Pembrolizumab in the Treatment of Advanced, Progressive Adrenocortical Carcinoma.

Launched by MARIA SKLODOWSKA-CURIE NATIONAL RESEARCH INSTITUTE OF ONCOLOGY · Sep 29, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called pembrolizumab to treat advanced adrenocortical carcinoma, a rare and aggressive type of cancer that affects the adrenal glands. The trial specifically focuses on patients who have already received chemotherapy but their cancer has continued to progress. The goal is to determine how well pembrolizumab works and how safe it is when given to adults over 18 who have this type of cancer and meet specific health criteria.

To participate, patients need to have a confirmed diagnosis of adrenocortical carcinoma and show that their cancer has worsened within the last six months after initial chemotherapy. Participants will receive pembrolizumab through an intravenous (IV) infusion every three weeks, and some may also take additional medications to help enhance the treatment's effectiveness. Throughout the trial, researchers will monitor the patients for their response to treatment, any side effects, and how the therapy affects their quality of life. The study is currently recruiting participants, so if you or someone you know is interested, it's important to discuss eligibility with a healthcare provider.

Gender

ALL

Eligibility 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 \<2
• • 5. Measurable disease according to RECIST 1.1
• • 6. Confirmed progression according to RECIST 1.1 within the last 6 months in patients, who received at least one line chemotherapy according to the EDP or EDP-M
• 7. Adequate function of the marrow and internal organs:
• • 1. hemoglobin ≥ 9g%, neutrophils\> 1500 / mm3, platelets\> 100 thousand / mm3
• • 2. bilirubin ≤ 2 x upper limit of normal (UNL), Alat, Aspat ≤ 3 x UNL (if livermetastases are present ≤ 5 x UNL)
• • 3. creatinine clearance \> 40 ml / min
• • 4. coagulation parameters: INR, PT, APTT \<1.5 x UNL (exception: patients undergoing anticoagulation therapy, where INR, PT, APTT remain within the therapeutic range recommended for the patient)
• • 8. For women of reproductive age : confirmed negative pregnancy test result, and the requirement of dual barrier contraception
• • 9. For men of reproductive age: the requirement of dual barrier contraception
• 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