General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT06325683

Background Information

The purpose of this study is to compare the usual treatment to using the study drugs, Relatlimab and Nivolumab. The use of the study drugs, Relatlimab and Nivolumab, could shrink or stabilize your cancer. But, they could also cause side effects, which are described in the risks section below.

This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study drugs increase the life of patients compared to the usual approach.

The chemotherapy drug, Lomustine, is already approved by the FDA for use in brain and Hodgkin's lymphoma cancers. The study drugs, Nivolumab in combination with Relatlimab, are already approved by the FDA for use in skin cancer. The study drug, Nivolumab, is already approved by the FDA for use in bladder, colorectal, kidney, Hodgkin's lymphoma, liver, lung, and skin cancers. The study drugs, Nivolumab in combination with Relatlimab, are considered investigational in your cancer. There will be about 184 people taking part in this study.

 

For more information, please visit: https://clinicaltrials.gov/study/NCT06325683

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Drive 
Fairfax VA 22031
Principal Investigator

Adam Cohen, MD

Eligibility Information

  • Patients must be in first recurrence of glioblastoma following radiation therapy and temozolomide
  • No prior therapies except radiation, temozolomide, TTFields, and/or Gliadel wafers
  • No prior use of Nivolumab or other anti-PD1 agents
  • Patients must be neurologically stable off corticosteroids for at least 5 days prior to registration
    • Age: ≥ 18 years
    • Karnofsky Performance Status: ≥ 60%
  • No current symptomatic pulmonary disease

Ineligibility Information

  • Distinguishing inflammatory pneumonitis is often a diagnosis of exclusion for patients who do not respond to antibiotics and have no causal organism identified, influenza and COVID must be excluded
  • Most patients with respiratory failure or hypoxia will be treated with steroids
  • Bronchoscopy may be required and analysis of lavage fluid for lymphocytic predominance may be helpful
  • Patients with new lung nodules should be evaluated for sarcoid like granuloma