NCT04096911

Combination of PD-1 Monoclonal Antibody and HPV Vaccine in Patients With Cervical Cancer

A Single-arm, Single-center, Phase II Clinical Study Evaluating Efficacy of PD-1 Monoclonal Antibody Combined With HPV Vaccine in the Patients With Cervical Cancer（CC）Who Fails in or Can Not Endure the Standard Treatment

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Buhai Wang · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators propose to evaluate the efficacy of the combination of Pd-1 Monoclonal Antibody and HPV Vaccine in the patients with cervical cancer who fails in or can not endure the standard treatment

Detailed description

The phase II study is a research which treat cervical carcinoma patients who recurred after at least one prior chemotherapy regimen with Sintilimab and HPV Vaccine. The primary endpoint is objective response rate; secondary endpoints are Progression-Free Survival, Overall Survival and duration of response. Efficacy will be assessed according to RECIST 1.1; progression-free survival is the time from study entry to time of progression or death, whichever occurs first; overall survival is the time from study entry to time of death or the date of last contact,. Furthermore, exploratory studies will be performed on archival tumor material (PD-L1 expression, next-generation sequencing).

Conditions

• Uterine Cervical Neoplasms
• Cervical Cancer
• Cervical Neoplasms
• Cervix Cancer

Interventions

Type	Name	Description
DRUG	Sintilimab	Sintilimab 200 mg intravenously every 3 weeks
DRUG	quadrivalent HPV vaccine	The first dose of quadrivalent HPV vaccine intramuscularly at the day before the first dose of Sintilimab ，the second and third doses of quadrivalent HPV vaccine intramuscularly at the 60th and 180th days respectively

Timeline

• Start date: 2019-07-31
• Primary completion: 2021-03-31
• Completion: 2021-03-31
• First posted: 2019-09-20
• Last updated: 2019-09-20

Locations

1 site across 1 country: China