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.

Patient Parameters

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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