Single Agent Pembrolizumab in Subjects With Advanced Adrenocortical Carcinoma (NCT02673333) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Single Agent Pembrolizumab in Subjects With Advanced Adrenocortical Carcinoma
United States39 participantsStarted 2016-02
Plain-language summary
Pembrolizumab is a type of immunotherapy, and the purpose of this study is to find out what effects, good and/or bad, pembrolizumab has on you, and your cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Be willing and able to provide written informed consent for the trial.
* Be ≥ 18 years of age on day of signing informed consent.
* Have histologically- or cytologically- confirmed unresectable or metastatic ACC that is considered incurable by local therapies.
* Have an ECOG performance status of 0 or 1.
* Have measurable disease based on RECIST v1.1
* Have provided tissue for PD-L1 biomarker analysis from either archived tissue or a newly obtained core or excisional biopsy.
* Consent for use of archived tissue for research purposes.
* Demonstrate adequate organ function, all screening labs should be performed within 28 days of treatment initiation.
Hematological
* Absolute neutrophil count (ANC) ≥1,500 /mcL
* Platelets ≥100,000 / mcL Renal
* Serum creatinine ≤1.5 X upper limit of normal (ULN) OR Measured or calculateda creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥60 mL/min for subject with creatinine levels \> 1.5 X institutional ULN Hepatic
* Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \> 1.5 ULN
* AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases Coagulation
* International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
* Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless …