The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.

Clinical Trial Details

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Other or Multiple Cancer Types

Brentuximab vedotin

A Phase 2 Study of Brentuximab Vedotin in Combination With Pembrolizumab in Subjects With Metastatic Solid Malignancies
Phase 2
NCT04609566

Active enrolling

Globe
Locations

United States, Canada

Study design

Participant Group/Arm

EXPERIMENTAL: Combination Therapy

brentuximab vedotin + pembrolizumab

Intervention/Treatment

DRUG: brentuximab vedotin

1.8 mg/kg given into the vein (IV; intravenously) every 3 weeks

DRUG: pembrolizumab

200 mg given intravenously every 3 weeks

Key eligibility criteria

Inclusion 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
  • Participants must have
    • 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 inhibito
  • 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.
  • 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.
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.

Key dates

Study start date
  • January 2021
Estimated primary completion date
  • September 2026

Key endpoints

Primary Outcome Measures
Outcome Measure

Confirmed objective response rate (ORR) based on investigator assessment using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria

Measure Description

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.

Time Frame

Up to approximately 2 years

Secondary Outcome Measures:
Outcome Measure

Duration of response (DOR) based on investigator assessment using RECIST v1.1 criteria

Measure Description

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.

Time Frame

Up to approximately 3 years

Outcome Measure

Progression-free survival (PFS) based on investigator assessment using RECIST v1.1 criteria

Measure Description

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.

Time Frame

Up to approximately 3 years

Outcome Measure

ORR per iRECIST by investigator assessment

Measure Description

ORR per iRECIST is defined as the proportion of participants with confirmed CR or PR based on iRECIST guidelines

Time Frame

Up to approximately 2 years

Outcome Measure

iDOR per iRECIST by investigator assessment

Measure Description

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.

Time Frame

Up to approximately 3 years

Outcome Measure

iPFS per iRECIST by investigator assessment

Measure Description

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.

Time Frame

Up to approximately 3 years

Outcome Measure

Incidence of adverse events (AEs)

Measure Description

National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Analyses of AEs will be summarized with descriptive statistics.

Time Frame

Up to approximately 2 years

Number of participants

140

Collaborators and investigators

Sponsor: Seagen Inc.

Collaborator: Merck Sharp & Dohme LLC

This information is current as of May 28th 2024.