Trial Outcomes & Findings for PD-1 Antibody SHR-1210 in Patients With Relapsed or Refractory Classic Hodgkin's Lymphoma (NCT NCT03155425)

Last Updated: 2024-02-01

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

75 participants

Primary outcome timeframe

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.

Results posted on

2024-02-01

Participant Flow

Participant milestones

Participant milestones
Measure	Injection SHR-1210 SHR-1210 injection, 200 mg/dose, intravenous infusion.
Overall Study STARTED	75
Overall Study COMPLETED	75
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PD-1 Antibody SHR-1210 in Patients With Relapsed or Refractory Classic Hodgkin's Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Injection SHR-1210 n=75 Participants SHR-1210 injection, 200 mg/dose, intravenous infusion.
Age, Continuous	34 years n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	75 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment China	75 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Injection SHR-1210 n=75 Participants SHR-1210 injection, 200 mg/dose, intravenous infusion.
ORR Assess by IRC	76.0 percentage Interval 64.7 to 85.1

SECONDARY outcome

Timeframe: 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.

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 )

Outcome measures

Outcome measures
Measure	Injection SHR-1210 n=75 Participants SHR-1210 injection, 200 mg/dose, intravenous infusion.
DoR Assess by IRC	31.7 months Interval 16.7 to insufficient number of patients with events

SECONDARY outcome

Timeframe: Up to 3 years

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 )

Outcome measures

Outcome measures
Measure	Injection SHR-1210 n=75 Participants SHR-1210 injection, 200 mg/dose, intravenous infusion.
PFS Assess by IRC	22.5 months Interval 14.7 to insufficient number of patients with events

SECONDARY outcome

Timeframe: 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.

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)

Outcome measures

Outcome measures
Measure	Injection SHR-1210 n=75 Participants SHR-1210 injection, 200 mg/dose, intravenous infusion.
TTR Assess by IRC	2.0 months Interval 1.7 to 5.7

SECONDARY outcome

Timeframe: Up to 3 years

Overall Survival

Outcome measures

Outcome measures
Measure	Injection SHR-1210 n=75 Participants SHR-1210 injection, 200 mg/dose, intravenous infusion.
OS	NA months insufficient number of patients with events

SECONDARY outcome

Timeframe: Up to 3 years

Outcome measures

Outcome measures
Measure	Injection SHR-1210 n=75 Participants SHR-1210 injection, 200 mg/dose, intravenous infusion.
Incidence and Severity of Adverse Events (AE)	75 participants

Adverse Events

Injection SHR-1210

Serious events: 12 serious events

Other events: 74 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Injection SHR-1210 n=75 participants at risk SHR-1210 injection, 200 mg/dose, intravenous infusion.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.7% 2/75 • 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.
Respiratory, thoracic and mediastinal disorders Immune-Mediated Pneumonitis	2.7% 2/75 • 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.
Respiratory, thoracic and mediastinal disorders Nasal Polyps	1.3% 1/75 • 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.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.3% 1/75 • 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.
Infections and infestations Pneumonia	2.7% 2/75 • 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.
Infections and infestations Appendicitis	1.3% 1/75 • 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.
Infections and infestations Soft Tissue Infection	1.3% 1/75 • 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.
Investigations Blood Bilirubin Increased	1.3% 1/75 • 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.
Investigations Blood Creatine Phosphokinase Increased	1.3% 1/75 • 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.
General disorders Chest Discomfort	1.3% 1/75 • 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.
General disorders Inflammation	1.3% 1/75 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor Pseudoprogression	1.3% 1/75 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Immune System Disorders	1.3% 1/75 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasal Mucosa Reactive Capillary Endothelial Proliferation	1.3% 1/75 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Reactive Cutaneous Capillary Endothelial Proliferation	1.3% 1/75 • 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.
Renal and urinary disorders Nephrotic Syndrome	1.3% 1/75 • 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.
Renal and urinary disorders Renal Injury	1.3% 1/75 • 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.
Blood and lymphatic system disorders Lymphadenitis	1.3% 1/75 • 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.

