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This is an open-label, multicenter, non-randomized, phase 2 trial to evaluate efficacy and safety of SHR-1210 in patients with relapsed or refractory classic Hodgkin's lymphoma. The primary objective is to assess ORR of SHR-1210 in patients with relapsed or refractory classic Hodgkin's lymphoma.
The primary objective of this phase 2 study is to assess objective response rate of SHR-1210 in patients with relapsed or refractory classic Hodgkin's lymphoma. The secondary objective is to observe the duration of response, progression free survival, time to response, overall survival and safety of SHR-1210 in relapsed or refractory classic Hodgkin's lymphoma. Pharmacokinetic index is also investigated in 12 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Injection SHR-1210 | Experimental | SHR-1210 injection, 200 mg/dose, intravenous infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1210 | Drug | A humanized monoclonal immunoglobulin |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR Assess by IRC | rate of subjects achieved complete response plus partial response in all evaluable subjects (Response was assessed with CT and PET using 2014 Lugano Criteria for Malignant Lymphomas, CR is disappearance of all tumor lesions, PR is over 50% decrease of the sum of the product of the perpendicular diameters from baseline ;overall response:PR+CR) | CT was conducted at baseline, at weeks 9, 17, 25, 37, 49, 65, 81, and 97, and then every 26 weeks; PET was conducted at baseline, weeks 17 and 25. ORR of 36 weeks based on CT and PET were reported. |
| Measure | Description | Time Frame |
|---|---|---|
| DoR Assess by IRC | Duration of Response (Response was assessed with CT and PET using 2014 Lugano Criteria for Malignant Lymphomas, disease progression is over 50% increase of an product of perpendicular diameters of any target lesion from nadir with any diameter increased over 0.5cm for lesions <=2cm or increased by 1cm for lesions >2cm,or appearance of new lesions, or progression of non-target lesion ) |
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Inclusion Criteria:
Histologically confirmed classic Hodgkin's lymphoma;
Relapsed or refractory cHL and meet any of the following criterions: a) did not achieve remission or progression after autologous hematopoietic stem cell transplantation. b) at least 2 lines of systemic chemotherapy and are not suitable for autologous stem cell transplantation;
Subjects enrolled have measurable lesion (s) according to Lugano 2014 criteria;
ECOG performance status of 0 or 1;
Life expectancy ≥ 12 weeks;
Adequate laboratory parameters during the screening period as evidenced by the following:
Women of childbearing potential (WOCBP) must be willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy while on treatment and for at least 60 days after receiving the last dose of study treatment. Women of childbearing potential with pregnancy test negative within 7 days before entering the group; male subjects with WOCBP partner should receive Surgical sterilization or consent to employ a highly effective method of birth control/contraception to prevent pregnancy while on treatment and for at least 120 days after receiving the last dose of study treatment;
Able to understand and sign an informed consent form (ICF).
Exclusion Criteria:
(1) Active, known or suspected autoimmune disease. Subjects who were in a stable state without systemic immunosuppressive therapy were admitted; (2) Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic corticosteroids > 10mg; doses > 10 mg/day topical prednisone or equivalent are prohibited within 2 weeks before entering the group; (3) Received anti-tumor vaccines or other anti-tumor therapy with immune stimulation within 3 months before the first dose SHR-1210; (4) Prior exposure to any PD-1/PD-L1/PD -L 2 or CTLA -4 antibody; (5) Participating in other clinical studies or less than 4 weeks before the end of a clinical trial; (6) Known and highly Suspicion of interstitial pneumonia; (7) Other active malignancies that required treating. (subjects with skin basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma or cervical carcinoma who had no disease recurrence within 5 years after the start of treatment were excluded); (8) Received chemotherapy, radiotherapy, immunotherapy, including topical therapy within 4 weeks. Previous anti-tumor therapy related adverse reactions (except hair loss) did not recover to CTCAE ≤1; (9) Prior allo-HSCT; (10) ASCT within 90 days; (11) Impact of major surgery or severe trauma had been eliminated for less than 14 days; (12) Active pulmonary tuberculosis; (13) Severe acute or chronic infection requiring systemic therapy; (14) Suffering from heart failure (New York Heart Association standard III and given appropriate medical treatment. Uncontrolled coronary artery disease and arrhythmia. History of myocardial infarction within 6 months; (15) Inoculated with live vaccine within 4 weeks before receiving the investigational drug. Injections of inactivated influenza vaccine for seasonal influenza are permitted, but not live attenuated influenza vaccines for intranasal use.
