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.
Name: brentuximab vedotin
Name: pembrolizumab
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.
Measure: Confirmed objective response rate (ORR) based on investigator assessment using RECIST 1.1 criteria Time: Up to approximately 2 yearsDescription: 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: Duration of response (DOR) based on investigator assessment using RECIST 1.1 criteria Time: Up to approximately 3 yearsDescription: PFS is defined as the time from start of study treatment to first documentation of objective tumor progression (PD per RECIST 1.1)
Measure: Progression-free survival (PFS) based on investigator assessment using RECIST 1.1 criteria Time: Up to approximately 3 yearsDescription: 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: ORR per iRECIST by investigator assessment Time: Up to approximately 2 yearsDescription: 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 casuse, whichever comes first.
Measure: DOR per iRECIST by investigator assessment Time: Up to approximately 3 yearsDescription: National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Analyses of AEs will be summarized with descriptive statistics.
Measure: Incidence of adverse events (AEs) Time: Up to approximately 2 yearsAllocation: N/A
Single Group Assignment
There is one SNP
Analyses of AEs will be summarized with descriptive statistics.. Inclusion Criteria - Must have relapsed or refractory metastatic squamous or nonsquamous non-small cell lung cancer (NSCLC; EGFR, ALK, ROS1, and BRAF negative) 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 therapy (nivolumab or pembrolizumab) or have been on a PD-1 checkpoint inhibitor containing therapy as the last previous line of therapy within 90 days prior to enrollment; PD-1 checkpoint inhibitor therapy should be the immediate prior line of treatment. --- V600E ---
Inclusion Criteria - Must have relapsed or refractory metastatic squamous or nonsquamous non-small cell lung cancer (NSCLC; EGFR, ALK, ROS1, and BRAF negative) 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 therapy (nivolumab or pembrolizumab) or have been on a PD-1 checkpoint inhibitor containing therapy as the last previous line of therapy within 90 days prior to enrollment; PD-1 checkpoint inhibitor therapy should be the immediate prior line of treatment. --- V600E ---