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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03198130
Recruitment Status : Active, not recruiting
First Posted : June 23, 2017
Last Update Posted : August 15, 2019
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:
This study is being conducted to compare the relationship of patient response to treatment to changes in tumor microenvironment.

Condition or disease Intervention/treatment Phase
Recurrent Squamous Cell Carcinoma of Head Recurrent Squamous Cell Carcinoma of Neck Metastatic Squamous Cell Carcinoma of Head Metastatic Squamous Cell Carcinoma Neck Drug: REGN2810 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : July 3, 2017
Actual Primary Completion Date : June 27, 2019
Estimated Study Completion Date : February 13, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: REGN2810
REGN2810 administered IV over a 30 minute infusion
Drug: REGN2810
Intravenous (IV) use




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Number of participants with treatment-related adverse events [ Time Frame: Up to 54 weeks ]
  3. Concentrations of REGN2810 in serum [ Time Frame: Up to 54 weeks ]
  4. Anti-REGN2810 antibody levels [ Time Frame: Up to 54 weeks ]
  5. The overall response rate (ORR) in patients treated with REGN2810 [ Time Frame: Up to 54 weeks ]
  6. The progression-free survival (PFS) in patients treated with REGN2810 [ Time Frame: Up to 54 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. 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.
  2. 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
  3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
  4. Adequate hepatic function
  5. Adequate renal function
  6. Adequate bone marrow function
  7. Provide signed informed consent
  8. Willing and able to comply with clinic visits and study-related procedures

Key Exclusion Criteria:

  1. 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)
  2. Prior treatment with an agent that blocks the programmed death-1/programmed death-ligand 1 (PD-1/PD-L1) pathway
  3. Prior treatment with other immune modulating anti-cancer agents
  4. Untreated or active brain metastases or spinal cord compression
  5. Immunosuppressive corticosteroid doses within 4 weeks prior to the first dose of REGN2810
  6. Prior treatment with idelalisib

Other protocol-defined inclusion/exclusion criteria will apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198130


Locations
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Korea, Republic of
Seoul National University
Seoul, Korea, Republic of, 03080
Yonsei University College of Medicine, Severence Hospital
Seoul, Korea, Republic of, 03722
Samsung Medical Center
Seoul, Korea, Republic of, 06351
United Kingdom
University Birmingham
Birmingham, United Kingdom
Guy's and St. Thomas' NHS Foundation Trust
London, United Kingdom
Royal Cancer Hospital
London, United Kingdom
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals

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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03198130     History of Changes
Other Study ID Numbers: R2810-ONC-1655
2016-004029-18 ( EudraCT Number )
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019

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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
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Cemiplimab
Antineoplastic Agents, Immunological
Antineoplastic Agents