Clinical Trials for Adrenocortical Carcinoma
This article provides detailed information about 4 ongoing clinical trials investigating new treatments for adrenocortical carcinoma. These studies are evaluating immunotherapy approaches, combinations of chemotherapy with hormones, and strategies to prevent cancer recurrence after surgery. Trials are currently recruiting patients in France, Germany, Italy, Poland, and Sweden.
Clinical trial locations
- France
- Germany
- Italy
- Poland
- Sweden
Study of Pembrolizumab for Patients with Advanced Adrenocortical Carcinoma
This trial is investigating pembrolizumab, an immunotherapy medication, for treating advanced stages of adrenocortical carcinoma. The study focuses on patients whose cancer has continued to progress despite previous treatment.
Who can join: Eligible participants must be over 18 years old with a confirmed diagnosis and measurable disease that has worsened in the last 6 months after receiving at least one line of treatment with EDP or EDP-M. Candidates need to have adequate bone marrow and organ function, including hemoglobin levels of at least 9 g/dL, neutrophils greater than 1,500 per cubic millimeter, and platelets above 100,000 per cubic millimeter. Liver function must show bilirubin no more than 2 times the upper limit of normal, and kidney function must demonstrate creatinine clearance above 40 mL per minute. Both men and women of reproductive age must use double barrier contraception, and women must have a negative pregnancy test.
Who cannot join: The trial excludes patients with a different type of cancer, those outside the specified age range, patients without advanced or progressive disease, and individuals unable to follow study procedures. Vulnerable populations that cannot be safely included are also excluded.
What the study involves: Pembrolizumab is given as an injection into a vein. The study will monitor how the cancer responds to treatment, including whether it shrinks or stops growing. Researchers will track how long patients live without the cancer worsening and assess overall survival and quality of life. The trial also closely monitors any side effects participants may experience.
Study drug: Pembrolizumab is an immunotherapy known as a checkpoint inhibitor. It works by blocking a specific protein on cancer cells called PD-1, which allows the immune system to better recognize and destroy cancer cells.
Study on Cemiplimab and Mitotane for Patients with Advanced Adrenocortical Cancer
This study is evaluating cemiplimab as a maintenance treatment for patients with advanced disease who have not experienced progression after initial chemotherapy. The trial will last up to 36 months with regular clinic visits to monitor health and treatment effects.
Who can join: Men and women over 18 years old who are willing and able to attend clinic visits and provide informed consent can participate. Patients must have confirmed adrenocortical carcinoma, previously received EDP-M treatment, and show no worsening of disease after the first 4 to 6 cycles. An ECOG Performance Status of 0 or 1 is required, meaning patients are fully active or have minor symptoms. Adequate organ and bone marrow function is essential, including hemoglobin above 9.0 g/dL, neutrophil count above 1.5 x 10⁹/L, and platelet count above 75 x 10⁹/L. Women of childbearing potential must have a negative pregnancy test within 24 hours before starting treatment and agree to use effective birth control for 6 months after treatment ends.
Who cannot join: Patients who have not completed 4 to 6 cycles of EDP-M treatment or whose disease has progressed after EDP-M cannot participate. The trial also excludes those without advanced disease, patients outside the specified age range, individuals unable to give informed consent, pregnant or breastfeeding women, people with serious health conditions that could interfere with the study, and those participating in another clinical trial.
What the study involves: Cemiplimab is administered as an intravenous infusion at a dose of 350 mg. Regular clinic visits include physical examinations, blood tests, and other assessments to monitor treatment response and manage side effects. Patients complete questionnaires to evaluate their quality of life and symptoms. Treatment continues until the study ends or is no longer beneficial, followed by scheduled follow-up visits.
Study drug: Cemiplimab is an immunotherapy that helps the immune system recognize and attack cancer cells. It blocks the PD-1 protein on immune cells, enhancing their ability to fight cancer effectively.
Study on Mitotane Alone or with Cisplatin and Etoposide for Patients with High-Risk Adrenocortical Carcinoma After Surgery
This trial compares two treatment approaches for patients at high risk of cancer recurrence after surgery. One group receives mitotane alone, while the other receives mitotane combined with cisplatin and etoposide. These treatments aim to prevent the cancer from returning after surgical removal of the tumor.
Who can join: Participants must have a confirmed diagnosis through histology with a Weiss score of 3 or higher, or for oncocytic type, meet Lin-Weiss-Bisceglia criteria. Eligible patients must be at high risk of recurrence, defined as Stage I-III disease within 90 days after surgery with complete or near-complete tumor removal. The Ki67 level must be more than 10 percent, indicating faster cancer cell growth. Imaging tests within 12 weeks before joining must show no clear evidence of cancer spread, though small unclear nodules are acceptable. Patients must be at least 18 years old with an ECOG performance status of 0 to 2. Women of childbearing potential and men must use effective birth control during the study.
