Neoadjuvant Immunotherapy in Brain Metastases

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Sarah Sammons, MD
Study ID
NCT04434560
Phase
PHASE2
Status
Terminated

Conditions

  • Brain Metastases, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Nivolumab will be given at the FDA-approved dose of 3 mg/kg.
  • Ipilimumab — DRUG
    Ipilimumab will be given at the FDA-approved dose of 1 mg/kg.

Study Details

The purpose of this phase 2 study is to assess the feasibility and efficacy of neoadjuvant immunotherapy in patients with previously untreated, surgically-resectable, solid tumor brain metastases. The primary objectives of this study are to 1) assess the feasibility of neoadjuvant ipilimumab and nivolumab treatment before surgery and stereotactic radiosurgery (SRS) in patients with solid tumor brain metastases as measured by the proportion of patients who have their surgery delayed or surgery never occurs, and 2) demonstrate that neoadjuvant immunotherapy will increase proliferation of circulating T-cells compared to baseline measurements. Exploratory objectives include describing patient progression free survival and overall survival, time to local and distant intracranial progression, and the rate of radiation necrosis. The rate of radionecrosis will also be explored, as immune expression profiles.

Key Dates

Start date
Nov 4, 2020
Status verified
Jul 2022
Primary completion
Jun 17, 2021
Completion
Jun 17, 2021

Study Design

Enrollment
1 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • No Intervention: Standard of Care (no neoadjuvant immunotherapy)
    Patients will proceed to surgical resection with no nivolumab/ipilimumab given prior to surgery.
  • Experimental: Neoadjuvant Immunotherapy
    Patients will receive a single dose of neoadjuvant nivolumab and ipilimumab 7 days (± 3 days) prior to surgical resection.

Primary Outcome Measure

Proportion of Patients Who Have Their Surgery Delayed by More Than 4 Days or Surgery Never Occurs as a Direct or Indirect Result of Ipilimumab and Nivolumab Treatment. [ Time Frame: 10 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710-

Find similar trials in Durham, NC

By research site
Duke University Medical Center· Durham, NC

Related Studies