Study of Radiotherapy and Pembrolizumab in People With Adrenocortical Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks prior to study Day 1 (the first day of ablative RT).
Has undergone radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields (to include Y90).
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to study Day 1. The use of physiologic doses of corticosteroids for adrenal and pituitary insufficiency is not considered a form of systemic steroid therapy and would not exclude a subject from the study.
Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. The use of non-immunotherapy monoclonal antibodies (such as dupilumab (for eczema), omalizumab (for urticaria), benralizumab (for asthma)) would not exclude a subject from the study.
Trial design
Design model
Single group
Treatments tested in this trial
Ablative Radiotherapy
RadiationAll participants will first undergo ablative RT
Pembrolizumab
DrugAfter completion of ablative RT, all subjects may begin pembrolizumab treatment
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Participants with Adrenocortical CarcinomaExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of participants evaluated for AEs
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).
Time frame
up to 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov