Combining VX15/2503 with immune therapies for head and neck cancer
Integrated Pilot Biomarker Trial of VX15/2503 in Combination With Ipilimumab or Nivolumab in Patients With Head and Neck Cancer
This study is testing if a new antibody called VX15/2503, alone or with other immune therapies, can help people with head and neck cancer feel better and improve their treatment outcomes.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Drugs / interventions | ipilimumab, prednisone, nivolumab |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT03690986 on ClinicalTrials.gov |
What this trial studies
This phase I trial investigates the effectiveness of the monoclonal antibody VX15/2503, both alone and in combination with immune checkpoint inhibitors ipilimumab or nivolumab, in treating patients with stage I-IVA head and neck squamous cell carcinoma. The study aims to evaluate the impact of these treatments on the immune profile within the tumor microenvironment and in peripheral blood. Patients are randomized into six groups, receiving different combinations of the treatments, followed by standard surgical care. The trial also seeks to assess the safety profile of these combinations compared to single-agent VX15/2503.
Who should consider this trial
Good fit: Ideal candidates include individuals with stage I-IVA head and neck squamous cell carcinoma who have not received prior treatment and are eligible for surgical resection.
Not a fit: Patients with advanced head and neck cancer who have already undergone treatment or have non-resectable tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the immune response against head and neck cancer, potentially improving patient outcomes.
How similar studies have performed: Other studies have shown promise with similar combinations of immune therapies, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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
Where this trial is running
Atlanta, Georgia
- Emory University Hospital Midtown — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Conor Steuer, MD — Emory University
- Study coordinator: Conor Steuer, MD
- Email: csteuer@emory.edu
- Phone: 404-686-1753
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.