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Anti-PD-1 Antibody Alone or in Combination With Decitabine/Chemotherapy in Relapsed or Refractory Malignancies

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ClinicalTrials.gov Identifier: NCT02961101
Recruitment Status : Recruiting
First Posted : November 10, 2016
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Han weidong, Chinese PLA General Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Malignancies Multiple Drug: Anti-PD-1 antibody Drug: Decitabine Drug: Chemotherapy Phase 1 Phase 2

Detailed Description:

Primary objective: To assess the feasibility and safety for Anti-PD-1 antibody alone or in combination with decitabine and/or chemotherapy administered every 3 weeks to subjects with relapsed or refractory malignancies.

Secondary objectives: 1) To assess the antitumor activity of Anti-PD-1 antibody alone or in combination with decitabine and/or chemotherapy in subjects with relapsed or refractory malignancies. 2) To characterize the immunological effects of Anti-PD-1 antibody alone or in combination with decitabine and/or chemotherapy. 3) To characterize the immunological effects of Anti-PD-1 antibody alone or in combination with decitabine and/or chemotherapy.

Exploratory objectives: 1) To analysis of potential biological parameters correlated to clinical response and toxicities. 2) To search predictive biomarkers to guide the choose of patients undergoing the treatment of Anti-PD-1 antibody alone or in combination with decitabine and/or chemotherapy.

Safety Evaluation: Adverse events will be assessed continuously during the study and for 100 days post last treatment, and will be evaluated according to the NCI CTCAE Version 4.0.

Efficacy Evaluation: 1) Treatment response to lymphoma was defined using the International Workshop to Standardize Response Criteria for Lymphomas; 2) Treatment response to solid tumors was defined using Response Evaluation Criteria in Solid Tumors (RECIST1.1).

evaluation index: BOR; ORR; PFS and OS.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2016
Actual Primary Completion Date : May 2019
Estimated Study Completion Date : May 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Anti-PD-1 antibody+decitabine
Decitabine will be administrated at 10mg/d on day1 to 5, followed by Anti-PD-1 antibody 200mg on day8 IV Q3 weeks until progression.
 Drug: Anti-PD-1 antibody
Anti-PD-1 antibody will be given at 1-3mg/kg on day8 by IV every three weeks

Drug: Decitabine
Decitabine will be given at 10mg/d on day 1to 5 by IV every three weeks
Experimental: Anti-PD-1 antibody
Anti-PD-1 antibody 200mg IV Q3 weeks until progression.
 Drug: Anti-PD-1 antibody
Anti-PD-1 antibody will be given at 1-3mg/kg on day8 by IV every three weeks
Experimental: Anti-PD-1 antibody+chemotherapy
Chemotherapy will be given depends on the cancer type and treatment regimen before enrollment. Chemotherapy was administrated on day1 , followed by Anti-PD-1 antibody 200mg on day2 IV Q3 weeks until progression.
 Drug: Anti-PD-1 antibody
Anti-PD-1 antibody will be given at 1-3mg/kg on day8 by IV every three weeks

Drug: Chemotherapy
Chemotherapy be given depends on the cancer type and treatment regimen before enrollment.


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Objective response by Response Evaluation Criteria in Solid Tumors (RECIST1.1). [ Time Frame: 3 years ]
  2. Objective response by the International Workshop to Standardize Response Criteria for lymphomas. [ Time Frame: 3 years ]
  3. Progression free survival [ Time Frame: 3 years ]
  4. Overall survival [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 12 to 75 years of age.
  3. ECOG performance of less than 2.
  4. Life expectancy of at least 3 months.
  5. 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.
  6. 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.

  7. Subjects must have adequate bone marrow, live, renal, lung and heart functions.

    1. Absolute neutrophil count greater than or equal to 1,000/μL.
    2. Platelet count greater than or equal to 70,000/µL.
    3. Serum bilirubin level less than or equal to 1.5 x upper limits of normal (ULN).
    4. Serum creatinine less than or equal to 1.5 x ULN.
    5. Alanine aminotransferase [ALT or SGPT] and aspartate aminotransferase [AST or SGOT] less than or equal to 2.5 x ULN.

