NCT04609566
Completed
Phase 2
A Phase 2 Study of Brentuximab Vedotin in Combination With Pembrolizumab in Participants With Metastatic Solid Malignancies
Seagen, a wholly owned subsidiary of Pfizer119 sites in 1 country161 target enrollmentJanuary 26, 2021
Overview
- Phase
- Phase 2
- Intervention
- brentuximab vedotin
- Conditions
- Melanoma
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
- Enrollment
- 161
- Locations
- 119
- Primary Endpoint
- Confirmed objective response rate (ORR) based on investigator assessment using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria
- Status
- Completed
- Last Updated
- last month
Overview
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.
Investigators
Eligibility 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.
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.
Arms & Interventions
Combination Therapy
brentuximab vedotin + pembrolizumab
Intervention: brentuximab vedotin
Combination Therapy
brentuximab vedotin + pembrolizumab
Intervention: pembrolizumab
Outcomes
Primary Outcomes
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 Outcomes
- Duration of response (DOR) based on investigator assessment using RECIST v1.1 criteria(Up to approximately 3 years)
- Progression-free survival (PFS) based on investigator assessment using RECIST v1.1 criteria(Up to approximately 3 years)
- ORR per iRECIST by investigator assessment(Up to approximately 2 years)
- iDOR per iRECIST by investigator assessment(Up to approximately 3 years)
- iPFS per iRECIST by investigator assessment(Up to approximately 3 years)
- Incidence of adverse events (AEs)(Up to approximately 2 years)
Study Sites (119)
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