Description:
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.
Title
- Brief Title: Brentuximab Vedotin With Pembrolizumab in Metastatic Solid Tumors
- 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
Clinical Trial IDs
- ORG STUDY ID:
SGN35-033
- SECONDARY ID:
KEYNOTE B81
- NCT ID:
NCT04609566
Conditions
- Melanoma
- Non-small Cell Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
brentuximab vedotin | ADCETRIS | Combination Therapy |
pembrolizumab | KEYTRUDA | Combination Therapy |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Combination Therapy | Experimental | brentuximab vedotin + pembrolizumab | - brentuximab vedotin
- pembrolizumab
|
Eligibility 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Confirmed objective response rate (ORR) based on investigator assessment using RECIST 1.1 criteria |
Time Frame: | Up to approximately 2 years |
Safety Issue: | |
Description: | 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
Measure: | Duration of response (DOR) based on investigator assessment using RECIST 1.1 criteria |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | 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. |
Measure: | Progression-free survival (PFS) based on investigator assessment using RECIST 1.1 criteria |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | PFS is defined as the time from start of study treatment to first documentation of objective tumor progression (PD per RECIST 1.1) |
Measure: | ORR per iRECIST by investigator assessment |
Time Frame: | Up to approximately 2 years |
Safety Issue: | |
Description: | 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 |
Measure: | DOR per iRECIST by investigator assessment |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
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. |
Measure: | Incidence of adverse events (AEs) |
Time Frame: | Up to approximately 2 years |
Safety Issue: | |
Description: | National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Analyses of AEs will be summarized with descriptive statistics. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Seagen Inc. |
Trial Keywords
Last Updated
August 17, 2021