carcinoma MedDRA version: 20.0 Level: PT Classification code 10001388 Term: Adrenocortical carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: KEYTRUDA 25 mg/ml concentrate for solution infusion
Product Name: Keytruda
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Pembrolizumab
CAS Number: 1374853
Sponsors
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie, Panstwowy Instytut Badawczy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1- Signing the informed consent form to participate in the study 2- Age over 18 years of age 3- Histopathologically confirmed adrenocortical carcinoma 4- The general condition of the patient was assessed according to the Eastern Cooperative Oncology Group (ECOG) scale 1500 / mm3, platelets> 100 thousand / mm3 bilirubin = 2 x upper limit of normal (UNL), Alat, Aspat = 3 x UNL (if liver metastases are present = 5 x UNL) c. creatinine clearance> 40 ml / min d. coagulation parameters: INR, PT, APTT =65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
Exclusion criteria: 1- Pre-treatment with an immune checkpoint inhibitor 2- Any cancer therapy within the last 7 days (including mitotane) 3- Persistent side effects of previous anti-cancer therapy in the> G1 stage or after surgical treatment (exception: alopecia) 4- Immunosuppressive therapy present or conducted within the last 4 weeks 5- Glucocorticoid therapy in a dose higher than the replacement dose (subject to the permitted use: inhaled or topical steroids, single administration of a steroid, e.g. in case of an allergic reaction to contrast, use of mineralocorticosteroids, steroids in the course of asthma or COPD) 6- Previous allograft marrow or organ transplant 7- Current or diagnosed in the last 2 years autoimmune disease with the exception of vitiligo, psoriasis not requiring systemic treatment, autoimmune disease of the thyroid gland 8- Active or previously documented inflammatory disease of the large intestine 9- Previous non-infectious pneumonia requiring steroid therapy 10- Hepatitis B or C 11- Active tuberculosis 12- Current active infection requiring systemic treatment 13- Symptomatic, untreated central nervous system (CNS) metastases (exception: patients with asymptomatic CNS metastases with prior surgery or radiotherapy and no history of intracranial bleeding) 14- Circulatory failure NYHA =3 15- Corrected QT interval> 500 ms 16- Significant coexisting disease, including neoplastic, except for basal cell carcinoma of the skin, carcinoma in situ: prostate, cervix, breast 17- Other significant comorbid disease that, in the investigator's opinion, would pose risks to the patient during therapy 18- Pregnancy or breastfeeding 19- Patients requiring dialysis 20- The patient's inability to meet the requirements specified in the study protocol 21- Vaccination with live vaccine within 3 months before starting treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the effectiveness of the drug pembrolizumab in the treatment of advanced, progressive adrenocortical carcinoma;Secondary Objective: - To evaluate the safety of pembrolizumab in the treatment of advanced, progressive adrenal cortex carcinoma - To assess the impact of therapy on the quality of life Exploratory: -To identify potential markers such as tumor tissue infiltration (TIL), PD-L1 expression, microsatellite instability (MSI) and closely related tumor tissue mutation (TMB) count) influencing and / or conditioning the clinical response to pembrolizumab;Primary end point(s): The purpose of the study is to assess response to treatment, defined by the following endpoints: - Objective Response Rate – percentage of patients who achieved a partial (PR) or complete (CR) response to treatment - Progression-Free Survival (PFS) – time from first dose of treatment until disease progression or death from any cause - Duration of Response (DoR) – duration of response to treatment (from the start of CR or PR) until disease progression or death from any cause - Overall Survival (OS) – time from initiating treatment to death from any cause;Timepoint(s) of evaluation of this end point: will be formally summarized upon completion of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Number of Adverse Events and Serious Adverse Events (AE and SAE) related and not related to treatment according to CTCAE - Quality of life assessed based on the QLQ-C30 questionnaire ;Timepoint(s) of evaluation of this end point: will be formally summarized upon completion of the study | — |
Countries
Poland
Contacts
Public ContactBarbara Ewa Ziólkowska
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie, Panstwowy Instytut Badawczy
Outcome results
None listed