Efficacy and Safety Evaluation of IBI308 in Treatment of Patients With Relapsed/Refractory Classical Hodgkin's Lymphoma: a Multicenter, Single Arm, Phase II Study (ORIENT-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03114683
Recruitment Status : Not yet recruiting
First Posted : April 14, 2017
Last Update Posted : April 14, 2017
Information provided by (Responsible Party):
Innovent Biologics (Suzhou) Co. Ltd.

Brief Summary:
The study is to evaluate ORR, CR, PR DCR DOR PFS and safety of IBI308 in treatment of patients with Relaspsed/Refractory Hodgkin's Lymphoma.

Condition or disease Intervention/treatment Phase
Relapsed/Refractory Classical Hodgkin's Lymphoma Drug: PD1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Evaluation of IBI308 in Treatment of Patients With Relapsed/Refractory Classical Hodgkin's Lymphoma: a Multicenter, Single Arm, Phase II Study
Estimated Study Start Date : April 30, 2017
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: IBI308 Drug: PD1
IBI308 200mg/3 weeks

Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: average 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histopathological confirmed classical Hodgkin's lymphoma (cHL).
  2. Relapsed/refractory cHL, which failed second line and above therapy (including radiotherapy and autologous hematopoietic stem cell transplantation, ASCT); subject with no response to or with progression after ASCT is eligible.
  3. At least one measurable disease (long axis>15 mm or short axis>10 mm, with uptake on 18FDG-PET)
  4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2.
  5. Signed written informed consent form and willing and able to comply with scheduled visits and other requirements of the study.
  6. Age ≥ 18.
  7. Life expectancy of at least 12 weeks.
  8. Subjects of reproductive potential must be willing to use adequate contraception during the course of the study and through 90 days after the last dose of study medication.
  9. Adequate organ and bone marrow function:

    1. Count of Blood Cells: absolute neutrophil count (ANC) ≥ 0.75 × 109 / L; platelet count (PLT) ≥ 50 × 109 / L; hemoglobin content (HGB) ≥ 8.0 g / Dl; no granulocyte colony-stimulating factor, platelet or red blood cells infusion in the last 14 days.
    2. Liver function: serum total bilirubin (TBIL) ≤ 1.5 × normal upper limit (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN.
    3. Renal function: serum creatinine (Cr) ≤ 1.5 × ULN
    4. Thyroid function: thyroid stimulating hormone (TSH) in normal range.

Exclusion Criteria:

  1. Known nodular lymphocyte predominant Hodgkin lymphoma.
  2. Known central nervous system lymphoma.
  3. Received ASCT within 90 days of the first dose of study medication.
  4. Prior exposure to any anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibody.
  5. Currently participating in an interventional clinical study, unless participating in observational study or during follow-up period of an interventional study.
  6. Received any investigational agent within 4 weeks of the first dose of study medication.
  7. Received last dose of radiotherapy or anti-tumor therapy (chemotherapy, targeted therapy, tumor immunotherapy or arterial embolization) within 3 weeks of the first dose of study medication; received last dose of nitrosourea or mitomycin C within 6 weeks of the first dose of study medication.
  8. Received systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 4 weeks of first dose. Inhaled or topical steroids and adrenal replacement steroid doses are permitted in the absence of active autoimmune disease.
  9. Received a live vaccine within 4 weeks of the first dose of study medication or plan to receive live vaccine during study period.
  10. Underwent major operation (craniotomy, thoracotomy or laparotomy) within 4 weeks of the first dose of study medication or open wound, ulcer or fracture.
  11. Unrecovered toxicity (grade >1, according to NCI CTCAE 4.03) due to prior anti-tumor therapy before the first dose of study medication.
  12. Active, known or suspected autoimmune disease or has a history of the disease within the last 2 years (subjects with vitiligo, psoriasis, alopecia or Grave's disease, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or type I diabetes mellitus only requiring insulin replacement, but not required systemic treatment in the last 2 years, are permitted to enroll).
  13. Known primary immunodeficiency.
  14. Active tuberculosis.
  15. Known history of allogeneic organ or allogeneic hemopoietic stem cell transplantation.
  16. Known allergy or hypersensitivity to any monoclonal antibodies or any components used in their preparation.
  17. Uncontrolled concomitant disease, including but not limited to :

    1. Human Immunodeficiency Virus (HIV) infection (HIV antibody positive)
    2. Active or poorly controlled severe infection
    3. Symptomatic congestive heart failure (New York Heart Association grade II-IV) or symptomatic, poorly controlled arrhythmia
    4. Poorly controlled arterial hypertension (SBP ≥ 160mmHg or DBP ≥ 100mmHg) with standard treatment
    5. Prior arterial thromboembolism event, including myocardial infarction, unstable angina, stroke and transient ischemic attack, within 6 months of enrollment
    6. Prior life-threatening blood loss or grade 3/4 gastrointestinal/varicosity bleeding requiring blood infusion, endoscopic or surgical intervention within 3 months of enrollment
    7. Prior deep vein thrombosis, pulmonary embolism or any other severe thromboembolism events (implanted port or catheter caused thrombosis, or superficial vein thrombosis are not considered as severe thromboembolism) within 3 months before enrollment
    8. History of uncontrolled metabolic disorder, non-malignant organ or systemic disease or secondary carcinomatous reaction, with high medical risk and/or uncertainty of life expectancy evaluation
    9. With hepatic encephalopathy, hepatorenal syndrome or hepatic cirrhosis of Child-Pugh grade B or higher.
    10. History of intestinal obstruction or the following diseases: inflammatory bowel disease or extensive bowel resection (partial colonic resection or extensive small bowel resection, concomitant with chronic diarrhea), Crohn's disease, ulcerative colitis or chronic diarrhea
    11. Other acute or chronic diseases, mental illness, or abnormal laboratory test results that may lead to the following outcomes: increase the risk of participating in study or study drug administration, or interfere with the interpretation of the study results and considered by investigator as "NOT" eligible to participate in this study
  18. Known acute or chronic active hepatitis B infection (chronic HBV carrier or non-active HBsAg positive subject is eligible) or acute or chronic active hepatitis C (HCV antibody negative subject is eligible; HCV RNA examination is required for HCV antibody positive subject, subject is eligible if result was negative)
  19. History of gastrointestinal perforation and /or fistula within 6 months before enrollment
  20. Subjects with a history of interstitial lung disease
  21. Uncontrolled third space effusion, eg. ascites or pleural effusion cannot be drained or controlled
  22. Other primary malignancy, with the exception of:

    1. Curative malignancy, without active disease in the last 5 years and with very low recurrence risk
    2. Non-melanoma skin cancer or malignant freckle-like nevus with adequate treatment and no evidence of recurrence ;
    3. Adequately treated in-situ carcinoma
  23. Women who are pregnant or nursing.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Innovent Biologics (Suzhou) Co. Ltd. Identifier: NCT03114683     History of Changes
Other Study ID Numbers: CIBI308B201
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases