Single arm phase II study on Pembrolizumab in preneoplastic high grade HPV-related vulvar and cervical lesions - MITO CERV 4

FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE0 sites46 target enrollmentJune 17, 2021

ConditionsPatients with pre neoplastic high grade HPV-related vulvar and cervical lesions MedDRA version: 20.0Level: PTClassification code 10054932Term: Vulvar dysplasiaSystem Organ Class: 10038604 - Reproductive system and breast disorders MedDRA version: 20.0Level: PTClassification code 10008263Term: Cervical dysplasiaSystem Organ Class: 10038604 - Reproductive system and breast disorders Therapeutic area: Diseases [C] - Cancer [C04]

DrugsKEYTRUDA - 50 MG- POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE- USO ENDOVENOSO- FLACONCINO (VETRO) 1 FLACONCINO

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients with pre neoplastic high grade HPV-related vulvar and cervical lesions
Sponsor: FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
Enrollment: 46
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 17, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE

Eligibility Criteria

Inclusion Criteria

•\- Female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of cervical HSIL OR vulvar VIN 2\-3 lesions will be enrolled in this study.
•\- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
•a.) Not a woman of childbearing potential (WOCBP)
•b.) A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 3 months after the last dose of study treatment.
•\- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
•\- Have provided archival tumor tissue sample (if pre treatment biopsy performed at other institution) or newly obtained core or excisional biopsy of the lesion. Formalin\-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
•Note: If submitting unstained cut slides, newly cut slides should be submitted to the testing laboratory within 14 days from the date slides are cut.
•\- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\. Evaluation of ECOG is to be performed within 7 days prior to the date of registration .
•\- Have adequate organ function as defined in the following table (Table 1\). Specimens must be collected within 10 days prior to the start of study treatment.
•Are the trial subjects under 18? no

Exclusion Criteria

•1\.A WOCBP who has a positive urine pregnancy test within 72 hours prior to study drug treatment.
•2\.Has received prior therapy with an anti\-PD\-1, anti\-PD\-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co\-inhibitory T\-cell receptor (eg, CTLA\-4, OX 40, CD137\).
•3\.Has received prior systemic anti\-cancer therapy including investigational agents within 4 weeks
•4\.Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation\-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1\-week washout is permitted for palliative radiation (\=2 weeks of radiotherapy) to non\-CNS disease.
•5\.Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette–Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
•6\.Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
•7\.Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
•8\.Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
•9\.Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
•10\.Has severe hypersensitivity (\=Grade 3\) to pembrolizumab and/or any of its excipients.