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The purpose of this study is to compare efficacy of IMM01 plus Tiselizumab with physician's choice chemotherapy of bendamustine or gemcitabine in participants with PD-(L)1-refractory classical Hodgkin Lymphoma. The study will also assess the safety and tolerability of IMM01 plus Tiselizumab. The primary study hypotheses are that IMM01 plus Tiselizuma is superior to physician's choice chemotherapy with respect to progression-free survival (PFS) and overall survival (OS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMM01 plus Tiselizuma | Experimental | Participants will receive IMM01 (2.0mg/kg) intravenously each week and tislelizumab (200mg) once every 3 weeks in 3-week treatment cycle, for up to 2 years. |
|
| Physician's Choice Chemotherapy | Active Comparator | Participants will receive physician's choice of either bendamustine or gemcitabie. Gemciabine: 90 or 120 mg/m^2 on Day 1 and Day 2, IV, 4-week cycle, for up to 6 cycles. Gemcitabine: 1000 mg/m^2 on Day 1 and Day 8, IV, 3-week cycle, for up to 6 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Biological | IV infusion |
| |
| IMM01 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) per Lugano 2014 as Assessed by Independent Review Committee (IRC) | PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. | approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from randomization to death due to any cause. | approximately 36 months |
| Duration of Response (DOR) | DOR is defined as the time from the first documented evidence of complete response or partial response until disease progression or death due to any cause, whichever occurs first. |
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Inclusion Criteria:
Exclusion Criteria:
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| Biological |
2.0mg/kg, IV infusion |
|
|
| Bendamustine | Drug | IV infusion |
|
| Gemcitabine | Drug | IV infusion |
|
| approximately 24 months |
| Number of Participants Who Experienced At Least One Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. | approximately 18 months |
| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| D000069461 | Bendamustine Hydrochloride |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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