Pepinemab with or without Ipilimumab and/or Nivolumab in Treating Patients with Stage I-IVA Head and Neck Squamous Cell Cancer
Head and Neck Cancer
Skin Cancer (Non-Melanoma)
Unknown Primary
18 Years and older, Male and Female
Winship4402-18 (primary)
NCI-2018-01263
IRB00103534
Summary
This phase I trial studies how well pepinemab with or without ipilimumab and/or nivolumab work in treating participants with stage I-IVA head and neck squamous cell cancer. Immunotherapy with monoclonal antibodies, such as pepinemab, ipilimumab, and nivolumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Objectives
PRIMARY OBJECTIVE:
I. To evaluate the effect of the pepinemab (VX15/2503) alone and VX15/2503 in combination with immune checkpoint inhibitors, ipilimumab or nivolumab, on the immune profile in the tumor microenvironment and in peripheral blood.
SECONDARY OBJECTIVE:
I. To extend the previously reported safety profile of single agent VX15/2503 to the combination of VX15/2503 and immune checkpoint inhibitors, ipilimumab or nivolumab, in patients with head and neck squamous cell carcinoma.
OUTLINE: Patients are randomized to 1 of 6 groups.
GROUP I: Patients receive pepinemab intravenously (IV) over 60 minutes on day 1. Beginning days 17-36, patients undergo standard of care surgery.
GROUP II: Patients receive pepinemab IV over 60 minutes and ipilimumab IV over 90 minutes on day 1. Beginning days 17-36, patients undergo standard of care surgery.
GROUP III: Patients receive pepinemab IV over 60 minutes and nivolumab IV over 60 minutes on day 1. Beginning days 17-36, patients undergo standard of care surgery.
GROUP IV: Patients receive nivolumab IV over 60 minutes on day 1. Beginning days 17-36, patients undergo standard of care surgery.
GROUP V: Patients ipilimumab IV over 90 minutes on day 1. Beginning days 17-36, patients undergo standard of care surgery.
GROUP VI: Patients undergo standard of care surgery.
After completion of study treatment, patients are followed up at 4-8 weeks.
Eligibility
- Must be at least >= 18 years of age
- 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/uL
- Platelets >= 100,000/uL
- Hemoglobin >= 9.0 g/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 < 1.1U/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
Treatment Sites in Georgia
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