Squamous Cell Carcinoma of the Head and NeckPhase 1NCT02124850
A Phase Ib Study of Neoadjuvant of Cetuximab Plus Motolimod and Cetuximab Plus Motolimod Plus Nivolumab
A Phase 1 study testing Motolimod, Cetuximab and Nivolumab in people with Squamous Cell Carcinoma of the Head and Neck, run by Celgene at 1 site in United States.
Trial summary
Protocol VRXP-A106 will enroll patients with Stage II-IVA head and neck cancer patients who will be treated with surgical resection. Cetuximab and motolimod (Cohort 1); and cetuximab, motolimod, and nivolumab (Cohort 2) will be administered for a 3-4 week period before surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Head and Neck
- What is being tested?
- Motolimod, Cetuximab and Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2014to 31 Oct 2016
- 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
- Previously untreated stage II, III, or IVA histologically or cytologically confirmed squamous cell carcinoma of the head and neck
- Primary tumors of the oral cavity, oropharynx, hypopharynx, or larynx
- Macroscopic complete resection of the primary tumor must be planned
- Age ≥ 18 years
- ECOG performance status 0-1
- Adequate hematologic, renal and hepatic function
- Have signed written informed consent
Who cannot join
- Subjects who fail to meet inclusion criteria
- Primary tumors of the sinuses, paranasal sinuses, or nasopharynx, or unknown primary tumors
- Prior severe infusion reaction to a monoclonal antibody
- Pregnancy or breastfeeding
- Evidence of distant metastasis
- Any other malignancy active within 5 years except for non-melanoma skin cancer or carcinoma in situ of the cervix, DCIS or LCIS of the breast
Show all 18Show fewer
- Prior history of head and neck cancer
- Prior therapy with motolimod, nivolumab, or other agents targeting PD-1/PD-L1
- Prior therapy targeting the EGFR pathway
- Acute hepatitis, known HIV, or active uncontrolled infection
- Patients with active autoimmune disease
- History of uncontrolled cardiac disease within prior 6 months
- Uncontrolled peptic or gastric ulcer disease, or gastrointestinal bleeding within prior 6 months
- Active alcohol abuse or other illness or circumstance that carries a likelihood of inability to comply with study treatment and follow-up or otherwise compromise the study's objectives
- Treatment with a non-approved or investigational drug within 30 days prior to Day 1 of study treatment
- Live vaccine within 30 days of planned start of study therapy
- History of pneumonitis or interstitial lung disease
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
About this study
Official title: A Phase Ib Study of Neoadjuvant Immune Biomarker Modulation With Cetuximab Plus Motolimod and With Cetuximab Plus Motolimod Plus Nivolumab
Protocol VRXP-A106 will enroll patients with Stage II-IVA head and neck cancer patients who will be treated with surgical resection. Cetuximab and motolimod (Cohort 1); and cetuximab, motolimod, and nivolumab (Cohort 2) will be administered for a 3-4 week period before surgery. The primary objective of the study is to determine the extent to which the administration of neoadjuvant motolimod plus cetuximab and motolimod plus cetuximab and nivolumab modulates immune biomarkers (NK, mDC and T cell activation as well as tumor infiltration and serum cytokines) in peripheral blood and head and neck cancer tumors. An exploratory objective of the study is to assess whether modulation of biomarkers as described above can predict anti-tumor response.
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Motolimod plus cetuximab | Experimental | Cohort 1: motolimod plus cetuximab Receives: Drug: Motolimod; Drug: Cetuximab |
| Motolimod, cetuximab, and nivolumab | Experimental | Cohort 2: motolimod, cetuximab, and nivolumab Receives: Drug: Motolimod; Drug: Cetuximab; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in immune biomarkers including FcγR genotype, NK activation, tumor infiltration and serum cytokines, mDC, T cell activation, and tumor-antigen specific cytotoxic T lymphocyte induction.
