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Pepinemab with or without Ipilimumab and/or Nivolumab in Treating Patients with Stage I-IVA Head and Neck Squamous Cell Cancer

Status
Active
Cancer Type
Head and Neck Cancer
Skin Cancer (Non-Melanoma)
Unknown Primary
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03690986
Protocol IDs
Winship4402-18 (primary)
NCI-2018-01263
IRB00103534
Study Sponsor
Emory University Hospital/Winship Cancer Institute

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

  1. Must be at least >= 18 years of age
  2. Stage I-IVA cytologically or histologically-proven head and neck squamous cell carcinoma (HNSCC), p16 positive and negative allowed
  3. Oropharyngeal tumors must have p16 testing done
  4. Cancer confirmed to be surgically resectable, with surgery evaluation with planned resection
  5. Archival tissue prior to treatment available from at most 6 months prior to study enrollment. Otherwise new pre-treatment biopsy mandatory
  6. No prior treatment for HNSCC
  7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  8. Absolute neutrophil count >= 1,500 cells/uL
  9. Platelets >= 100,000/uL
  10. Hemoglobin >= 9.0 g/dL (may receive packed red blood cell [prbc] transfusion)
  11. Total bilirubin =< 1.5 x the upper limit of normal (ULN)
  12. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN
  13. Albumin >= 3.0 g/dL
  14. Serum creatinine =< 1.5 x ULN
  15. Calculated creatinine clearance of >= 50 mL/min
  16. 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
  17. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
  18. Ability to understand and willingness to sign a written informed consent document
  19. 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
  20. Male subjects must agree to use adequate contraception (e.g., condoms; abstinence) for the duration of study treatment and 3 months after completion
  21. Female subjects of childbearing age must have a negative serum pregnancy test at study entry

Treatment Sites in Georgia

Emory University Hospital - Midtown


550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.