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New treatment option for Adrenocortical Carcinoma
Official title Pembrolizumab in the Treatment of Advanced, Progressive Adrenocortical Carcinoma.
ClinicalTrials.gov ID: NCT05563467
What this study is testing
What is Pembrolizumab 25 MG/ML [Keytruda]?
Pembrolizumab 25 MG/ML [Keytruda] is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for adrenocortical carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signing the informed consent form to participate in the study
- Age over 18 years of age
- Histopathologically confirmed adrenocortical carcinoma
- The general condition of the patient was assessed according to the Eastern Cooperative Oncology Group (ECOG) scale \<2
- Measurable disease according to RECIST 1.1
You likely can't join if
- Pre-treatment with an immune checkpoint inhibitor
- Any cancer therapy within the last 7 days (including mitotane)
- Persistent side effects of previous anti-cancer therapy in the\> G1 stage or after surgical treatment (exception: alopecia)
- Immunosuppressive therapy present or conducted within the last 4 weeks
- Glucocorticoid therapy in a dose higher than the replacement dose (subject to the permitted use: inhaled or topical steroids, single administration...
- Previous allograft marrow or organ transplant
See the full eligibility criteria
- Signing the informed consent form to participate in the study
- Age over 18 years of age
- Histopathologically confirmed adrenocortical carcinoma
- The general condition of the patient was assessed according to the Eastern Cooperative Oncology Group (ECOG) scale \<2
- Measurable disease according to RECIST 1.1
- 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
- Adequate function of the marrow and internal organs:
- hemoglobin ≥ 9g%, neutrophils\> 1500 / mm3, platelets\> 100 thousand / mm3
- bilirubin ≤ 2 x upper limit of normal (UNL), Alat, Aspat ≤ 3 x UNL (if livermetastases are present ≤ 5 x UNL)
- creatinine clearance \> 40 ml / min
- 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)
- For women of reproductive age : confirmed negative pregnancy test result, and the requirement of dual barrier contraception
- For men of reproductive age: the requirement of dual barrier contraception
- Pre-treatment with an immune checkpoint inhibitor
- Any cancer therapy within the last 7 days (including mitotane)
- Persistent side effects of previous anti-cancer therapy in the\> G1 stage or after surgical treatment (exception: alopecia)
- Immunosuppressive therapy present or conducted within the last 4 weeks
- 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...
- Previous allograft marrow or organ transplant
- 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
- Active or previously documented inflammatory disease of the large intestine
- Previous non-infectious pneumonia requiring steroid therapy
- Hepatitis B or C
- Active tuberculosis
- Current active infection requiring systemic treatment
- Symptomatic, untreated central nervous system (CNS) metastases (exception: patients with asymptomatic CNS metastases with prior surgery or radiotherapy and no history of intracranial bleeding)
- Circulatory failure NYHA ≥3
- Corrected QT interval\> 500 ms
- Significant coexisting disease, including neoplastic, except for basal cell carcinoma of the skin, carcinoma in situ: prostate, cervix, breast
- Other significant comorbid disease that, in the investigator's opinion, would pose risks to the patient during therapy
- Pregnancy or breastfeeding
- Patients requiring dialysis
- The patient's inability to meet the requirements specified in the study protocol
- Vaccination with live vaccine within 3 months before starting treatment
The study team makes the final eligibility decision.
Where it's taking place
- Gliwice, Silesian Voivodeship, Poland
- Cracow, Poland
- Poznan, Poland
- Warsaw, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gliwice, Silesian Voivodeship, Poland; Cracow, Poland; Poznan, Poland; Warsaw, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.