NCT06066333 · Memorial Sloan Kettering Cancer Center
Study of Radiotherapy and Pembrolizumab in People With Adrenocortical Carcinoma
What this study is about
The purpose of this study is to determine whether pembrolizumab given after standard ablative Radiotherapy is a safe treatment that causes few or mild side effects in people with advanced Adrenocortical Carcinoma.
View original scientific description
The purpose of this study is to determine whether pembrolizumab given after standard ablative Radiotherapy is a safe treatment that causes few or mild side effects in people with advanced Adrenocortical Carcinoma.
Interventions
RADIATION
Ablative Radiotherapy
All participants will first undergo ablative RT
DRUG
Pembrolizumab
After completion of ablative RT, all subjects may begin pembrolizumab treatment
Primary outcome measures
Number of participants evaluated for AEs
Time frame: up to 1 year
The primary objective of this pilot study is to evaluate the safety of treatment with ablative Radiotherapy/RT followed by pembrolizumab in patients with advanced Adrenocortical Carcinoma/ACC by evaluating treatment related adverse events. AEs will be recorded according to "Common Terminology Criteria for Adverse Events" v5.0 (CTCAE).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Be willing and able to provide written informed consent for the trial.
- Be ≥ 15 years of age on day of signing informed consent.
- Have histologically- or cytologically- confirmed metastatic ACC with symptomatic liver metastases.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- Adequate performance status: 1. Patients \< 16 years of age: Lansky ≥ 50% 2. Patients ≥ 16 years of age: Karnofsky ≥ 50%
- Have measurable disease based on RECIST v1.1.
- Have radiologic documentation of extrahepatic tumor, defined as extrahepatic metastases.
- Consent for use of archived tissue for research purposes. Archival tissue (1 block or 20 unstained slides) will be requested, when available.
- Demonstrate adequate organ function as defined in Table 1, all screening labs should be performed within 28 days of treatment initiation. Table 1: Adequate Organ Function Laboratory Value Hematological Absolute neutrophil count (ANC) ≥1,500 / mcL Plate
Where
- Basking Ridge, New Jersey
- Middletown, New Jersey
- Montvale, New Jersey
- Commack, New York
- Harrison, New York
- New York, New York
- Uniondale, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 15, 2026 · Source of record for eligibility and locations