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Adrenocortical CarcinomaPhase 2PEMBR-01NCT05563467

Pembrolizumab in the Treatment of Advanced, Progressive Adrenocortical Carcinoma.

A Phase 2 study testing Pembrolizumab 25 MG/ML [Keytruda] in people with Adrenocortical Carcinoma, run by Maria Sklodowska-Curie National Research Institute of Oncology at 4 sites in Poland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adrenocortical Carcinoma
What is being tested?
Pembrolizumab 25 MG/ML [Keytruda]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
4 sitesPoland
Study dates
31 Jan 2023to 31 May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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 mineralocorticosteroids, steroids in the course of asthma or COPD)
  • Previous allograft marrow or organ transplant
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  • 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

Trial locations and contacts

4 sites in 1 country.

Poland4 sites

  • Maria Sklodowska-Curie National Research Institute of Oncology

    Gliwice, Silesian Voivodeship, 44-102

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie

    Krakow

  • Uniwersytecki Szpital Kliniczny W Poznaniu

    Poznan

  • Medical University Of Warsaw

    Warsaw

Other trials in Poland

About this study

Official title: 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 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.

Read more

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.

Being tested
Pembrolizumab 25 MG/ML [Keytruda]
Keywords
advanced adrenocortical carcinoma, progressive adrenocortical carcinoma, pembrolizumab
Medical subject headings
Adrenocortical Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pembrolizumab 25 MG/ML [Keytruda]Drug

    The treatment scheme will be based on pembrolizumab administered intravenously in cycles of every 3 weeks 200 mg, with supportive treatment with steroidogenesis inhibitor (metyrapone or ketoconazole) for adrenocortical carcinoma producing cortisol.

Study groups in NCT05563467
Study groupRoleWhat they receive
Pembrolizumab TreatmentExperimentalNot described
Receives: Drug: Pembrolizumab 25 MG/ML [Keytruda]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of the effectiveness of pembrolizumab (Keytruda) in the treatment of advanced, progressive adrenocortical carcinoma.

    Outcome will be assessed based on i.a. objective response rate (ORR).

    Measured: through study completion, an average of 4 years

Secondary outcomes (2)

  1. Assessment of the safety of pembrolizumab (Keytruda) in the treatment of advanced, progressive adrenocortical carcinoma.

    Number of Adverse Events and Serious Adverse Events (AE and SAE) related and not related to treatment according to CTCAE.

    Measured: through study completion, an average of 4 years

  2. Assessment of the impact of therapy on the patient's quality of life.

    Quality of life assessed based on the QLQ-C30 questionnaire in which patients will respond during the clinical trial.

    Measured: through study completion, an average of 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2022
  2. Study start31 Jan 2023
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05563467
Sponsor's protocol ID
PEMBR-01
Acronym
PEMBR-01
Status last verified
Nov 2026
First submitted
23 Aug 2022
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab 25 MG/ML [Keytruda] in people with Adrenocortical Carcinoma, run by Maria Sklodowska-Curie National Research Institute of Oncology at 4 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of the effectiveness of pembrolizumab (Keytruda) in the treatment of advanced, progressive adrenocortical carcinoma. (time frame: through study completion, an average of 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05563467.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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