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Metastatic Malignant Neoplasm in the BrainPhase 1NCT02716948

SRS and Nivolumab in Treating Patients With Newly Diagnosed Melanoma Metastases in the Brain or Spine

A Phase 1 study testing Laboratory Biomarker Analysis, Nivolumab and Stereotactic Radiosurgery in people with Metastatic Malignant Neoplasm in the Brain and Metastatic Malignant Neoplasm in the Spine, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase I pilot trial studies the side effects of stereotactic radiosurgery and nivolumab in treating patients with newly diagnosed melanoma that has spread to the brain or spine. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Laboratory Biomarker Analysis, Nivolumab and Stereotactic Radiosurgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteUnited States
Study dates
23 Jun 2016to 27 Aug 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically confirmed diagnosis of melanoma; the pathologic confirmation may be from another metastatic site or from metastatic brain or spine lesions
  • Patients must have stage IV melanoma, with newly identified brain or spine metastases
  • Patients must have measurable lesion in the brain or spine that is >= 3 mm seen on magnetic resonance imaging (MRI) with contrast; NOTE: contrasted pre-treatment MRI scan must be obtained =< 21 days prior to stereotactic radiosurgery treatment
  • Karnofsky performance scale >= 70%
  • Leukocytes >= 3,000/mcL
  • Absolute neutrophil count >= 1,500/mcL
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  • Platelets >= 100,000/mcL
  • Total bilirubin =< 2 x institutional upper limit of normal
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/ alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal
  • Creatinine within normal institutional limits OR according to Johns Hopkins MRI policy
  • Women of child bearing potential (WOCBP) must use a reliable form of contraception during the study treatment period and for up to 12 weeks following the last dose of study drug
  • Men must agree to the use of male contraception during the study treatment period and for at least 12 weeks after the last dose of study drug
  • Ability to understand and the willingness to sign written informed consent document(s)

Who cannot join

  • Prior whole brain radiation or conventional radiation to the spine at the site of new lesion
  • Prior chemotherapy within 28 days of starting treatment
  • Prior therapy with investigational drugs within 28 days or at least 5 half-lives (whichever is longer) before study administration
  • Prior therapy with an anti- programmed cell death 1 (PD-1), anti- programmed cell death-ligand 1 (PD-L1), or anti-PDL-2 antibody
  • Neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
  • Known allergy to compounds of similar chemical or biologic composition to nivolumab
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  • Pregnant or breastfeeding women
  • Known history of human immunodeficiency virus
  • Active infection requiring therapy, positive tests for hepatitis B surface antigen or hepatitis C ribonucleic acid (RNA)
  • Active autoimmune disease, history of autoimmune disease or history of syndrome that required systemic steroids or immunosuppressive medications, e.g. organ, tissue, or allogenic hematopoietic stem cell transplant (HSCT) recipients. Exceptions include those with vitiligo or resolved childhood asthma/atopy. Subjects with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study
  • Use of any live vaccines against infectious diseases up to 4 weeks (28 days) before receiving nivolumab. (NOTE: Inactivated seasonal influenza vaccines are permitted and do not require a 4-week waiting period before starting study treatment).
  • Prisoners or subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness
  • Patients with both brain and spine metastases will be excluded from the trial

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

Other trials in United States

About this study

Official title: A Pilot Study of Stereotactic Radiosurgery Combined With Nivolumab in Patients With Newly Diagnosed Melanoma Metastases in the Brain and Spine

This phase I pilot trial studies the side effects of stereotactic radiosurgery and nivolumab in treating patients with newly diagnosed melanoma that has spread to the brain or spine. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor to more precisely target the cancer. Monoclonal antibodies, such as nivolumab may interfere with the ability of tumor cells to grow and spread. Giving stereotactic radiosurgery together with nivolumab may be a better treatment for melanoma.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the safety profile of stereotactic radiosurgery with nivolumab in combination to treat patients with newly diagnosed melanoma brain or spinal metastases.

SECONDARY OBJECTIVES:

  1. To estimate local control rate in brain and spine. II. To estimate systematic control rate. III. To estimate progression-free survival.

TERTIARY OBJECTIVES:

  1. To explore peripheral blood immune response during and after treatment.

OUTLINE:

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.

Being tested
Laboratory Biomarker Analysis, Nivolumab, Stereotactic Radiosurgery
Medical subject headings
Brain Neoplasms, Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • NivolumabBiological

    Also called BMS-936558, MDX-1106, ONO-4538, Opdivo

    Given IV

  • Stereotactic RadiosurgeryRadiation

    Also called Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, Stereotactic Radiation Therapy, Stereotactic Radiotherapy

    Undergo stereotactic radiosurgery

Study groups in NCT02716948
Study groupRoleWhat they receive
Treatment (nivolumab, stereotactic radiosurgery)ExperimentalPatients 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.
Receives: Other: Laboratory Biomarker Analysis; Biological: Nivolumab; Radiation: Stereotactic Radiosurgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of serious adverse events (SAE) graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) version 4.0

    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).

    Measured: Up 12 weeks after first dose of study treatment

Secondary outcomes (5)

  1. Changes in the immune profile of peripheral blood during and after treatment with nivolumab in combination with stereotactic radiosurgery (immune response)

    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.

    Measured: Baseline to up to 12 months

  2. Incidence of toxicity graded according to the NCI CTC 4.0

    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.

    Measured: Up to 30 days after completion of study treatment

  3. 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

    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.

    Measured: From date of initial nivolumab treatment to first date that progressive disease is objectively documented, assessed up to 3 years

  4. Progression-free survival according to Response Evaluation Criteria in Solid Tumors criteria 1.1

    The probability of progression-free survival will be estimated using the Kaplan-Meier method.

    Measured: From the date of initial diagnosis (at surgery) to the date of progressive disease was defined (documented), assessed up to 3 years

  5. 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

    The systematic control rate will be estimated using binomial distribution along with 95% confidence.

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2016 (estimated)
  2. Study start23 Jun 2016
  3. Primary completion27 Aug 2021
  4. Study completion27 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02716948
Sponsor's protocol ID
J15214
Other IDs
NCI-2016-00370, IRB00086553
Status last verified
Nov 2021
First submitted
17 Mar 2016
Last updated
30 Nov 2021
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Laboratory Biomarker Analysis, Nivolumab and Stereotactic Radiosurgery in people with Metastatic Malignant Neoplasm in the Brain and Metastatic Malignant Neoplasm in the Spine, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02716948.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.

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