Trial · NCT02648997
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Without Disease Progression At Six Months Following Initiation Of Study Therapy | 6 months | To evaluate the anti-tumor activity for single-agent nivolumab (cohort 1) or nivolumab plus ipilimumab following radiation therapy (cohort 2) among patients with recurrent/progressive grade I, II or III meningioma. |
| Secondary | Both Cohorts: Median Progression-Free Survival | 2 years | To evaluate additional measures of anti-tumor activity of single-agent nivolumab (cohort 1) and nivolumab plus ipilimumab after radiation therapy (cohort 2) among patients with recurrent/progressive grade I, II or III meningioma |
| Secondary | Both Cohorts: Median Overall Survival | 2 years | To evaluate additional measures of anti-tumor activity of single-agent nivolumab (cohort 1) and nivolumab plus ipilimumab after radiation therapy (cohort 2) among patients with recurrent/progressive grade I, II or III meningioma |
| Secondary | Both Cohorts: Objective Radiologic Response Rate | 2 years | To evaluate additional measures of anti-tumor activity of single-agent nivolumab (cohort 1) and nivolumab plus ipilimumab after radiation therapy (cohort 2) among patients with recurrent/progressive grade I, II or III meningioma |
| Secondary | Both Cohorts: Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0. | 2 years | 1.2.1 To evaluate the safety and tolerability of single-agent nivolumab (cohort 1) and nivolumab plus ipilimumab after radiation therapy (cohort 2) among patients with recurrent/progressive grade I, II or III meningioma |
| Other | Evaluate Circulating Immune Cell Subsets and Cytokines as Systemic Immune Correlative Markers | 2 years | Using fluorescence activated cell sorting (FACS), the absolute CD4 T cell count will be determined and phenotyping of T effector cells (CD4+CD69+) and T regulatory cells (CD4+CD25+FoxP3+) with determination of absolute number of naive, effector and regulatory T cells as well as percents/ratios of total population will also be determined. Soluble factors such as cytokines, chemokines, soluble receptors and antibodies to tumor antigens will be measured via commercially available multiplex assays and enzyme-linked immunosorbent assays (ELISA) |
| Other | Evaluate Archival Tumor Expression of PD-L1 and PD-1 Expressing Tumor Infiltrating Lymphocytes | 2 years | To evaluate correlative biomarkers of systemic immune response among patients with recurrent/progressive grade II or III meningioma treated with single-agent nivolumab (cohort 1) and nivolumab plus ipilimumab after radiation therapy (cohort 2) |
| Other | Evaluate Archival Tumor Expression of Immune Gene Expression Signature Utilizing the Nanostring Assay | 2 years | To evaluate correlative biomarkers of systemic immune response among patients with recurrent/progressive grade II or III meningioma treated with single-agent nivolumab (cohort 1) and nivolumab plus ipilimumab after radiation therapy (cohort 2) |
| Other | Assess Mean Changes From Baseline in the Level of Function Score for Each Domain of the Neurologic Assessment in Neuro-Oncology (NANO) Scale | 2 years | Evaluation Of Neurologic Function As Measured By The NANO Scale. |
| Other | Determine Difference in Tumor Growth Rates Before and After Treatment That Would Allow Detection of Treatment Efficacy. | 2 years | Evaluation of change in tumor growth rate as measured by volumetric analysis |
| Other | Determine if There Are Pre-treatment Predictors of Treatment Response Using Radiomic Analysis | 2 years | Evaluation of change in tumor growth rate as measured by volumetric analysis |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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