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A Study to Evaluate Immune Biomarker Modulation in Response to VTX-2337 in Combination With an Anti- PD-1 Inhibitor in Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT03906526
Recruitment Status : Not yet recruiting
First Posted : April 8, 2019
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
This is an open label, Phase 1b pre-operative window of opportunity biomarker trial to analyze the combination of intravenous tislelizumab given along with motolimod delivered either subcutaneously or by intratumoral injection in subjects with resectable HPV+/- squamous cell carcinoma of the head and neck.

Condition or disease Intervention/treatment Phase
Carcinoma, Squamous Cell Drug: A317 Drug: VTX-2337 Phase 1

Detailed Description:
This is an open-label, Phase 1b biomarker trial to analyze the combination of an anti-PD-1 inhibitor, tislelizumab, given along with toll-like receptor 8 (TLR 8) agonist, motolimod, in subjects with resectable, HPV-positive or HPV-negative, SCCHN. Subjects with previously untreated, resectable SCCHN, with no prior history of SCCHN, will be recruited onto this trial and will initially undergo pre-treatment diagnostic biopsy, tumor imaging by computed tomography (CT) or magnetic resonance imaging (MRI) scan and peripheral blood collection. These subjects will undergo pre-operative study treatment for a 3 to 4-week period prior to their scheduled surgical resection

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Multicenter Pre-Surgical Study to Evaluate Immune Biomarker Modulation in Response to Motolimod (VTX-2337) in Combination With Tislelizumab (BGB-A317) in Subjects With Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Estimated Study Start Date : April 15, 2019
Estimated Primary Completion Date : October 18, 2020
Estimated Study Completion Date : February 13, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Monotherapy Arm 1: Tislelizumab
Tislelizumab IV (1 infusion every 3 weeks)
Drug: A317
IV Tislelizumab
Other Name: BGB-A317

Experimental: Monotherapy Arm 2: Motolimod
Motolimod IT injection (1 injection every week)
Drug: VTX-2337
Motolimod
Other Name: VTX-378

Experimental: Combination Arm 3: Tislelizumab and Motolimod
Tislelizumab IV (1 infusion every 3 weeks) and motolimod IT injection (1 injection every week)
Drug: A317
IV Tislelizumab
Other Name: BGB-A317

Drug: VTX-2337
Motolimod
Other Name: VTX-378

Experimental: Combination Arm 4: Tislelizumab and Motolimod
Tislelizumab IV (1 infusion every 3 weeks) and motolimod SC injection (1 injection every week)
Drug: A317
IV Tislelizumab
Other Name: BGB-A317

Drug: VTX-2337
Motolimod
Other Name: VTX-378




Primary Outcome Measures :
  1. Numbers of CD8+ T cells within the tumor pre-treatment and post-surgery [ Time Frame: Screening through Study Day 52 ]
    Immune-modulation in this study will be measured in tumor tissue collected pre treatment and time of surgical resection by identifying and counting the number of tumor infiltrating CD8+ T cells.


Secondary Outcome Measures :
  1. Adverse Event(s) [ Time Frame: Up to approximately 112 days ]
    An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.

  2. Number of Patients With adverse events that lead to delay in resection > 7 days [ Time Frame: Screening through Study Day 52 ]
    Number of Patients With adverse events that lead to delay in resection > 7 days.



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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

Inclusion Criteria:

  • Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
  • Subject has Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
  • Subject has a new clinical or pathologic diagnosis of resectable HPV+ or HPV- SCCHN of the oral cavity, pharynx, or larynx
  • Macroscopic complete resection of the primary tumor must be planned and subjects should have no medical contraindication to surgery.
  • Subject consents to and has tumor accessible for tumor biopsy pre-treatment.
  • Females of childbearing potential (FCBP) and males must: Either commit to true abstinence from heterosexual intercourse or to use a highly effective contraceptive method
  • Have negative pregnancy test
  • Subjects must have the following laboratory values:

    • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    • Hemoglobin (Hgb) ≥ 8 g/dL.
    • Platelets (plt) ≥ 75 x 109/L without transfusion for 7 days
    • AST/SGOT and ALT/SGPT ≤ 2.5 x Upper Limit of Normal (ULN)
    • Serum bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for subjects with documented Gilbert syndrome)
    • Estimated serum creatinine clearance of ≥ 60 mL/min using the Cockcroft-Gault equation
    • INR < 1.5 x ULN and PTT < 1.5 x ULN

Exclusion Criteria:

  • Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
  • Subject has unresectable or inoperable tumors
  • Subject has primary tumors of the sinuses, paranasal sinuses, or nasopharynx, or unknown primary tumors
  • Subject has evidence of distant metastasis
  • Subject has a history of concurrent second cancers requiring active, ongoing systemic treatment
  • Subject has prior treatment with motolimod or other agents targeting PD-1/PD-L1.
  • Subject is a pregnant or nursing female.
  • Subject has active or uncontrolled infection including known HIV infection or known chronic hepatitis B or C.
  • Subject has active autoimmune disease.
  • Subject has clinically significant ophthalmologic disease.

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): NCT03906526


Contacts
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Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Sponsors and Collaborators
Celgene
Investigators
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Study Director: Aparna Mani, MD/PhD Celgene

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03906526     History of Changes
Other Study ID Numbers: VTX-2337-HN-001
U1111-1223-3488 ( Registry Identifier: WHO )
First Posted: April 8, 2019    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: See Plan Description
Access Criteria: See Plan Description
URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Celgene:
Motolimod
Tislelizumab
Resection
Head and Neck Cancer
Checkpoint inhibitor
TLR 8 agonist
Squamous Cell Carcinoma
Pre-Surgical

Additional relevant MeSH terms:
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Carcinoma
Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Neoplasms, Squamous Cell