Carcinoma, Squamous CellPhase 1NCT03906526
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
A Phase 1 study testing VTX-2337 and Nivolumab in people with Carcinoma, Squamous Cell, run by Celgene at 12 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Squamous Cell
- What is being tested?
- VTX-2337 and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 12 sitesUnited States
- Study dates
- 3 Jul 2019to 24 Jan 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Local Institution - 112
Birmingham, Alabama, 35294-3300
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300
Boston University
Boston, Massachusetts, 02215
Local Institution - 116
Boston, Massachusetts, 02215
University of Cincinnati
Cincinnati, Ohio, 45267-0501
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Local Institution - 101
Pittsburgh, Pennsylvania, 15232
University of Pittsburgh Medical Center Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Local Institution - 103
Sioux Falls, South Dakota, 57104-8805
Sanford Cancer Center
Sioux Falls, South Dakota, 57104-8805
Local Institution - 102
St Louis, Missouri, 63110
Washington University
St Louis, Missouri, 63110
About this study
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)
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.
- Conditions
- Carcinoma, Squamous Cell
- Being tested
- VTX-2337, Nivolumab
- Keywords
- Motolimod, Nivolumab, Head and Neck Cancer, Squamous Cell Carcinoma, Checkpoint inhibitor, anti-PD1 inhibitor, TLR 8 agonist
- Medical subject headings
- Carcinoma, Squamous Cell, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VTX-2337Drug
Also called VTX-378
Motolimod
NivolumabDrug
Also called Opdivo
IV Nivolumab
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy Arm 1: Nivolumab | Experimental | Nivolumab IV every 2 weeks Receives: Drug: Nivolumab |
| Monotherapy Arm 2: Motolimod | Experimental | Motolimod IT injection weekly Receives: Drug: VTX-2337 |
| Combination Arm 3: Nivolumab and Motolimod | Experimental | Nivolumab IV every 2 weeks and Motolimod IT injection weekly Receives: Drug: VTX-2337; Drug: Nivolumab |
| Combination Arm 4: Nivolumab and Motolimod | Experimental | Nivolumab IV every 2 weeks and Motolimod SC injection weekly Receives: Drug: VTX-2337; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Screening through Study Day 52
Secondary outcomes (2)
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.
Measured: Screening through Study Day 52
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.
Measured: Up to approximately 112 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start3 Jul 2019
- Primary completion24 Jan 2022
- Study completion24 Jan 2022
Why it stopped: Business objectives have changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Squamous CellStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906526
- Sponsor's protocol ID
- VTX-2337-HN-001
- Other IDs
- U1111-1223-3488
- Status last verified
- Feb 2023
- First submitted
- 5 Dec 2018
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03906526
- Acronym / sponsor ID
- VTX-2337-HN-001
- Conditions
- Carcinoma, Squamous Cell
- Keywords
- Motolimod, Nivolumab, Head and Neck Cancer, Squamous Cell Carcinoma, Checkpoint inhibitor, anti-PD1 inhibitor, TLR 8 agonist
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business objectives have changed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 24 Jan 2022 (actual)
- Study completion
- 24 Jan 2022 (actual)
- First posted
- 8 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Monotherapy Arm 1: Nivolumab | Experimental | Drug: NivolumabNivolumab IV every 2 weeks |
| Monotherapy Arm 2: Motolimod | Experimental | Drug: VTX-2337Motolimod IT injection weekly |
| Combination Arm 3: Nivolumab and Motolimod | Experimental | Drug: VTX-2337, Drug: NivolumabNivolumab IV every 2 weeks and Motolimod IT injection weekly |
| Combination Arm 4: Nivolumab and Motolimod | Experimental | Drug: VTX-2337, Drug: NivolumabNivolumab IV every 2 weeks and Motolimod SC injection weekly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VTX-2337Also: VTX-378Motolimod | Drug | Combination Arm 3: Nivolumab and Motolimod, Combination Arm 4: Nivolumab and Motolimod, Monotherapy Arm 2: Motolimod |
| NivolumabAlso: OpdivoIV Nivolumab | Drug | Combination Arm 3: Nivolumab and Motolimod, Combination Arm 4: Nivolumab and Motolimod, Monotherapy Arm 1: Nivolumab |
Primary outcome
Numbers of CD8+ T cells within the tumor pre-treatment and post-surgery
Time frame: Screening through Study Day 52
Tumor immune modulation will be evaluated by counting the number of tumor infiltration CD8+ T cells before and after treatment.
2 secondary outcomes
Number of Patients With adverse events that lead to delay in resection
Time frame: Screening through Study Day 52
Evaluation of safety and tolerability of nivolumab, motolimod and the combination of nivolumab with motolimod
Time frame: Up to approximately 112 days
Results and safety
The study was stopped early (reason given: Business objectives have changed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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/
Related trials for Carcinoma, Squamous Cell
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Active, not recruitingPhase 1
Triapine With Chemotherapy and Radiation Therapy in Treating Patients With IB2-IVA Cervical or Vaginal Cancer
Advanced Cervical Adenocarcinoma, Advanced Cervical Adenosquamous Carcinoma
RecruitingPhase 1
Study of XB010 in Subjects With Solid Tumors
Locally Advanced or Metastatic Solid Tumors, Esophageal Squamous Cell Cancer
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VTX-2337 and Nivolumab in people with Carcinoma, Squamous Cell, run by Celgene at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business objectives have changed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of CD8+ T cells within the tumor pre-treatment and post-surgery (time frame: Screening through Study Day 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.