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)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Recurrent Squamous Cell Carcinoma of Head
Recurrent Squamous Cell Carcinoma of Neck
Metastatic Squamous Cell Carcinoma of Head
Metastatic Squamous Cell Carcinoma Neck
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2017-06-23
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Correlation between changes in the tumor microenvironment and the change in tumor volume following REGN2810 treatment versus baseline.
timeFrame: At baseline and during REGN2810 treatment up to week 24
Secondary outcomes:
measure: Correlation between baseline tumor characteristics and the change in tumor volume following REGN2810 treatment
timeFrame: At baseline and during REGN2810 treatment up to week 24
measure: Number of participants with treatment-related adverse events
timeFrame: Up to 54 weeks
measure: Concentrations of REGN2810 in serum
timeFrame: Up to 54 weeks
measure: Anti-REGN2810 antibody levels
timeFrame: Up to 54 weeks
measure: The overall response rate (ORR) in patients treated with REGN2810
timeFrame: Up to 54 weeks
measure: The progression-free survival (PFS) in patients treated with REGN2810
timeFrame: Up to 54 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine, Severence Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Birmingham
country: United Kingdom
facility: University Birmingham
city: London
country: United Kingdom
facility: Guy's and St. Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal Cancer Hospital
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: