Brentuximab Vedotin With Pembrolizumab in Metastatic Solid Tumors

Non-small Cell Lung Cancer Clinical Trial

Official title:

A Phase 2 Study of Brentuximab Vedotin in Combination With Pembrolizumab in Subjects With Metastatic Solid Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04609566
• Other study ID #: SGN35-033
• Secondary ID: KEYNOTE-B81MK-34
• Status: Recruiting
• Phase: Phase 2
• Start date: January 26, 2021
• Est. completion date: September 30, 2026

Study information

• Verified date: June 2024
• Source: Seagen Inc.
• Contact: Seagen Trial Information Support
• Phone: 866-333-7436
• Email: clinicaltrials[@]seagen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: September 30, 2026
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma
• Non-small Cell Lung Cancer
• Squamous Cell Carcinoma of Head and Neck
• Squamous Cell Carcinoma of the Head and Neck

Intervention

Drug:
• brentuximab vedotin
1.8 mg/kg given into the vein (IV; intravenously) every 3 weeks
• pembrolizumab
200 mg given intravenously every 3 weeks

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec
Canada	McGill University Department of Oncology / McGill University Health Centre	Montreal	Quebec
Canada	University of Ottawa / Ottawa General Hospital	Ottawa	Ontario
United States	University of Colorado Hospital / University of Colorado	Aurora	Colorado
United States	Texas Oncology - Austin Central	Austin	Texas
United States	Northwestern University	Chicago	Illinois
United States	Affiliated Oncologists, LLC	Chicago Ridge	Illinois
United States	Oncology Hematology Care	Cincinnati	Ohio
United States	New York Oncology Hematology, P.C.	Clifton Park	New York
United States	Texas Oncology - Baylor Sammons Cancer Center	Dallas	Texas
United States	Rocky Mountain Cancer Centers - Aurora	Denver	Colorado
United States	Henry Ford Health System	Detroit	Michigan
United States	Willamette Valley Cancer Institute and Research Center	Eugene	Oregon
United States	Inova Schar Cancer Institute	Fairfax	Virginia
United States	Texas Oncology - Fort Worth 12th Avenue	Fort Worth	Texas
United States	cCARE - Northern	Fresno	California
United States	Memorial Healthcare System	Hollywood	Florida
United States	Oncology Consultants, PA	Houston	Texas
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	University of Kansas Cancer Center	Kansas City	Kansas
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute	Los Angeles	California
United States	The Angeles Clinic and Research Institute	Los Angeles	California
United States	Norton Cancer Institute	Louisville	Kentucky
United States	Minnesota Oncology Hematology P.A.	Minneapolis	Minnesota
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Memorial Healthcare System	Pembroke Pines	Florida
United States	Virginia Commonwealth University Medical Center	Richmond	Virginia
United States	Oncology and Hematology Associates of Southwest Virginia	Roanoke	Virginia
United States	California Cancer Associates for Research and Excellence Inc (cCARE)	San Marcos	California
United States	Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington	Seattle	Washington
United States	Highlands Oncology Group	Springdale	Arkansas
United States	Toledo Clinic Cancer Center	Toledo	Ohio
United States	Arizona Oncology Associates, PC - HOPE	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Seagen Inc.	Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmed objective response rate (ORR) based on investigator assessment using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria	Confirmed ORR per RECIST v1.1 is defined as the proportion of participants whose best overall response is a confirmed complete response (CR) or partial response (PR) per RECIST v1.1.	Up to approximately 2 years
Secondary	Duration of response (DOR) based on investigator assessment using RECIST v1.1 criteria	DOR per RECIST v1.1 is defined as the time from start of the first documentation of confirmed objective tumor response (CR or PR) per RECIST v1.1 to the first documentation of PD (per RECIST v1.1) or to death due to any cause, whichever comes first.	Up to approximately 3 years
Secondary	Progression-free survival (PFS) based on investigator assessment using RECIST v1.1 criteria	PFS is defined as the time from start of study treatment to first documentation of objective tumor progression (PD per RECIST v1.1), or to death due to any cause, whichever comes first.	Up to approximately 3 years
Secondary	ORR per iRECIST by investigator assessment	ORR per iRECIST is defined as the proportion of participants with confirmed CR or PR based on iRECIST guidelines	Up to approximately 2 years
Secondary	iDOR per iRECIST by investigator assessment	DOR per iRECIST is defined as the time from first documentation of confirmed objective response (CR or PR) based on iRECIST guidelines by investigator assessment to the first documentation of confirmed objective tumor progression per iRECIST by investigator assessment, or to death due to any cause, whichever comes first.	Up to approximately 3 years
Secondary	iPFS per iRECIST by investigator assessment	iPFS is defined as the time from start of study treatment to the first documentation of confirmed objective tumor progression per iRECIST by investigator assessment, treatment discontinuation following the unconfirmed progression or death due to any cause, whichever comes first.	Up to approximately 3 years
Secondary	Incidence of adverse events (AEs)	National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Analyses of AEs will be summarized with descriptive statistics.	Up to approximately 2 years