Pembrolizumab for Adrenocortical carcinoma

Inclusion criteria

• {"criterion_text":"- Informed consent form to participate in the study"}
• {"criterion_text":"- Age over 18"}
• {"criterion_text":"- Histopathologically confirmed adrenal cortex cancer"}
• {"criterion_text":"- The patient's general condition assessed according to the ECOG scale < 2"}
• {"criterion_text":"- Measurable disease according to RECIST 1.1"}
• {"criterion_text":"- Confirmed progression according to RECIST 1.1 within the last 6 months in patients who received at least 1 line of treatment with EDP or EDP-M"}
• {"criterion_text":"- Adequate function of the bone marrow and internal organs: a. hemoglobin ≥ 9g%, neutrophils > 1500/mm3, platelets > 100 thousand/mm3 b. bilirubin ≤ 2 x upper limit of normal (ULN), Alat, AST ≤ 3 x ULN (in the presence of liver metastases ≤ 5 x ULN) c. creatinine clearance > 40ml/min d. coagulation parameters: INR, PT, APTT < 1.5 x ULN (exception: patients undergoing anticoagulation therapy, where INR, PT, APTT remain within the therapeutic range recommended for a given patient)"}
• {"criterion_text":"- For women of reproductive age: confirmed negative pregnancy test result and the need to use double barrier contraception"}
• {"criterion_text":"- For men of reproductive age: the need to use double barrier contraception"}

Exclusion criteria

• {"criterion_text":"- Pretreatment with an immune checkpoint inhibitor"}
• {"criterion_text":"- Hepatitis B or C"}
• {"criterion_text":"- Active tuberculosis"}
• {"criterion_text":"- Current active infection requiring systemic treatment"}
• {"criterion_text":"- Symptomatic, untreated CNS metastases (exception: patients with asymptomatic CNS metastases, after previous surgical or radiotherapy treatment and without a history of intracranial bleeding)"}
• {"criterion_text":"- Circulatory failure NYHA ≥3"}
• {"criterion_text":"- Corrected QT interval > 500 ms"}
• {"criterion_text":"- Significant comorbid disease, including cancer, with the exception of basal cell carcinoma of the skin, in situ cancers: prostate, cervix, breast"}
• {"criterion_text":"- Another significant comorbid condition that, in the investigator's opinion, would pose a threat to the patient during therapy"}
• {"criterion_text":"- Pregnancy or breastfeeding"}
• {"criterion_text":"- Patients requiring dialysis"}
• {"criterion_text":"- Any anticancer therapy in the last 7 days"}
• {"criterion_text":"- Inability of the patient to meet the requirements specified in the study protocol"}
• {"criterion_text":"- Vaccination with a live vaccine within 3 months before starting treatment"}
• {"criterion_text":"- Persistent side effects of previously used anticancer therapy at stage > G1 or after previous surgical treatment (exception: alopecia)"}
• {"criterion_text":"- Current or recent immunosuppressive therapy"}
• {"criterion_text":"- Therapy with glucocorticosteroids at a dose higher than the replacement dose (subject to permissible use: inhaled or topical steroids, single administration of a steroid, e.g. in the case of an allergic reaction to contrast, the use of mineralocorticoids, steroids in the course of asthma)"}
• {"criterion_text":"- Previous allogeneic bone marrow transplant or organ transplant"}
• {"criterion_text":"- Autoimmune disease present or diagnosed within the last 2 years, except for vitiligo, psoriasis not requiring systemic treatment, autoimmune thyroid disease"}
• {"criterion_text":"- Active or previously documented inflammatory bowel disease"}
• {"criterion_text":"- Previous non-infectious pneumonia requiring steroid therapy"}

Primary endpoints

• {"endpoint_text":"- Objective Response Rate (ORR)","definition_or_measurement_approach":"Percentage of patients who achieved partial (PR) or complete (CR) response to treatment (assessed per RECIST 1.1)."}
• {"endpoint_text":"- Progression-Free Survival (PFS)","definition_or_measurement_approach":"Time from receipt of first dose of treatment to disease progression or death from any cause."}
• {"endpoint_text":"- Duration of Response (DoR)","definition_or_measurement_approach":"Duration of response to treatment until disease progression or death from any cause."}
• {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":"Time from start of treatment to death from any cause."}

Secondary endpoints

• {"endpoint_text":"- Quality of life assesed by QLQ-C30 questionnaire","definition_or_measurement_approach":"Quality of life measured using the EORTC QLQ-C30 questionnaire."}
• {"endpoint_text":"- Number of Adverse Events and Serious Adverse Events (AEs and SAEs) related and unrelated to treatment according to CTCAE","definition_or_measurement_approach":"Count and classification of AEs and SAEs related and unrelated to treatment graded according to CTCAE."}

Poland

Earliest CTIS Part Ii Submission Date

02-09-2024

Latest Decision Or Authorization Date

07-04-2026

Processing Time Days

582

Number Of Sites

4

Number Of Participants

24

Primary sponsor

Full Name

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Poland