18 and older, any sex, with Metastatic Malignant Neoplasm in the Brain or Metastatic Melanoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Dose Limiting ToxicitiesPrimary· 3 months after first pembrolizumab dose
Number of dose limiting toxicity events defined as Radiation Therapy Oncology Group grade 3 central nervous system toxicities which are irreversible severe neurological symptoms requiring medications. Toxicity events for each arm will be reported, and 95% confidence intervals will be estimated using the Clopper-Pearson method. Number of with DLT (%).
Group
Value
95% CI
Experimental: Arm A (Pembrolizumab, 30 Gray (Gy) Over 5 Fractions)
0
0 – 46
Experimental: Arm B (Pembrolizumab, 27 Gy Over 3 Fractions)
0
0 – 26
Experimental: Arm C (Pembrolizumab, 18-21 Gy in One Fraction)
0
0 – 41
Overall SurvivalSecondary· From first treatment on cycle 1, day 1 to the earlier of date of death and/or last follow up, assessed up to 3 years
Time from treatment initiation to death from any cause. Those who were alive were censored at last follow-up. Estimated using the Kaplan-Meier product-limit method. Median and 95% CI using Brookmeyer-Crowley method reported.
Group
Value
95% CI
Experimental: Arm A (Pembrolizumab, 30 Gray (Gy) Over 5 Fractions)
NA
0.99 – NA
Experimental: Arm B (Pembrolizumab, 27 Gy Over 3 Fractions)
32.8
4.89 – NA
Experimental: Arm C (Pembrolizumab, 18-21 Gy in One Fraction)
12.2
2.86 – NA
Rate of Symptomatic Radiation NecrosisSecondary· Up to 12 months after first pembrolizumab dose
Defined as proportion with evidence of necrosis on MRI images (radiographic evidence or radionecrosis) and a patient having neurological symptoms attributed to the location where the radiosurgery was done. The proportion will be reported, and a 95% confidence interval will be estimated using the Clopper-Pearson method. Number with symptomatic radiation necrosis.
Group
Value
95% CI
Arm A (Pembrolizumab, SRS 6 Gy, CLOSED):
0
0 – 46
Arm B (Pembrolizumab, SRS 9 Gy)
16.7
2.1 – 48
Arm C (Pembrolizumab, SRS 18-21 Gy)
14.3
0.3 – 58
Clinical Benefit (Intra-cranial)Secondary· From the first treatment on cycle 1, day 1 to the earlier of the recurrence event and/or last follow up/death, at least 6 months
Defined as proportion with a best overall response of stable disease or better for intracranial lesions present at baseline. Assessed using RECIST and immune RECIST Criteria. The proportion will be reported, and a 95% confidence interval will be estimated using the Clopper-Pearson method. Number with clinical benefit (%).
Group
Value
95% CI
Experimental: Arm A (Pembrolizumab, 30 Gray (Gy) Over 5 Fractions)
100
48 – 100
Experimental: Arm B (Pembrolizumab, 27 Gy Over 3 Fractions)
60
26 – 88
Experimental: Arm C (Pembrolizumab, 18-21 Gy in One Fraction)
20
0.5 – 72
Clinical Benefit (Extra-cranial)Secondary· From the first treatment on cycle 1, day 1 to the earlier of the recurrence event and/or last follow up/death, at least 6 months
Defined as proportion with a best overall response of stable disease or better for extra-cranial lesions present at baseline. Assessed using RECIST and immune RECIST Criteria. Assessed using RECIST and immune RECIST Criteria. The proportion will be reported, and a 95% confidence interval will be estimated using the Clopper-Pearson method. Number with clinical benefit (%).
Group
Value
95% CI
Experimental: Arm A (Pembrolizumab, 30 Gray (Gy) Over 5 Fractions)
60
15 – 95
Experimental: Arm B (Pembrolizumab, 27 Gy Over 3 Fractions)
55
23 – 83
Experimental: Arm C (Pembrolizumab, 18-21 Gy in One Fraction)
33
4 – 78
Adverse events — posted to ClinicalTrials.gov
Time frame: Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Experimental: Arm A (Pembrolizumab, 30 Gray (Gy) Over 5 Fractions)
Serious: 2/6 (33%)
Deaths: 3/6
Experimental: Arm B (Pembrolizumab, 27 Gy Over 3 Fractions)
Serious: 5/12 (42%)
Deaths: 7/12
Experimental: Arm C (Pembrolizumab, 18-21 Gy in One Fraction)
This pilot trial studies the side effects of giving pembrolizumab together with stereotactic radiosurgery to treat patients with melanoma or non-small cell lung cancer that has spread to the brain. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Giving pembrolizumab together with stereotactic radiosurgery may be a better treatment for patients with melanoma or non-small cell lung cancer that has spread to the brain.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem
· Phase 2, PHASE3
· not yet recruiting
NCT07275216 — Pembrolizumab in Combination With Chemotherapy for the Treatment of Frail Hodgkin Lymphoma Patients Ineligible for Stand
· Phase 2
· not yet recruiting
NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan
· Phase 1, PHASE2
· recruiting
NCT06724042 — Study of ISM5939 in Patients With Advanced and/or Metastatic Solid Tumors
· Phase 1
· not yet recruiting
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
· Phase 3
· not yet recruiting
Other recruiting trials for Metastatic Malignant Neoplasm in the Brain
Currently open trials in the same condition.
NCT07339085 — Advanced Magnetic Resonance Imaging for the Identification of Recurrent Brain Tumors and Radiation Necrosis
· NA
· recruiting
NCT06500455 — Testing Longer Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With Cancer That Has Spread to
· Phase 3
· recruiting
NCT06650163 — Zr-89 Crefmirlimab Berdoxam and Immuno-Positron Emission Tomography for the Imaging of Patients With Resectable Brain Tu
· Phase 1
· recruiting
NCT06328686 — Arginine and Whole Brain Radiation Therapy for the Treatment of Patients With Brain Metastases
· EARLY_PHASE1
· recruiting
NCT05588453 — Natural Killer Cell Therapy (UD TGFbetai NK Cells) and Temozolomide for the Treatment of Stage IV Melanoma Metastatic to
· Phase 1, PHASE2
· recruiting
Other Emory University trials
Trials by the same sponsor.
NCT06143345 — HIIT in Isolated IFG: A Proof-of-Concept Study
· NA
· withdrawn
NCT07189819 — Innovative Closed-loop Functional Electrical Stimulation Control System for Augmenting Post-stroke Gait
· NA
· not yet recruiting
NCT06451055 — Low-calorie Diet in Isolated Impaired Fasting Glucose
· NA
· not yet recruiting
NCT07405476 — Zanidatamab Before Surgery for the Treatment of HER2 Positive Colon and Rectal Cancer in Patients Planned for Curative I
· Phase 2
· recruiting
NCT06708351 — Enhancing Cervical Cancer Screening and Treatment in Women Living With HIV in Kenya, the ENHANCE LINKAge Trial
· NA
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Emory University
Last refreshed: 9 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02858869.