Brentuximab Vedotin With Pembrolizumab in Metastatic Solid Tumors
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|ClinicalTrials.gov Identifier: NCT04609566|
Recruitment Status : Recruiting
First Posted : October 30, 2020
Last Update Posted : August 17, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma Non-small Cell Lung Cancer||Drug: brentuximab vedotin Drug: pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Brentuximab Vedotin in Combination With Pembrolizumab in Subjects With Metastatic Solid Malignancies After Progression on Prior PD-1 Inhibitor Treatment|
|Actual Study Start Date :||January 26, 2021|
|Estimated Primary Completion Date :||March 31, 2022|
|Estimated Study Completion Date :||September 30, 2023|
Experimental: Combination Therapy
brentuximab vedotin + pembrolizumab
Drug: brentuximab vedotin
1.8 mg/kg given into the vein (IV; intravenously) every 3 weeks
Other Name: ADCETRIS
200 mg given intravenously every 3 weeks
Other Name: KEYTRUDA
- Confirmed objective response rate (ORR) based on investigator assessment using RECIST 1.1 criteria [ Time Frame: Up to approximately 2 years ]Confirmed ORR per RECIST 1.1 is defined as the proportion of participants whose best overall response is a confirmed complete response (CR) or partial response (PR) per RECIST 1.1.
- Duration of response (DOR) based on investigator assessment using RECIST 1.1 criteria [ Time Frame: Up to approximately 3 years ]DOR per RECIST 1.1 is defined as the time from start of the first documentation of confirmed objective tumor response (CR or PR) per RECIST 1.1 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 1.1 criteria [ Time Frame: 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 1.1)
- ORR per iRECIST by investigator assessment [ Time Frame: Up to approximately 2 years ]ORR per RECIST 1.1 is defined as the proportion of participants whose best overall response is confirmed CR or PR based on iRECIST guidelines
- DOR per iRECIST by investigator assessment [ Time Frame: 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.
- Incidence of adverse events (AEs) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04609566
|Contact: Seagen Trial Information Supportemail@example.com|
|Study Director:||Scott Knowles, MD, PhD||Seagen Inc.|