Trial Filter

BETA

An intelligent search tool for clinical trials

Sign In
Back|NCT03690986Recruiting
Official Title

Integrated Pilot Biomarker Trial of VX15/2503 in Combination With Ipilimumab or Nivolumab in Patients With Head and Neck Cancer

Phase
Phase 1
Sponsor
Emory University
Enrollment
50
Timeline
Nov 2018 → Nov 2027
About This Study

This phase I trial studies how well anti-semaphorin 4D (SEMA4D) monoclonal antibody VX15/2503 (VX15/2503) with or without ipilimumab and/or nivolumab work in treating patients with stage I-IVA head and neck squamous cell cancer. Monoclonal antibodies, such as VX15/2503, ipilimumab, and nivolumab, may interfere with the ability of tumor cells to grow and spread.

Eligibility Criteria

Inclusion Criteria

  • 1Stage I-IVA cytologically or histologically-proven head and neck squamous cell carcinoma (HNSCC), p16 positive and negative allowed
  • 2Oropharyngeal tumors must have p16 testing done
  • 3Cancer confirmed to be surgically resectable, with surgery evaluation with planned resection
  • 4Archival tissue prior to treatment available from at most 6 months prior to study enrollment. Otherwise new pre-treatment biopsy mandatory
  • 5No prior treatment for HNSCC
  • 6Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • 7Absolute neutrophil count ≥ 1,500 cells/µL
  • 8Platelets ≥ 100,000/µL
  • 9Hemoglobin ≥ 9.0g/dL (may receive packed red blood cell \[prbc\] transfusion)
  • 10Total bilirubin ≤ 1.5 x the upper limit of normal (ULN)
  • 11Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
  • 12Albumin ≥ 3.0 g/dL
  • 13Serum creatinine ≤ 1.5 x ULN
  • 14Calculated creatinine clearance of ≤ 50 mL/min
  • 15International normalized ratio (INR) ≤ 1.5. Anticoagulation is allowed only with low molecular weight heparin (LMWH). Patient receiving LMW heparin on stable therapeutic dose for more than 2 weeks or with factor Xa level \< 1.1 units/mL (U/mL) are allowed on the trial
  • 16Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
  • 17Ability to understand and willingness to sign a written informed consent document
  • 18Female subjects of childbearing potential must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for the duration of study treatment and 3 months after completion
  • 19Male subjects must agree to use adequate contraception (e.g., condoms; abstinence) for the duration of study treatment and 3 months after completion
  • 20Female subjects of childbearing age must have a negative serum pregnancy test at study entry

Exclusion Criteria

  • 1Poor venous access for study drug administration
  • 2Nasopharynx cancer, cancer of unknown primary, sinonasal cancer
  • 3Determined not to be a surgical candidate due to medical co-morbidities
  • 4Treatment with chronic immunosuppressants (e.g., cyclosporine following transplantation)
  • 5Prior organ allograft or allogeneic bone marrow transplantation
  • 6Subjects with any active autoimmune disease or history of known or suspected autoimmune disease except for subjects with vitiligo, resolved childhood asthma/atopy, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
  • 7Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
  • 8Women who are pregnant or lactating
  • 9Uncontrolled intercurrent illness including, but not limited to, human immunodeficiency virus (HIV)-positive subjects receiving combination antiretroviral therapy, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association \[NYHA\] class III or IV), unstable angina pectoris, ventricular arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • 10Other medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study
  • 11Clinical evidence of bleeding diathesis or coagulopathy
  • 12Prior invasive malignancy (except non-melanomatous skin cancer, low or intermediate risk prostate cancer, or in situ carcinoma fully resected) unless disease free for a minimum of one year
  • 13Patients that have had prior treatment for HNSCC are not eligible
  • 14Active bacterial or fungal infections requiring systemic treatment within 7 days of treatment
  • 15Use of other investigational drugs (drugs not marked for any indication) within 28 days or at least 5 half-lives (whichever is longer) before study drug administration
  • 16History of severe hypersensitivity reactions to other monoclonal antibodies
  • 17Non-oncology vaccines within 28 days prior to or after any dose of ipilimumab
  • 18No archival tissue available pre-study treatment, and repeat biopsy not feasible

Locations

1 site participating in this study

Emory University Hospital Midtown

Atlanta, Georgia 30308

Recruiting

Adedolapo Adedayo, MBBS

adedolapo.adedayo@emory.edu404-686-3925
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →