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Trial record 1 of 1 for:    NCT: 04609566
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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 : January 25, 2023
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Seagen Inc.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Melanoma Non-small Cell Lung Cancer Squamous Cell Carcinoma of the Head and Neck Drug: brentuximab vedotin Drug: pembrolizumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 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 : January 26, 2021
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: ADCETRIS

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


Outcome Measures
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Primary Outcome Measures :
  1. Confirmed objective response rate (ORR) based on investigator assessment using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria [ Time Frame: 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 :
  1. Duration of response (DOR) based on investigator assessment using RECIST v1.1 criteria [ Time Frame: 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.

  2. Progression-free survival (PFS) based on investigator assessment using RECIST v1.1 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 v1.1), or to death due to any cause, whichever comes first.

  3. ORR per iRECIST by investigator assessment [ Time Frame: Up to approximately 2 years ]
    ORR per iRECIST is defined as the proportion of participants with confirmed CR or PR based on iRECIST guidelines

  4. iDOR 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.

  5. iPFS per iRECIST by investigator assessment [ Time Frame: 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.

  6. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Seagen Trial Information Support 866-333-7436 clinicaltrials@seagen.com

Locations
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Sponsors and Collaborators
Seagen Inc.
Merck Sharp & Dohme LLC
Investigators
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Study Director: Scott Knowles, MD, PhD Seagen Inc.
More Information
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Responsible Party: Seagen Inc.
ClinicalTrials.gov Identifier: NCT04609566    
Other Study ID Numbers: SGN35-033
KEYNOTE B81 ( Other Identifier: Merck & Co )
First Posted: October 30, 2020    Key Record Dates
Last Update Posted: January 25, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Squamous Cell Carcinoma of Head and Neck
Neoplasms by Site
Neoplasms
Neoplasms by Histologic Type
Carcinoma, Squamous Cell
Carcinoma
 Neoplasms, Glandular and Epithelial
Head and Neck Neoplasms
Pembrolizumab
Brentuximab Vedotin
Antineoplastic Agents, Immunological
Antineoplastic Agents