Measured: change from baseline to up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study start28 Oct 2014
- Primary completion11 Aug 2016
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Squamous Cell Carcinoma of the Head and NeckStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amar Patel, MD, Study director, Celgene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02124850
- Sponsor's protocol ID
- VRXP-A106
- Status last verified
- Oct 2019
- First submitted
- 22 Apr 2014
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
https://clincancerres.aacrjournals.org/content/clincanres/early/2017/11/28/1078-0432.CCR-17-0357.full.pdf
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study of Neoadjuvant Immune Biomarker Modulation With Cetuximab Plus Motolimod and With Cetuximab Plus Motolimod Plus Nivolumab
- ClinicalTrials.gov ID
- NCT02124850
- Acronym / sponsor ID
- VRXP-A106
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 18 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2014 (actual)
- Primary completion
- 11 Aug 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 28 Apr 2014 (estimated)
- 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.
Protocol VRXP-A106 will enroll patients with Stage II-IVA head and neck cancer patients who will be treated with surgical resection. Cetuximab and motolimod (Cohort 1); and cetuximab, motolimod, and nivolumab (Cohort 2) will be administered for a 3-4 week period before surgery. The primary objective of the study is to determine the extent to which the administration of neoadjuvant motolimod plus cetuximab and motolimod plus cetuximab and nivolumab modulates immune biomarkers (NK, mDC and T cell activation as well as tumor infiltration and serum cytokines) in peripheral blood and head and neck cancer tumors. An exploratory objective of the study is to assess whether modulation of biomarkers as described above can predict anti-tumor response.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motolimod plus cetuximab | Experimental | Drug: Motolimod, Drug: CetuximabCohort 1: motolimod plus cetuximab |
| Motolimod, cetuximab, and nivolumab | Experimental | Drug: Motolimod, Drug: Cetuximab, Drug: NivolumabCohort 2: motolimod, cetuximab, and nivolumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Previously untreated stage II, III, or IVA histologically or cytologically confirmed squamous cell carcinoma of the head and neck
- Primary tumors of the oral cavity, oropharynx, hypopharynx, or larynx
- Macroscopic complete resection of the primary tumor must be planned
- Age ≥ 18 years
- ECOG performance status 0-1
Key exclusion criteria (18 listed)
- Subjects who fail to meet inclusion criteria
- Primary tumors of the sinuses, paranasal sinuses, or nasopharynx, or unknown primary tumors
- Prior severe infusion reaction to a monoclonal antibody
- Pregnancy or breastfeeding
- Evidence of distant metastasis
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 |
|---|---|---|
| MotolimodAlso: VTX-2337 | Drug | Motolimod plus cetuximab, Motolimod, cetuximab, and nivolumab |
| CetuximabAlso: Erbitux | Drug | Motolimod plus cetuximab, Motolimod, cetuximab, and nivolumab |
| NivolumabAlso: Opdivo | Drug | Motolimod, cetuximab, and nivolumab |
Primary outcome
The change in immune biomarkers including FcγR genotype, NK activation, tumor infiltration and serum cytokines, mDC, T cell activation, and tumor-antigen specific cytotoxic T lymphocyte induction.
Time frame: change from baseline to up to 4 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
- Results publicationhttps://clincancerres.aacrjournals.org/content/clincanres/early/2017/11/28/1078-0432.CCR-17-0357.full.pdf
Related trials for Squamous Cell Carcinoma of the Head and Neck
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
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
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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.
Amar Patel, MD study director
Celgene
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Motolimod, Cetuximab and Nivolumab in people with Squamous Cell Carcinoma of the Head and Neck, run by Celgene at 1 site 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 7 inclusion and 18 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 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The change in immune biomarkers including FcγR genotype, NK activation, tumor infiltration and serum cytokines, mDC, T cell activation, and tumor-antigen specific cytotoxic T lymphocyte induction. (time frame: change from baseline to up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02124850, which also lists 1 linked publication.
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 25 Oct 2019.