Pembrolizumab in the Treatment of Advanced, Progressive Adrenocortical Carcinoma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

20 Jan 2023 → ongoing

Decision date (initial)

2024-09-22

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Medical Research Agency

External identifiers

EU CT number

2024-517205-82-00

EudraCT number

2022-000494-91

ClinicalTrials.gov

NCT05563467

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

Evaluation of the efficacy of pembrolizumab in the treatment of advanced progressive adrenocortical cancer

Secondary objectives 2

1. Assessment of the safety of pembrolizumab in the treatment of advanced, progressive adrenocortical cancer
2. Assessment of the impact of therapy on the patient's quality of life

Conditions and MedDRA coding

adrenocortical carcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Informed consent form to participate in the study
2. Age over 18
3. Histopathologically confirmed adrenal cortex cancer
4. The patient's general condition assessed according to the 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 1 line of treatment with EDP or EDP-M
7. 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)
8. For women of reproductive age: confirmed negative pregnancy test result and the need to use double barrier contraception
9. For men of reproductive age: the need to use double barrier contraception

Exclusion criteria 21

1. Pretreatment with an immune checkpoint inhibitor
2. Any anticancer therapy in the last 7 days
3. Persistent side effects of previously used anticancer therapy at stage > G1 or after previous surgical treatment (exception: alopecia)
4. Current or recent immunosuppressive therapy
5. 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)
6. Previous allogeneic bone marrow transplant or organ transplant
7. Autoimmune disease present or diagnosed within the last 2 years, except for vitiligo, psoriasis not requiring systemic treatment, autoimmune thyroid disease
8. Active or previously documented inflammatory bowel disease
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 CNS metastases (exception: patients with asymptomatic CNS metastases, after previous surgical or radiotherapy treatment and without a history of intracranial bleeding)
14. Circulatory failure NYHA ≥3
15. Corrected QT interval > 500 ms
16. Significant comorbid disease, including cancer, with the exception of basal cell carcinoma of the skin, in situ cancers: prostate, cervix, breast
17. Another significant comorbid condition that, in the investigator's opinion, would pose a threat to the patient during therapy
18. Pregnancy or breastfeeding
19. Patients requiring dialysis
20. Inability of the patient to meet the requirements specified in the study protocol
21. Vaccination with a live vaccine within 3 months before starting treatment

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. Objective Response Rate (ORR)
2. Progression-Free Survival (PFS)
3. Duration of Response (DoR)
4. Overall Survival (OS)

Secondary endpoints 2

1. Quality of life assesed by QLQ-C30 questionnaire
2. Number of Adverse Events and Serious Adverse Events (AEs and SAEs) related and unrelated to treatment according to CTCAE

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Sponsor organisation

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Address

Ul. Wybrzeze Armii Krajowej 15

City

Gliwice

Postcode

44-102

Country

Poland

Scientific contact point

Organisation

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Contact name

Clinical Research Support Center

Public contact point

Organisation

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Contact name

Clinical Research Support Center

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications