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The aim of the trial is to improve efficacy of nivolumab in patients with relapsed or refractory HL who recently progressed on anti-PD1 therapy. Nivolumab is highly effective and well tolerated in rrHL, nevertheless CR-rates are low and a considerable proportion of patients suffers from progressive disease. Localized RT induces an immunogenic effect which might work synergistically and facilitate augmented systemic (i.e. abscopal) responses in combination with nivolumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Nivolumab 240 mg i.v. at 2-weekly intervals combined with 20Gy radiotherapy (RT) to a preferably progressive and not pre-irradiated single lesion. Nivolumab will be continued for a maximum of 18 months or until disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab plus radiotherapy | Other | Nivolumab 240 mg i.v. at 2-weekly intervals combined with 20Gy radiotherapy (RT) to a preferably progressive and not pre-irradiated single lesion. Nivolumab will be continued for a maximum of 18 months or until disease progression or unacceptable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Abscopal response rate (ARR-6) | Abscopal response rate (ARR-6) with abscopal response centrally confirmed as restaging result after RT to a single lesion and at least four but not more than six nivolumab infusions (RE-6 result) | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Engert, Prof. | University of Cologne, I. Dept. of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1st Department of Medicine, Cologne University Hospital | Cologne | Germany |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D013812 | Therapeutics |