Pembrolizumab in the Treatment of Advanced, Progressive Adrenocortical Carcinoma
- Conditions
- adrenocortical carcinoma
- Registration Number
- 2024-517205-82-00
- Lead Sponsor
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Brief Summary
Evaluation of the efficacy of pembrolizumab in the treatment of advanced progressive adrenocortical cancer
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruiting
- Sex
- Not specified
- Target Recruitment
- 24
Informed consent form to participate in the study
Age over 18
Histopathologically confirmed adrenal cortex cancer
The patient's general condition assessed according to the ECOG scale < 2
Measurable disease according to RECIST 1.1
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
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)
For women of reproductive age: confirmed negative pregnancy test result and the need to use double barrier contraception
For men of reproductive age: the need to use double barrier contraception
Pretreatment with an immune checkpoint inhibitor
Hepatitis B or C
Active tuberculosis
Current active infection requiring systemic treatment
Symptomatic, untreated CNS metastases (exception: patients with asymptomatic CNS metastases, after previous surgical or radiotherapy treatment and without a history of intracranial bleeding)
Circulatory failure NYHA ≥3
Corrected QT interval > 500 ms
Significant comorbid disease, including cancer, with the exception of basal cell carcinoma of the skin, in situ cancers: prostate, cervix, breast
Another significant comorbid condition that, in the investigator's opinion, would pose a threat to the patient during therapy
Pregnancy or breastfeeding
Patients requiring dialysis
Any anticancer therapy in the last 7 days
Inability of the patient to meet the requirements specified in the study protocol
Vaccination with a live vaccine within 3 months before starting treatment
Persistent side effects of previously used anticancer therapy at stage > G1 or after previous surgical treatment (exception: alopecia)
Current or recent immunosuppressive therapy
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)
Previous allogeneic bone marrow transplant or organ transplant
Autoimmune disease present or diagnosed within the last 2 years, except for vitiligo, psoriasis not requiring systemic treatment, autoimmune thyroid disease
Active or previously documented inflammatory bowel disease
Previous non-infectious pneumonia requiring steroid therapy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) Objective Response Rate (ORR)
Progression-Free Survival (PFS) Progression-Free Survival (PFS)
Duration of Response (DoR) Duration of Response (DoR)
Overall Survival (OS) Overall Survival (OS)
- Secondary Outcome Measures
Name Time Method Quality of life assesed by QLQ-C30 questionnaire Quality of life assesed by QLQ-C30 questionnaire
Number of Adverse Events and Serious Adverse Events (AEs and SAEs) related and unrelated to treatment according to CTCAE Number of Adverse Events and Serious Adverse Events (AEs and SAEs) related and unrelated to treatment according to CTCAE
Trial Locations
- Locations (4)
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
🇵🇱Gliwice, Poland
Medical University Of Warsaw
🇵🇱Warsaw, Poland
Uniwersytecki Szpital Kliniczny W Poznaniu
🇵🇱Poznan, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
🇵🇱Cracow, Poland
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy🇵🇱Gliwice, PolandBarbara ZiółkowskaSite contact+48322788822barbara.ziolkowska@gliwice.nio.gov.pl