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

NCT04465487 | Terminated Phase 1 FDA Drug

• 2 other identifiers: R6569-ONC-19332020-000075-20
• Study Type: interventional
• Target: 38
• Locations: 2 countries
• Sites: 10

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

Keywords

Unselected solid tumors dose escalation; HNSCC dose expansion; Advanced stage solid tumor malignancy; Unresectable; Metastatic

Outcome Measures

Primary Outcomes (7)

• Incidence of dose-limited toxicities (DLTs)

  Dose escalation period

  Up to 42 days

• Incidence and severity of treatment emergent adverse events(TEAEs)

  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)

  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)

  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

  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)

  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

  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 Outcomes (9)

• ORR

  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)

  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)

  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)

  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)

  Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months

Study Arms (2)

Dose Escalation

EXPERIMENTAL

REGN6569 lead-in, then combo therapy

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

Drug: REGN6569; Drug: Cemiplimab

Interventions

REGN6569 DRUG

Administered by intravenous (IV) infusion

Dose Escalation; Dose Expansion

Cemiplimab DRUG

Administered by IV infusion

Also known as: REGN2810, Libtayo

Dose Escalation; Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (10)

Angeles Clinic and Research Institute - Clinic/Outpatient Facility

Los Angeles, California, 90025, United States

Location

H.Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

START South Texas Accelerated Research Therapeutics

Grand Rapids, Michigan, 49503, United States

Location

Hospital Universitario Vall d'Hebrón

Barcelona, 08035, Spain

Location

ICO l'Hospitalet - Hospital Duran i Reynals

Barcelona, 08908, Spain

Location

MD Anderson Cancer Center

Madrid, 28033, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario Fundacion Jimenez

Madrid, 28040, Spain

Location

Hospital Universitario HM Sanchinarro

Madrid, 28050, Spain

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Neoplasm Metastasis

Interventions

cemiplimab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 10, 2020
• Study Start: October 5, 2020
• Primary Completion: February 7, 2025
• Study Completion: February 7, 2025
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 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 or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• 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).

Locations

US (4); ES (6)