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Low Dose Ipilimumab With Pembrolizumab in Treating Patients With Melanoma That Has Spread to the Brain
Phase 2 trial testing Ipilimumab in Clinical Stage IV Cutaneous Melanoma AJCC v8 in 24 participants. Completed in 21 August 2025.
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 21 February 2019 |
| Primary completion | 21 August 2025 |
| Estimated completion | 21 August 2025 |
| Sites | 1 location across United States |
M.D. Anderson Cancer Center — full company profile →
18 and older, any sex, with Clinical Stage IV Cutaneous Melanoma AJCC v8 or Metastatic Malignant Neoplasm in the Brain. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
clinical benefit rate (CBR), defined as CR + PR + SD \> 6 months, in the brain in subjects with MBM per modified RECIST 1.1 criteria who are treatment naïve to anti-PD-1 agents in metastatic setting (prior adjuvant anti-PD1 allowed).
| Group | Value | 95% CI |
|---|---|---|
| Cohort A: Treatment Naïve | 68.4 |
Assess CBR in the brain in subjects with MBM per modified RECIST 1.1 in patients who previously progressed on PD-1 inhibitors.
| Group | Value | 95% CI |
|---|---|---|
| Cohort B: Previously Progressed on PD-1 Inhibitors | 1 |
Assess OS and PFS.
| Group | Value | 95% CI |
|---|---|---|
| Cohort A: Treatment Naïve | 11.8 | 1.4 – NA |
| Cohort B: Previously Progressed on PD-1 Inhibitors | 1.4 | 1.3 – NA |
| Group | Value | 95% CI |
|---|---|---|
| Cohort A: Treatment Naïve | NA | 5.7 – NA |
| Cohort B: Previously Progressed on PD-1 Inhibitors | 11.0 | 8.8 – NA |
Evaluate the brain-specific safety and tolerability of the combination regimen in subjects with or without SRT received prior to study entry, or on study.
| Group | Value | 95% CI |
|---|---|---|
| Cohort A: Treatment Naïve | 0 | |
| Cohort B: Previously Progressed on PD-1 Inhibitors | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Cohort A: Treatment Naïve | 5 | |
| Cohort B: Previously Progressed on PD-1 Inhibitors | 0 |
Time frame: Approximately 4 years and 10 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Cohort A: Treatment Naïve | Cohort B: Previously Progr… |
|---|---|---|---|
| Cough/dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Thromboembolic event | Vascular disorders | — | — |
| Rash maculopapular | Skin and subcutaneous tissue disorders | — | — |
| ALT increased | Investigations | — | — |
| Hypotension | Vascular disorders | — | — |
| Fall | General disorders | — | — |
| Pruritis | Skin and subcutaneous tissue disorders | — | — |
| AST increased | Investigations | — | — |
| Lymphocyte count decrased | Investigations | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — |
| Nervous system disorders - Other, left sided hemiparesis | Nervous system disorders | — | — |
| Intracranial hemorrhage | Nervous system disorders | — | — |
| Colonic perforation | Gastrointestinal disorders | — | — |
| Syncope | Nervous system disorders | — | — |
| Hypoglycemia | Metabolism and nutrition disorders | — | — |
| Confusion | Psychiatric disorders | — | — |
| Reaction | System | Cohort A: Treatment Naïve | Cohort B: Previously Progr… |
|---|---|---|---|
| Fatigue | General disorders | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Creatinine increased | Investigations | — | — |
| Headache | Metabolism and nutrition disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — |
| Pain | General disorders | — | — |
| Alkaline phosphatase increased | Investigations | — | — |
| Cognitive disturbance | Nervous system disorders | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Hypercalcemia | Metabolism and nutrition disorders | — | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — |
| Gait disturbance | General disorders | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — |
| Blurred vision | Eye disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Edema limbs | General disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| Hypophosphatemia | Metabolism and nutrition disorders | — | — |
| Hypothyroidism | Endocrine disorders | — | — |
| Paraesthesia | Nervous system disorders | — | — |
| Proteinuria | Renal and urinary disorders | — | — |
| Weight loss | Investigations | — | — |
| White blood cell decreased | Investigations | — | — |
| Dry skin | Skin and subcutaneous tissue disorders | — | — |
| Hyperuricemia | Metabolism and nutrition disorders | — | — |
| Hypotension | Vascular disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — | — |
| Skin hypopigmentation | Skin and subcutaneous tissue disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — |
| Ataxia | Nervous system disorders | — | — |
| Back Pain | Musculoskeletal and connective tissue disorders | — | — |
Most-reported serious reactions: Cough/dyspnea, Thromboembolic event, Rash maculopapular, ALT increased, Hypotension, Fall, Pruritis, AST increased.
Data from ClinicalTrials.gov NCT03873818 adverse events section.
This phase II trial studies the side effects and how well low dose ipilimumab works in combination with pembrolizumab in treating patients with melanoma that has spread to the brain. Immunotherapy with monoclonal antibodies, such as ipilimumab and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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