Squamous Cell Carcinoma of Head and NeckPhase 1NCT04465487
Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies
A Phase 1 study testing REGN6569 and Cemiplimab in people with Squamous Cell Carcinoma of Head and Neck, run by Regeneron Pharmaceuticals at 10 sites in 2 countries.
Trial summary
There are two main goals of this study: The first is to find the highest safe dose of REGN6569 when given with cemiplimab. The second is to get some initial information about how well the REGN6569 in combination with cemiplimab may help shrink certain types of cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- REGN6569 and Cemiplimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 5 Oct 2020to 7 Feb 2025
- 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
- Dose escalation cohorts: Advanced stage (unresectable or metastatic) solid tumor malignancy, confirmed histologically or cytologically as defined in the protocol
- Dose expansion cohorts: Advanced stage (unresectable or metastatic) head and neck squamous cell carcinoma (HNSCC), confirmed histologically or cytologically. Patients must have evidence of progression on anti-Programmed death-1 (receptor)/Programmed death ligand 1 (PD-1/PD-L1) blockade either as monotherapy or in combination with other therapies, as defined in the protocol
- Mandatory biopsies: Able and willing to provide tumor tissue at baseline and while on treatment, with at least 1 soft tissue lesion amenable to biopsy by ultrasound or computed tomography (CT)-guided biopsy or under direct visualization as defined in the protocol
Who cannot join
- Has previously received GITR-targeted therapy
- Has received any previous systemic biologic therapy within 5 half-lives of first dose of study therapy as defined in the protocol
- Has any condition that requires ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 14 days prior to the first dose of study therapy
- Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments as defined in the protocol
- Has a known history of, or any evidence of, interstitial lung disease, or active, non-infectious pneumonitis in the past 5 years. A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved ≥6 months prior to first dose of study therapy
- Has uncontrolled infection with human immunodeficiency virus, hepatitis B or hepatitis C infection, or diagnosis of immunodeficiency
Show all 10Show fewer
- Has received a live vaccine within 4 weeks of planned start of study medication. For dose escalation only: Has received a COVID-19 vaccination within 1 week of planned start of study medication or for which the planned COVID-19 vaccinations would not be completed 1 week prior to start of study.
- Has had prior allogeneic stem cell transplantation or received organ transplants at any time, or autologous stem cell transplantation
- Has a history of malignancy within 2 years of date of first planned dose on study as defined in the protocol
- Note: Other protocol-defined Inclusion/ Exclusion criteria apply
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Spain6 sites
Hospital Universitario Vall d'Hebrón
Barcelona, 08035
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona, 08908
MD Anderson Cancer Center
Madrid, 28033
Hospital Universitario Ramon y Cajal
Madrid, 28034
Hospital Universitario Fundacion Jimenez
Madrid, 28040
Hospital Universitario HM Sanchinarro
Madrid, 28050
United States4 sites
University of Michigan
Ann Arbor, Michigan, 48109
START South Texas Accelerated Research Therapeutics
Grand Rapids, Michigan, 49503
Angeles Clinic and Research Institute - Clinic/Outpatient Facility
Los Angeles, California, 90025
H.Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: A Phase 1 Study of REGN6569, an Anti-GITR mAb, With Cemiplimab in Patients With Advanced Solid Tumor Malignancies
There are two main goals of this study: The first is to find the highest safe dose of REGN6569 when given with cemiplimab. The second is to get some initial information about how well the REGN6569 in combination with cemiplimab may help shrink certain types of cancer.
The study is also looking at:
- Side effects that may be experienced by people taking REGN6569 alone and with cemiplimab
- How REGN6569 and cemiplimab work in the body
- How much REGN6569 and cemiplimab is in your blood
- To see if REGN6569 can lower the number of Treg cells in tumors
- To see if REGN6569 and cemiplimab can shrink tumors when given together
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Being tested
- REGN6569, Cemiplimab
- Keywords
- Unselected solid tumors dose escalation, HNSCC dose expansion, Advanced stage solid tumor malignancy, Unresectable, Metastatic
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN6569Drug
Administered by intravenous (IV) infusion
CemiplimabDrug
Also called REGN2810, Libtayo
Administered by IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | REGN6569 lead-in, then combo therapy Receives: Drug: REGN6569; Drug: Cemiplimab |
| Dose Expansion | Experimental | Randomized 1:1 between cohorts Cohort 1: Concurrent start of REGN6569 + cemiplimab Cohort 2: REGN6569 lead-in, then combo therapy Receives: Drug: REGN6569; Drug: Cemiplimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limited toxicities (DLTs)
Dose escalation period
Measured: Up to 42 days
Incidence and severity of treatment emergent adverse events(TEAEs)
Dose escalation period
Measured: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Incidence and severity of adverse events of special interest (AESIs)
Dose escalation period
Measured: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Incidence and severity of serious adverse events (SAEs)
Dose escalation period
Measured: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Incidence and severity of grade ≥3 laboratory abnormalities
Dose escalation period
Measured: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Objective response rate (ORR)
Dose expansion period
Measured: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Characterize percentage change in intratumoral glucocorticoid-induced tumor necrosis factor receptor-Related (GITR)+ Treg density
Dose expansion period
Measured: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Secondary outcomes (9)
ORR
Dose escalation period
Measured: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Disease control rate (DCR)
Dose escalation and expansion periods
Measured: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Duration of Response (DOR)
Dose escalation and expansion periods
Measured: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Progression-free Survival (PFS)
Dose escalation and expansion periods
Measured: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Overall survival (OS)
Dose escalation and expansion periods
Measured: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Drug concentrations of REGN6569 in serum
Dose escalation and expansion periods
Measured: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Drug concentrations of cemiplimab in serum
Dose escalation and expansion periods
Measured: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Immunogenicity as measured by anti-drug antibodies (ADA) to REGN6569
Dose escalation and expansion periods
Measured: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Immunogenicity as measured by anti-drug antibodies (ADA) to cemiplimab
Dose escalation and expansion periods
Measured: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start5 Oct 2020
- Primary completion7 Feb 2025
- Study completion7 Feb 2025
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of Head and NeckStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465487
- Sponsor's protocol ID
- R6569-ONC-1933
- Other IDs
- 2020-000075-20
- Status last verified
- Feb 2025
- First submitted
- 7 Jul 2020
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of REGN6569, an Anti-GITR mAb, With Cemiplimab in Patients With Advanced Solid Tumor Malignancies
- ClinicalTrials.gov ID
- NCT04465487
- Acronym / sponsor ID
- R6569-ONC-1933
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Keywords
- Unselected solid tumors dose escalation, HNSCC dose expansion, Advanced stage solid tumor malignancy, Unresectable, Metastatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 7 Feb 2025 (actual)
- Study completion
- 7 Feb 2025 (actual)
- First posted
- 10 Jul 2020 (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.
