Trial Outcomes & Findings for A Study of Tislelizumab as Monotherapy in Relapsed or Refractory Classical Hodgkin Lymphoma (NCT NCT03209973)
NCT ID: NCT03209973
Last Updated: 2025-02-05
Results Overview
ORR is defined as the proportion of participants who achieve a best response of Complete Response (CR) or Partial Response (PR), as assessed by Independent Review committee (IRC) per the Lugano Classification
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
From the date of first dose Up to approximately 3 year and 7 months
Results posted on
2025-02-05
Participant Flow
70 participants were enrolled at 11 sites in China. The first participant dose date was on 21 April 2017. The study was completed on 02 November 2020.
Participant milestones
| Measure |
Tislelizumab
Tislelizumab 200 mg administered intravenously (IV) every-3-weeks (Q3W) until progressive disease (PD), unacceptable toxicity, death, or study withdrawal by the participant.
|
|---|---|
|
Overall Study
STARTED
|
70
|
|
Overall Study
Completed Primary Outcome Period
|
66
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
70
|
Reasons for withdrawal
| Measure |
Tislelizumab
Tislelizumab 200 mg administered intravenously (IV) every-3-weeks (Q3W) until progressive disease (PD), unacceptable toxicity, death, or study withdrawal by the participant.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Death
|
8
|
|
Overall Study
Transferred to Long Term Extension (LTE) study
|
32
|
|
Overall Study
Sponsor Decision
|
18
|
|
Overall Study
Participant Withdrew Due to Higher Risk than Benefit of Treatment
|
1
|
|
Overall Study
Participant Refused to Return to Treatment
|
2
|
Baseline Characteristics
A Study of Tislelizumab as Monotherapy in Relapsed or Refractory Classical Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Tislelizumab
n=70 Participants
Tislelizumab 200 mg administered IV Q3W until PD, unacceptable toxicity, death, or study withdrawal by the participant.
|
|---|---|
|
Age, Continuous
|
36.2 years
STANDARD_DEVIATION 12.73 • n=5 Participants
|
|
Age, Customized
<65
|
66 Participants
n=5 Participants
|
|
Age, Customized
≥ 65 and < 75 years
|
4 Participants
n=5 Participants
|
|
Age, Customized
≥ 75
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
70 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
70 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the date of first dose Up to approximately 3 year and 7 monthsPopulation: Modified Safety Analysis Set: All participants in the safety analysis set who had confirmed classical Hodgkin lymphoma.
ORR is defined as the proportion of participants who achieve a best response of Complete Response (CR) or Partial Response (PR), as assessed by Independent Review committee (IRC) per the Lugano Classification
Outcome measures
| Measure |
Tislelizumab
n=70 Participants
Tislelizumab 200 mg administered intravenously (IV) every-3-weeks (Q3W)
|
|---|---|
|
Overall Response Rate (ORR)
|
87.1 Percentage of Participants
Interval 77.0 to 93.9
|
SECONDARY outcome
Timeframe: From the date of first dose until end of study (Up to approximately 3 years and 7 months)Population: Modified Safety Analysis set
PFS is defined as the time from the first dose of tislelizumab to the date of Progressive Disease (PD) or death, whichever occurs first, assessed by IRC per the Lugano Classification
Outcome measures
| Measure |
Tislelizumab
n=70 Participants
Tislelizumab 200 mg administered intravenously (IV) every-3-weeks (Q3W)
|
|---|---|
|
Progression-free Survival (PFS)
|
31.5 Months
Interval 16.53 to
NA = upper limit of confidence interval not estimable due to insufficient event number greater than median value
|
SECONDARY outcome
Timeframe: From the date of first dose until end of study (Up to approximately 3 years and 7 months)Population: Modified Safety Analysis set; Participants with available data were included in the analysis.
DOR is defined as the time from the date that response criteria are first met to the date that PD is objectively documented or death, whichever occurs first, assessed by IRC per the Lugano Classification
Outcome measures
| Measure |
Tislelizumab
n=61 Participants
Tislelizumab 200 mg administered intravenously (IV) every-3-weeks (Q3W)
|
|---|---|
|
Duration of Response (DOR)
|
31.3 Months
Interval 20.73 to
NA = upper limit of confidence interval not estimable due to insufficient event number greater than Median Value
|
SECONDARY outcome
Timeframe: From the date of first dose until end of study (Up to approximately 3 years and 7 months)Population: Modified safety analysis set
CRR is defined as the percentage of participants who achieve a best response of CR, assessed by IRC per the Lugano Classification
Outcome measures
| Measure |
Tislelizumab
n=70 Participants
Tislelizumab 200 mg administered intravenously (IV) every-3-weeks (Q3W)
|
|---|---|
|
Rate of Complete Response (CRR)
|
67.1 Percentage of participants
Interval 54.9 to 77.9
|
SECONDARY outcome
Timeframe: From the date of first dose until end of study (Up to approximately 3 years and 7 months)Population: Modified safety analysis set; participants with available data were included in the analysis.
