

  Up to approximately 30 months

• OS

  Up to approximately 40 months

• Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status Score and Physical Function Score.

  Baseline and up to approximately 40 months

• Number of participants with adverse events (AEs)

  Up to approximately 40 months

Study Arms (1)

treatment arm

EXPERIMENTAL

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.

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

Interventions

Cadonilimab（AK104） DRUG

q3w iv

treatment arm

EBRT RADIATION

45-50.4Gy

treatment arm

BT RADIATION

≥80Gy

treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and voluntarily sign written informed consent.
• Women aged ≥18 years at the time of study entry.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2.
• Life expectancy ≥12 weeks.
• Intolerance to chemotherapy regimens.
• Histologically confirmed cervical cancer.
• Histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix;
• 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).
• Locally advanced cervical cancer（LACC）: The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stage IB3/IIA2, IIB-IVA.
• At least one measurable tumor lesion according to RECIST v1.1 criteria.
• Available archived tumor tissue samples or recent biopsies.
• Adequate organ function.
• 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)

You may not qualify if:

• Other histological types of cervical cancer (eg, neuroendocrine carcinoma, small cell carcinoma, sarcoma, etc).
• Evidence of distant metastases.
• Have received total hysterectomy.
• Subject with other active malignancies within 2 years prior enter the study.
• Subject who cannot receive brachytherapy.
• Active or prior documented autoimmune disease that may relapse.
• History of interstitial lung disease or noninfectious pneumonitis.
• Subject with the clinically significant cardio-cerebrovascular disease.
• History of severe hypersensitivity reactions to other mAbs.
• Prior allogeneic stem cell transplantation or organ transplantation.
• 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.
• Receipt of live attenuated vaccines within 30 days prior to the first dose of the study drug.
• 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).
• 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.

Sponsors & Collaborators

• Chongqing University Cancer Hospital: lead
• Liaoning Cancer Hospital & Institute: collaborator
• Henan Cancer Hospital: collaborator
• Fujian Cancer Hospital: collaborator

Study Sites (1)

Chongqing university Cancer Hospital

Chongqing, CHN, 400000, China

RECRUITING

Study Officials

• Qi Zhou, MD

  Chongqing University Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xingtao Long, MD

CONTACT

+8602365075619; longxingtao2009@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 24, 2022
• First Posted: January 18, 2023
• Study Start: December 29, 2022
• Primary Completion: December 30, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)