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A Phase II a Study of Lenvatinib, a Multi-targeted Tyrosine Kinase Inhibitor, Combined With Pembrolizumab (PD-1 Inhibitor) for the Treatment of Metastatic Gastroesophageal Cancer Patients Who Have Progressed on First or Subsequent Line Therapies
Phase 2 trial testing Lenvatinib in GastroEsophageal Cancer in 24 participants. Completed in 16 January 2024.
| Lead sponsor | NYU Langone Health |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 24 October 2017 |
| Primary completion | 10 March 2023 |
| Estimated completion | 16 January 2024 |
| Sites | 2 locations across United States |
NYU Langone Health — full company profile →
Adults 18 to 100, any sex, with GastroEsophageal Cancer or Gastric Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall response rate as measured by RECIST 1.1; percentage of participants who experience a best overall response of either Complete Response (CR) or Partial Response (PR).
| Group | Value | 95% CI |
|---|---|---|
| Lenvatinib & Pembrolizumab | 25 | 8.7 – 49 |
Estimated using Kaplan-Meier curve; interval from start of treatment to death due to any cause.
| Group | Value | 95% CI |
|---|---|---|
| Lenvatinib & Pembrolizumab | 21.4 | 15.7 – 74.0 |
Estimated using Kaplan-Meier Curves; interval between the date of start of treatment and the earlier date of objective disease progression per RECIST 1.1 criteria or death due to any cause in the absence of progression.
| Group | Value | 95% CI |
|---|---|---|
| Lenvatinib & Pembrolizumab | 12.9 | 8.6 – 41.3 |
Time frame: 18 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Lenvatinib & Pembrolizumab |
|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Alkaline Phosphatase Increased | Investigations | — |
| Back Pain | Musculoskeletal and connective tissue disorders | — |
| Blood Bilirubin Increased | Investigations | — |
| Small Intestinal Obstruction | Gastrointestinal disorders | — |
| Confusion | Psychiatric disorders | — |
| Death Nos | General disorders | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Fall | Injury, poisoning and procedural complications | — |
| Generalized Muscle Weakness | Musculoskeletal and connective tissue disorders | — |
| Acute Kidney Injury | Renal and urinary disorders | — |
| Gastric Hemorrhage | Gastrointestinal disorders | — |
| Hepatic Failure | Hepatobiliary disorders | — |
| Lung Infection | Infections and infestations | — |
| Renal Colic | Renal and urinary disorders | — |
| Sepsis | Infections and infestations | — |
| Reaction | System | Lenvatinib & Pembrolizumab |
|---|---|---|
| Lymphocyte Count Decreased | Investigations | — |
| Nausea | General disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Fatigue | General disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| White Blood Cell Count Decreased | Investigations | — |
| Platelet Count Decreased | Investigations | — |
| Aspartate Aminotransferase Increased | Investigations | — |
| Diarrhea | Gastrointestinal disorders | — |
| Headache | Nervous system disorders | — |
| Hypokalemia | Metabolism and nutrition disorders | — |
| Proteinuria | Renal and urinary disorders | — |
| Hypertension | Vascular disorders | — |
| Hypocalcemia | Metabolism and nutrition disorders | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — |
| Dizziness | Nervous system disorders | — |
| Weight Loss | Investigations | — |
| Alanine Aminotransferase Increased | Investigations | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Chills | General disorders | — |
| Ast Increased | Investigations | — |
| Creatinine Increased | Investigations | — |
| Dry Mouth | Gastrointestinal disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Fever | General disorders | — |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | — |
| Insomnia | Psychiatric disorders | — |
| Neutrophil Count Decreased | Investigations | — |
| Pruritis | Skin and subcutaneous tissue disorders | — |
| Rash Acneiform | Skin and subcutaneous tissue disorders | — |
| ALT increased | Investigations | — |
| Ascites | Gastrointestinal disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Dry Skin | Skin and subcutaneous tissue disorders | — |
| Dysgeusia | Nervous system disorders | — |
| Dyspepsia | Gastrointestinal disorders | — |
| Dysphagia | Gastrointestinal disorders | — |
| Flank Pain | Musculoskeletal and connective tissue disorders | — |
Most-reported serious reactions: Abdominal Pain, Anorexia, Vomiting, Alkaline Phosphatase Increased, Back Pain, Blood Bilirubin Increased, Small Intestinal Obstruction, Confusion.
Data from ClinicalTrials.gov NCT03321630 adverse events section.
This is an open label, single arm phase II study, to determine the overall response rate for the combination of lenvatinib and pemrolizumab in patients with metastatic gastroesophageal cancer who have progressed on first or subsequent line therapies. Given the significant cross talk between angiogenesis and the immune response, combined therapy with lenvatinib and pemrolizumab in advanced gastroesophageal cancer patient will provide improved outcomes compared to standard treatment with currently approved agents.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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