- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03198130
An Exploratory Tumor Biopsy-driven Study to Understand the Relationship Between Biomarkers and Clinical Response in Patients With Head and Neck Cancer Receiving REGN2810 (Anti-PD-1)
March 17, 2020 updated by: Regeneron Pharmaceuticals
An Exploratory Tumor Biopsy-Driven Study to Understand the Relationship Between Biomarkers and Clinical Response in Immunomodulatory Treatment-Naïve Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of Head and Neck Receiving REGN2810 (Anti-PD-1)
This study is being conducted to compare the relationship of patient response to treatment to changes in tumor microenvironment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 06351
- Samsung Medical Center
-
Seoul, Korea, Republic of, 03080
- Seoul National University
-
Seoul, Korea, Republic of, 03722
- Yonsei University College of Medicine, Severence Hospital
-
-
-
-
-
Birmingham, United Kingdom
- University Birmingham
-
London, United Kingdom
- Guy's and St. Thomas' NHS Foundation Trust
-
London, United Kingdom
- Royal Cancer Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Key Inclusion Criteria:
- Histologically confirmed diagnosis of recurrent and/or metastatic SCCHN (squamous cell carcinoma of the head and neck) with no curative options with at least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and accessible for biopsies. Primary tumor sites of oral cavity, oropharynx, larynx, or hypopharynx are included.
- Have failed/are refractory to at least first line chemotherapy OR deemed unsuitable candidate for first line chemotherapy due to medical co-morbidities or patient preference
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- Adequate hepatic function
- Adequate renal function
- Adequate bone marrow function
- Provide signed informed consent
- Willing and able to comply with clinic visits and study-related procedures
Key Exclusion Criteria:
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse event (irAEs)
- Prior treatment with an agent that blocks the programmed death-1/programmed death-ligand 1 (PD-1/PD-L1) pathway
- Prior treatment with other immune modulating anti-cancer agents
- Untreated or active brain metastases or spinal cord compression
- Immunosuppressive corticosteroid doses within 4 weeks prior to the first dose of REGN2810
- Prior treatment with idelalisib
Other protocol-defined inclusion/exclusion criteria will apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: REGN2810
REGN2810 administered IV over a 30 minute infusion
|
Intravenous (IV) use
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Correlation between changes in the tumor microenvironment and the change in tumor volume following REGN2810 treatment versus baseline.
Time Frame: At baseline and during REGN2810 treatment up to week 24
|
At baseline and during REGN2810 treatment up to week 24
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Correlation between baseline tumor characteristics and the change in tumor volume following REGN2810 treatment
Time Frame: At baseline and during REGN2810 treatment up to week 24
|
At baseline and during REGN2810 treatment up to week 24
|
Number of participants with treatment-related adverse events
Time Frame: Up to 54 weeks
|
Up to 54 weeks
|
Concentrations of REGN2810 in serum
Time Frame: Up to 54 weeks
|
Up to 54 weeks
|
Anti-REGN2810 antibody levels
Time Frame: Up to 54 weeks
|
Up to 54 weeks
|
The overall response rate (ORR) in patients treated with REGN2810
Time Frame: Up to 54 weeks
|
Up to 54 weeks
|
The progression-free survival (PFS) in patients treated with REGN2810
Time Frame: Up to 54 weeks
|
Up to 54 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 3, 2017
Primary Completion (ACTUAL)
June 27, 2019
Study Completion (ACTUAL)
February 21, 2020
Study Registration Dates
First Submitted
June 19, 2017
First Submitted That Met QC Criteria
June 21, 2017
First Posted (ACTUAL)
June 23, 2017
Study Record Updates
Last Update Posted (ACTUAL)
March 19, 2020
Last Update Submitted That Met QC Criteria
March 17, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R2810-ONC-1655
- 2016-004029-18 (EUDRACT_NUMBER)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Recurrent Squamous Cell Carcinoma of Head
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingRecurrent Head and Neck Squamous Cell Carcinoma | Metastatic Squamous Cell Carcinoma of the Hypopharynx | Metastatic Squamous Cell Carcinoma of the Larynx | Metastatic Squamous Cell Carcinoma of the Oral Cavity | Metastatic Squamous Cell Carcinoma of the Oropharynx | Recurrent Hypopharyngeal... and other conditionsUnited States
-
Ohio State University Comprehensive Cancer CenterRecruitingRecurrent Laryngeal Squamous Cell Carcinoma | Recurrent Oral Cavity Squamous Cell Carcinoma | Recurrent Pharyngeal Squamous Cell Carcinoma | Locally Recurrent Head and Neck Squamous Cell Carcinoma | Head and Neck Carcinoma of Unknown Primary | Resectable Head and Neck Squamous Cell CarcinomaUnited States
-
Vanderbilt-Ingram Cancer CenterBoehringer Ingelheim; National Comprehensive Cancer NetworkWithdrawnSquamous Cell Carcinoma | Recurrent Squamous Cell Carcinoma of the Head or Neck | Metastatic Squamous Cell Carcinoma of the Head or Neck
-
National Cancer Institute (NCI)RecruitingRecurrent Head and Neck Squamous Cell Carcinoma | Recurrent Hypopharyngeal Squamous Cell Carcinoma | Recurrent Laryngeal Squamous Cell Carcinoma | Recurrent Oral Cavity Squamous Cell Carcinoma | Recurrent Oropharyngeal Squamous Cell CarcinomaUnited States
-
BioAtla, Inc.RecruitingHead and Neck Cancer | Metastatic Cancer | Squamous Cell Carcinoma of Head and Neck | Recurrent Squamous Cell Carcinoma of the Head and Neck | Metastatic Squamous Cell Carcinoma of the Head and NeckUnited States
-
Glenn J. HannaSecura Bio, Inc.Active, not recruitingMetastatic Head and Neck Cancer | Advanced Head and Neck Squamous Cell Carcinoma | Recurrent Squamous Cell Carcinoma of the Head and Neck | Squamous Cell Carcinoma of the Head and Neck (SCCHN) | Advanced Head and Neck CancerUnited States
-
Hyunseok Kang, MDNeoImmuneTechRecruitingRecurrent Head and Neck Squamous Cell Carcinoma | Recurrent Hypopharyngeal Squamous Cell Carcinoma | Recurrent Laryngeal Squamous Cell Carcinoma | Recurrent Oral Cavity Squamous Cell Carcinoma | Recurrent Oropharyngeal Squamous Cell Carcinoma | Resectable Oropharyngeal Squamous Cell CarcinomaUnited States
-
Southwest Oncology GroupNational Cancer Institute (NCI)WithdrawnRecurrent Squamous Cell Carcinoma of the Hypopharynx | Recurrent Squamous Cell Carcinoma of the Larynx | Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity | Recurrent Squamous Cell Carcinoma of the Oropharynx | Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal...
-
Vaccinex Inc.Merck Sharp & Dohme LLCRecruitingRecurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC)United States
-
Case Comprehensive Cancer CenterNot yet recruitingHead and Neck Squamous Cell Carcinoma | Recurrent Squamous Cell Carcinoma of the Head and Neck | Metastatic Squamous Cell CarcinomaUnited States
Clinical Trials on REGN2810
-
Regeneron PharmaceuticalsSanofiTerminatedNon-small Cell Lung CancerUnited States, Italy, Lithuania
-
Regeneron PharmaceuticalsSanofiActive, not recruitingNon-small Cell Lung CancerUnited States, France, Korea, Republic of, Italy, Austria, China, Georgia, Greece, Ireland, Lithuania, Malaysia, Poland, Romania, Russian Federation, Slovakia, Thailand, Turkey, Ukraine
-
National Institute of Allergy and Infectious Diseases...Regeneron PharmaceuticalsTerminated
-
Regeneron PharmaceuticalsTerminatedCarcinoma, Non-Small-Cell LungUnited States
-
Regeneron PharmaceuticalsRecruitingMetastatic Castration-resistant Prostate Cancer (mCRPC) | Clear Cell Renal Cell Carcinoma (ccRCC)United States
-
Regeneron PharmaceuticalsSanofiRecruitingBasal Cell Carcinoma | Cutaneous Squamous Cell CarcinomaUnited States
-
Regeneron PharmaceuticalsSanofiActive, not recruitingCutaneous Squamous Cell CarcinomaUnited States, Germany, Australia
-
Regeneron PharmaceuticalsSanofiNo longer availableCutaneous Squamous Cell Carcinoma
-
Regeneron PharmaceuticalsWithdrawnAdvanced MalignanciesUnited States