There are two main goals of this study: The first is to find the highest safe dose of REGN6569 when given with cemiplimab. The second is to get some initial information about how well the REGN6569 in combination with cemiplimab may help shrink certain types of cancer.
The study is also looking at:
- Side effects that may be experienced by people taking REGN6569 alone and with cemiplimab
- How REGN6569 and cemiplimab work in the body
- How much REGN6569 and cemiplimab is in your blood
- To see if REGN6569 can lower the number of Treg cells in tumors
- To see if REGN6569 and cemiplimab can shrink tumors when given together
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: REGN6569, Drug: CemiplimabREGN6569 lead-in, then combo therapy |
| Dose Expansion | Experimental | Drug: REGN6569, Drug: CemiplimabRandomized 1:1 between cohorts Cohort 1: Concurrent start of REGN6569 + cemiplimab Cohort 2: REGN6569 lead-in, then combo therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Dose escalation cohorts: Advanced stage (unresectable or metastatic) solid tumor malignancy, confirmed histologically or cytologically as defined in the protocol
- Dose expansion cohorts: Advanced stage (unresectable or metastatic) head and neck squamous cell carcinoma (HNSCC), confirmed histologically or cytologically. Patients must have evidence of progression on anti-Programmed death-1 (receptor)/Programmed death ligand 1 (PD-1/PD-L1) blockade either as monotherapy or in combination with other therapies, as defined in the protocol
- Mandatory biopsies: Able and willing to provide tumor tissue at baseline and while on treatment, with at least 1 soft tissue lesion amenable to biopsy by ultrasound or computed tomography (CT)-guided biopsy or under direct visualization as defined in the protocol
Key exclusion criteria (10 listed)
- Has previously received GITR-targeted therapy
- Has received any previous systemic biologic therapy within 5 half-lives of first dose of study therapy as defined in the protocol
- Has any condition that requires ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 14 days prior to the first dose of study therapy
- Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments as defined in the protocol
- Has a known history of, or any evidence of, interstitial lung disease, or active, non-infectious pneumonitis in the past 5 years. A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved ≥6 months prior to first dose of study therapy
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 |
|---|---|---|
| REGN6569Administered by intravenous (IV) infusion | Drug | Dose Escalation, Dose Expansion |
| CemiplimabAlso: REGN2810, LibtayoAdministered by IV infusion | Drug | Dose Escalation, Dose Expansion |
Primary outcome
Incidence of dose-limited toxicities (DLTs)
Time frame: Up to 42 days
Dose escalation period
Incidence and severity of treatment emergent adverse events(TEAEs)
Time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Dose escalation period
Incidence and severity of adverse events of special interest (AESIs)
Time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Dose escalation period
Incidence and severity of serious adverse events (SAEs)
Time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Dose escalation period
Incidence and severity of grade ≥3 laboratory abnormalities
Time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Dose escalation period
Objective response rate (ORR)
Time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Dose expansion period
Characterize percentage change in intratumoral glucocorticoid-induced tumor necrosis factor receptor-Related (GITR)+ Treg density
Time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Dose expansion period
9 secondary outcomes
ORR
Time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Disease control rate (DCR)
Time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Duration of Response (DOR)
Time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Progression-free Survival (PFS)
Time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Overall survival (OS)
Time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Drug concentrations of REGN6569 in serum
Time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Drug concentrations of cemiplimab in serum
Time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Immunogenicity as measured by anti-drug antibodies (ADA) to REGN6569
Time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Immunogenicity as measured by anti-drug antibodies (ADA) to cemiplimab
Time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
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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
10 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 REGN6569 and Cemiplimab in people with Squamous Cell Carcinoma of Head and Neck, run by Regeneron Pharmaceuticals at 10 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 3 inclusion and 10 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 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain, 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: Sponsor Decision). 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?
Incidence of dose-limited toxicities (DLTs) (time frame: Up to 42 days). The study lists 7 primary outcomes in all. 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 2025.