Clinical trial NCT04609566: Brentuximab Vedotin With Pembrolizumab in Metastatic Solid Tumors
Official title: A Phase 2 Study of Brentuximab Vedotin in Combination With Pembrolizumab in Subjects With Metastatic Solid Malignancies
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Melanoma
Non-small Cell Lung Cancer
Squamous Cell Carcinoma of the Head and Neck
Keywords: Seattle Genetics
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2020-10-30
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

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

* 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.

Primary outcomes:
measure: Confirmed objective response rate (ORR) based on investigator assessment using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Duration of response (DOR) based on investigator assessment using RECIST v1.1 criteria
timeFrame: Up to approximately 3 years
measure: Progression-free survival (PFS) based on investigator assessment using RECIST v1.1 criteria
timeFrame: Up to approximately 3 years
measure: ORR per iRECIST by investigator assessment
timeFrame: Up to approximately 2 years
measure: iDOR per iRECIST by investigator assessment
timeFrame: Up to approximately 3 years
measure: iPFS per iRECIST by investigator assessment
timeFrame: Up to approximately 3 years
measure: Incidence of adverse events (AEs)
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Oncology Associates, PC - HOPE
state: Arizona
city: Springdale
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Fresno
country: United States
facility: cCARE - Northern
state: California
city: Los Angeles
country: United States
facility: The Angeles Clinic and Research Institute
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute
state: California
city: San Marcos
country: United States
facility: California Cancer Associates for Research and Excellence Inc (cCARE)
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital / University of Colorado
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers - Aurora
state: Colorado
city: Hollywood
country: United States
facility: Memorial Healthcare System
state: Florida
city: Pembroke Pines
country: United States
facility: Memorial Healthcare System
state: Florida
city: Chicago Ridge
country: United States
facility: Affiliated Oncologists, LLC
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Cancer Center
state: Kansas
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology P.A.
state: Minnesota
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Clifton Park
country: United States
facility: New York Oncology Hematology, P.C.
state: New York
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Toledo
country: United States
facility: Toledo Clinic Cancer Center
state: Ohio
city: Eugene
country: United States
facility: Willamette Valley Cancer Institute and Research Center
state: Oregon
city: Austin
country: United States
facility: Texas Oncology - Austin Central
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Baylor Sammons Cancer Center
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology - Fort Worth 12th Avenue
state: Texas
city: Houston
country: United States
facility: Oncology Consultants, PA
state: Texas
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
city: Roanoke
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia
state: Virginia
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington
state: Washington
city: Ottawa
country: Canada
facility: University of Ottawa / Ottawa General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montreal
country: Canada
facility: McGill University Department of Oncology / McGill University Health Centre
state: Quebec
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: