Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This is a single center non-blinded randomized multi-cohort non-comparative phase II trial with a Simon's two-stage design.
In the first stage, 13 evaluable patients will be accrued per cohort. Evaluable is defined as: at least one administration of nivolumab and availability of paired biopsies for immunohistochemistry (for induction treatment cohorts pre-induction and pre-nivolumab biopsies).
If there are 1 or no responses observed in these 13 patients, the cohort will be stopped. Otherwise, 21 additional patients will be accrued for a total of 34.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Experimental | no induction treatment, nivolumab 240 mg flat-dose, every 2 weeks |
|
| Cisplatin induction | Experimental | Cisplatin 40mg/m2, weekly for two weeks, after 2 weeks followed by nivolumab 240 mg flat-dose, every 2 weeks |
|
| Low dose doxorubicin induction | Experimental | Low dose doxorubicin 15mg flat dose, weekly for 8 weeks, after 2 weeks followed by nivolumab 240 mg flat-dose, every 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug | 240 mg flat-dose, every 2 weeks. From 20 weeks onwards, nivolumab will be administered every 4 weeks with a flat-dose of 480 mg starting from week 20 onwards |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | Time from randomization to date of first tumor progression | assessed monthly until progression or date of death; median 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | complete response or partial response according to iRECIST and RECIST1.1 | assessed at week 6, 12 and 20 and every 8 weeks thereafter; assessed up to 120 months |
| Clinical benefit rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marleen Kok, MD | Contact | +3120 512 | 9111 | m.kok@nki.nl |
| Leonie Voorwerk, MD | Contact | +3120 512 | 9111 | l.voorwerk@nki.nl |
| Name | Affiliation | Role |
|---|---|---|
| Marleen Kok, MD | NKI-AvL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antoni van Leeuwenhoek | Recruiting | Amsterdam | 1066 CX | Netherlands |
Not provided
Patients are randomized between experimental cohorts and a control cohort.
Not provided
Not provided
Patients are randomized between experimental cohorts and a control cohort.
Not provided
| Cisplatin | Drug | 40mg/m2, weekly for two weeks |
|
| Low dose doxorubicin | Drug | 15mg flat dose, weekly for 8 weeks |
|
Beneficial response (complete response, partial response or stable disease) according to RECIST 1.1 and iRECIST
| assessed at week 6, 12 and 20 and every 8 weeks thereafter; assessed up to 120 months |
| Overall survival | time from nivolumab initiation to death from any cause | assessed monthly until date of death; median 12 months |
| Toxicity of all study regimens | adverse events will be graded according to NCI Common Toxicity Criteria v 5.0 | assessed until 100 days after of treatment end |
| Progression Free Survival after 6 cycles | the number of patients free of progression after 6 cycles of nivolumab | time from nivolumab initiation to tumor progression or death from any cause; assessed up to 120 months |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D002945 | Cisplatin |
| D004317 | Doxorubicin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
Not provided
Not provided