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This study is an interventional, explorative, prospective study to show whether shortening of infusion times for patients using nivolumab, pembrolizumab, ipilimumab, trastuzumab, bevacizumab, durvalumab or atezolizumab continues to be associated with an acceptable safety profile.
Infusion times will be gradually shortened if tolerability allowes.
After two cycles with normal infusion times, infusion time will be shortened to 15 mintues en 10 minutes subsequently if no infusion reaction occurs.
Patient satisfaction will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nivolumab | Experimental | If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles. |
|
| Pembrolizumab | Experimental | If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles. |
|
| ipilimumab | Experimental | If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles. |
|
| Durvalumab | Experimental | If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles. |
|
| Atezolizumab | Experimental | If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug | Gradual shortening of infusion times |
| |
| Pembrolizumab |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of infusion related reactions | During or within 30 minutes after the end of the infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma levels of the administered mAb | Within 15 minutes before start of the infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction with shortened infusion time assessed by the VAS | Scale 1-10, 1: not satisfied at all, 10: most satisfied | Directly after infusion in fourth cycle (cycle length ranges from 21-42 days, depending on the specific antibody) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elianne CS de Boer | Contact | +31886245000 | polioncologie@isala.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Isala Hospital | Recruiting | Zwolle | 8025AB | Netherlands |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| C582435 | pembrolizumab |
| D000074324 | Ipilimumab |
| C000613593 | durvalumab |
| C000594389 | atezolizumab |
| D000068258 | Bevacizumab |
| D000068878 | Trastuzumab |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| bevacizumab |
| Experimental |
If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles. |
|
| Trastuzumab | Experimental | If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles. |
|
| Rituximab | Experimental | If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 15 minutes in the following cycles. |
|
| Drug |
Gradual shortening of infusion times |
|
| Ipilimumab | Drug | Gradual shortening of infusion times |
|
| Durvalumab | Drug | Gradual shortening of infusion times |
|
| Atezolizumab | Drug | Gradual shortening of infusion times |
|
| Bevacizumab | Drug | Gradual shortening of infusion times |
|
| Trastuzumab | Drug | Gradual shortening of infusion times |
|
| Rituximab | Drug | Gradual shortening of infusion times |
|
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D058846 | Antibodies, Monoclonal, Murine-Derived |