SRS and Nivolumab in Treating Patients With Newly Diagnosed Melanoma Metastases in the Brain or Spine
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|ClinicalTrials.gov Identifier: NCT02716948|
Recruitment Status : Recruiting
First Posted : March 23, 2016
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Malignant Neoplasm in the Brain Metastatic Malignant Neoplasm in the Spine Stage IV Skin Melanoma||Other: Laboratory Biomarker Analysis Biological: Nivolumab Radiation: Stereotactic Radiosurgery||Phase 1|
I. To assess the safety profile of stereotactic radiosurgery with nivolumab in combination to treat patients with newly diagnosed melanoma brain or spinal metastases.
I. To estimate local control rate in brain and spine. II. To estimate systematic control rate. III. To estimate progression-free survival.
I. To explore peripheral blood immune response during and after treatment.
Patients receive nivolumab intravenously (IV) over 60 minutes on day 1. Patients then undergo stereotactic radiosurgery on day 8 per standard of care. Courses with nivolumab repeats every 14 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, every 10 weeks, and then every 3 months thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Stereotactic Radiosurgery Combined With Nivolumab in Patients With Newly Diagnosed Melanoma Metastases in the Brain and Spine|
|Actual Study Start Date :||June 23, 2016|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||March 2022|
Experimental: Treatment (nivolumab, stereotactic radiosurgery)
Patients receive nivolumab IV over 60 minutes on day 1. Patients then undergo stereotactic radiosurgery on day 8 per standard of care. Courses with nivolumab repeats every 14 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Radiation: Stereotactic Radiosurgery
Undergo stereotactic radiosurgery
- Incidence of serious adverse events (SAE) graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) version 4.0 [ Time Frame: Up 12 weeks after first dose of study treatment ]All SAEs will be tabulated by type and grade. Proportion of individual type of SAE event will be estimated using the binomial distribution along with 95% confidence interval (exact method).
- Changes in the immune profile of peripheral blood during and after treatment with nivolumab in combination with stereotactic radiosurgery (immune response) [ Time Frame: Baseline to up to 12 months ]Correlative outcomes will be summarized using descriptive statistics. Logistic regression model will be considered to explore potential association between the control rate and correlative outcomes.
- Incidence of toxicity graded according to the NCI CTC 4.0 [ Time Frame: Up to 30 days after completion of study treatment ]Toxicity events will be tabulated by type and grade. The severity and frequency of the toxicity will be tabulated by the tested dose or doses using descriptive statistics. The proportions of patient who experienced grade 3 or above toxicities will be estimated, along with 95% confidence intervals by each type of toxicity.
- Local control rate in brain defined as no change in number of lesions at initial treatment in the brain and change on size of targeted lesion is =< 25% from initial measurement [ Time Frame: From date of initial nivolumab treatment to first date that progressive disease is objectively documented, assessed up to 3 years ]The local control rate will be estimated using binomial distribution along with 95% confidence. The duration of the local control will be summarized using median and range.
- Progression-free survival according to Response Evaluation Criteria in Solid Tumors criteria 1.1 [ Time Frame: From the date of initial diagnosis (at surgery) to the date of progressive disease was defined (documented), assessed up to 3 years ]The probability of progression-free survival will be estimated using the Kaplan-Meier method.
- Systematic control rate in spine defined as no change in number of lesions at initial treatment in the spine and change on size of targeted lesion is =< 25% from initial measurement [ Time Frame: Up to 3 years ]The systematic control rate will be estimated using binomial distribution along with 95% confidence.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02716948
|Contact: Kelly Szajna, RN, BSNemail@example.com|
|Contact: Whitney Webb, RN, MSNfirstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins University/Sidney Kimmel Cancer Center||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Michael K. Lim 410-614-1627 email@example.com|
|Principal Investigator: Michael K. Lim|
|Principal Investigator:||Michael Lim||Johns Hopkins University/Sidney Kimmel Cancer Center|