Lung Cancer Clinical Trial
Brentuximab Vedotin With Pembrolizumab in Metastatic Solid Tumors
Summary
This trial will find out whether brentuximab vedotin and pembrolizumab work together to treat different types of cancer. There will be several different types of cancer studied in the trial. The cancer must have spread to other parts of the body (metastatic) and must have gotten worse (progressed) after being treated with a PD-1 inhibitor treatment.
The study will also find out what side effects occur. A side effect is anything the treatment does besides treat cancer.
This is a multi-cohort study.
Eligibility Criteria
Inclusion Criteria
Must have relapsed or refractory metastatic squamous or nonsquamous non-small cell lung cancer (NSCLC) (without known targetable EGFR, ALK, ROS1, or BRAF mutations) or metastatic cutaneous melanoma (regardless of mutation status)
Melanoma participants must be currently on PD-1 checkpoint inhibitor (CPI) therapy (e.g. nivolumab or pembrolizumab) or had their last dose of PD-1 CPI containing therapy as the last previous line of therapy within 90 days prior to enrollment; PD-1 checkpoint inhibitor therapy must be the immediate prior line of treatment.
Participants must have progressed on treatment with an anti-PD-1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies. PD-1 treatment progression is defined by meeting all of the following criteria.
Have received at least 2 doses of an approved anti-PD-1 mAb.
Have demonstrated disease progression (PD) after PD-1 as defined by RECIST v1.1.
Progressive disease has been documented within 90 days from the last dose of anti-PD-1 mAb.
Participants with melanoma will need iRECIST confirmation of progression with a second assessment at least four weeks after the initial date of progressive disease
NSCLC participants on PD-1 containing therapy for less than 90 days will need iRECIST confirmation of progression at least 4 weeks after the initial date of progressive disease
Tumor tissue sample obtained within 3 months prior to enrollment is required, and no systemic anticancer therapy given after the sample was obtained.
An Eastern Cooperative Oncology Group (ECOG) Performance Status score of equal or less than 1
Exclusion Criteria
Has known active CNS metastases and/or carcinomatous meningitis.
Prior immunosuppressive chemotherapy, any immunotherapy other than anti-PD1 within 4 weeks of first study drug dose.
History of another malignancy within 3 years before the first dose of study drug or any evidence of residual disease from a previously diagnosed malignancy.
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There are 28 Locations for this study
Tucson Arizona, 85704, United States More Info
Principal Investigator
Springdale Arkansas, 72762, United States More Info
Principal Investigator
Fresno California, 93720, United States More Info
Principal Investigator
Los Angeles California, 90025, United States More Info
Principal Investigator
Los Angeles California, 90048, United States More Info
Principal Investigator
San Marcos California, 92069, United States More Info
Principal Investigator
Aurora Colorado, 80045, United States More Info
Principal Investigator
Lone Tree Colorado, 80124, United States More Info
Principal Investigator
Chicago Ridge Illinois, 60415, United States More Info
Principal Investigator
Chicago Illinois, 60611, United States More Info
Principal Investigator
Iowa City Iowa, 52242, United States More Info
Principal Investigator
Kansas City Kansas, 66160, United States More Info
Principal Investigator
Louisville Kentucky, 40202, United States More Info
Principal Investigator
Detroit Michigan, 48202, United States
Minneapolis Minnesota, 55404, United States More Info
Principal Investigator
Las Vegas Nevada, 89169, United States
Clifton Park New York, 12065, United States More Info
Principal Investigator
Cincinnati Ohio, 45242, United States More Info
Principal Investigator
Toledo Ohio, 43623, United States More Info
Principal Investigator
Eugene Oregon, 97401, United States More Info
Principal Investigator
Austin Texas, 78731, United States More Info
Principal Investigator
Dallas Texas, 75246, United States More Info
Principal Investigator
Fort Worth Texas, 76104, United States More Info
Principal Investigator
Houston Texas, 77030, United States More Info
Principal Investigator
Fairfax Virginia, 22031, United States More Info
Principal Investigator
Norfolk Virginia, 23502, United States More Info
Principal Investigator
Roanoke Virginia, 24014, United States More Info
Principal Investigator
Seattle Washington, 98109, United States More Info
Principal Investigator
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