18 and older, any sex, with Classical Hodgkin Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Response Rate (ORR)Primary· From first dose to primary analysis data cutoff (12 Dec 2022) or new anti-lymphoma therapy start, whichever came first. Median follow-up was 11.4 months.
ORR was defined as the percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) by Positron Emission Tomography (PET) and Computed Tomography (CT) per the Lugano Classification and as determined by the investigator. CR was defined as the complete disappearance of all target lesions on PET-CT, with no new lesions detected. PR was defined as a significant reduction in metabolic activity or lesion size consistent with partial tumor shrinkage as per Lugano criteria.
Group
Value
95% CI
Cohort 1
64.3
35.1 – 87.2
Cohort 2
64.5
45.4 – 80.8
Total
64.4
48.8 – 78.1
Complete Response Rate (CRR)Secondary· From first dose to primary analysis data cutoff (12 Dec 2022) or new anti-lymphoma therapy start, whichever came first. Median follow-up was 11.4 months.
CRR was defined as the percentage of participants who achieved a best overall response of complete response (CR) by PET-CT or CT per the Lugano Classification and determined by the investigator. CR was defined as the complete disappearance of all target lesions on PET-CT or CT, with no new lesions detected.
Group
Value
95% CI
Cohort 1
42.9
17.7 – 71.1
Cohort 2
25.8
11.9 – 44.6
Total
31.1
18.2 – 46.6
Duration of Response (DOR)Secondary· From first dose to primary analysis data cutoff (12 Dec 2022) or new anti-lymphoma therapy start, whichever came first. Median follow-up was 11.4 months.
DOR was defined as the time from the date that response criteria (CR or PR) were first met to the date of objectively documented disease progression or death, whichever occurred first. Participants without an event were censored at the data cutoff or end of study, whichever occurred first. Participants who received new anti-lymphoma therapies, including Hematopoietic Stem Cell Transplantation (HSCT), before having an event were censored at the date of therapy initiation. Only participants with confirmed response were included in the analysis. Median DOR was estimated using the Kaplan-Meier met
Group
Value
95% CI
Cohort 1
12.25
5.55 – 12.25
Cohort 2
6.64
2.79 – NA
Total
12.25
3.02 – NA
Time to Response (TTR)Secondary· From first dose to primary analysis data cutoff (12 Dec 2022) or new anti-lymphoma therapy start, whichever came first. Median follow-up was 11.4 months.
TRR was defined as the time from the date of the first dose of tislelizumab to the date the response criteria were first met CR or PR per the Lugano Classification, and was analyzed only in participants who achieved an overall response; CR was defined as complete disappearance of disease, PR as ≥50% reduction in tumor burden, and Overall Response Rate (ORR) included participants with either CR or PR.
Group
Value
95% CI
Cohort 1
2.69
2.1 – 5.5
Cohort 2
2.69
0.3 – 5.6
Total
2.69
0.3 – 5.6
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)Secondary· From the date of the first dose of tislelizumab through 90 days after the last dose (maximum duration of tislelizumab exposure was 168 weeks)
Adverse events (AEs) were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. Treatment-emergent adverse events (TEAEs) were defined as any AE that began or worsened in severity after the first dose of study treatment and up to 90 days following the last dose, regardless of initiation of new anti-lymphoma therapy. The following safety data are reported:
Number of participants with any TEAEs: Participants who experienced at least one TEAE of any grade.
Number of participants with any Grade ≥3 TEAEs: Participants who exper
Number of participants with any TEAEs
Group
Value
95% CI
Cohort 1
12
Cohort 2
30
Number of participants with any TEAEs with grade >= 3
Group
Value
95% CI
Cohort 1
4
Cohort 2
12
Number of participants with any SAEs
Group
Value
95% CI
Cohort 1
4
Cohort 2
9
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks)..
Reporting threshold: 3%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cohort 1
Serious: 4/14 (29%)
Deaths: 3/14
Cohort 2
Serious: 9/31 (29%)
Deaths: 9/31
Serious adverse events (17 terms)
Reaction
System
Cohort 1
Cohort 2
Coeliac disease
Gastrointestinal disorders
—
—
Chest pain
General disorders
—
—
Pyrexia
General disorders
—
—
Peritonitis
Infections and infestations
—
—
Sepsis
Infections and infestations
—
—
Infusion related reaction
Injury, poisoning and procedural complications
—
—
Tendon rupture
Injury, poisoning and procedural complications
—
—
Alanine aminotransferase increased
Investigations
—
—
Aspartate aminotransferase increased
Investigations
—
—
Blood creatine phosphokinase increased
Investigations
—
—
Lipase increased
Investigations
—
—
Troponin increased
Investigations
—
—
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
—
—
Polyarthritis
Musculoskeletal and connective tissue disorders
—
—
Cutaneous t-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Dyspnoea
Respiratory, thoracic and mediastinal disorders
—
—
Skin ulcer
Skin and subcutaneous tissue disorders
—
—
Other adverse events (137 terms — click to expand)
This was a Phase 2 trial evaluating the effectiveness and safety of tislelizumab in participants with relapsed or hard-to-treat classical Hodgkin lymphoma (cHL). Participants were grouped by prior treatments. The main outcome was to assess overall response rate (ORR) across both cohorts. Participants continued receiving the study treatment until their disease got worse, side effects became too severe, or they chose to stop for other reasons.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
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· Phase 2
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by BeiGene
Last refreshed: 24 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04318080.