Brentuximab Vedotin With Pembrolizumab in Metastatic Solid Tumors
- Conditions
- MelanomaNon-small Cell Lung CancerSquamous Cell Carcinoma of the Head and Neck
- Registration Number
- NCT04609566
- Lead Sponsor
- Seagen Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 140
Inclusion Criteria<br><br> - Participants must have<br><br> - Metastatic squamous or nonsquamous non-small cell lung cancer (NSCLC) (without<br> known targetable EGFR, ALK, ROS1, or BRAF mutations) who either<br><br> - a) have not yet received frontline therapy for metastatic disease and<br> without prior exposure to anti PD-1/PD-L1 or<br><br> - b) are relapsed/refractory with progression on anti PD-1/PD therapy.<br><br> - Relapsed/refractory metastatic cutaneous melanoma (regardless of mutation<br> status) with progression on a PD-1 inhibitor<br><br> - Metastatic head and neck squamous cell carcinoma (HNSCC) who have not yet<br> received frontline therapy for metastatic disease and without prior exposure to<br> a PD-1/PD-L1 inhibitor.<br><br> - Cohorts 1-4 only: Melanoma participants must be currently on PD-1 checkpoint<br> inhibitor (CPI) therapy (e.g. nivolumab or pembrolizumab) or had their last dose of<br> PD-1 CPI containing therapy as the last previous line of therapy within 90 days<br> prior to enrollment; PD-1 CPI therapy must be the immediate prior line of treatment.<br><br> - Cohorts 1-4 only: Participants must have progressed on treatment with an anti-PD-1<br> monoclonal antibody (mAb) administered either as monotherapy, or in combination with<br> other CPIs or other therapies. PD-1 treatment progression is defined by meeting all<br> of the following criteria.<br><br> - Have received at least 2 doses of an approved PD-1 inhibitor.<br><br> - Have demonstrated disease progression (PD) after a PD-1 inhibitor as defined by<br> RECIST v1.1.<br><br> - Progressive disease has been documented within 90 days from the last dose<br> of PD-1 inhibitor.<br><br> - Participants with melanoma will need iRECIST confirmation of progression<br> with a second assessment at least four weeks after the initial date of<br> progressive disease<br><br> - NSCLC participants on PD-1 inhibitor containing therapy for less than 90<br> days will need iRECIST confirmation of progression at least 4 weeks after<br> the initial date of progressive disease<br><br> - Tumor tissue sample obtained within 3 months prior to enrollment is required, and no<br> systemic anticancer therapy given after the sample was obtained.<br><br> - An Eastern Cooperative Oncology Group (ECOG) Performance Status score of equal or<br> less than 1<br><br>Exclusion Criteria<br><br> - Has known active central nervous system (CNS) metastases and/or carcinomatous<br> meningitis.<br><br> - Prior immunosuppressive chemotherapy, any immunotherapy other than a PD-1 inhibitor<br> within 4 weeks of first study drug dose.<br><br> - History of another malignancy within 3 years before the first dose of study drug or<br> any evidence of residual disease from a previously diagnosed malignancy.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Confirmed objective response rate (ORR) based on investigator assessment using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria
- Secondary Outcome Measures
Name Time Method Duration of response (DOR) based on investigator assessment using RECIST v1.1 criteria;Progression-free survival (PFS) based on investigator assessment using RECIST v1.1 criteria;ORR per iRECIST by investigator assessment;iDOR per iRECIST by investigator assessment;iPFS per iRECIST by investigator assessment;Incidence of adverse events (AEs)