OncoMatch/Clinical Trials/NCT03295227
Pembrolizumab in Treating Participants With Unresectable Thymoma or Thymic Cancer
Is NCT03295227 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Pembrolizumab for stage iii thymoma ajcc v8.
Treatment: Pembrolizumab — This phase I trial studies the sides effects and best dose of pembrolizumab in treating participants with thymoma or thymic cancer that cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Check if I qualifyExtracted eligibility criteria
Disease stage
Required: Stage III, IIIA, IIIB, IV, IVA, IVB (AJCC v8)
Stage III Thymoma AJCC v8; Stage IIIA Thymoma AJCC v8; Stage IIIB Thymoma AJCC v8; Stage IV Thymoma AJCC v8; Stage IVA Thymoma AJCC v8; Stage IVB Thymoma AJCC v8; Unresectable Thymic Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1 therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
Cannot have received: anti-cancer monoclonal antibody
Exception: within 4 weeks prior to study day 1 or not recovered from adverse events
Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or who has not recovered (i.e., ≤ grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
Cannot have received: chemotherapy
Exception: within 2 weeks prior to study day 1 or not recovered from adverse events (≤ grade 1 or at baseline); ≤ grade 2 neuropathy allowed
Has had prior chemotherapy, targeted small molecule therapy, or radiation 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. Note: Subjects with ≤ grade 2 neuropathy are an exception to this criterion and may qualify for the study.
Cannot have received: targeted small molecule therapy
Exception: within 2 weeks prior to study day 1 or not recovered from adverse events (≤ grade 1 or at baseline); ≤ grade 2 neuropathy allowed
Has had prior chemotherapy, targeted small molecule therapy, or radiation 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. Note: Subjects with ≤ grade 2 neuropathy are an exception to this criterion and may qualify for the study.
Cannot have received: radiation therapy
Exception: within 2 weeks prior to study day 1 or not recovered from adverse events (≤ grade 1 or at baseline); ≤ grade 2 neuropathy allowed
Has had prior chemotherapy, targeted small molecule therapy, or radiation 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. Note: Subjects with ≤ grade 2 neuropathy are an exception to this criterion and may qualify for the study.
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1500/mcL; Platelets ≥ 100000/mcL; Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L without transfusion or EPO dependency
Kidney function
Serum creatinine ≤ 1.5 X ULN OR ≥ 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN
Liver function
Serum total bilirubin ≤ 1.5 X ULN OR direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN; AST and ALT ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases; Albumin ≥ 2.5 mg/dL
Absolute neutrophil count ≥ 1500/mcL; Platelets ≥ 100000/mcL; Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L without transfusion or EPO dependency; Serum creatinine ≤ 1.5 X ULN OR ≥ 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN; Serum total bilirubin ≤ 1.5 X ULN OR direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN; AST and ALT ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases; Albumin ≥ 2.5 mg/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
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