Exclusion Criteria:

  1. Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
  2. Serious uncontrolled medical disorders or active infections, pulmonary and intestinal infection especially.
  3. Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month .
  4. Prior organ allograft.
  5. Women who are pregnant or breastfeeding.
  6. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02961101


Contacts
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Contact: Weidong Han, doctor +86-010-66937463 hanwdrsw@sina.com
Contact: Qingming Yang, doctor +86-010-55499341 yangqm@medmail.com.cn

Locations
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China, Beijing
Biotherapeutic Department of Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Weidong Han, Doctor    +86-10-66937463    hanwdrsw@sina.com   
Contact: Qingming Yang, Doctor    +86-10-55499341    yangqm@medmail.com.cn   
Principal Investigator: Yang Liu, Doctor         
Principal Investigator: Chunmeng Wang, Master         
Principal Investigator: Wenying Zhang, Master         
Principal Investigator: Meixia Chen, Doctor         
Principal Investigator: Weidong Han, Doctor         
Principal Investigator: Qingming Yang, Doctor         
Principal Investigator: Qian Mei, Doctor         
Principal Investigator: Jing Nie, Doctor         
Sub-Investigator: Yan Zhang, Doctor         
Sub-Investigator: Kaichao Feng, Doctor         
Sub-Investigator: Jingdan Qiu, Doctor         
Sub-Investigator: Hejin Jia, Doctor         
Sub-Investigator: Xiang Li, Master         
Sub-Investigator: Liang Dong, Master         
Sub-Investigator: Lu Shi, Master         
Sponsors and Collaborators
Han weidong
Investigators
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Study Director: Chunmeng Wang, Master Biotherapeutic Department of Chinese PLA General Hospital, Beijing, China, 100853
Study Director: Wenying Zhang, Master Biotherapeutic Department of Chinese PLA General Hospital, Beijing, China, 100853
Study Director: Yang Liu, Doctor Biotherapeutic Department of Chinese PLA General Hospital, Beijing, China, 100853
Study Director: Meixia Chen, Doctor Biotherapeutic Department of Chinese PLA General Hospital, Beijing, China, 100853
Principal Investigator: Yan Zhang, Doctor Biotherapeutic Department of Chinese PLA General Hospital, Beijing, China, 100853
Study Director: Qian Mei, Doctor Department of Molecular Biology, Institute of Basic Medicine, Chinese PLA General Hospital, Beijing, 100853, China.
Study Director: Jing Nie, Doctor Department of Molecular Biology, Institute of Basic Medicine, Chinese PLA General Hospital, Beijing, 100853, China.
Principal Investigator: Xiang Li, Master Department of Molecular Biology, Institute of Basic Medicine, Chinese PLA General Hospital, Beijing, 100853, China.
Principal Investigator: Liang Dong, Master Department of Molecular Biology, Institute of Basic Medicine, Chinese PLA General Hospital, Beijing, 100853, China.
Principal Investigator: Lu Shi, Master Department of Molecular Biology, Institute of Basic Medicine, Chinese PLA General Hospital, Beijing, 100853, China.
Principal Investigator: Kaichao Feng, Doctor Biotherapeutic Department of Chinese PLA General Hospital, Beijing, China, 100853
Principal Investigator: Jingdan Qiu, Doctor Biotherapeutic Department of Chinese PLA General Hospital, Beijing, China, 100853
Principal Investigator: Hejin Jia, Doctor Biotherapeutic Department of Chinese PLA General Hospital, Beijing, China, 100853
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Han weidong, Principal Investigator, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02961101    
Other Study ID Numbers: CHN-PLAGH-BT-019
First Posted: November 10, 2016    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Keywords provided by Han weidong, Chinese PLA General Hospital:
relapsed or refractory
malignancies
decitabine
anti-PD-1 antibody
chemotherapy
Additional relevant MeSH terms:
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Neoplasms
Decitabine
Antibodies
Immunologic Factors
Physiological Effects of Drugs
 Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors