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New treatment option for Head and Neck Squamous Cell Carcinoma (HNSCC)
Official title A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT06769698
What this study is testing
What is FDC fianlimab+cemiplimab?
FDC fianlimab+cemiplimab is an investigational medicine, being studied as a potential treatment for head and neck squamous cell carcinoma (hnscc).
Also referred to as REGN3767, REGN2810.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- PD-L1 expression Combined Positive Score (CPS) ≥1 documented with a previously PD-L1 obtained Immunohistochemistry (IHC) result prior to screening...
- Oropharynx cancer participants only: HPV status, based on a previously documented result prior to screening, must have been established in a surgical...
- At least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as described in the protocol
You likely can't join if
- Medical Conditions
- Participants who have Progressive Disease (PD) within 6 months of completion of curatively intended systemic treatment for locoregionally advanced...
- 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...
- History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required...
See the full eligibility criteria
- 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 Key
- 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...
- 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 Note: Other protocol defined...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- Edgewood, Kentucky, United States
- Louisville, Kentucky, United States
- Detroit, Michigan, United States
- Omaha, Nebraska, United States
- Columbus, Ohio, United States
- Willow Grove, Pennsylvania, United States
- Knoxville, Tennessee, United States
- Nashville, Tennessee, United States
- Lubbock, Texas, United States
- The Woodlands, Texas, United States
- Fairfax, Virginia, United States
- Bundaberg, Queensland, Australia
- Melbourne, Victoria, Australia
- Clermont-Ferrand, Auvergne-Rhône, France
- Marseille, Bordeaux, France
- Paris, Île-de-France Region, France
- Milan, Italy
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Orlando, Florida, United States; Atlanta, Georgia, United States; Edgewood, Kentucky, United States; Louisville, Kentucky, United States; Detroit, Michigan, United States and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.