NCT06769698

Brief Summary

This study is researching an experimental drug called fianlimab (also called REGN3767), combined with a medication called cemiplimab compared against cemiplimab combined with placebo (a placebo looks like a treatment but does not contain any real medicine), collectively called "study drugs" in this form. The study is focused on participants with head and neck cancers who have not been previously treated for head and neck cancer that has come back or spread to other parts of the body, referred to as recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). The study is looking at several other research questions, including:

  • What side effects may happen from taking the study drugs
  • How much of each study drug is in the blood at different times
  • Whether the body makes antibodies against the study drug(s) individually (which could make the study drugs less effective or could lead to side effects)
  • Compatible research to better understand the study drugs and HNSCC

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
56mo left

Started Apr 2026

Longer than P75 for phase_2

Geographic Reach
2 countries

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Apr 2026Dec 2030

First Submitted

Initial submission to the registry

January 6, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 10, 2025

Completed
1.3 years until next milestone

Study Start

First participant enrolled

April 14, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2028

Expected
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2030

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

2.1 years

First QC Date

January 6, 2025

Last Update Submit

May 5, 2026

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC)

Keywords

Recurrent or Metastatic (R/M)Positive for Programmed Death Ligand 1 (PD-L1) ExpressionHuman Papillomavirus (HPV)

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate (ORR)

    Up to 90 days after last study treatment, approximately 58 months

Secondary Outcomes (17)

  • Incidence of Adverse Events (AEs)

    Up to 90 days after last study treatment, approximately 58 months

  • Severity of AEs

    Up to 90 days after last study treatment, approximately 58 months

  • Incidence of Treatment Emergent Adverse Events (TEAEs)

    Up to 90 days after last study treatment, approximately 58 months

  • Incidence of immune-mediated Adverse Events (imAEs)

    Up to 90 days after last study treatment, approximately 58 months

  • Incidence of treatment-related AEs

    Up to 90 days after last study treatment, approximately 58 months

  • +12 more secondary outcomes

Study Arms (2)

Cohort 1

EXPERIMENTAL

Approximately 60 participants with HPV (human papillomavirus) positive HNSCC. Randomized 1:1 to Fianlimab + Cemiplmab Fixed Dose Combination (FDC) versus Cemiplimab + Placebo.

Drug: FDC fianlimab+cemiplimabDrug: CemiplimabDrug: Placebo

Cohort 2

EXPERIMENTAL

Approximately 60 participants with HPV negative HNSCC. Randomization is the same as in Cohort 1.

Drug: FDC fianlimab+cemiplimabDrug: CemiplimabDrug: Placebo

Interventions

FDC fianlimab+cemiplimabDRUG

Fixed-Dose Combination (FDC) Administered per the protocol

Also known as: REGN3767, REGN2810, Libtayo
Cohort 1Cohort 2
CemiplimabDRUG

Administered per the protocol

Also known as: R2810, Libtayo
Cohort 1Cohort 2
PlaceboDRUG

Administered per the protocol

Cohort 1Cohort 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have histologically confirmed (by local pathology) R/M HNSCC that is considered incurable by local therapies
  • Primary tumor location of oral cavity, oropharynx, larynx, or hypopharynx (patients with cervical neck node SCC with occult primary as described in the protocol
  • PD-L1 expression Combined Positive Score (CPS) ≥1 documented with a previously PD-L1 obtained Immunohistochemistry (IHC) result prior to screening, as described in protocol
  • Oropharynx cancer participants only: HPV status, based on a previously documented result prior to screening, must have been established in a surgical biopsy specimen or a core biopsy specimen as described in the protocol
  • At least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as described in the protocol
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ and bone marrow function as described in the protocol

You may not qualify if:

  • Medical Conditions
  • Participants who have Progressive Disease (PD) within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC as described in the protocol
  • Participants who have a primary tumor site of nasopharynx, paranasal sinus or salivary gland (any histology)
  • Head and neck SCC with unknown primary site as described in the protocol
  • Participants with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date as described in the protocol
  • History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management
  • History or current evidence of significant cardiovascular disease including, myocarditis, congestive heart failure (as defined by New York Heart Association Functional Classification III and IV), unstable angina, serious uncontrolled arrhythmia, and myocardial infarction 6 months prior to study enrollment.
  • Prior/Concomitant Therapy
  • Participants who have received prior systemic anticancer therapy in the R/M HNSCC setting as described in the protocol
  • Participants with a condition requiring corticosteroid therapy (\>10 mg prednisone/prednisolone/day or equivalent) within 14 days of the first dose of study drug as described in the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Orlando Health

Orlando, Florida, 32806, United States

RECRUITING

Emory University School of Medicine

Atlanta, Georgia, 30308, United States

RECRUITING

St. Elizabeth Healthcare

Edgewood, Kentucky, 41017, United States

RECRUITING

Norton Cancer Institute

Louisville, Kentucky, 40202, United States

RECRUITING

Oncology Hematology West P.C. dba Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

RECRUITING

Joe Arrington Cancer Research & Treatment Center

Lubbock, Texas, 79410, United States

RECRUITING

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

RECRUITING

Peter MacCallum Cancer Centre (PMCC)

Melbourne, Victoria, 3050, Australia

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and NeckRecurrenceNeoplasm Metastasis

Interventions

cemiplimab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by SiteDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplastic Processes

Study Officials

  • Clinical Trial Management

    Regeneron Pharmaceuticals

    STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643clinicaltrials@regeneron.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2025

First Posted

January 10, 2025

Study Start

April 14, 2026

Primary Completion (Estimated)

June 4, 2028

Study Completion (Estimated)

December 28, 2030

Last Updated

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

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 can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
More information

Locations

AU(1)US(9)