A Phase 2 interventional study of Sintilimab and quadrivalent HPV vaccine in Uterine Cervical Neoplasms, Cervical Cancer and Cervical Neoplasms, sponsored by Buhai Wang. Status unknown at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-20.
Sponsored by Buhai Wang · Phase 2, Interventional, and Treatment
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
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).
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 20 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →This is the only study on the registry with Buhai Wang as lead sponsor.
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Appropriate for study entry based on the following diagnostic workup:
Further protocol-specific assessments:
Exclusion Criteria:
Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
Sintilimab 200 mg intravenously every 3 weeks ,3 doses of quadrivalent HPV vaccine intramuscularly at day 1,60,180
Drug: Sintilimab · Drug: quadrivalent HPV vaccine
Sintilimab 200 mg intravenously every 3 weeks
Also known as: IBI308
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
Also known as: Gardasil 4
Objective Response Rate
complete response plus partial response as determined by RECIST 1.1
Time frame: 24 months
Progression-free survival
Kaplan-Meier median estimates and curves will be used to describe PFS survival functions
Time frame: Time from study entry to time of progression or death, whichever occurs first, assessed up to 42 months
Overall survival
Kaplan-Meier median estimates and curves will be used to describe OS survival functions
Time frame: Time from study entry to time of death or the date of last contact, assessed up to 42 months
Duration of Response
Kaplan-Meier median estimates and curves will be used to describe DOR survival functions
Time frame: Time from the first evaluation of the tumor is CR or PR to the first evaluation is PD or death, assessed up to 42 months
This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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