Actively Recruiting
Pembrolizumab in the Treatment of Advanced, Progressive Adrenocortical Carcinoma.
Led by Maria Sklodowska-Curie National Research Institute of Oncology · Updated on 2025-04-02
24
Participants Needed
4
Research Sites
225 weeks
Total Duration
On this page
Sponsors
M
Maria Sklodowska-Curie National Research Institute of Oncology
Lead Sponsor
B
Biostat Sp. z o.o.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pembrolizumab in the Treatment of Advanced, Progressive Adrenocortical Carcinoma.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent to participate in the study
- Age over 18 years
- Histopathologically confirmed adrenocortical carcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status less than 2
- Measurable disease according to RECIST 1.1 criteria
- Confirmed disease progression within the last 6 months after at least one line of chemotherapy with EDP or EDP-M
- Adequate bone marrow and organ function: hemoglobin ≥ 9 g%, neutrophils > 1500/mm3, platelets > 100,000/mm3
- Bilirubin ≤ 2 times the upper limit of normal (ULN), ALT and AST ≤ 3 times ULN (or ≤ 5 times ULN if liver metastases are present)
- Creatinine clearance > 40 ml/min
- Coagulation parameters (INR, PT, APTT) < 1.5 times ULN (except patients on anticoagulants within therapeutic range)
- For women of reproductive age: negative pregnancy test and use of dual barrier contraception
- For men of reproductive age: use of dual barrier contraception
You will not qualify if you...
- Previous treatment with an immune checkpoint inhibitor
- Any cancer therapy within the last 7 days (including mitotane)
- Persistent side effects from prior anti-cancer therapy above grade 1, except alopecia
- Immunosuppressive therapy within the last 4 weeks
- Glucocorticoid therapy above replacement dose (exceptions include inhaled or topical steroids, single steroid doses, mineralocorticosteroids, steroids for asthma or COPD)
- Previous bone marrow or organ transplant
- Active or recent (within 2 years) autoimmune disease except vitiligo, psoriasis not needing systemic treatment, or autoimmune thyroid disease
- Active or past inflammatory bowel disease
- Previous non-infectious pneumonia needing steroid treatment
- Hepatitis B or C infection
- Active tuberculosis
- Current active infection needing systemic treatment
- Symptomatic untreated brain metastases (except asymptomatic with prior treatment and no bleeding history)
- Severe heart failure (NYHA class 3 or higher)
- Corrected QT interval > 500 ms
- Significant other diseases including cancers except basal cell skin carcinoma or carcinoma in situ of prostate, cervix, or breast
- Other serious comorbidities posing risk during therapy as judged by investigator
- Pregnancy or breastfeeding
- Need for dialysis
- Inability to comply with study requirements
- Live vaccine within 3 months before treatment start
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Maria Sklodowska-Curie National Research Institute of Oncology
Gliwice, Silesian Voivodeship, Poland, 44-102
Actively Recruiting
2
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Cracow, Poland
Actively Recruiting
3
Uniwersytecki Szpital Kliniczny W Poznaniu
Poznan, Poland
Actively Recruiting
4
Medical University Of Warsaw
Warsaw, Poland
Actively Recruiting
Research Team
B
Barbara Ziółkowska, MD,PhD
CONTACT
A
Agnieszka Kotecka-Blicharz, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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