Pembrolizumab in the Treatment of Advanced, Progressive Adrenocortical Carcinoma.
Status:
Not yet recruiting
Trial end date:
2027-05-31
Target enrollment:
Participant gender:
Summary
This study is a national, multicenter, interventional, phase II clinical trial on the use of
pembrolizumab in advanced adrenocortical carcinoma, with confirmed progression within 6
months, following EDP or EDP-M ( etoposide, doxorubicin, cisplatin- mitotan) chemotherapy.
Adrenocortical carcinoma is a very rare entity with poor prognosis and limited therapeutic
options. Only radical surgical treatment of the early stages gives a chance for complete
cure, however the risk of recurrence still remains high.
The results of clinical trials conducted outside Poland indicate a possible potential role of
immunotherapy as a rescue treatment for adrenocortical carcinoma after standard therapeutic
methods have been exhausted.
This study will evaluate the efficacy and tolerability of treatment with the immune
checkpoint inhibitor pembrolizumab in locally advanced, non-operable or metastatic
adrenocortical carcinoma after first line chemotherapy failure.
The study population will include adult patients (>18 years of age) with histopathologically
confirmed adrenocortical carcinoma and confirmed progression according to RECIST 1.1 within 6
months, after first line chemotherapy with the EDP and EDP-M scheme. Patients must meet the
inclusion criteria and must not meet the exclusion criteria described in the PEMBR-01 study
protocol. The planned number of patients in the study is 24.
The treatment regimen will be based on Pembrolizumab administered intravenously in 3 weeks
cycles at a dose of 200mg. For hormonally active tumors producing cortisol, it is
hypothesized that the use of pembrolizumab in combination with effective steroidogenesis
inhibition may enhance the effect of immunotherapy. In the study, metyrapone or ketoconazole
will be used for this purpose.
The primary endpoint of the study will be the objective response rate to the treatment. The
secondary endpoints will be progression-free survival, duration of response, overall
survival, and treatment safety as well as the effect of therapy on patients' quality of life.
Concurrently, the analysis of biomarkers in tumor tissue will be carried out, including
tumour infiltrating lymphocytes, expression of programmed death ligand, microsatellite
instability and tumour mutation burden.
Phase:
Phase 2
Details
Lead Sponsor:
Maria Sklodowska-Curie National Research Institute of Oncology