4. laboratory test:
(1) known HIV positive or known AIDS; (2) Untreated active hepatitis; co-infection with hepatitis B and hepatitis C.
5. Other factors that may lead to the study termination, such as severe disease or abnormal laboratory tests or family or social factors affecting subjects safety or test data and sample collection.
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| Name | Affiliation | Role |
|---|---|---|
| Zhenyu Xiao, MD | Jiangsu Hengrui Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China | ||
| Jiangsu Cancer Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31420358 | Derived | Song Y, Wu J, Chen X, Lin T, Cao J, Liu Y, Zhao Y, Jin J, Huang H, Hu J, Luo J, Zhang L, Xue H, Zhang Q, Wang W, Chen C, Feng J, Zhu J. A Single-Arm, Multicenter, Phase II Study of Camrelizumab in Relapsed or Refractory Classical Hodgkin Lymphoma. Clin Cancer Res. 2019 Dec 15;25(24):7363-7369. doi: 10.1158/1078-0432.CCR-19-1680. Epub 2019 Aug 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Injection SHR-1210 | SHR-1210 injection, 200 mg/dose, intravenous infusion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Injection SHR-1210 | SHR-1210 injection, 200 mg/dose, intravenous infusion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | ORR Assess by IRC | rate of subjects achieved complete response plus partial response in all evaluable subjects (Response was assessed with CT and PET using 2014 Lugano Criteria for Malignant Lymphomas, CR is disappearance of all tumor lesions, PR is over 50% decrease of the sum of the product of the perpendicular diameters from baseline ;overall response:PR+CR) | Posted | Number | 95% Confidence Interval | percentage | CT was conducted at baseline, at weeks 9, 17, 25, 37, 49, 65, 81, and 97, and then every 26 weeks; PET was conducted at baseline, weeks 17 and 25. ORR of 36 weeks based on CT and PET were reported. |
|
3 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Injection SHR-1210 | SHR-1210 injection, 200 mg/dose, intravenous infusion. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operation Director: Chenglei Qiao | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | +86-18036618600 | chenglei.qiao@hengrui.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 19, 2017 | Apr 27, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 30, 2020 | Apr 27, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
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| CT was conducted at baseline, at weeks 9, 17, 25, 37, 49, 65, 81, and 97, and then every 26 weeks; PET was conducted at baseline, weeks 17 and 25. DoR of 36 weeks based on CT and PET were reported. |
| PFS Assess by IRC | Progression-free Survival (Response was assessed with CT and PET using 2014 Lugano Criteria for Malignant Lymphomas, disease progression is over 50% increase of an product of perpendicular diameters of any target lesion from nadir with any diameter increased over 0.5cm for lesions <=2cm or increased by 1cm for lesions >2cm,or appearance of new lesions, or progression of non-target lesion ) | Up to 3 years |
| TTR Assess by IRC | Time to response (Response was assessed with CT and PET using 2014 Lugano Criteria for Malignant Lymphomas, CR is disappearance of all tumor lesions, PR is over 50% decrease of the sum of the product of the perpendicular diameters from baseline ;overall response:PR+CR) | CT was conducted at baseline, at weeks 9, 17, 25, 37, 49, 65, 81, and 97, and then every 26 weeks; PET was conducted at baseline, weeks 17 and 25. |
| OS | Overall Survival | Up to 3 years |
| Incidence and Severity of Adverse Events (AE) | Up to 3 years |
| Nanjing |
| Jiangsu |
| 210009 |
| China |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | DoR Assess by IRC | Duration of Response (Response was assessed with CT and PET using 2014 Lugano Criteria for Malignant Lymphomas, disease progression is over 50% increase of an product of perpendicular diameters of any target lesion from nadir with any diameter increased over 0.5cm for lesions <=2cm or increased by 1cm for lesions >2cm,or appearance of new lesions, or progression of non-target lesion ) | Posted | Median | 95% Confidence Interval | months | CT was conducted at baseline, at weeks 9, 17, 25, 37, 49, 65, 81, and 97, and then every 26 weeks; PET was conducted at baseline, weeks 17 and 25. DoR of 36 weeks based on CT and PET were reported. |
