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Radiotherapy + Pembrolizumab for Adrenocortical Cancer

Phase 2
Recruiting
Led By Nitya Raj, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have histologically- or cytologically- confirmed metastatic ACC with symptomatic liver metastases
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0
Must not have
Has had prior chemotherapy, targeted small molecule therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent
Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new cancer treatment to see if it's safe and causes few or mild side effects.

Who is the study for?
Adults with advanced Adrenocortical Carcinoma (ACC) and liver metastases, ECOG performance status of 0, measurable disease, adequate organ function. Must not have had recent treatments or other cancers, no active infections or immunodeficiencies, and agree to contraception.
What is being tested?
The trial is testing the safety and side effects of Pembrolizumab following ablative Radiotherapy in patients with ACC. The goal is to see if this combination treatment causes few or mild side effects.
What are the potential side effects?
Potential side effects may include immune system reactions affecting organs, fatigue, skin reactions, digestive issues and changes in blood tests. Specific risks will be monitored closely throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has spread to my liver and is causing symptoms.
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I am fully active and can carry on all pre-disease activities without restriction.
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My cancer has spread outside of the liver.
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I am 18 years old or older.
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I am using two birth control methods or am not able to have children, and will continue for 120 days after the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had chemotherapy or targeted therapy in the last 2 weeks and have recovered from previous treatment side effects.
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I have an autoimmune disease that needed treatment in the last 3 months.
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I have or had lung inflammation that needed steroids.
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I am currently being treated for an infection.
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I have been diagnosed with HIV.
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My cancer has spread to my brain or the membranes around my brain.
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I have been treated with specific immune-targeting drugs before.
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I have had radiation therapy in the same area as my current cancer.
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I haven't had monoclonal antibody treatment in the last 4 weeks or have recovered from its side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants evaluated for AEs

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants with Adrenocortical CarcinomaExperimental Treatment2 Interventions
Participants with histologically proven metastatic Adrenocortical Carcinoma/ACC with both intra-hepatic and extra-hepatic sites of disease.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~3150

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,974 Previous Clinical Trials
598,256 Total Patients Enrolled
Nitya Raj, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
53 Total Patients Enrolled
~7 spots leftby Sep 2026
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