Using pembrolizumab to treat advanced adrenocortical carcinoma

A Multicentre, Open-label Phase 2 Study to Evaluate the Efficacy and Safety of Pembrolizumab in the Treatment of Advanced, Progressive Adrenocortical Carcinoma.

This study is testing if pembrolizumab can help adults with advanced adrenocortical carcinoma who haven't responded to their first treatment feel better and improve their condition.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology (other)
• Drugs / interventions: chemotherapy, pembrolizumab, immunotherapy, doxorubicin
• Locations: 4 sites (Gliwice, Silesian Voivodeship and 3 other locations)
• Trial ID: NCT05563467 on ClinicalTrials.gov

What this trial studies

This phase II clinical trial investigates the efficacy and tolerability of pembrolizumab, an immune checkpoint inhibitor, in patients with advanced, progressive adrenocortical carcinoma who have experienced disease progression after first-line chemotherapy. The study aims to enroll adults with histopathologically confirmed adrenocortical carcinoma and measurable disease, assessing their response to treatment based on RECIST criteria. The trial is conducted across multiple centers in Poland, focusing on patients who have limited therapeutic options due to the aggressive nature of their cancer.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 years with confirmed advanced adrenocortical carcinoma and measurable disease who have shown progression after first-line chemotherapy.

Not a fit: Patients with early-stage adrenocortical carcinoma or those who have not received prior chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced adrenocortical carcinoma who have exhausted standard treatment options.

How similar studies have performed: Previous studies have indicated potential success for immunotherapy approaches in treating adrenocortical carcinoma, suggesting that this trial builds on promising findings.

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

Where this trial is running

Gliwice, Silesian Voivodeship and 3 other locations

• Maria Sklodowska-Curie National Research Institute of Oncology — Gliwice, Silesian Voivodeship, Poland (RECRUITING)
• Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie — Cracow, Poland (RECRUITING)
• Uniwersytecki Szpital Kliniczny W Poznaniu — Poznan, Poland (RECRUITING)
• Medical University Of Warsaw — Warsaw, Poland (RECRUITING)

Study contacts

• Study coordinator: Barbara Ziółkowska, MD,PhD

Conditions: Adrenocortical Carcinoma, advanced adrenocortical carcinoma, progressive adrenocortical carcinoma, pembrolizumab