Stereotactic Radiosurgery and Immune Checkpoint Inhibitors with NovoTTF-200M for the Treatment of Melanoma Brain Metastases

Active:	Yes
Cancer Type:	Melanoma	NCT ID:	NCT05341349
Trial Phases:	Phase I	Protocol IDs:	RAD5236-21 (primary) NCI-2021-05980 STUDY00003588
Eligibility:	22 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT05341349

Summary

This phase I trial finds out the side effects and possible benefits of stereotactic radiosurgery and immune checkpoint inhibitors with NovoTTF-200M for the treating of melanoma that has spread to the brain (brain metastases). Stereotactic radiosurgery is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. It is used to treat brain tumors and other brain disorders that cannot be treated by regular surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. NovoTTF-200M is a portable battery operated device which produces tumor treating fields in the body by means of surface electrodes placed on the skin. Tumor treating fields are low intensity, intermediate frequency electric fields that pulse through the skin to disrupt cancer cells' ability to divide. Giving stereotactic radiosurgery and immune checkpoint inhibitors with NovoTTF-200M may work better than stereotactic radiosurgery and immune checkpoint inhibitors.

Objectives

PRIMARY OBJECTIVE:
I. To determine the safety of combining tumor treating fields therapy (TTFields) to the two therapeutic backbones (stereotactic radiosurgery [SRS]+pembrolizumab and SRS+dual-checkpoint.

SECONDARY OBJECTIVES:
I. To evaluate skin toxicity (grade 1 & 2 dermatitis > 20% and grade 3 & 4 toxicity above 2% at 4-6 weeks and 3 months).
II. Control of the treated lesion in the brain with SRS+ immune checkpoint inhibitors (ICI) (i.e. local control), development of additional sites of disease in the brain that were not initially treated with SRS (i.e. anywhere intra-cranial failure), intra-cranial progression free survival (local control of the area that received SRS and anywhere intra-cranial failure), extra-cranial disease response (overall progression free survival), and overall survival.
III. To evaluate treatment response at un-irradiated and extra-cranial sites (i.e. the abscopal effect) with all three arms.
IV. To compare differences in potential serological and immune biomarkers, pretreatment, during treatment, and post treatment.
V. Symptomatic radionecrosis rates at 3 and 6 months.

OUTLINE: Patients are assigned to 1 of 2 arms.

ARM I: Patients receive standard of care pembrolizumab and undergo 3-5 fractions SRS. Patients also undergo TTFields over 8 hours daily using NovoTTF-200M device until intra-cranial progression or until end of immunotherapy treatments at the discretion of the treating physician in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, magnetic resonance imaging (MRI), computed tomography (CT) and/or position emission tomography (PET) during screening and on study.

ARM II: Patients receive standard of care nivolumab and ipilimumab and undergo 3-5 fractions SRS. Patients also undergo TTFields over 8 hours daily using NovoTTF-200M device until intra-cranial progression or until end of immunotherapy treatments at the discretion of the treating physician in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, MRI, CT and/or PET during screening and on study.

After completion of study treatment, patients are followed up for 28 days.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.