Brief Summary
Cervical cancer is the fourth commonest female cancer in the world. Most patients present at early stage and the disease can be readily treated by radical surgery and / or chemo-irradiation. For those who have distant spread or recurrence, platinum-based chemotherapy is the usual treatment option. When this first-line chemotherapy fails, the conventional treatment is second-line chemotherapy agents. However the response rate is poor and the disease may soon progress even after initial response. There is an urgent need for a more effective treatment.
Aim of This Study
Our study aims to evaluate the efficacy and safety of the combination of two investigational drugs, avelumab (an immunotherapy drug) with axitinib (an agent that targets against abnormal vessel growth) in patients with persistent or recurrent cervical cancer following platinum-based chemotherapy. This combination has been tested in renal cancer where the response was encouraging and the side effects were manageable.
Study Design
| Avelumab: | intravenously every two weeks in a 4-weekly cycle up to 12 cycles or until disease progression or intolerable side effects (whichever occurs first) |
| Axitinib: | orally twice a day in a 4-weekly cycle up to 12 cycles or until disease progression or intolerable side effects (whichever occurs first) |
The treatment will also be stopped in case of patient refusal, patient loss to follow up, or termination of the study by the coordinating site, whichever comes first.
Eligibility Criteria
- Participants must be at least 18 years old.
- Participants must have histologically confirmed cervical cancer, that is either persistent or recurrent after at least one prior course of platinum-based chemotherapy.
- Participants should not be amenable to further surgery or radiotherapy except for the purpose of symptomatic relief.
- Participants must have good performance status, adequate bone marrow, kidney, liver, thyroid and neurological function
For further information, please contact our research team
Protocol Number
WI224193 / UW 18-417
Study Status
Estimated start date: May 2019
Principal Investigator
Dr. Ka Yu Tse (tseky@hku.hk)
Clinical Associate Professor
The University of Hong Kong
Location
Division of Gynaecology Oncology
Department of Obstetrics and Gynaecology
Queen Mary Hospital
The University of Hong Kong
ClinicalTrials.gov Identifier
NCT03826589 https://www.clinicaltrials.gov/ct2/show/NCT03826589?term=alarice&rank=1
Contact for Further Information and Safety Desk
| Tel: | 852-2255 4265 or 852-9061 9609 |
| Fax: | 852-28550947 |
| Email: | lsk382@hku.hk, tinawei@hku.hk |
| Address: | 6/F Professorial Block Department of Obstetrics and Gynaecology Queen Mary Hospital The University of Hong Kong 102 Pokfulam Road Hong Kong |