Study on Radiotherapy and Pembrolizumab for People with Adrenocortical Carcinoma
Sponsor: Memorial Sloan Kettering Cancer Center
Sponsor score: 60
Inactive
ClinicalTrials ID:NCT06066333
This clinical trial is testing whether pembrolizumab, given after standard radiation therapy, is a safe treatment with few or mild side effects for people with advanced adrenocortical carcinoma.
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Program Overview
The aim of this study is to find out if pembrolizumab, when given after standard radiation therapy, is a safe treatment option for people with advanced adrenocortical carcinoma (ACC). Researchers want to see if this combination causes only mild or manageable side effects.
Eligibility Criteria
Inclusion Criteria
- Be willing and able to provide written consent to participate in the trial.
- Be 15 years or older.
- Have confirmed advanced adrenocortical carcinoma (ACC) with symptoms affecting the liver.
- Have a performance status that allows for daily activities, as measured by specific health scales.
- Have measurable cancer based on standard criteria.
- Have cancer that has spread beyond the liver.
- Agree to provide a sample of previous tumor tissue for research, if available.
- Have adequate organ function based on specific blood tests.
- Women of childbearing age must have a negative pregnancy test before starting treatment and agree to use two forms of birth control or be surgically sterile during the study and for 120 days after the last dose.
- Men must agree to use effective contraception during the study and for 120 days after the last dose.
Exclusion Criteria
- Currently participating in another study or have used an investigational drug or device within 4 weeks before starting this study.
- Have had radiation therapy to the same area as the study cancer that would overlap with the study treatment.
- Have an immune system deficiency or are taking medications that suppress the immune system within 7 days before starting the study.
- Have received a monoclonal antibody treatment within 4 weeks before starting the study and have not recovered from any side effects.
- Have had chemotherapy or targeted therapy within 2 weeks before starting the study and have not recovered from any side effects.
- Have another progressing cancer that requires treatment, except for certain skin cancers or cervical cancer that has been treated.
- Have active cancer in the brain or spinal cord, unless previously treated and stable.
- Have an active autoimmune disease requiring treatment within the past 3 months.
- Have lung disease or a history of lung inflammation that required steroids.
- Have an active infection requiring treatment.
- Have any condition or history that might interfere with the study or is not in the best interest of the participant.
- Have psychiatric or substance abuse issues that would interfere with the study.
- Are pregnant or breastfeeding, or planning to conceive or father a child during the study and for 120 days after.
- Have received prior therapy targeting specific immune pathways.
- Have a known history of HIV.
- Have active Hepatitis B or C.
- Have received a live vaccine within 30 days before starting the study.
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