Recurrent Squamous Cell Carcinoma of HeadPhase 1NCT03198130
An Exploratory Tumor Biopsy-driven Study to Understand the Relationship Between Biomarkers and Clinical Response in Patients With Head and Neck Cancer Receiving REGN2810 (Anti-PD-1)
A Phase 1 study testing REGN2810 in people with Recurrent Squamous Cell Carcinoma of Head and Recurrent Squamous Cell Carcinoma of Neck, run by Regeneron Pharmaceuticals at 6 sites in 2 countries.
Trial summary
This study is being conducted to compare the relationship of patient response to treatment to changes in tumor microenvironment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Squamous Cell Carcinoma of Head, Recurrent Squamous Cell Carcinoma of Neck, Metastatic Squamous Cell Carcinoma of Head
- What is being tested?
- REGN2810
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 3 Jul 2017to 21 Feb 2020
- 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
- Histologically confirmed diagnosis of recurrent and/or metastatic SCCHN (squamous cell carcinoma of the head and neck) with no curative options with at least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and accessible for biopsies. Primary tumor sites of oral cavity, oropharynx, larynx, or hypopharynx are included.
- Have failed/are refractory to at least first line chemotherapy OR deemed unsuitable candidate for first line chemotherapy due to medical co-morbidities or patient preference
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- Adequate hepatic function
- Adequate renal function
- Adequate bone marrow function
- Provide signed informed consent
- Willing and able to comply with clinic visits and study-related procedures
Who cannot join
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse event (irAEs)
- Prior treatment with an agent that blocks the programmed death-1/programmed death-ligand 1 (PD-1/PD-L1) pathway
- Prior treatment with other immune modulating anti-cancer agents
- Untreated or active brain metastases or spinal cord compression
- Immunosuppressive corticosteroid doses within 4 weeks prior to the first dose of REGN2810
- Prior treatment with idelalisib
- Other protocol-defined inclusion/exclusion criteria will apply
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
South Korea3 sites
Seoul National University
Seoul, 03080
Yonsei University College of Medicine, Severence Hospital
Seoul, 03722
Samsung Medical Center
Seoul, 06351
United Kingdom3 sites
University Birmingham
Birmingham
Guy's and St. Thomas' NHS Foundation Trust
London
Royal Cancer Hospital
London
About this study
Official title: An Exploratory Tumor Biopsy-Driven Study to Understand the Relationship Between Biomarkers and Clinical Response in Immunomodulatory Treatment-Naïve Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of Head and Neck Receiving REGN2810 (Anti-PD-1)
This study is being conducted to compare the relationship of patient response to treatment to changes in tumor microenvironment.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN2810Drug
Also called cemiplimab, Libtayo
Intravenous (IV) use
| Study group | Role | What they receive |
|---|---|---|
| REGN2810 | Experimental | REGN2810 administered IV over a 30 minute infusion Receives: Drug: REGN2810 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between changes in the tumor microenvironment and the change in tumor volume following REGN2810 treatment versus baseline.
Measured: At baseline and during REGN2810 treatment up to week 24
Secondary outcomes (6)
Correlation between baseline tumor characteristics and the change in tumor volume following REGN2810 treatment
Measured: At baseline and during REGN2810 treatment up to week 24
Number of participants with treatment-related adverse events
Measured: Up to 54 weeks
Concentrations of REGN2810 in serum
Measured: Up to 54 weeks
Anti-REGN2810 antibody levels
Measured: Up to 54 weeks
The overall response rate (ORR) in patients treated with REGN2810
Measured: Up to 54 weeks
The progression-free survival (PFS) in patients treated with REGN2810
Measured: Up to 54 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start3 Jul 2017
- Primary completion27 Jun 2019
- Study completion21 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Squamous Cell Carcinoma of HeadStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198130
- Sponsor's protocol ID
- R2810-ONC-1655
- Other IDs
- 2016-004029-18, 2016
- Status last verified
- Mar 2020
- First submitted
- 19 Jun 2017
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Tumor Biopsy-Driven Study to Understand the Relationship Between Biomarkers and Clinical Response in Immunomodulatory Treatment-Naïve Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of Head and Neck Receiving REGN2810 (Anti-PD-1)
- ClinicalTrials.gov ID
- NCT03198130
- Acronym / sponsor ID
- R2810-ONC-1655
- Conditions
- Recurrent Squamous Cell Carcinoma of Head, Recurrent Squamous Cell Carcinoma of Neck, Metastatic Squamous Cell Carcinoma of Head, Metastatic Squamous Cell Carcinoma Neck
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- 3 Jul 2017 (actual)
- Primary completion
- 27 Jun 2019 (actual)
- Study completion
- 21 Feb 2020 (actual)
- First posted
- 23 Jun 2017 (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 study is being conducted to compare the relationship of patient response to treatment to changes in tumor microenvironment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| REGN2810 | Experimental | Drug: REGN2810REGN2810 administered IV over a 30 minute infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed diagnosis of recurrent and/or metastatic SCCHN (squamous cell carcinoma of the head and neck) with no curative options with at least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and accessible for biopsies. Primary tumor sites of oral cavity, oropharynx, larynx, or hypopharynx are included.
- Have failed/are refractory to at least first line chemotherapy OR deemed unsuitable candidate for first line chemotherapy due to medical co-morbidities or patient preference
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- Adequate hepatic function
- Adequate renal function
Key exclusion criteria (7 listed)
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse event (irAEs)
- Prior treatment with an agent that blocks the programmed death-1/programmed death-ligand 1 (PD-1/PD-L1) pathway
- Prior treatment with other immune modulating anti-cancer agents
- Untreated or active brain metastases or spinal cord compression
- Immunosuppressive corticosteroid doses within 4 weeks prior to the first dose of REGN2810
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 |
|---|---|---|
| REGN2810Also: cemiplimab, LibtayoIntravenous (IV) use | Drug | REGN2810 |
Primary outcome
Correlation between changes in the tumor microenvironment and the change in tumor volume following REGN2810 treatment versus baseline.
Time frame: At baseline and during REGN2810 treatment up to week 24
6 secondary outcomes
Correlation between baseline tumor characteristics and the change in tumor volume following REGN2810 treatment
Time frame: At baseline and during REGN2810 treatment up to week 24
Number of participants with treatment-related adverse events
Time frame: Up to 54 weeks
Concentrations of REGN2810 in serum
Time frame: Up to 54 weeks
Anti-REGN2810 antibody levels
Time frame: Up to 54 weeks
The overall response rate (ORR) in patients treated with REGN2810
Time frame: Up to 54 weeks
The progression-free survival (PFS) in patients treated with REGN2810
Time frame: Up to 54 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
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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.
Clinical Trial Management study director
Regeneron Pharmaceuticals
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing REGN2810 in people with Recurrent Squamous Cell Carcinoma of Head and Recurrent Squamous Cell Carcinoma of Neck, run by Regeneron Pharmaceuticals at 6 sites in 2 countries.
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 8 inclusion and 7 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: finished, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea, United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation between changes in the tumor microenvironment and the change in tumor volume following REGN2810 treatment versus baseline. (time frame: At baseline and during REGN2810 treatment up to week 24). 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 19 Mar 2020.