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8110 Gatehouse Road, Falls Church, VA 22042

A Phase 2 Study of Brentuximab Vedotin in Combination with Pembrolizumab in Subjects with Metastatic Solid Malignancies After Progression on Prior PD-1 Inhibitor Treatment (SGN35-033)

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General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT04609566

Background Information

This clinical trial will use a drug called brentuximab vedotin. The Food and Drug Administration (FDA) has approved brentuximab vedotin for sale in the United States for certain diseases, but not for melanoma. The brand name for brentuximab vedotin is ADCETRIS®. Brentuximab vedotin is still being studied in clinical trials like this one to find out about the side effects and if it works in certain kinds of lung and skin cancers.

In this study, brentuximab vedotin will be given along with another drug called pembrolizumab (also called KEYTRUDA®). This combination of these two drugs is investigational. “Investigational” means that the drug combination is not approved by the FDA. Pembrolizumab is a type of anticancer drug. Pembrolizumab is approved by the FDA to treat several types of cancer.

Brentuximab vedotin with pembrolizumab is being studied to find out what the side effects are and to see if these study drugs work for skin cancer. Learning about the side effects of these drugs and how they work together will help understand if they’re better or worse than other treatments.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Dr.
Fairfax, VA 22031

A department of Inova Fairfax Hospital

Eligibility Information

  • Adults, 18 years of age or older
  • Subjects with relapsed or refractory metastatic squamous or nonsquamous NSCLC (EGFR, ALK, ROS1, and BRAF negative) or metastatic cutaneous melanoma (including subjects without targetable gene mutations and BRAF-V600E/V600K subjects who have failed targeted therapy).
  • Subjects must be currently on PD-1 CPI therapy (nivolumab or pembrolizumab) or had their last dose of PD-1 checkpoint inhibitor therapy within 90 days prior to enrollment; PD-1 inhibitor therapy must be the last previous line of therapy.
  • Subjects must have progressed on treatment in the metastatic setting with an anti-PD1 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:

    a. Subjects with refractory disease must have progressed without a prior objective response during or after prior PD-1 inhibitor therapy within 3 months.
    OR
    b. Subjects with relapsed diseased must have progressed after having developed a prior objective response of CR/PR for at least 3 months or SD for at least 6 months.
    AND
    c. Has received at least 2 doses of an approved anti-PD-1. d. Has demonstrated disease progression (PD) after PD-1
     
  • Additional eligibility in protocol.

Ineligibility Information

  • Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
  • Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy (e.g., immunoglobulin replacement, other monoclonal antibody therapies) 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. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year overall survival ≥90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.
  • History of progressive multifocal leukoencephalopathy (PML).
  • Active cerebral/meningeal disease related to the underlying malignancy. Subjects with a history of cerebral/meningeal disease related to the underlying malignancy are allowed if prior CNS disease has been treated definitively.
  • Subjects who are pregnant or breastfeeding.
  • Known hypersensitivity to any excipient contained in the drug formulation of brentuximab vedotin or pembrolizumab.
  • Known to be positive for hepatitis B by surface antigen expression. Known to be positive for hepatitis C infection (positive by polymerase chain reaction or on antiviral therapy for hepatitis C within the last 6 months). Subjects who have been treated for hepatitis C infection are permitted if they have documented sustained virologic response of 12 weeks.
  • Previous treatment with brentuximab vedotin.
  • Current therapy with other systemic anti-neoplastic or investigational agents.
  • Grade 3 or higher pulmonary disease unrelated to underlying malignancy.
  • Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association Class III-IV within 6 months prior to their first dose of brentuximab vedotin.
  • Additional ineligibility in protocol.

Additional information can be found at: https://clinicaltrials.gov/ct2/show/NCT04609566