Clinical Trials/NCT04096911

NCT04096911

Unknown

Phase 2

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

Buhai Wang1 site in 1 country20 target enrollmentJuly 31, 2019

ConditionsUterine Cervical Neoplasms Cervical Cancer Cervical Neoplasms Cervix Cancer

Interventionsquadrivalent HPV vaccine Sintilimab

DrugsSintilimab quadrivalent HPV vaccine

Overview

Phase: Phase 2
Intervention: quadrivalent HPV vaccine
Conditions: Uterine Cervical Neoplasms
Sponsor: Buhai Wang
Enrollment: 20
Locations: 1
Primary Endpoint: Objective Response Rate
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

July 31, 2019

End Date

March 31, 2021

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Buhai Wang

Responsible Party

Sponsor Investigator

Principal Investigator

Buhai Wang

doctor

Northern Jiangsu People's Hospital

Eligibility Criteria

Inclusion Criteria

•Patients must have persistent, recurrent or metastatic squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the cervix with documented disease progression (disease not amendable to curative therapy)
•All patents must have measurable disease as defined by RECIST 1.1; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be \>= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam;lymph nodes must be \>= 15 mm in short axis when measured by CT or MRI
•Patients must have at least one "target" lesion" to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
•In the state of HPV infection
•Appropriate for study entry based on the following diagnostic workup:
•History/physical examination within 28 days prior to registration
•Imaging of target lesion(s) within 28 days prior to registration
•Further protocol-specific assessments:
•Recovery from adverse effects of recent surgery, radiotherapy or chemotherapy
•Any other prior therapy directed at the malignant tumor including chemotherapy, biologic/targeted agents and immunologic agents must be discontinued at least three weeks prior to registration Investigation agents must be discontinued for at least 30 days prior to registration

Exclusion Criteria

•Has disease which is amenable to radical treatment with surgery or radiation or a combination of treatments.
•Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
•Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
•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.
•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.
•Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
•Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
•Has a known additional malignancy that is progressing or requires active treatment.
•Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment.
•Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen's syndrome will not be excluded from the study.

Arms & Interventions

Sintilimab and HPV Vaccine

Sintilimab 200 mg intravenously every 3 weeks ，3 doses of quadrivalent HPV vaccine intramuscularly at day 1,60,180

Intervention: quadrivalent HPV vaccine

Sintilimab and HPV Vaccine

Sintilimab 200 mg intravenously every 3 weeks ，3 doses of quadrivalent HPV vaccine intramuscularly at day 1,60,180

Intervention: Sintilimab

Outcomes

Primary Outcomes

Objective Response Rate

Time Frame: 24 months

complete response plus partial response as determined by RECIST 1.1

Secondary Outcomes

Progression-free survival(Time from study entry to time of progression or death, whichever occurs first, assessed up to 42 months)
Overall survival(Time from study entry to time of death or the date of last contact, assessed up to 42 months)
Duration of Response(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)