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The aim of this trial is to develop an effective and well-tolerated regimen for treatment of r/r cHL by introducing the anti-PD-1 antibody pembrolizumab and adding it to well-established chemotherapy regimens (ICE, DHAP). Synergistic effects of conventional agents with checkpoint inhibition may facilitate a highly effective therapy with limited toxicity, which might eventually substitute the very toxic high-dose chemotherapy (HDCT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembrolizumab plus Chemotherapy | Experimental | All patients will receive 1 dose of 200 mg pembrolizumab IV as single agent upfront, followed by 2 cycles of IV P-ICE (pembrolizumab, ifosfamide, carboplatin, etoposide) and a PET/CT-based restaging. Following a PET-guided treatment strategy, patients will then receive either another 2 cycles of IV P-ICE in case of a negative PET (i.e., Deauville score 1-3), or 2 to 4 cycles of IV P-DHAP (pembrolizumab, dexamethasone, cytarabine, cisplatin) in case of a positive PET (i.e., Deauville score > 3). After completion of treatment with P-ICE or P-DHAP, respectively, patients will receive a consolidation therapy with pembrolizumab for another 6 cycles. In case of non-CR after at least 4 cycles of combination therapy (4x P-ICE or 2x P-ICE + 2x P-DHAP), physicians may decide to go for HDCT or an alternative standard of care treatment option. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab plus Chemotherapy (ICE or DHAP) | Drug | Pembrolizumab (200mg) alone or in combination with ICE (or DHAP in case of PET positive findings after P-ICE) will be admistered. 6 additional courses of pembrolizumab will be administered after the completion P-ICE or P-DHAP |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Metabolic Response Rate (CMR) | The proportion of patients with a Deauville score of 1-3 in the centrally reviewed restaging after treatment with 1 x pembrolizumab + 4 cycles of pembrolizumab and chemotherapy combined (4x P-ICE or 2x P-ICE + 2x P-DHAP) | after completion of P+chemotherapy, an average of 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Fuchs | Contact | +49221478 | 88160 | ghsg@uk-koeln.de |
| Name | Affiliation | Role |
|---|---|---|
| Andreas Engert, Prof. | 1st Department of Medicine, Cologne Universit Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1st Department of Medicine, Cologne University Hospital | Recruiting | Cologne | Germany |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D004358 | Drug Therapy |
| D007053 | Ice |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D014867 | Water |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 |
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| Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D014887 | Weather |
| D008685 | Meteorological Concepts |
| D004778 | Environment and Public Health |