Actively Recruiting
Study of Radiotherapy and Pembrolizumab in People With Adrenocortical Carcinoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-15
12
Participants Needed
7
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Study of Radiotherapy and Pembrolizumab in People With Adrenocortical Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent for the trial
- Be 15 years of age or older on day of signing informed consent
- Have histologically- or cytologically-confirmed metastatic adrenocortical carcinoma with symptomatic liver metastases
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or adequate performance status: Lansky ≥ 50% for patients under 16 years; Karnofsky ≥ 50% for patients 16 years or older
- Have measurable disease based on RECIST v1.1 criteria
- Have radiologic documentation of extrahepatic tumor defined as extrahepatic metastases
- Consent to use of archived tissue for research purposes, if available
- Demonstrate adequate organ function based on laboratory values within 28 days of treatment start
- Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before treatment
- Female subjects of childbearing potential must be willing to use two methods of birth control or be surgically sterile, or abstain from heterosexual activity during the study and for 120 days after last dose
- Male subjects must agree to use adequate contraception during the study and for 120 days after last dose
You will not qualify if you...
- Currently participating or participated in an investigational drug or device study within 4 weeks before study start
- Prior radiotherapy overlapping the study cancer region
- Diagnosis of immunodeficiency or receiving systemic steroid or immunosuppressive therapy within 7 days before study start (physiologic corticosteroids for adrenal or pituitary insufficiency allowed)
- Prior monoclonal antibody therapy within 4 weeks before study start or not recovered from related adverse events
- Prior chemotherapy or targeted therapy within 2 weeks before study start or not recovered from related adverse events (except ≤ Grade 2 neuropathy or alopecia)
- Major surgery without adequate recovery before therapy
- Known additional progressing malignancy requiring active treatment (except certain skin cancers and treated cervical cancer)
- Active central nervous system metastases or carcinomatous meningitis (stable treated brain metastases allowed without steroids for 7 days prior)
- Active autoimmune disease needing systemic treatment in past 3 months or severe autoimmune history (some exceptions apply)
- Evidence of interstitial lung disease or pneumonitis requiring steroids or current pneumonitis
- Active infection requiring systemic therapy
- Conditions, therapies, or lab abnormalities that interfere with study participation or results, per investigator judgment
- Known psychiatric or substance abuse disorders interfering with study cooperation
- Pregnant or breastfeeding, or expecting to conceive or father children during the study and 120 days after last treatment
- Prior therapy with specific immune checkpoint inhibitors
- Known HIV infection
- Known active Hepatitis B or C infection
- Received live or live-attenuated vaccine within 30 days before study start (killed vaccines allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk-Commack
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
N
Nitya Raj, MD
CONTACT
R
Rohit Thummalapalli, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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