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Brentuximab Vedotin With Pembrolizumab in Metastatic Solid Tumors

Sponsor
Seagen Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04609566
Collaborator
Merck Sharp & Dohme LLC (Industry)
110
Enrollment
26
Locations
1
Arm
29.1
Anticipated Duration (Months)
4.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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) 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
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
110 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 :
Jan 26, 2021
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Combination Therapy

brentuximab vedotin + pembrolizumab

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

    • Drug: pembrolizumab
    200 mg given intravenously every 3 weeks
    Other Names:
  • KEYTRUDA

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Confirmed objective response rate (ORR) based on investigator assessment using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) criteria [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.

    Secondary Outcome Measures

    1. Duration of response (DOR) based on investigator assessment using RECIST 1.1 criteria [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.

    2. Progression-free survival (PFS) based on investigator assessment using RECIST 1.1 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 1.1)

    3. ORR per iRECIST by investigator assessment [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

    4. DOR 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.

    5. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria

    • Must have relapsed or refractory metastatic squamous or nonsquamous non-small cell lung cancer (NSCLC) (without known targetable EGFR, ALK, ROS1, or BRAF mutations) or metastatic cutaneous melanoma (regardless of mutation status)

    • 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 checkpoint inhibitor therapy must be the immediate prior line of treatment.

    • Participants must have progressed on treatment with an anti-PD-1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other checkpoint inhibitors 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 anti-PD-1 mAb.

    • Have demonstrated disease progression (PD) after PD-1 as defined by RECIST v1.1.

    • Progressive disease has been documented within 90 days from the last dose of anti-PD-1 mAb.

    • 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 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 CNS metastases and/or carcinomatous meningitis.

    • Prior immunosuppressive chemotherapy, any immunotherapy other than anti-PD1 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Oncology Associates, PC - HOPE Tucson Arizona United States 85704
    2 cCARE - Northern Fresno California United States 93720
    3 The Angeles Clinic and Research Institute Los Angeles California United States 90025
    4 Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute Los Angeles California United States 90048
    5 California Cancer Associates for Research and Excellence Inc (cCARE) San Marcos California United States 92069
    6 University of Colorado Hospital / University of Colorado Aurora Colorado United States 80045
    7 Rocky Mountain Cancer Centers Lone Tree Colorado United States 80124
    8 Affiliated Oncologists, LLC Chicago Ridge Illinois United States 60415
    9 Northwestern University Chicago Illinois United States 60611
    10 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
    11 University of Kansas Cancer Center Kansas City Kansas United States 66160
    12 Norton Cancer Institute Louisville Kentucky United States 40202
    13 Henry Ford Health System Detroit Michigan United States 48202
    14 Minnesota Oncology Hematology P.A. Minneapolis Minnesota United States 55404
    15 Comprehensive Cancer Centers of Nevada Las Vegas Nevada United States 89169
    16 New York Oncology Hematology, P.C. Clifton Park New York United States 12065
    17 Oncology Hematology Care Cincinnati Ohio United States 45242
    18 Toledo Clinic Cancer Center Toledo Ohio United States 43623
    19 Willamette Valley Cancer Institute and Research Center Eugene Oregon United States 97401
    20 Texas Oncology - Austin Central Austin Texas United States 78731
    21 Texas Oncology - Baylor Sammons Cancer Center Dallas Texas United States 75246
    22 Texas Oncology - Fort Worth 12th Avenue Fort Worth Texas United States 76104
    23 Inova Schar Cancer Institute Fairfax Virginia United States 22031
    24 Virginia Oncology Associates Norfolk Virginia United States 23502
    25 Oncology and Hematology Associates of Southwest Virginia Roanoke Virginia United States 24014
    26 Seattle Cancer Care Alliance / University of Washington Seattle Washington United States 98109-1023

    Sponsors and Collaborators

    • Seagen Inc.
    • Merck Sharp & Dohme LLC

    Investigators

    • Study Director: Scott Knowles, MD, PhD, Seagen Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seagen Inc.
    ClinicalTrials.gov Identifier:
    NCT04609566
    Other Study ID Numbers:
    • SGN35-033
    • KEYNOTE B81
    First Posted:
    Oct 30, 2020
    Last Update Posted:
    Aug 17, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Seagen Inc.
    Seattle Genetics
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung
    Pembrolizumab
    Brentuximab Vedotin

    Study Results

    No Results Posted as of Aug 17, 2022