- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04465487
Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies
January 22, 2024 updated by: Regeneron Pharmaceuticals
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
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
85
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Clinical Trials Administrator
- Phone Number: 844-734-6643
- Email: clinicaltrials@regeneron.com
Study Locations
-
-
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Barcelona, Spain, 08035
- Recruiting
- Hospital Universitario Vall d'Hebron
-
Barcelona, Spain, 08908
- Recruiting
- Ico L'Hospitalet - Hospital Duran I Reynals
-
Madrid, Spain, 28034
- Recruiting
- Hospital Universitario Ramón y Cajal
-
Madrid, Spain, 28033
- Recruiting
- MD Anderson Cancer Center
-
Madrid, Spain, 28050
- Recruiting
- Hospital Universitario HM Sanchinarro
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Madrid, Spain, 28040
- Recruiting
- Hospital Universitario Fundacion Jimenez
-
-
-
-
California
-
Los Angeles, California, United States, 90025
- Active, not recruiting
- Angeles Clinic and Research Institute - Clinic/Outpatient Facility
-
-
Florida
-
Tampa, Florida, United States, 33612
- Active, not recruiting
- H.Lee Moffitt Cancer Center and Research Institute
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- Recruiting
- University of Michigan
-
Grand Rapids, Michigan, United States, 49503
- Active, not recruiting
- Start South Texas Accelerated Research Therapeutics
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Key Inclusion Criteria:
- 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:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dose Escalation
REGN6569 lead-in, then combo therapy
|
Administered by intravenous (IV) infusion
Administered by IV infusion
Other Names:
|
Experimental: Dose Expansion
Randomized 1:1 between cohorts Cohort 1: Concurrent start of REGN6569 + cemiplimab Cohort 2: REGN6569 lead-in, then combo therapy
|
Administered by intravenous (IV) infusion
Administered by IV infusion
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of dose-limited toxicities (DLTs)
Time Frame: Up to 42 days
|
Dose escalation period
|
Up to 42 days
|
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
|
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)
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
|
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)
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
|
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
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
|
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)
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
|
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
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
|
Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 escalation period
|
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
|
Dose escalation and expansion periods
|
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
|
Dose escalation and expansion periods
|
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
|
Dose escalation and expansion periods
|
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
|
Dose escalation and expansion periods
|
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
|
Dose escalation and expansion periods
|
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
|
Dose escalation and expansion periods
|
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
|
Dose escalation and expansion periods
|
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
|
Dose escalation and expansion periods
|
Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Trial Management, Regeneron Pharmaceuticals
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 5, 2020
Primary Completion (Estimated)
April 1, 2025
Study Completion (Estimated)
June 22, 2026
Study Registration Dates
First Submitted
July 7, 2020
First Submitted That Met QC Criteria
July 7, 2020
First Posted (Actual)
July 10, 2020
Study Record Updates
Last Update Posted (Actual)
January 23, 2024
Last Update Submitted That Met QC Criteria
January 22, 2024
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R6569-ONC-1933
- 2020-000075-20 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
IPD Sharing Time Frame
Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
IPD Sharing Access Criteria
Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency [EMA], Pharmaceuticals and Medical Devices Agency [PMDA], etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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