Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies
Public ClinicalTrials.gov record NCT04465487. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1 Study of REGN6569, an Anti-GITR mAb, With Cemiplimab in Patients With Advanced Solid Tumor Malignancies
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT04465487
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 38 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 4, 2020
- Primary completion
- Feb 6, 2025
- Completion
- Feb 6, 2025
- Last update posted
- Feb 23, 2025
2020 – 2025
United States locations
- U.S. sites
- 4
- U.S. states
- 3
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Angeles Clinic and Research Institute - Clinic/Outpatient Facility | Los Angeles | California | 90025 | — |
| H.Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| START South Texas Accelerated Research Therapeutics | Grand Rapids | Michigan | 49503 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04465487, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 23, 2025 · Synced Sep 12, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04465487 live on ClinicalTrials.gov.