RECRUITING
I'm interested ...!!
Brentuximab Vedotin With Pembrolizumab in Metastatic Solid Tumors
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). 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.
Conditions:
🦠 Melanoma 🦠 Non-small Cell Lung Cancer 🦠 Squamous Cell Carcinoma of the Head and Neck
🗓️ Study Start (Actual) 26 January 2021
🗓️ Primary Completion (Estimated) 31 October 2025
✅ Study Completion (Estimated) 30 September 2026
👥 Enrollment (Estimated) 140
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Tucson, Arizona, United States
📍 Springdale, Arkansas, United States
📍 Fresno, California, United States
📍 Los Angeles, California, United States
📍 Los Angeles, California, United States
📍 San Marcos, California, United States
📍 Aurora, Colorado, United States
📍 Denver, Colorado, United States
📍 Hollywood, Florida, United States
📍 Pembroke Pines, Florida, United States
📍 Chicago Ridge, Illinois, United States
📍 Chicago, Illinois, United States
📍 Iowa City, Iowa, United States
📍 Kansas City, Kansas, United States
📍 Louisville, Kentucky, United States
📍 Detroit, Michigan, United States
📍 Minneapolis, Minnesota, United States
📍 Omaha, Nebraska, United States
📍 Las Vegas, Nevada, United States
📍 Clifton Park, New York, United States
📍 Cincinnati, Ohio, United States
📍 Toledo, Ohio, United States
📍 Eugene, Oregon, United States
📍 Austin, Texas, United States
📍 Dallas, Texas, United States
📍 Fort Worth, Texas, United States
📍 Houston, Texas, United States
📍 Fairfax, Virginia, United States
📍 Norfolk, Virginia, United States
📍 Richmond, Virginia, United States
📍 Roanoke, Virginia, United States
📍 Seattle, Washington, United States
📍 Ottawa, Ontario, Canada
📍 Montreal, Quebec, Canada
📍 Montreal, Quebec, Canada
More locations available...

📋 Eligibility Criteria

Description

  • Inclusion Criteria
  • * Participants must have
  • * Metastatic squamous or nonsquamous non-small cell lung cancer (NSCLC) (without known targetable EGFR, ALK, ROS1, or BRAF mutations) who either
  • * a) have not yet received frontline therapy for metastatic disease and without prior exposure to anti PD-1/PD-L1 or
  • * b) are relapsed/refractory with progression on anti PD-1/PD therapy.
  • * Relapsed/refractory metastatic cutaneous melanoma (regardless of mutation status) with progression on a PD-1 inhibitor
  • * Metastatic head and neck squamous cell carcinoma (HNSCC) who have not yet received frontline therapy for metastatic disease and without prior exposure to a PD-1/PD-L1 inhibitor.
  • * Cohorts 1-4 only: 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 CPI therapy must be the immediate prior line of treatment.
  • * Cohorts 1-4 only: Participants must have progressed on treatment with an anti-PD-1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other CPIs 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 PD-1 inhibitor.
  • * Have demonstrated disease progression (PD) after a PD-1 inhibitor as defined by RECIST v1.1.
  • * Progressive disease has been documented within 90 days from the last dose of PD-1 inhibitor.
  • * 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 inhibitor 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 central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • * Prior immunosuppressive chemotherapy, any immunotherapy other than a PD-1 inhibitor 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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 23 October 2020
  • First Submitted that Met QC Criteria 23 October 2020
  • First Posted 30 October 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 22 July 2024
  • Last Update Posted 23 July 2024
  • Last Verified July 2024
I'm interested ...!!