Brentuximab Vedotin With Pembrolizumab in Metastatic Solid Tumors

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    110
  • sponsor
    Seagen Inc.
Updated on 26 May 2022
cancer
melanoma skin
lung cancer
BRAF
progressive disease
pembrolizumab
ROS1
EGFR
nivolumab
targeted therapy
pd-1 inhibitor
lung carcinoma
malignant melanoma of skin
metastatic cutaneous melanoma
proto-oncogene tyrosine-protein kinase ros

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.

Details
Condition Melanoma, Non-small Cell Lung Cancer
Treatment Pembrolizumab, brentuximab vedotin
Clinical Study IdentifierNCT04609566
SponsorSeagen Inc.
Last Modified on26 May 2022

Eligibility

Yes No Not Sure

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 demonstrated disease progression (PD) after PD-1 as defined by RECIST v1.1
Have received at least 2 doses of an approved anti-PD-1 mAb
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
Tumor tissue sample obtained within 3 months prior to enrollment is required, and no
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
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

Prior immunosuppressive chemotherapy, any immunotherapy other than anti-PD1 within 4 weeks of first study drug dose
Has known active CNS metastases and/or carcinomatous meningitis
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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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