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Pembrolizumab Plus Bevacizumab for Treatment of Brain Metastases in Metastatic Melanoma or Non-small Cell Lung Cancer (NSCLC)
Phase 2 trial testing Pembrolizumab plus Bevacizumab in Melanoma in 41 participants. Completed in 31 March 2025.
| Lead sponsor | Yale University |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 41 |
| Start date | 1 May 2016 |
| Primary completion | 11 September 2024 |
| Estimated completion | 31 March 2025 |
| Sites | 2 locations across United States |
Yale University
18 and older, any sex, with Melanoma or Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Brain metastasis response rate (BMRR) using modified RECIST (mRECIST) criteria
| Group | Value | 95% CI |
|---|---|---|
| Untreated Brain Metastases From Melanoma | 54.1 | |
| Untreated Brain Metastases From NSCLC | 75 |
Number of patients using steroids to control of cerebral edema for greater than 96 hours
| Group | Value | 95% CI |
|---|---|---|
| Untreated Brain Metastases From Melanoma | 3 | |
| Untreated Brain Metastases From NSCLC | 1 |
best overall response rate (ORR) by mRECIST criteria in the brain or RECIST criteria in the body
| Group | Value | 95% CI |
|---|---|---|
| Untreated Brain Metastases From Melanoma | 54.1 | |
| Untreated Brain Metastases From NSCLC | 75 |
| Group | Value | 95% CI |
|---|---|---|
| Untreated Brain Metastases From Melanoma | 56.3 | |
| Untreated Brain Metastases From NSCLC | 75 |
Progression-free survival by mRECIST criteria in the brain or RECIST criteria in the body
| Group | Value | 95% CI |
|---|---|---|
| Untreated Brain Metastases From Melanoma | 2.2 | 0.41 – NA |
| Untreated Brain Metastases From NSCLC | NA | NA – NA |
| Group | Value | 95% CI |
|---|---|---|
| Untreated Brain Metastases From Melanoma | 1.2 | 0.23 – NA |
| Untreated Brain Metastases From NSCLC | NA | NA – NA |
Number of participants that experienced at least 1 treatment related adverse event.
| Group | Value | 95% CI |
|---|---|---|
| Untreated Brain Metastases From Melanoma | 32 | |
| Untreated Brain Metastases From NSCLC | 3 |
Time frame: up to 2 years from the start of treatment. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Untreated Brain Metastases… | Untreated Brain Metastases… |
|---|---|---|---|
| Investigations - Other, specify | Investigations | — | — |
| Hypophysitis | Endocrine disorders | — | — |
| Wound dehiscence and infection | Vascular disorders | — | — |
| Pericardial tamponade | Cardiac disorders | — | — |
| Reaction | System | Untreated Brain Metastases… | Untreated Brain Metastases… |
|---|---|---|---|
| Headache | Nervous system disorders | — | — |
| Fatigue | General disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Arthralgias | Musculoskeletal and connective tissue disorders | — | — |
| Investigations - Other, specify | Investigations | — | — |
| Hypothyroidism | Endocrine disorders | — | — |
| Pruritis | Skin and subcutaneous tissue disorders | — | — |
| Vitiligo | Skin and subcutaneous tissue disorders | — | — |
| Motor neuropathy | Nervous system disorders | — | — |
| Sensory neuropathy | Nervous system disorders | — | — |
| Investigations - Other, specify | Investigations | — | — |
| Investigations - Other, specify | Investigations | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Investigations - Other, specify | Investigations | — | — |
| Mucositis | Gastrointestinal disorders | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — | — |
| Proteinuria | Renal and urinary disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| Thromboembolic Event | Vascular disorders | — | — |
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — |
| Adrenal insufficiency | Endocrine disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Dry eyes | Eye disorders | — | — |
| Investigations - Other, specify | Investigations | — | — |
| Failure to thrive | Metabolism and nutrition disorders | — | — |
| Hematuria | Renal and urinary disorders | — | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — |
| Bruising | Injury, poisoning and procedural complications | — | — |
| Gingival bleed | General disorders | — | — |
| Microscopic diverticular perforation | Gastrointestinal disorders | — | — |
| Stroke | Nervous system disorders | — | — |
| Dysarthria | Nervous system disorders | — | — |
| Tremor | Nervous system disorders | — | — |
| Ataxia | Nervous system disorders | — | — |
| Encephalitis | Nervous system disorders | — | — |
| Peripheral Sensory Neuropathy | Nervous system disorders | — | — |
| General disorders and administration site conditions - Other, specify | General disorders | — | — |
| Infections and infestations - Other, specify | Infections and infestations | — | — |
Most-reported serious reactions: Investigations - Other, specify, Hypophysitis, Wound dehiscence and infection, Pericardial tamponade.
Data from ClinicalTrials.gov NCT02681549 adverse events section.
The purpose of this phase 2 trial is to study the activity of pembrolizumab in combination with bevacizumab in patients with untreated brain metastases from melanoma or NSCLC to determine activity and safety of the drug combination. Furthermore, in patients who undergo resection of biopsy of a brain metastasis, we will evaluate biomarkers predictive of treatment benefit, and will also conduct correlative biomarker studies on extra-cerebral specimens in all patients in whom a systemic biopsy is feasible or in archival tumor tissue when available. A total of 53 eligible patients will be enrolled on this trial (40 with melanoma and 13 with NSCLC). Individual cohorts of the study can be stopped if insufficient activity is observed in the first stage of that cohort. The study will accrue for approximately 84 months, and will be open for approximately 12 additional months as patients on study are being followed.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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