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Pembrolizumab in the Treatment of Advanced, Progressive Adrenocortical Carcinoma
EU CTIS ID: 2024-517205-82-00
What this study is testing
Evaluation of the efficacy of pembrolizumab in the treatment of advanced progressive adrenocortical cancer
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Informed consent form to participate in the study
- Age over 18
- Histopathologically confirmed adrenal cortex cancer
- The patient's general condition assessed according to the 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 1 line of treatment with EDP or EDP-M
You likely can't join if
- Pretreatment with an immune checkpoint inhibitor
- Hepatitis B or C
- Active tuberculosis
- Current active infection requiring systemic treatment
- Symptomatic, untreated CNS metastases (exception: patients with asymptomatic CNS metastases, after previous surgical or radiotherapy treatment and without a history of intracranial bleeding)
- Circulatory failure NYHA ≥3
See the full eligibility criteria
- Informed consent form to participate in the study
- Age over 18
- Histopathologically confirmed adrenal cortex cancer
- The patient's general condition assessed according to the 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 1 line of treatment with EDP or EDP-M
- Adequate function of the bone marrow and internal organs: a. hemoglobin ≥ 9g%, neutrophils > 1500/mm3, platelets > 100 thousand/mm3 b. bilirubin ≤ 2 x upper limit of normal (ULN), Alat, AST ≤ 3 x ULN (in the presence of liver metastases ≤ 5 x ULN) c. creatinine clearance > 40ml/min d. coagulation parameters: INR, PT, APTT < 1.5 x ULN (exception: patients undergoing anticoagulation therapy, where INR, PT, APTT remain within the therapeutic range recommended for a given patient)
- For women of reproductive age: confirmed negative pregnancy test result and the need to use double barrier contraception
- For men of reproductive age: the need to use double barrier contraception
- Pretreatment with an immune checkpoint inhibitor
- Hepatitis B or C
- Active tuberculosis
- Current active infection requiring systemic treatment
- Symptomatic, untreated CNS metastases (exception: patients with asymptomatic CNS metastases, after previous surgical or radiotherapy treatment and without a history of intracranial bleeding)
- Circulatory failure NYHA ≥3
- Corrected QT interval > 500 ms
- Significant comorbid disease, including cancer, with the exception of basal cell carcinoma of the skin, in situ cancers: prostate, cervix, breast
- Another significant comorbid condition that, in the investigator's opinion, would pose a threat to the patient during therapy
- Pregnancy or breastfeeding
- Patients requiring dialysis
- Any anticancer therapy in the last 7 days
- Inability of the patient to meet the requirements specified in the study protocol
- Vaccination with a live vaccine within 3 months before starting treatment
- Persistent side effects of previously used anticancer therapy at stage > G1 or after previous surgical treatment (exception: alopecia)
- Current or recent immunosuppressive therapy
- Therapy with glucocorticosteroids at a dose higher than the replacement dose (subject to permissible use: inhaled or topical steroids, single administration of a steroid, e.g. in the case of an allergic reaction to contrast, the use of mineralocorticoids, steroids in the course of asthma)
- Previous allogeneic bone marrow transplant or organ transplant
- Autoimmune disease present or diagnosed within the last 2 years, except for vitiligo, psoriasis not requiring systemic treatment, autoimmune thyroid disease
- Active or previously documented inflammatory bowel disease
- Previous non-infectious pneumonia requiring steroid therapy
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.