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Brief Title: Avelumab With Axitinib in Persistent or Recurrent Cervical Cancer After Platinum-based Chemotherapy
Official Title: Avelumab With Axitinib in Persistent or Recurrent Cervical Cancer After Platinum-based Chemotherapy - a Proof-of-concept Study (ALARICE Study)
Study ID: NCT03826589
Brief Summary: This is a single-arm, Simon's 2-stage, proof-of-concept trial. The aim is to evaluate the efficacy and safety of avelumab with axitinib in patients with persistent or recurrent cervical cancer following platinum-based chemotherapy. The study hypothesis is that the combination of avelumab and axitinib can significantly improve the objective response rate (ORR) with acceptable toxicity compared to traditional chemotherapy.
Detailed Description: Cervical cancer is the fourth commonest female cancer in the world. When there is distant metastasis or recurrence, platinum-based chemotherapy is the usual treatment option. Once this first-line chemotherapy fails, the prognosis is dismal. Various second-line agents including second-line chemotherapy agents and immune checkpoint inhibitors have unsatisfactory response rate.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
The University of Hong Kong, Hong Kong, , Hong Kong
Name: Ka Yu Tse
Affiliation: The University of Hong Kong
Role: PRINCIPAL_INVESTIGATOR