RECRUITING

VX15/2503 in Combination With Ipilimumab or Nivolumab in Patients With Head and Neck Cancer

Conditions

Squamous Cell Carcinoma of the Head and Neck

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2018-11-01

Study Completion:2025-07-26

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03690986

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Stage I-IVA cytologically or histologically-proven head and neck squamous cell carcinoma (HNSCC), p16 positive and negative allowed * Oropharyngeal tumors must have p16 testing done * Cancer confirmed to be surgically resectable, with surgery evaluation with planned resection * Archival tissue prior to treatment available from at most 6 months prior to study enrollment. Otherwise new pre-treatment biopsy mandatory * No prior treatment for HNSCC * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Absolute neutrophil count ≥ 1,500 cells/µL * Platelets ≥ 100,000/µL * Hemoglobin ≥ 9.0g/dL (may receive packed red blood cell \[prbc\] transfusion) * Total bilirubin ≤ 1.5 x the upper limit of normal (ULN) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN * Albumin ≥ 3.0 g/dL * Serum creatinine ≤ 1.5 x ULN * Calculated creatinine clearance of ≤ 50 mL/min * International 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 * Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures * Ability to understand and willingness to sign a written informed consent document * Female 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 * Male subjects must agree to use adequate contraception (e.g., condoms; abstinence) for the duration of study treatment and 3 months after completion * Female subjects of childbearing age must have a negative serum pregnancy test at study entry	* Poor venous access for study drug administration * Nasopharynx cancer, cancer of unknown primary, sinonasal cancer * Determined not to be a surgical candidate due to medical co-morbidities * Treatment with chronic immunosuppressants (e.g., cyclosporine following transplantation) * Prior organ allograft or allogeneic bone marrow transplantation * Subjects 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 * Subjects 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 * Women who are pregnant or lactating * Uncontrolled 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 * Other 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 * Clinical evidence of bleeding diathesis or coagulopathy * Prior 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 * Patients that have had prior treatment for HNSCC are not eligible * Active bacterial or fungal infections requiring systemic treatment within 7 days of treatment * Use 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 * History of severe hypersensitivity reactions to other monoclonal antibodies * Non-oncology vaccines within 28 days prior to or after any dose of ipilimumab * No archival tissue available pre-study treatment, and repeat biopsy not feasible

Inclusion Criteria

Exclusion Criteria

* Stage I-IVA cytologically or histologically-proven head and neck squamous cell carcinoma (HNSCC), p16 positive and negative allowed
* Oropharyngeal tumors must have p16 testing done
* Cancer confirmed to be surgically resectable, with surgery evaluation with planned resection
* Archival tissue prior to treatment available from at most 6 months prior to study enrollment. Otherwise new pre-treatment biopsy mandatory
* No prior treatment for HNSCC
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Absolute neutrophil count ≥ 1,500 cells/µL
* Platelets ≥ 100,000/µL
* Hemoglobin ≥ 9.0g/dL (may receive packed red blood cell \[prbc\] transfusion)
* Total bilirubin ≤ 1.5 x the upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
* Albumin ≥ 3.0 g/dL
* Serum creatinine ≤ 1.5 x ULN
* Calculated creatinine clearance of ≤ 50 mL/min
* International 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
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
* Ability to understand and willingness to sign a written informed consent document
* Female 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
* Male subjects must agree to use adequate contraception (e.g., condoms; abstinence) for the duration of study treatment and 3 months after completion
* Female subjects of childbearing age must have a negative serum pregnancy test at study entry

* Poor venous access for study drug administration
* Nasopharynx cancer, cancer of unknown primary, sinonasal cancer
* Determined not to be a surgical candidate due to medical co-morbidities
* Treatment with chronic immunosuppressants (e.g., cyclosporine following transplantation)
* Prior organ allograft or allogeneic bone marrow transplantation
* Subjects 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
* Subjects 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
* Women who are pregnant or lactating
* Uncontrolled 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
* Other 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
* Clinical evidence of bleeding diathesis or coagulopathy
* Prior 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
* Patients that have had prior treatment for HNSCC are not eligible
* Active bacterial or fungal infections requiring systemic treatment within 7 days of treatment
* Use 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
* History of severe hypersensitivity reactions to other monoclonal antibodies
* Non-oncology vaccines within 28 days prior to or after any dose of ipilimumab
* No archival tissue available pre-study treatment, and repeat biopsy not feasible

Contacts and Locations

Study Contact

Conor Steuer, MD

CONTACT

404-686-1753

csteuer@emory.edu

Nabil Saba, MD

CONTACT

nfsaba@emory.edu

Principal Investigator

Conor Steuer, MD

PRINCIPAL_INVESTIGATOR

Emory University

Study Locations (Sites)

Emory University Hospital Midtown

Atlanta, Georgia, 30308

United States

Collaborators and Investigators

Sponsor: Emory University

Conor Steuer, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-11-01

Study Completion Date2025-07-26

Study Record Updates

Study Start Date2018-11-01

Study Completion Date2025-07-26

Terms related to this study

Additional Relevant MeSH Terms

Squamous Cell Carcinoma of the Head and Neck