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Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors

ABSTRACT: This trial will study tisotumab vedotin to find out whether it is an effective treatment for certain solid tumors and what side effects (unwanted effects) may occur. There are seven parts to this study. * In Part A, the treatment will be given to participants every 3 weeks (3-week cycles). * In Part B, participants will receive tisotumab vedotin on Days 1, 8, and 15 every 4-week cycle. * In Part C, participants will receive tisotumab vedotin on Days 1 and 15 of every 4-week cycle. * In Part D, participants will be given treatment on Day 1 of every 3-week cycle. Participants in Part D will get tisotumab vedotin with either: * Pembrolizumab or, * Pembrolizumab and carboplatin, or * Pembrolizumab and cisplatin * In Part E, participants will receive tisotumab vedotin on Days 1 and 15 of every 4-week cycle. * In Part F, participants will receive tisotumab vedotin on Days 1, 15, and 29 of every 6-week cycle. Participants in Part F will get tisotumab vedotin with pembrolizumab. * In Part G, participants will receive tisotumab vedotin on Days 1, 15, and 29 of every 6-week cycle. Participants in Part G will get tisotumab vedotin with pembrolizumab and carboplatin.

DISEASE(S): Pancreatic Adenocarcinoma Non-resectable,Colorectal Adenocarcinoma,Exocrine Pancreatic Cancer,Head And Neck Cancer Metastatic,Pancreatic Adenocarcinoma,Carcinoma,Non-small Cell Lung Cancer Stage Iv,Locally Advanced Or Metastatic Disease In Solid Tumors,Colorectal Cancer,Carcinoma, Squamous Cell Of Head And Neck,Pancreatic Carcinoma,Progression Of Non-small Cell Lung Cancer,Pancreatic Cancer Metastatic,Nsclc,Colorectal Neoplasms,Colorectal Cancer Metastatic,Carcinoma, Non-small-cell Lung,Pancreatic Neoplasms,Pancreatic Neoplasm,Metastatic Colorectal Cancer,Pancreatic Adenocarcinoma Metastatic,Pancreatic Cancer Non-resectable,Non-small Cell Lung Cancer Stage Iiib,Pancreatic Cancer,Head And Neck Cancer Stage Iv,Carcinoma, Squamous Cell,Squamous Cell Carcinoma Of Head And Neck,Head And Neck Cancer Stage Iii,Colorectal Cancer Stage Iv,Colorectal Neoplasms Malignant,Pancreatic Carcinoma Metastatic,Pancreatic Carcinoma Stage Iv,Non-small Cell Lung Cancer Metastatic,Pancreatic Carcinoma Stage Ivb,Pancreatic Carcinoma Stage Iva,Head And Neck Cancer

PROVIDER: 2269862 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Abstract Background. Epidermal growth factor receptor (EGFR) is a targetable molecule in basal-like breast cancer, which comprises most “triple negative” breast cancer (TNBC), the only breast cancer subtype without established targeted therapy. Methods. In this randomized phase II trial, metastatic TNBC patients received the anti-EGFR antibody cetuximab (250mg/kg/week iv) with carboplatin (AUC2/wk iv) added on progression, or concomitant cetuximab + carboplatin. Molecular subtyping was done on archival specimens and those with accessible tumors provided fresh tissue, before and after 7-14 days of therapy, for microarray analyses to explore EGFR pathway inhibition. Results. Of 102 TNBC patients 74% were of the basal-like molecular subtype. Response rate to cetuximab was 6% (2/31), and was 16% (4/25) to cetuximab + carboplatin after progression. Upfront cetuximab + carboplatin produced responses in 17% (12/71); 31% responded or had prolonged disease stabilization. Time to progression was 2.1 months (95% CI 1.8-5.5) and overall survival 10.4 months (95% CI 7.7-13.1) for those treated with the combination regimen. Among 16 patients with evaluable serial biopsies, genomic patterns of the EGFR pathway showed activated status in 13 and inhibition by therapy in 5. Conclusions. While most TNBC were basal-like, a significant proportion were different subtypes. The aggressive nature of metastatic TNBC leads to limited survival. Despite a promising preclinical rationale and evidence of EGFR pathway activation in most, targeted treatment with cetuximab as a single agent had marginal activity and cetuximab added to carboplatin demonstrated modest activity. Serial biopsies as part of metastatic breast cancer studies are feasible, and this study confirmed that the EGFR pathway was inhibited by therapy in only a minority suggesting ligand-independent activation in most tumors. Tissue acquisition and drug selection based upon individualized pathway activation status should be an important part of future studies of TNBC. This series contains 36 microarrays that are from 18 patients with fresh frozen tissue available from the metastatic site. Pretreatment samples (Bx0) are available for two patients. Pretreatment and post single agent treatment (7-14 days after start of treatment with cetuximab; BxSingle) are available for three patients. Pretreatment and post combination treatment (7-14 days after start of treatment with cetuximab plus carboplatin; BxCombo) are available for eight patients. Two patients have a pretreatment sample, a sample after 7-14 days of treatment with single agent cetuximab, and a third sample 7-14 days on cetuximab plus carboplatin after switching to the combination arm upon progression on the single agent arm. Samples were hybridized with Stratagene common reference spiked with RNA from two breast cancer cell lines (ME16C and MCF-7) on Custom 1x44K Agilent microarrays. Arrays were scanned on an Axon 4000B scanner and analyzed with GenePix Pro software.

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Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors

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