Back to resultsA Study to Evaluate Immune Biomarker Modulation in Response to VTX-2337 in Combination With an Anti- PD-1 Inhibitor in Head and Neck Cancer
Primary Purpose
Carcinoma, Squamous Cell
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
VTX-2337
Nivolumab
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Squamous Cell focused on measuring Motolimod, Nivolumab, Head and Neck Cancer, Squamous Cell Carcinoma, Checkpoint inhibitor, anti-PD1 inhibitor, TLR 8 agonist
Eligibility Criteria
Inclusion Criteria:
- Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
- Subject has Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
- Subject has a new clinical or pathologic diagnosis of resectable HPV+ or HPV- SCCHN of the oral cavity, pharynx, or larynx
- Macroscopic complete resection of the primary tumor must be planned and subjects should have no medical contraindication to surgery.
- Subject consents to and has tumor accessible for tumor biopsy pre-treatment.
- Subjects must have acceptable hematopoietic, liver, renal, and coagulation function as assessed by laboratory tests.
Exclusion Criteria:
- Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
- Subject has unresectable or inoperable tumors
- Subject has primary tumors of the sinuses, paranasal sinuses, or nasopharynx, or unknown primary tumors
- Subject has evidence of distant metastasis
- Subject is a pregnant or nursing female.
- Subject has active or uncontrolled infection including known HIV infection or known chronic hepatitis B or C.
- Subject has active autoimmune disease.
- Subject has clinically significant ophthalmologic disease.
Sites / Locations
- Local Institution - 112
- University of Alabama at Birmingham
- Boston University
- Local Institution - 116
- Local Institution - 102
- Washington University
- University of Cincinnati
- The Ohio State University Comprehensive Cancer Center
- Local Institution - 101
- University of Pittsburgh Medical Center Hillman Cancer Center
- Local Institution - 103
- Sanford Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Monotherapy Arm 1: Nivolumab
Monotherapy Arm 2: Motolimod
Combination Arm 3: Nivolumab and Motolimod
Combination Arm 4: Nivolumab and Motolimod
Arm Description
Nivolumab IV every 2 weeks
Motolimod IT injection weekly
Nivolumab IV every 2 weeks and Motolimod IT injection weekly
Nivolumab IV every 2 weeks and Motolimod SC injection weekly
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Evaluation of safety and tolerability of nivolumab, motolimod and the combination of nivolumab with motolimod
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03906526
Brief Title
A Study to Evaluate Immune Biomarker Modulation in Response to VTX-2337 in Combination With an Anti- PD-1 Inhibitor in Head and Neck Cancer
Official Title
A Phase 1b Multicenter Pre-Surgical Study to Evaluate Immune Biomarker Modulation in Response to Motolimod (VTX-2337) in Combination With Nivolumab in Subjects With Resectable Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
Business objectives have changed
Study Start Date
July 3, 2019 (Actual)
Primary Completion Date
January 24, 2022 (Actual)
Study Completion Date
January 24, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Squamous Cell
Keywords
Motolimod, Nivolumab, Head and Neck Cancer, Squamous Cell Carcinoma, Checkpoint inhibitor, anti-PD1 inhibitor, TLR 8 agonist
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Monotherapy Arm 1: Nivolumab
Arm Type
Experimental
Arm Description
Nivolumab IV every 2 weeks
Arm Title
Monotherapy Arm 2: Motolimod
Arm Type
Experimental
Arm Description
Motolimod IT injection weekly
Arm Title
Combination Arm 3: Nivolumab and Motolimod
Arm Type
Experimental
Arm Description
Nivolumab IV every 2 weeks and Motolimod IT injection weekly
Arm Title
Combination Arm 4: Nivolumab and Motolimod
Arm Type
Experimental
Arm Description
Nivolumab IV every 2 weeks and Motolimod SC injection weekly
Intervention Type
Drug
Intervention Name(s)
VTX-2337
Other Intervention Name(s)
VTX-378
Intervention Description
Motolimod
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo
Intervention Description
IV Nivolumab
Primary Outcome Measure Information:
Title
Numbers of CD8+ T cells within the tumor pre-treatment and post-surgery
Description
Tumor immune modulation will be evaluated by counting the number of tumor infiltration CD8+ T cells before and after treatment.
Time Frame
Screening through Study Day 52
Secondary Outcome Measure Information:
Title
Number of Patients With adverse events that lead to delay in resection
Description
Study will evaluate the number of patients who experience adverse events that lead to a significant delay in surgical resection.
Time Frame
Screening through Study Day 52
Title
Evaluation of safety and tolerability of nivolumab, motolimod and the combination of nivolumab with motolimod
Description
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.
Time Frame
Up to approximately 112 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
Subject has Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
Subject has a new clinical or pathologic diagnosis of resectable HPV+ or HPV- SCCHN of the oral cavity, pharynx, or larynx
Macroscopic complete resection of the primary tumor must be planned and subjects should have no medical contraindication to surgery.
Subject consents to and has tumor accessible for tumor biopsy pre-treatment.
Subjects must have acceptable hematopoietic, liver, renal, and coagulation function as assessed by laboratory tests.
Exclusion Criteria:
Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
Subject has unresectable or inoperable tumors
Subject has primary tumors of the sinuses, paranasal sinuses, or nasopharynx, or unknown primary tumors
Subject has evidence of distant metastasis
Subject is a pregnant or nursing female.
Subject has active or uncontrolled infection including known HIV infection or known chronic hepatitis B or C.
Subject has active autoimmune disease.
Subject has clinically significant ophthalmologic disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 112
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Local Institution - 116
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Local Institution - 102
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0501
Country
United States
Facility Name
The Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Local Institution - 101
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
University of Pittsburgh Medical Center Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Local Institution - 103
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104-8805
Country
United States
Facility Name
Sanford Cancer Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104-8805
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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/
IPD Sharing Time Frame
See Plan Description
IPD Sharing Access Criteria
See Plan Description
IPD Sharing URL
https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
Learn more about this trial
A Study to Evaluate Immune Biomarker Modulation in Response to VTX-2337 in Combination With an Anti- PD-1 Inhibitor in Head and Neck Cancer
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