Brentuximab Vedotin With Pembrolizumab in Metastatic Solid Tumors

• Status: Recruiting
• Trial end date: 2023-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seagen Inc.
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Brentuximab Vedotin; Pembrolizumab

Criteria

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 (including participants without targetable gene mutations and BRAF-V600E/V600K participants who have failed targeted therapy)

• 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 within 90 days prior to enrollment; PD-1 inhibitor therapy must be the last previous line of therapy.

• 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.

• Participants with refractory disease must have progressed without a prior objective response during or after prior PD-1 inhibitor therapy within 3 months or have stable disease (SD) for <6 months OR

• Participants with relapsed diseased must have progressed after having developed a prior objective response of CR/PR for at least 3 months or SD for at least 6 months AND

• 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.

• 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, therapeutic radiation, or any immunotherapy 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.