A Single-arm, Multicenter, Phase II Study to Evaluate Candonilimab（AK104） Combined With Radiotherapy For The Treatment of Locally Advanced Cervical Cancer
Overview
- Phase
- Phase 2
- Intervention
- EBRT
- Conditions
- Locally Advanced Cervical Cancer
- Sponsor
- Chongqing University Cancer Hospital
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- ORR assessed by Investigator
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
Candonilimab（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 candonilimab plus radiotherapy in participants with locally advanced cervical cancer who do not tolerate chemotherapy.
Investigators
Qi Zhou
Professor
Chongqing University Cancer Hospital
Eligibility Criteria
Inclusion Criteria
- •Able to understand and voluntarily sign written informed consent.
- •Women aged ≥18 years at the time of study entry.
- •Eastern Cancer Cooperative performance status (ECOG PS) score of 0 or
- •Life expectancy ≥12 weeks.
- •Participants' 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.
Exclusion Criteria
- •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 to randomization.
- •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.
Arms & Interventions
treatment arm
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.
Intervention: EBRT
treatment arm
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.
Intervention: Cadonilimab（AK104）
treatment arm
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.
Intervention: BT
Outcomes
Primary Outcomes
ORR assessed by Investigator
Time Frame: Up to 2 years
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR per RECIST v1.1.
Secondary Outcomes
- DCR(Up to 2 years)
- PFS(Up to approximately 30 months)
- Number of participants with adverse events (AEs)(Up to approximately 40 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)