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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1223-3488 | Registry Identifier | WHO |
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This is an open label, Phase 1b pre-operative window of opportunity biomarker trial to analyze the combination of intravenous (IV) anti-PD-1 inhibitor, nivolumab, given along with toll-like receptor 8 (TLR 8) agonist motolimod delivered either subcutaneously (SC) or by intratumoral injection (IT) in subjects with squamous cell carcinoma of the head and neck (SCCHN). Subjects with previously untreated, resectable SCCHN, will be recruited onto this trial and will initially undergo pre-treatment diagnostic imaging and biological sample collection. These subjects will undergo pre-operative study treatment for a 3 to 4-week period prior to a scheduled surgical resection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monotherapy Arm 1: Nivolumab | Experimental | Nivolumab IV every 2 weeks |
|
| Monotherapy Arm 2: Motolimod | Experimental | Motolimod IT injection weekly |
|
| Combination Arm 3: Nivolumab and Motolimod | Experimental | Nivolumab IV every 2 weeks and Motolimod IT injection weekly |
|
| Combination Arm 4: Nivolumab and Motolimod | Experimental | Nivolumab IV every 2 weeks and Motolimod SC injection weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VTX-2337 | Drug | Motolimod |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numbers of CD8+ T cells within the tumor pre-treatment and post-surgery | Tumor immune modulation will be evaluated by counting the number of tumor infiltration CD8+ T cells before and after treatment. | Screening through Study Day 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With adverse events that lead to delay in resection | Study will evaluate the number of patients who experience adverse events that lead to a significant delay in surgical resection. | Screening through Study Day 52 |
| Evaluation of safety and tolerability of nivolumab, motolimod and the combination of nivolumab with motolimod |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 112 | Birmingham | Alabama | 35294-3300 | United States | ||
| University of Alabama at Birmingham |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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Information relating to our policy on data sharing and the process for requesting data can be found at the following link:
https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
See Plan Description
See Plan Description
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|
| Nivolumab | Drug | IV Nivolumab |
|
|
Subject will be monitored for AEs both during treatment and for a specified period after last dose of study treatment. AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. |
| Up to approximately 112 days |
| Birmingham |
| Alabama |
| 35294-3300 |
| United States |
| Boston University | Boston | Massachusetts | 02215 | United States |
| Local Institution - 116 | Boston | Massachusetts | 02215 | United States |
| Local Institution - 102 | St Louis | Missouri | 63110 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267-0501 | United States |
| The Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| Local Institution - 101 | Pittsburgh | Pennsylvania | 15232 | United States |
| University of Pittsburgh Medical Center Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Local Institution - 103 | Sioux Falls | South Dakota | 57104-8805 | United States |
| Sanford Cancer Center | Sioux Falls | South Dakota | 57104-8805 | United States |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C573973 | VTX-2337 |
| D000077594 | Nivolumab |
| 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 |
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