Brentuximab Vedotin With Pembrolizumab in Metastatic Solid Tumors

Phase 2

Active, not recruiting

• Conditions: Non-small Cell Lung Cancer; Melanoma; Squamous Cell Carcinoma of the Head and Neck
• Interventions: Drug: brentuximab vedotin; Drug: pembrolizumab

• Registration Number: NCT04609566
• Lead Sponsor: Seagen, a wholly owned subsidiary of Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-23
• Study First Submitted QC: 2020-10-23
• Study First Posted: 2020-10-30
• Study Start: 2021-01-26
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-23
• Last Update Posted: 2025-06-26
• Primary Completion: 2029-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination Therapy	brentuximab vedotin	brentuximab vedotin + pembrolizumab
Combination Therapy	pembrolizumab	brentuximab vedotin + pembrolizumab

Primary Outcome Measures

Name	Time	Method
Confirmed objective response rate (ORR) based on investigator assessment using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria	Up to approximately 2 years	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.

Secondary Outcome Measures

Name	Time	Method
Duration of response (DOR) based on investigator assessment using RECIST v1.1 criteria	Up to approximately 3 years	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.
Progression-free survival (PFS) based on investigator assessment using RECIST v1.1 criteria	Up to approximately 3 years	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.
ORR per iRECIST by investigator assessment	Up to approximately 2 years	ORR per iRECIST is defined as the proportion of participants with confirmed CR or PR based on iRECIST guidelines
iDOR per iRECIST by investigator assessment	Up to approximately 3 years	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.
iPFS per iRECIST by investigator assessment	Up to approximately 3 years	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.
Incidence of adverse events (AEs)	Up to approximately 2 years	National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Analyses of AEs will be summarized with descriptive statistics.

Trial Locations

Locations (52)

Arizona Oncology Associates, PC - HOPE; 🇺🇸 Tucson, Arizona, United States

Highlands Oncology Group, PA; 🇺🇸 Springdale, Arkansas, United States

California Cancer Associates for Research and Excellence, Inc (cCARE); 🇺🇸 Encinitas, California, United States

California Cancer Associates for Research and Excellence, Inc. cCARE; 🇺🇸 Fresno, California, United States

The Angeles Clinic And Research Institute, A Cedars-Sinai Affiliate; 🇺🇸 Los Angeles, California, United States

Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute (SOCCI); 🇺🇸 Los Angeles, California, United States

California Cancer Associates for Research and Excellence Inc (cCARE); 🇺🇸 San Marcos, California, United States

The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate (Emergency Back-Up Only); 🇺🇸 Santa Monica, California, United States

Rocky Mountain Cancer Centers, LLP; 🇺🇸 Thornton, Colorado, United States

Clinical and Translational Research Center (CTRC); 🇺🇸 Aurora, Colorado, United States

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