This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback
Trial record 1 of 247989 for:    ALL
Previous Study | Return to List | Next Study

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)

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified June 2017 by Regeneron Pharmaceuticals
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT03198130
First received: June 19, 2017
Last updated: June 21, 2017
Last verified: June 2017
  Purpose
This study is being conducted to compare the relationship of patient response to treatment to changes in tumor microenvironment.

Condition Intervention 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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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)

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • 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:
  • 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 ]
  • The overall response rate (ORR) in patients treated with REGN2810 [ Time Frame: Baseline up to 6 weeks following last dose of REGN2810 ]
  • The progression-free survival (PFS) in patients treated with REGN2810 [ Time Frame: Baseline up to 6 weeks following last dose of REGN2810 ]
  • Number of participants with treatment-related adverse events [ Time Frame: Baseline up to 6 weeks following last dose of REGN2810 ]

Estimated Enrollment: 30
Anticipated Study Start Date: June 21, 2017
Estimated Study Completion Date: August 23, 2019
Estimated Primary Completion Date: August 23, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: REGN2810
REGN2810 administered IV over a 30 minute infusion
Drug: REGN2810
Intravenous (IV) use

  Eligibility

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

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

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 brain metastases that may be considered active
  5. Immunosuppressive corticosteroid doses within 4 weeks prior to the first dose of REGN2810

Other protocol-defined inclusion/exclusion criteria will apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03198130

Contacts
Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

Locations
Korea, Republic of
Yonsei University College of Medicine, Severence Hospital Not yet recruiting
Seoul, Korea, Republic of, 03722
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03198130     History of Changes
Other Study ID Numbers: R2810-ONC-1655
Study First Received: June 19, 2017
Last Updated: June 21, 2017

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:
Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell

ClinicalTrials.gov processed this record on June 23, 2017