Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies

NCT ID: NCT04465487

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-05
• Study Completion Date: 2025-02-07

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Escalation

REGN6569 lead-in, then combo therapy

Group Type: EXPERIMENTAL

REGN6569

Intervention Type: DRUG

Administered by intravenous (IV) infusion

Cemiplimab

Intervention Type: DRUG

Administered by IV infusion

Dose Expansion

Randomized 1:1 between cohorts Cohort 1: Concurrent start of REGN6569 + cemiplimab Cohort 2: REGN6569 lead-in, then combo therapy

Group Type: EXPERIMENTAL

REGN6569

Intervention Type: DRUG

Administered by intravenous (IV) infusion

Cemiplimab

Intervention Type: DRUG

Administered by IV infusion

Interventions

REGN6569

Administered by intravenous (IV) infusion

Intervention Type: DRUG

Cemiplimab

Administered by IV infusion

Intervention Type: DRUG

Other Intervention Names

REGN2810; Libtayo

Eligibility Criteria

Inclusion Criteria

1. Dose escalation cohorts: Advanced stage (unresectable or metastatic) solid tumor malignancy, confirmed histologically or cytologically as defined in the protocol

2. 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

3. 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

Exclusion Criteria

1. Has previously received GITR-targeted therapy

2. Has received any previous systemic biologic therapy within 5 half-lives of first dose of study therapy as defined in the protocol

3. 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

4. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments as defined in the protocol

5. 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

6. Has uncontrolled infection with human immunodeficiency virus, hepatitis B or hepatitis C infection, or diagnosis of immunodeficiency

7. 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.

8. Has had prior allogeneic stem cell transplantation or received organ transplants at any time, or autologous stem cell transplantation

9. Has a history of malignancy within 2 years of date of first planned dose on study as defined in the protocol

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

Angeles Clinic and Research Institute - Clinic/Outpatient Facility

Los Angeles, California, United States

H.Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

University of Michigan

Ann Arbor, Michigan, United States

START South Texas Accelerated Research Therapeutics

Grand Rapids, Michigan, United States

Hospital Universitario Vall d'Hebrón

Barcelona, , Spain

ICO l'Hospitalet - Hospital Duran i Reynals

Barcelona, , Spain

MD Anderson Cancer Center

Madrid, , Spain

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Hospital Universitario Fundacion Jimenez

Madrid, , Spain

Hospital Universitario HM Sanchinarro

Madrid, , Spain

Countries

United States; Spain

Other Identifiers

2020-000075-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

R6569-ONC-1933

Identifier Type: -

Identifier Source: org_study_id