|
|
|
| Secondary | PFS Assess by IRC | Progression-free Survival (Response was assessed with CT and PET using 2014 Lugano Criteria for Malignant Lymphomas, disease progression is over 50% increase of an product of perpendicular diameters of any target lesion from nadir with any diameter increased over 0.5cm for lesions <=2cm or increased by 1cm for lesions >2cm,or appearance of new lesions, or progression of non-target lesion ) | Posted | Median | 95% Confidence Interval | months | Up to 3 years |
|
|
|
| Secondary | TTR Assess by IRC | Time to response (Response was assessed with CT and PET using 2014 Lugano Criteria for Malignant Lymphomas, CR is disappearance of all tumor lesions, PR is over 50% decrease of the sum of the product of the perpendicular diameters from baseline ;overall response:PR+CR) | Posted | Median | Full Range | months | CT was conducted at baseline, at weeks 9, 17, 25, 37, 49, 65, 81, and 97, and then every 26 weeks; PET was conducted at baseline, weeks 17 and 25. |
|
|
|
| Secondary | OS | Overall Survival | Posted | Median | 95% Confidence Interval | months | Up to 3 years |
|
|
|
| Secondary | Incidence and Severity of Adverse Events (AE) | Posted | Number | participants | Up to 3 years |
|
|
|
| 75 |
| 12 |
| 75 |
| 74 |
| 75 |
| Immune-Mediated Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nasal Polyps | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Appendicitis | Infections and infestations | Systematic Assessment |
|
| Soft Tissue Infection | Infections and infestations | Systematic Assessment |
|
| Blood Bilirubin Increased | Investigations | Systematic Assessment |
|
| Blood Creatine Phosphokinase Increased | Investigations | Systematic Assessment |
|
| Chest Discomfort | General disorders | Systematic Assessment |
|
| Inflammation | General disorders | Systematic Assessment |
|
| Tumor Pseudoprogression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Immune System Disorders | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Nasal Mucosa Reactive Capillary Endothelial Proliferation | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Reactive Cutaneous Capillary Endothelial Proliferation | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Nephrotic Syndrome | Renal and urinary disorders | Systematic Assessment |
|
| Renal Injury | Renal and urinary disorders | Systematic Assessment |
|
| Lymphadenitis | Blood and lymphatic system disorders | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Asthenia | General disorders | Systematic Assessment |
|
| Reactive angioendotheliomatosis | Immune system disorders | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
|
| White blood cell count decreased | Investigations | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | Systematic Assessment |
|
| Weight increased | Investigations | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | Systematic Assessment |
|
| Platelet count decreased | Investigations | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | Systematic Assessment |
|
| Protein urine present | Investigations | Systematic Assessment |
|
| Weight decreased | Investigations | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | Systematic Assessment |
|
| Bilirubin conjugated increased | Investigations | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | Systematic Assessment |
|
| Blood uric acid increased | Investigations | Systematic Assessment |
|
| Blood bilirubin unconjugated increased | Investigations | Systematic Assessment |
|
| Blood glucose increased | Investigations | Systematic Assessment |
|
| Occult blood positive | Investigations | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
All clinical study findings and documents will be regarded as confidential. The investigator and members of his/her research team must not disclose such information without prior written approval from the sponsor.
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |