Phase 1
N=6
Nivolumab With DC Vaccines for Recurrent Brain Tumors
Malignant Glioma · Astrocytoma · Glioblastoma
Bottom Line
View on ClinicalTrials.gov: NCT02529072 ↗Enrolled (actual)
6
Serious AEs
50.0%
Results posted
Mar 2020
Primary outcome: Primary: The Safety of Administering DC Vaccines With Nivolumab — 0; 0 Percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- nivolumab (Drug); DC (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gary Archer Ph.D.
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Safety of Administering DC Vaccines With Nivolumab |
0; 0 | — |
| SECONDARY Overall Survival |
8.0; 15.3 | — |
| SECONDARY Progression Free Survival (PFS) |
4.3; 6.3 | — |
Summary
Patients will be randomized to one of two treatment arms - Group I and Group II. Group I will receive nivolumab monotherapy until surgical resection, and Group II will receive nivolumab alone and with DC vaccine therapy until surgical resection. During surgical resection blood and tumor samples will be assessed and compared. Following surgery, both groups will continue to receive DC vaccines (total of 8) and nivolumab therapy until confirmed progression.
Eligibility Criteria
Inclusion Criteria
- Age 18-80 years of age
- First or second recurrence of MG (WHO Grade III or IV glioma or astrocytoma) in surgically accessible areas with prior histologic diagnosis of MG
- Bevacizumab-naïve - no prior exposure to Bevacizumab
- Karnofsky Performance Status (KPS) of ≥ 70%
- Radiation Therapy (RT) with ≥ 45 Gray (Gy) tumor dose, completed ≥ 8 weeks prior to study entry
- Laboratory values must meet the following criteria:
- White Blood Count (WBC) ≥ 2000/microliters (uL)
- Neutrophils ≥ 1500/uL
- Platelets ≥ 100x103/uL
- Hemoglobin ≥ 9.0 g/dL
- Serum creatinine ≤ 1.5x the upper limit of normal (ULN) or creatinine clearance (CrCl)≥ 40 mL/min (using the Cockcroft-Gault formula) c. Female CrCl = (140 - age in years) x weight in kg x 0.85 /72 x serum creatinine in mg/dL d. Male CrCl = (140 - age in years) x weight in kg x 1.00/72 x serum creatinine in mg/dL
- Aspartate Aminotransferase (AST) ≤ 3x ULN
- Alanine Aminotransferase (ALT) ≤ 3x ULN
- Bilirubin≤ 1.5x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin 101.5o F) illness
- Known immunosuppressive disease, autoimmune disease or human immunodeficiency virus infection, Hepatitis B or Hepatitis C
- Known allergy or hypersensitivity to tetanus, or any other tetanus or diphtheria toxoid-containing vaccine, or any component of this vaccine (i.e., aluminum phosphate, formaldehyde)
- Known severe (Grade 3 or 4) infusion-related allergy or hypersensitivity to any monoclonal antibody
- Previous radiation therapy with anything other than standard radiation therapy (such as previous stereotactic radiosurgery) or previous treatment with an immune checkpoint inhibitor (i.e., nivolumab, pembrolizumab, ipilimumab)
- Unstable or severe intercurrent medical conditions such as severe heart (New York Association Class 3 or 4) or lung (FEV1 4 mg/day at time of consent
- Prior inguinal lymph node dissection.
Data sourced from ClinicalTrials.gov (NCT02529072). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.