Pembrolizumab in the treatment of advanced, progressive adrenocortical carcinoma.

Phase 1

• Conditions: carcinoma; MedDRA version: 20.0Level: PTClassification code 10001388Term: Adrenocortical carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2022-000494-91-PL
• Lead Sponsor: arodowy Instytut Onkologii im. Marii Sklodowskiej-Curie, Panstwowy Instytut Badawczy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-17
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 24

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:
a.hemoglobin = 9g%, neutrophils> 1500 / mm3, platelets> 100 thousand / mm3
bilirubin = 2 x upper limit of normal (UNL), Alat, Aspat = 3 x UNL (if liver metastases are present = 5 x UNL)
c. creatinine clearance> 40 ml / min
d. 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified