Anti-PD-1 Antibody Alone or in Combination With Decitabine/Chemotherapy in Relapsed or Refractory Malignancies
Anti-PD-1 Antibody Alone or in Combination With Low-dose Decitabine and/or Chemotherapy in Relapsed or Refractory Malignancies: an Open-label Phase I/II Trial
Han weidong
250 participants
May 1, 2016
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to assess the feasibility, safety, and efficacy of anti-PD-1 antibody alone or in combination with low-dose decitabine in patients with relapsed or refractory malignancies, including Non-Hodgkin'lymphoma, Hodgkin'lymphoma, gastrointestinal cancers, hepatocellular carcinoma, breast cancer, ovarian cancer or lung cancer or renal-cell cancer or pancreatic cancer or bile duct cancer.
Eligibility
Inclusion Criteria12
- Subjects must have histological confirmation of relapsed or refractory malignancies,including Non-Hodgkin'lymphoma, Hodgkin'lymphoma, gastrointestinal cancers, hepatocellular carcinoma, breast cancer, ovarian cancer or lung cancer or renal-cell cancer or pancreatic cancer or bile duct cancer.
- 12 to 75 years of age.
- ECOG performance of less than 2.
- Life expectancy of at least 3 months.
- Subjects with lymphoma must have at least one measureable lesion >1 cm as defined by lymphoma response criteria; with solid tumors must have at least one measureable lesion >1 cm per RECIST1.1.
- Subjects must have received at least two prior chemotherapy regimen, and must be off therapy for at least 4 weeks prior to Day 1. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months.
- Subjects must have adequate bone marrow, live, renal, lung and heart functions.
- Absolute neutrophil count greater than or equal to 1,000/μL.
- Platelet count greater than or equal to 70,000/µL.
- Serum bilirubin level less than or equal to 1.5 x upper limits of normal (ULN).
- Serum creatinine less than or equal to 1.5 x ULN.
- Alanine aminotransferase \[ALT or SGPT\] and aspartate aminotransferase \[AST or SGOT\] less than or equal to 2.5 x ULN.
Exclusion Criteria6
- Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
- Serious uncontrolled medical disorders or active infections, pulmonary and intestinal infection especially.
- Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month .
- Prior organ allograft.
- Women who are pregnant or breastfeeding.
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
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Interventions
Anti-PD-1 antibody will be given at 1-3mg/kg on day8 by IV every three weeks
Decitabine will be given at 10mg/d on day 1to 5 by IV every three weeks
Chemotherapy be given depends on the cancer type and treatment regimen before enrollment.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT02961101