Other adverse events

Other adverse events
Measure	Injection SHR-1210 n=75 participants at risk SHR-1210 injection, 200 mg/dose, intravenous infusion.
Blood and lymphatic system disorders Anaemia	22.7% 17/75 • 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.
Cardiac disorders Arrhythmia	5.3% 4/75 • 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.
Endocrine disorders Hypothyroidism	32.0% 24/75 • 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.
Endocrine disorders Hyperthyroidism	6.7% 5/75 • 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.
Gastrointestinal disorders Diarrhoea	10.7% 8/75 • 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.
General disorders Pyrexia	44.0% 33/75 • 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.
General disorders Asthenia	8.0% 6/75 • 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.
Immune system disorders Reactive angioendotheliomatosis	97.3% 73/75 • 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.
Infections and infestations Upper respiratory tract infection	54.7% 41/75 • 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.
Infections and infestations Nasopharyngitis	16.0% 12/75 • 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.
Infections and infestations Urinary tract infection	12.0% 9/75 • 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.
Infections and infestations Herpes zoster	6.7% 5/75 • 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.
Injury, poisoning and procedural complications Infusion related reaction	16.0% 12/75 • 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.
Investigations Alanine aminotransferase increased	29.3% 22/75 • 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.
Investigations White blood cell count decreased	29.3% 22/75 • 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.
Investigations Neutrophil count decreased	25.3% 19/75 • 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.
Investigations Weight increased	25.3% 19/75 • 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.
Investigations Aspartate aminotransferase increased	22.7% 17/75 • 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.
Investigations Blood thyroid stimulating hormone increased	17.3% 13/75 • 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.
Investigations Blood bilirubin increased	16.0% 12/75 • 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.
Investigations Platelet count decreased	16.0% 12/75 • 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.
Investigations Gamma-glutamyltransferase increased	14.7% 11/75 • 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.
Investigations Lymphocyte count decreased	9.3% 7/75 • 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.
Investigations Protein urine present	9.3% 7/75 • 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.
Investigations Weight decreased	9.3% 7/75 • 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.
Investigations Blood alkaline phosphatase increased	8.0% 6/75 • 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.
Investigations Electrocardiogram QT prolonged	8.0% 6/75 • 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.
Investigations Bilirubin conjugated increased	6.7% 5/75 • 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.
Investigations Blood lactate dehydrogenase increased	6.7% 5/75 • 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.
Investigations Blood uric acid increased	6.7% 5/75 • 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.
Investigations Blood bilirubin unconjugated increased	5.3% 4/75 • 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.
Investigations Blood glucose increased	5.3% 4/75 • 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.
Investigations Occult blood positive	5.3% 4/75 • 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.
Metabolism and nutrition disorders Hypokalaemia	13.3% 10/75 • 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.
Metabolism and nutrition disorders Hyperuricaemia	9.3% 7/75 • 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.
Metabolism and nutrition disorders Hyperglycaemia	5.3% 4/75 • 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.
Metabolism and nutrition disorders Hyperlipidaemia	5.3% 4/75 • 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.
Musculoskeletal and connective tissue disorders Pain in extremity	6.7% 5/75 • 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.
Musculoskeletal and connective tissue disorders Back pain	5.3% 4/75 • 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.
Nervous system disorders Headache	5.3% 4/75 • 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.
Renal and urinary disorders Proteinuria	12.0% 9/75 • 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.
Respiratory, thoracic and mediastinal disorders Cough	17.3% 13/75 • 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.
Skin and subcutaneous tissue disorders Pruritus	12.0% 9/75 • 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.
Skin and subcutaneous tissue disorders Rash	8.0% 6/75 • 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.

Additional Information

Clinical Operation Director: Chenglei Qiao

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Phone: +86-18036618600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER