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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-00069 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This early phase I study collects blood samples and monitors the levels of pembrolizumab and nivolumab as they move through the body in patients with melanoma and/or non-small cell lung cancer. Pembrolizumab and nivolumab are a monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Studying samples of blood in the laboratory from patients receiving pembrolizumab and nivolumab may help doctors learn more about the effects of pembrolizumab and nivolumab on cells. It may also help doctors understand how well patients respond to treatment. Information from this study may be used in the future to guide physicians to make dosage adjustments based on serum concentrations of drug to minimize adverse side effects and maximize the effect of the drug.
PRIMARY OBJECTIVE:
I. To perform a steady-state PK study on patients who are taking monoclonal antibody therapy (25 patients starting pembrolizumab and 25 patients starting nivolumab for melanoma or non-small cell lung cancer).
II. Develop and validate a liquid chromatography tandem mass spectrometry (LC-MS/MS) assay to measure pembrolizumab and nivolumab in serum.
III. Measure patient samples for pembrolizumab/nivolumab at various clinical time points.
IV. Use the pharmacokinetic data (drug concentrations) to determine the area under the curve (AUC), maximum observed serum concentration (Cmax), clearance, half-life (t1/2), and trough steady-state drug concentrations.
V. Compare the data to the clinical efficacy (defined using Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria)1, as well as, presence of auto-immune side effects using multiple variable regression modeling in Statistical Analysis System (SAS) version (v)9.4 or other statistical software.
OUTLINE:
Patients undergo collection of blood samples and have medical records reviewed on study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (biospecimen collection, chart review) | Patients undergo collection of blood samples and have medical records reviewed on study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of blood samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| Development and validation of a laboratory developed test (LDT) using liquid chromatography tandem mass spectrometry to measure pemborlizumab and nivolumab. | Verify the accuracy, precision, linearity, sensitivity and specificity of a mass spectrometry assay for pembrolizumab and nivolumab in serum | Up to 1 year |
| Measurement of patient samples for pembrolizumab | Using a validated LDT liquid chromatography tandem mass spectrometry assay measure the concentration of pembrolizumab in serum. | Through study completion at several time points, an average of 3 weeks after taking pembrolizumab for at least 21 weeks. |
| Measurement of patient samples for nivolumab | Using a validated LDT liquid chromatography tandem mass spectrometry assay measure the concentration of nivolumab in serum. | Through study completion at several time points, an average of 1 month after taking nivolumab for at least 14 weeks |
| Correlation of steady-state concentrations of pembrolizumab correlate with clinical efficacy and/or toxicity | Will assess if therapeutic drug monitoring correlates with efficacy and/or toxicity of pembrolizumab. Concentrations in serum will be determined using a LDT mass spectrometry assay. | Through study completion, an average of 3 weeks after taking pembrolizumab for at least 21 weeks. |
| Correlation of steady-state concentrations of nivolumab correlate with clinical efficacy | Will assess if therapeutic drug monitoring correlates with efficacy and/or toxicity of nivolumab. Concentrations in serum will be determined using a LDT mass spectrometry assay. | Through study completion, an average of 1 month after taking nivolumab for at least 14 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with melanoma or non-small cell lung cancer who are taking monoclonal antibody therapy at Mayo Clinic Cancer Center
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| Name | Affiliation | Role |
|---|---|---|
| Paul J Jannetto | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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Serum
| Electronic Health Record Review | Other | Medical records are reviewed |
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Clinical efficacy | Tumor response will be determined using Response Evaluation Criteria in Solid Tumors1.1 criteria. Clinical efficacy defined as achieving an objective response (complete response or partial response) versus stable disease, or disease progression. | After 6 months (24 weeks or more) of treatment |
| Presence of auto-immune side effects | Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse events, version 4.0. Investigators will indicate if it was potentially immune related (i.e. grade 3-4 adverse events such as pneumonitis, diarrhea/colitis, hypophysitis/adrenal insufficiency, hyper/hypothyroidism, autoimmune hepatitis, severe skin reactions, nephritis/kidney failure, uveitis, myositis) in combination with other basic laboratory tests that are routinely monitored. Will use multiple variable regression modeling in Statistical Analysis System version 9.4 or other statistical software. | Through study completion, an average of 1 month |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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