TTR is defined as the time from the date of the first dose of tislelizumab to the time the response criteria are first met, assessed by IRC per the Lugano Classification
Outcome measures
| Measure |
Tislelizumab
n=61 Participants
Tislelizumab 200 mg administered intravenously (IV) every-3-weeks (Q3W)
|
|---|---|
|
Time to Response (TTR)
|
12.0 Weeks
Interval 11.86 to 12.29
|
SECONDARY outcome
Timeframe: From the date of first dose until end of study (Up to approximately 3 years and 7 months)Population: The Safety Analysis Set included all participants who received any dose of tislelizumab.
An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study drug, whether considered related to study drug or not. An SAE is any untoward medical occurrence that, at any dose: * Results in death. * Is life-threatening. * Requires hospitalization or prolongation of existing hospitalization * Results in disability/incapacity * Is a congenital anomaly/birth defect * Is considered a significant medical AE by the investigator based on medical judgement
Outcome measures
| Measure |
Tislelizumab
n=70 Participants
Tislelizumab 200 mg administered intravenously (IV) every-3-weeks (Q3W)
|
|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Participants with At least one TEAE
|
68 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAE
|
18 Participants
|
SECONDARY outcome
Timeframe: From the date of first dose until end of study (Up to approximately 3 years and 7 months)Population: The Safety Analysis Set included all participants who received any dose of tislelizumab.
Clinical laboratory (e.g. hematology, serum chemistry, urinalysis) values were evaluated for each laboratory parameter and participants with clinically significant changes are summarized.
Outcome measures
| Measure |
Tislelizumab
n=70 Participants
Tislelizumab 200 mg administered intravenously (IV) every-3-weeks (Q3W)
|
|---|---|
|
Number of Participants With Significant Changes in Clinical Laboratory Results
|
0 Participants
|
SECONDARY outcome
Timeframe: From the date of first dose until end of study (Up to approximately 3 years and 7 months)Population: The Safety Analysis Set included all participants who received any dose of tislelizumab.
Outcome measures
| Measure |
Tislelizumab
n=70 Participants
Tislelizumab 200 mg administered intravenously (IV) every-3-weeks (Q3W)
|
|---|---|
|
Number of Participants With Significant Changes in Electrocardiograms
Postbaseline corrected QT interval > 450 msec
|
0 Participants
|
|
Number of Participants With Significant Changes in Electrocardiograms
≥ 1 postbaseline electrocardiogram
|
21 Participants
|
|
Number of Participants With Significant Changes in Electrocardiograms
Increase corrected QT interval of ≤ 30 msec
|
18 Participants
|
|
Number of Participants With Significant Changes in Electrocardiograms
Increase > 30 msec but ≤ 60 msec corrected QT interval
|
4 Participants
|
Adverse Events
Tislelizumab
Serious events: 18 serious events
Other events: 68 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Tislelizumab
n=70 participants at risk
Tislelizumab 200 mg administered intravenously (IV) every-3-weeks (Q3W)
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
1.4%
1/70 • Number of events 1 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.4%
1/70 • Number of events 7 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Gastrointestinal disorders
Ascites
|
1.4%
1/70 • Number of events 1 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
General disorders
Death
|
1.4%
1/70 • Number of events 1 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
General disorders
Pyrexia
|
2.9%
2/70 • Number of events 2 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Infections and infestations
Hepatitis B
|
1.4%
1/70 • Number of events 1 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
1.4%
1/70 • Number of events 1 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Infections and infestations
Pneumonia
|
2.9%
2/70 • Number of events 4 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
1.4%
1/70 • Number of events 1 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Infections and infestations
Urinary tract infection
|
1.4%
1/70 • Number of events 1 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Infections and infestations
Varicella
|
1.4%
1/70 • Number of events 1 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Injury, poisoning and procedural complications
Traumatic lung injury
|
1.4%
1/70 • Number of events 1 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Investigations
Blood glucose increased
|
1.4%
1/70 • Number of events 1 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.4%
1/70 • Number of events 1 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.4%
1/70 • Number of events 1 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Nervous system disorders
Seizure
|
1.4%
1/70 • Number of events 1 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Renal and urinary disorders
Focal segmental glomerulosclerosis
|
1.4%
1/70 • Number of events 1 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Renal and urinary disorders
Hydronephrosis
|
1.4%
1/70 • Number of events 1 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Renal and urinary disorders
Renal injury
|
1.4%
1/70 • Number of events 1 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Renal and urinary disorders
Renal tubular injury
|
1.4%
1/70 • Number of events 1 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
1.4%
1/70 • Number of events 2 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
1.4%
1/70 • Number of events 1 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.9%
2/70 • Number of events 2 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
1.4%
1/70 • Number of events 1 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
Other adverse events
| Measure |
Tislelizumab
n=70 participants at risk
Tislelizumab 200 mg administered intravenously (IV) every-3-weeks (Q3W)
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
12.9%
9/70 • Number of events 18 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.6%
