search
Back to results

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

Primary Purpose

Squamous Cell Carcinoma of Head and Neck

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
REGN6569
Cemiplimab
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma of Head and Neck focused on measuring Unselected solid tumors dose escalation, HNSCC dose expansion, Advanced stage solid tumor malignancy, Unresectable, Metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key 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 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

    All Cohorts:

  4. Has no prior history of immune checkpoint blockade (ICB) therapy
  5. Has exhausted all approved available treatment options for their disease, with no other standard therapy likely to convey clinical benefit as defined in the protocol

Key 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

Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Sites / Locations

  • Angeles Clinic and Research Institute - Clinic/Outpatient Facility
  • H.Lee Moffitt Cancer Center and Research Institute
  • University of Michigan
  • START South Texas Accelerated Research Therapeutics
  • Hospital Universitario Vall d'Hebrón
  • ICO l'Hospitalet - Hospital Duran i Reynals
  • MD Anderson Cancer Center
  • Hospital Universitario Ramon y Cajal
  • Hospital Universitario Fundacion Jimenez
  • Hospital Universitario HM Sanchinarro

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

REGN6569+cemiplimab

Arm Description

REGN6569 lead-in

Outcomes

Primary Outcome Measures

Incidence of dose-limited toxicities (DLTs)
Dose escalation period
Incidence and severity of treatment emergent adverse events(TEAEs)
Dose escalation period
Incidence and severity of adverse events of special interest (AESIs)
Dose escalation period
Incidence and severity of serious adverse events (SAEs)
Dose escalation period
Incidence and severity of grade ≥3 laboratory abnormalities
Dose escalation period
Objective response rate (ORR)
Dose expansion period
Percentage change in glucocorticoid-induced tumor necrosis factor receptor-Related(GITR)+ Treg density
Dose expansion period

Secondary Outcome Measures

ORR
Dose escalation period
Disease control rate (DCR)
Dose escalation and expansion periods
Duration of Response (DOR)
Dose escalation and expansion periods
Progression-free Survival (PFS)
Dose escalation and expansion periods
Overall survival (OS)
Dose escalation and expansion periods
Drug concentrations of REGN6569 in serum
Dose escalation and expansion periods
Drug concentrations of cemiplimab in serum
Dose escalation and expansion periods
Immunogenicity as measured by anti-drug antibodies (ADA) to REGN6569
Dose escalation and expansion periods
Immunogenicity as measured by anti-drug antibodies (ADA) to cemiplimab
Dose escalation and expansion periods

Full Information

First Posted
July 7, 2020
Last Updated
May 8, 2023
Sponsor
Regeneron Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT04465487
Brief Title
Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies
Official Title
A Phase 1 Study of REGN6569, an Anti-GITR mAb, With Cemiplimab in Patients With Advanced Solid Tumor Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
July 8, 2026 (Anticipated)
Study Completion Date
July 8, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
For dose escalation cohorts, the primary objective is to evaluate the safety and tolerability of REGN6569 as monotherapy lead-in and in combination with cemiplimab. For dose expansion cohorts, the co-primary objectives are: To assess the preliminary efficacy of REGN6569 in combination with cemiplimab, as measured by objective response rate (ORR) To assess the preliminary pharmacodynamic activity of REGN6569 as lead-in monotherapy, as measured by intratumoral Glucocorticoid-Induced Tumor necrosis factor receptor-Related (GITR)+ Treg depletion Secondary Objectives are: For dose escalation cohorts: To assess preliminary efficacy of REGN6569 in combination with cemiplimab, as measured by ORR, disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) To characterize the pharmacokinetics (PK) of REGN6569 alone and in combination with cemiplimab To assess the immunogenicity of REGN6569 and cemiplimab For expansion cohorts: To characterize the safety profile in each expansion cohort To assess preliminary efficacy of REGN6569 in combination with cemiplimab, as measured by DCR, DOR, PFS, and OS To characterize the PK of REGN6569 alone and in combination with cemiplimab To assess the immunogenicity of REGN6569 and cemiplimab

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of Head and Neck
Keywords
Unselected solid tumors dose escalation, HNSCC dose expansion, Advanced stage solid tumor malignancy, Unresectable, Metastatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
85 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
REGN6569+cemiplimab
Arm Type
Experimental
Arm Description
REGN6569 lead-in
Intervention Type
Drug
Intervention Name(s)
REGN6569
Intervention Description
Administered by intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
Cemiplimab
Other Intervention Name(s)
REGN2810, Libtayo
Intervention Description
Administered by IV infusion
Primary Outcome Measure Information:
Title
Incidence of dose-limited toxicities (DLTs)
Description
Dose escalation period
Time Frame
Up to 42 days
Title
Incidence and severity of treatment emergent adverse events(TEAEs)
Description
Dose escalation period
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
Title
Incidence and severity of adverse events of special interest (AESIs)
Description
Dose escalation period
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
Title
Incidence and severity of serious adverse events (SAEs)
Description
Dose escalation period
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
Title
Incidence and severity of grade ≥3 laboratory abnormalities
Description
Dose escalation period
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
Title
Objective response rate (ORR)
Description
Dose expansion period
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
Title
Percentage change in glucocorticoid-induced tumor necrosis factor receptor-Related(GITR)+ Treg density
Description
Dose expansion period
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
Secondary Outcome Measure Information:
Title
ORR
Description
Dose escalation period
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
Title
Disease control rate (DCR)
Description
Dose escalation and expansion periods
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
Title
Duration of Response (DOR)
Description
Dose escalation and expansion periods
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
Title
Progression-free Survival (PFS)
Description
Dose escalation and expansion periods
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
Title
Overall survival (OS)
Description
Dose escalation and expansion periods
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
Title
Drug concentrations of REGN6569 in serum
Description
Dose escalation and expansion periods
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
Title
Drug concentrations of cemiplimab in serum
Description
Dose escalation and expansion periods
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
Title
Immunogenicity as measured by anti-drug antibodies (ADA) to REGN6569
Description
Dose escalation and expansion periods
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
Title
Immunogenicity as measured by anti-drug antibodies (ADA) to cemiplimab
Description
Dose escalation and expansion periods
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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 All Cohorts: Has no prior history of immune checkpoint blockade (ICB) therapy Has exhausted all approved available treatment options for their disease, with no other standard therapy likely to convey clinical benefit 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 Note: Other protocol-defined Inclusion/ Exclusion criteria apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Angeles Clinic and Research Institute - Clinic/Outpatient Facility
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
H.Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
START South Texas Accelerated Research Therapeutics
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Hospital Universitario Vall d'Hebrón
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
ICO l'Hospitalet - Hospital Duran i Reynals
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
MD Anderson Cancer Center
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Fundacion Jimenez
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario HM Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/

Learn more about this trial

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

We'll reach out to this number within 24 hrs