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.

View Eligibility Criteria

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.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

140

Study ID:

NCT04609566

Recruitment Status:

Recruiting

Sponsor:

Seagen Inc.

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There are 30 Locations for this study

See Locations Near You

Arizona Oncology Associates, PC - HOPE
Tucson Arizona, 85704, United States More Info
Stacey Kimball
Contact
520-324-4778
[email protected]
Richard Rosenberg
Principal Investigator
Highlands Oncology Group
Springdale Arkansas, 72762, United States More Info
J. Thaddeus Beck
Principal Investigator
cCARE - Northern
Fresno California, 93720, United States More Info
Stephanie Lopez
Contact
559-326-1222
[email protected]
Steven Hager
Principal Investigator
The Angeles Clinic and Research Institute
Los Angeles California, 90025, United States More Info
Teresa Mata
Contact
310-231-2115
[email protected]
Inderjit Mehmi
Principal Investigator
Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute
Los Angeles California, 90048, United States More Info
Inderjit Mehmi
Principal Investigator
California Cancer Associates for Research and Excellence Inc (cCARE)
San Marcos California, 92069, United States More Info
Negia Gamboa
Contact
Edward McClay
Principal Investigator
University of Colorado Hospital / University of Colorado
Aurora Colorado, 80045, United States More Info
Sarah Dickens
Contact
[email protected]
Karl Lewis
Principal Investigator
Rocky Mountain Cancer Centers
Lone Tree Colorado, 80124, United States More Info
Robert Jotte
Principal Investigator
Memorial Healthcare System
Hollywood Florida, 33021, United States More Info
Atif Hussein
Principal Investigator
Affiliated Oncologists, LLC
Chicago Ridge Illinois, 60415, United States More Info
Rami Haddad
Principal Investigator
Northwestern University
Chicago Illinois, 60611, United States More Info
Ginny Keeling
Contact
312-695-1365
[email protected]
Sunandana Chandra
Principal Investigator
University of Iowa Hospitals and Clinics
Iowa City Iowa, 52242, United States More Info
Yousef Zakharia
Principal Investigator
University of Kansas Cancer Center
Kansas City Kansas, 66160, United States More Info
Gary Doolittle
Principal Investigator
Norton Cancer Institute
Louisville Kentucky, 40202, United States More Info
Tabatha Matsumoto
Contact
[email protected]
John Hamm
Principal Investigator
Henry Ford Health System
Detroit Michigan, 48202, United States
Minnesota Oncology Hematology P.A.
Minneapolis Minnesota, 55404, United States More Info
Lynn Anderson
Contact
612-884-6331
[email protected]
Timothy Larson
Principal Investigator
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89169, United States
New York Oncology Hematology, P.C.
Clifton Park New York, 12065, United States More Info
Ambri Cicchinelli
Contact
518-489-2607
[email protected]
Stephen Wrzesinski
Principal Investigator
Oncology Hematology Care
Cincinnati Ohio, 45242, United States More Info
Nicole Clary
Contact
800-710-4674
[email protected]
Patrick Ward
Principal Investigator
Toledo Clinic Cancer Center
Toledo Ohio, 43623, United States More Info
Jennifer Martinez
Contact
419-479-5605
[email protected]
Rex Mowat
Principal Investigator
Willamette Valley Cancer Institute and Research Center
Eugene Oregon, 97401, United States More Info
Roosevelt Anderson
Contact
541-741-3451
[email protected]
Joseph Fiorillo
Principal Investigator
Texas Oncology - Austin Central
Austin Texas, 78731, United States More Info
Francisca Fernandez
Contact
512-427-9400
[email protected]
Jeffrey Yorio
Principal Investigator
Texas Oncology - Baylor Sammons Cancer Center
Dallas Texas, 75246, United States More Info
Rita Lopez
Contact
214-370-1846
[email protected]
Charles Cowey
Principal Investigator
Texas Oncology - Fort Worth 12th Avenue
Fort Worth Texas, 76104, United States More Info
Nori Sullivan
Contact
817-413-1760
[email protected]
Rachel Theriault
Principal Investigator
Oncology Consultants, PA
Houston Texas, 77030, United States More Info
Julio Peguero
Principal Investigator
Inova Schar Cancer Institute
Fairfax Virginia, 22031, United States More Info
Stephanie Van Bebber
Contact
571-472-4724
[email protected]
Sekwon Jang
Principal Investigator
Virginia Oncology Associates
Norfolk Virginia, 23502, United States More Info
Wendi Gobhardt
Contact
[email protected]
Graham Watson
Principal Investigator
Oncology and Hematology Associates of Southwest Virginia
Roanoke Virginia, 24014, United States More Info
Amanda Gillespie-Twardy
Principal Investigator
Seattle Cancer Care Alliance / University of Washington
Seattle Washington, 98109, United States More Info
Rebecca Wood
Contact
206-606-6970
[email protected]
Sylvia Lee
Principal Investigator
Jewish General Hospital
Montreal Quebec, H3T1E, Canada More Info
Wilson Miller
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

140

Study ID:

NCT04609566

Recruitment Status:

Recruiting

Sponsor:


Seagen Inc.

How clear is this clinincal trial information?

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