NCT05341349

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

Active, enrolled Phase 1 Last updated 30 July 2025

What this trial tests

Phase 1 trial testing Ipilimumab in Clinical Stage IV Cutaneous Melanoma AJCC v8 in 1 participant. Participants enrolled and being followed up; not accepting new ones.

Timeline

13 October 2022

Primary endpoint
6 March 2026

6 March 2027

Quick facts

Lead sponsor	Emory University
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1
Start date	13 October 2022
Primary completion	6 March 2026
Estimated completion	6 March 2027
Sites	1 location across United States

Drugs / interventions tested

• Ipilimumab — full drug profile →
• Nivolumab (nivolumab) — full drug profile →
• Pembrolizumab (pembrolizumab) — full drug profile →
• Stereotactic Radiosurgery
• Tumor Treating Fields Therapy

Conditions studied

• Clinical Stage IV Cutaneous Melanoma AJCC v8 — all drugs for Clinical Stage IV Cutaneous Melanoma AJCC v8 →
• Melanoma of Unknown Primary — all drugs for Melanoma of Unknown Primary →
• Metastatic Malignant Neoplasm in the Brain — all drugs for Metastatic Malignant Neoplasm in the Brain →
• Metastatic Melanoma — all drugs for Metastatic Melanoma →

Sponsor

Emory University

Who can join

22 and older, any sex, with Clinical Stage IV Cutaneous Melanoma AJCC v8 or Melanoma of Unknown Primary. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I trial finds out the side effects and possible benefits of stereotactic radiosurgery and immune checkpoint inhibitors with NovoTTF-100M 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-100M 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-100M may work better than stereotactic radiosurgery and immune checkpoint inhibitors.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Therapeutic potential of tumor treating fields for malignant brain tumors.
   Zhou Y, Xing X, Zhou J, Jiang H, et al · · 2023 · cited 8× · PMID 36987739 · DOI 10.1002/cnr2.1813
2. Current Status and Molecular Mechanisms of Resistance to Immunotherapy in Oral Malignant Melanoma.
   Usta SZ, Uchihashi T, Kodama S, Kurioka K, et al · · 2023 · cited 5× · PMID 38139110 · DOI 10.3390/ijms242417282
3. Tumor-Treating Fields and Related Treatments in the Management of Pediatric Brain Tumors.
   Rousseau J, Lapointe S, Roberge D. · · 2025 · cited 3× · PMID 40277742 · DOI 10.3390/curroncol32040185
4. Building Team Medicine in the Management of CNS Metastases.
   Baskaran AB, Buerki RA, Khan OH, Gondi V, et al · · 2023 · cited 3× · PMID 37373596 · DOI 10.3390/jcm12123901
5. Delayed and Concurrent Stereotactic Radiosurgery in Immunotherapy-Naïve Melanoma Brain Metastases.
   Hadley CE, Matsui JK, Blakaj DM, Beyer S, et al · · 2024 · cited 1× · PMID 39594689 · DOI 10.3390/cancers16223733
6. The role of radiotherapy in immunotherapy strategies in the central nervous system.
   Gallitto M, Pan PC, Chan MD, Milano MT, et al · · 2024 · cited 1× · PMID 38437664 · DOI 10.1093/neuonc/noad184
7. Immune Modulation in Cancer: The Role of Tumor-Treating Fields (TTFields).
   Liu M, Hage ME, Zhao J, Linnebacher M. · · 2025 · PMID 41347753 · DOI 10.1002/cpz1.70270
8. Advancement in tumor treating fields of mechanism, clinical applications, and future directions.
   Zang M, Zhu S, Niu Q. · · 2025 · PMID 40495024 · DOI 10.1007/s12672-025-02861-0