Who cannot join: The trial excludes patients who have not had surgery to remove the tumor, those with a different type of cancer, individuals unable to take study medications due to allergies or medical reasons, pregnant or breastfeeding women, patients with severe heart, liver, or kidney problems, those currently in another clinical trial, patients with active infections requiring treatment, and individuals with a history of serious illness that could interfere with the study.
What the study involves: Participants are randomly assigned to receive either mitotane alone or mitotane with cisplatin and etoposide. Mitotane is taken orally, while cisplatin and etoposide are given intravenously. The combination group receives four 21-day cycles of cisplatin and etoposide. Regular monitoring includes physical examinations, blood tests, and imaging tests every 12 weeks to check for cancer recurrence. Quality of life is assessed at the start of treatment, after 6 weeks, after 6 months, and at study completion.
Study drugs: Mitotane is taken as oral tablets and works by slowing or stopping cancer cell growth and altering hormone production in the adrenal glands. Cisplatin is a platinum-based chemotherapy given intravenously that damages cancer cell DNA to prevent their growth and division. Etoposide, given intravenously or orally, is a topoisomerase inhibitor that interferes with an enzyme cancer cells need to divide and grow.
Study on the Effectiveness of Adding Progesterone to Chemotherapy with Etoposide, Doxorubicin, Cisplatin, and Mitotane for Advanced Adrenocortical Carcinoma Patients
This trial evaluates whether adding the hormone progesterone to standard chemotherapy can improve outcomes for patients with advanced or metastatic disease. Participants are randomly assigned to receive either chemotherapy with progesterone or chemotherapy with a placebo.
Who can join: Eligible participants must have confirmed adrenocortical carcinoma that is locally advanced or metastatic and cannot be removed with surgery. Patients must have an ECOG performance status of 0-2, meaning they are fully active or have some limitations but can still care for themselves. A life expectancy of more than 3 months is required, and participants must be older than 18 years. Adequate blood counts and organ function are essential, including neutrophils greater than 1,000 per mm³ and platelets above 80,000 per mm³. Effective contraception must be used during the study, and patients must be able to follow study procedures and provide written informed consent.
Who cannot join: The study excludes patients with a different type of cancer, those not in the advanced or metastatic stage, individuals outside the specified age range, patients unable to follow study procedures or take medications as required, pregnant or breastfeeding women, those with another serious medical condition that might interfere with the study, patients participating in another clinical trial simultaneously, individuals who have had recent surgery or treatment that might affect results, those with known allergies to study medications, and patients with a history of drug or alcohol abuse.
What the study involves: The chemotherapy regimen includes cisplatin, etoposide, and doxorubicin given through intravenous infusion, plus mitotane taken orally as tablets. Participants receive either progesterone or placebo according to their assigned group. Treatment is given in cycles with specific dosages and schedules. Regular monitoring and assessments evaluate treatment response and manage side effects. The primary goal is to compare the proportion of patients achieving an objective response between the two groups. The trial is expected to conclude by December 31, 2026.
Study drugs: Progesterone is a hormone being tested to see if it can enhance the effectiveness of standard chemotherapy. It works by binding to progesterone receptors and influencing gene expression and cellular responses. Mitotane reduces hormone production from the adrenal gland and is part of the standard treatment regimen. The EDP scheme is a combination of chemotherapy drugs that work together to stop cancer cell growth.
Summary
Four ongoing clinical trials are currently recruiting patients with adrenocortical carcinoma across several European countries. The studies reflect different treatment approaches depending on disease stage and previous treatments.
Two trials focus on advanced disease using immunotherapy approaches. The pembrolizumab study in Poland evaluates checkpoint inhibitor therapy for patients whose cancer has progressed despite previous treatment. The cemiplimab trial in Italy investigates maintenance immunotherapy for patients who have responded to initial chemotherapy.
The other two trials explore combination approaches. A multi-country study in France, Germany, and Sweden compares mitotane alone versus mitotane combined with cisplatin and etoposide for high-risk patients after surgery, aiming to prevent recurrence. An Italian trial investigates whether adding progesterone to standard chemotherapy improves outcomes in advanced disease.
Italy hosts two of the four trials, showing notable research activity in this rare cancer. The studies collectively address different clinical scenarios: preventing recurrence after surgery, treating advanced disease, and maintaining disease control after initial therapy. All trials require adequate organ function and exclude patients with certain serious health conditions, pregnant or breastfeeding women, and those unable to follow study procedures.
