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Pembrolizumab in Treating Patients With Advanced Uveal Melanoma | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Pembrolizumab in Treating Patients With Advanced Uveal Melanoma

A Multicenter Phase II Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) in Patients With Advanced Uveal Melanoma

NCT02359851•Vanderbilt-Ingram Cancer Center

View on ClinicalTrials.gov

Summary

This phase II trial studies how well pembrolizumab works in treating patients with uveal melanoma that has spread to other places in the body and usually cannot be cured or controlled with treatment. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells.

Detailed Description

PRIMARY OBJECTIVES: I. To evaluate objective response rate (ORR) in patients with advanced uveal melanoma receiving pembrolizumab. SECONDARY OBJECTIVES: I. To evaluate progression-free survival (PFS) in patients with advanced uveal melanoma receiving pembrolizumab. II. To evaluate safety, tolerability and adverse experience profile of pembrolizumab in uveal melanoma. III. To evaluate overall survival (OS) in patients with advanced uveal melanoma receiving pembrolizumab. TERTIARY OBJECTIVES: I. To evaluate objective response rate (ORR; complete response + partial response) in patients with advanced uveal melanoma receiving pembrolizumab as stratified by programmed cell death-ligand 1 (PD-L1) expression and guanine nucleotide-binding protein (GNA)Q/GNA11 mutation status. II. To evaluate ORR in patients previously treated with ipilimumab or with mitogen-activated protein kinase kinase (MEK) inhibitors. OUTLINE: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 3 weeks for 24 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 12 weeks.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Be willing and able to provide written informed consent/assent for the trial
•Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
•Histologic confirmation of advanced (metastatic or unresectable) uveal melanoma. If uveal melanoma has been diagnosed clinically and/or by gene expression profiling, patients may be included following discussion with the principal investigator.
•Have provided tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion
•Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
•Absolute neutrophil count (ANC) \>= 1,500/mcL
•Platelets \>= 100,000/mcL
•Hemoglobin \>= 9 g/dL or \>= 5.6 mmol/L
•Serum creatinine =\< 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate \[GFR\] can also be used in place of creatinine or creatinine clearance \[CrCl\]) \>= 60 mL/min for subject with creatinine levels \> 1.5 X institutional ULN; creatinine clearance should be calculated per institutional standard
•Serum total bilirubin =\< 1.5 X ULN OR direct bilirubin =\< ULN for subjects with total bilirubin levels \> 1.5 ULN
+6 more criteria

Exclusion Criteria

•Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment
•Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
•Has had a prior monoclonal antibody within 4 weeks prior to study day 1 or who has not recovered (i.e., =\< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
•Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., =\< grade 1 or at baseline) from adverse events due to a previously administered agent
•* Note: subjects with =\< grade 2 neuropathy are an exception to this criterion and may qualify for the study
•* Note: if subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
•Has a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy
•Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis; subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment
•Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjögren's syndrome will not be excluded from the study
•Has evidence of interstitial lung disease or active, non-infectious pneumonitis
+8 more criteria

Locations (2)

University of Chicago

Chicago, Illinois, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Key Dates

Start Date

May 1, 2015

Primary Completion Date

May 1, 2017

Completion Date

August 27, 2019

Last Updated

September 18, 2019

Enrollment

ACTUAL participants

Conditions

Stage IIIA Uveal MelanomaStage IIIB Uveal MelanomaStage IIIC Uveal MelanomaStage IV Uveal Melanoma

Interventions

Pembrolizumab

BIOLOGICAL

Laboratory Biomarker Analysis

OTHER

Neoadjuvant and Adjuvant Checkpoint Blockade

NCT02519322

Cutaneous MelanomaMucosal Melanoma+9 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 18, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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