6/70 • Number of events 10 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
4.3%
3/70 • Number of events 33 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.7%
4/70 • Number of events 6 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.7%
4/70 • Number of events 9 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Endocrine disorders
Hyperthyroidism
|
4.3%
3/70 • Number of events 4 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Endocrine disorders
Hypothyroidism
|
37.1%
26/70 • Number of events 64 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
10/70 • Number of events 13 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Gastrointestinal disorders
Nausea
|
8.6%
6/70 • Number of events 7 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Gastrointestinal disorders
Toothache
|
4.3%
3/70 • Number of events 3 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
7/70 • Number of events 7 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
General disorders
Asthenia
|
7.1%
5/70 • Number of events 9 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
General disorders
Chills
|
5.7%
4/70 • Number of events 4 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
General disorders
Pyrexia
|
57.1%
40/70 • Number of events 55 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
5.7%
4/70 • Number of events 4 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Hepatobiliary disorders
Liver injury
|
4.3%
3/70 • Number of events 7 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Infections and infestations
Influenza
|
5.7%
4/70 • Number of events 7 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
5/70 • Number of events 10 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Infections and infestations
Pharyngitis
|
4.3%
3/70 • Number of events 3 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Infections and infestations
Pneumonia
|
8.6%
6/70 • Number of events 7 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
38.6%
27/70 • Number of events 72 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Infections and infestations
Urinary tract infection
|
4.3%
3/70 • Number of events 4 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
14/70 • Number of events 34 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Investigations
Amylase increased
|
4.3%
3/70 • Number of events 17 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Investigations
Aspartate aminotransferase increased
|
15.7%
11/70 • Number of events 16 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Investigations
Bilirubin conjugated increased
|
8.6%
6/70 • Number of events 12 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Investigations
Blood bilirubin increased
|
10.0%
7/70 • Number of events 19 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Investigations
Blood bilirubin unconjugated increased
|
7.1%
5/70 • Number of events 14 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Investigations
Blood creatine phosphokinase increased
|
11.4%
8/70 • Number of events 15 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.7%
4/70 • Number of events 4 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Investigations
Blood thyroid stimulating hormone increased
|
11.4%
8/70 • Number of events 11 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Investigations
Blood uric acid increased
|
7.1%
5/70 • Number of events 7 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.7%
4/70 • Number of events 5 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Investigations
Lymphocyte count decreased
|
4.3%
3/70 • Number of events 14 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Investigations
Neutrophil count decreased
|
14.3%
10/70 • Number of events 48 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Investigations
Neutrophil count increased
|
4.3%
3/70 • Number of events 5 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Investigations
Platelet count decreased
|
10.0%
7/70 • Number of events 19 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Investigations
Weight decreased
|
17.1%
12/70 • Number of events 25 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Investigations
Weight increased
|
34.3%
24/70 • Number of events 79 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Investigations
White blood cell count decreased
|
21.4%
15/70 • Number of events 52 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Investigations
White blood cell count increased
|
5.7%
4/70 • Number of events 4 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
8.6%
6/70 • Number of events 8 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
14.3%
10/70 • Number of events 21 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.7%
4/70 • Number of events 7 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
4.3%
3/70 • Number of events 3 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
5/70 • Number of events 8 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.6%
6/70 • Number of events 7 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Nervous system disorders
Headache
|
10.0%
7/70 • Number of events 7 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Nervous system disorders
Hypoaesthesia
|
4.3%
3/70 • Number of events 4 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Nervous system disorders
Paraesthesia
|
4.3%
3/70 • Number of events 3 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.4%
15/70 • Number of events 20 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.3%
3/70 • Number of events 4 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.6%
13/70 • Number of events 18 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.7%
11/70 • Number of events 15 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
|
Vascular disorders
Hypertension
|
4.3%
3/70 • Number of events 5 • From the date of first dose until end of study (Up to approximately 3 years and 7 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \& may request a further delay to protect its IP rights.
- Publication restrictions are in place
Restriction type: OTHER