Recurrent, platinum-resistant, CPS >1 positive ovarian, Fallopian tube and primary peritoneal cancer patients MedDRA version: 20.0 Level: LLT Classification code 10006888 Term: Ca ovary System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10016180 Term: Fallopian tube cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Leve
Conditions
Interventions
Trade Name: KEYTRUDA (pembrolizumab, MK3475)
Product Name: KEYTRUDA
Product Code: [MK-3475]
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Pembrolizumab
CAS Number: 1374853-91-4
Curre
Sponsors
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Platinum resistant (platinum free interval 1-6 months from last platinum dose) ovarian, Fallopian tube or primary peritoneal cancer 2. CPS score>1 3. Be willing and able to provide written informed consent/assent for the trial. 4. Be 18 years of age on day of signing informed consent. 5. Have measurable disease or evaluable based on RECIST 1.1 (patients with only CA 125 increase without evidence of disease are not included) . 6. Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen. 7. Have a performance status of 0 or 1 on the ECOG Performance Scale. 8. Demonstrate adequate organ function, all screening labs should be performed within 10 days of treatment initiation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment. 2. Has received >2 previous CHT lines 3. 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. 4. Has a known history of active TB (Bacillus Tuberculosis) 5. Hypersensitivity to pembrolizumab or any of its excipients. 6. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., = Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. 7. 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. 8. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. 9. 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. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability. 10. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 11. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. 12. Has an active infection requiring systemic therapy. 13. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 14. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 15. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. 16. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication 17. Patients should not be breast-feeding during treatment and for 120 days following the end of treatment 18. Has received prior therapy with an anti-P
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To Compare overall survival (OS) in patients treated with Pembrolizumab single agent with historical controls;Secondary Objective: • To assess progression free survival (PFS) of patients receiving pembrolizumab • To assess the activity of pembrolizumab • To assess the safety and tolerability of patients receiving pembrolizumab • To assess patient-reported outcome (PRO) of patients receiving pembrolizumab Exploratory Objectives: - To investigate the relationship between different CPS score cut off and response to Pembrolizumab treatment utilizing newly obtained or archival FFPE tumor tissue - To investigate the relationship between lymphoid or myeloid-derived suppression cells (MDSC) or T-regulatory cells (T-regs) and response to Pembrolizumab treatment using archival FFPE tumor tissue and blood sampling;Primary end point(s): Overall survival (OS);Timepoint(s) of evaluation of this end point: 44 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Tasso di risposta in pazienti trattati con pembrolizumab, secondo i criteri RECIST 1.1; Adverse Events and laboratory abnormalities evaluated according to CTCAE version 5.0; • Progression free survival (PFS) of patients receiving pembrolizumab; Funzionalità fisica (eventuali disagi/problemi riscontrati nella conduzione delle attività quotidiane), psicologica e sociale (stati emotivi, rapporti sociali, benessere psicofisico) in pazienti trattati con pembrolizumab, attraverso la somministrazione dei questionari (NCCN- FACT) FACT-Ovarian Symptom Index 18 (FOSI-18) ed Euro-Quality of Life 5D (eEQ-5D) tool.;Timepoint(s) of evaluation of this end point: 44 months; 44 months; 44 months; 44 months | — |
Countries
Italy
Contacts
Public ContactDirezione Scientifica Policlinico A
FONDAZIONE POLICLINICO GEMELLI
Outcome results
None listed