Description:
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 three
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 may receive tisotumab vedotin on Days 1 and 15 or
Days 1, 8, and 15 on a 4-week cycle.
Title
- Brief Title: Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors
- Official Title: Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
SGNTV-001
- SECONDARY ID:
2017-005076-26
- NCT ID:
NCT03485209
Conditions
- Colorectal Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Exocrine Pancreatic Cancer
- Carcinoma, Squamous Cell of Head and Neck
Interventions
Drug | Synonyms | Arms |
---|
tisotumab vedotin | | Tisotumab Vedotin - 3Q4W Schedule |
Purpose
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 three
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 may receive tisotumab vedotin on Days 1 and 15 or
Days 1, 8, and 15 on a 4-week cycle.
Detailed Description
The primary goal of this trial is to assess the activity, safety, and tolerability of
tisotumab vedotin for the treatment of selected solid tumors. Patients will be treated with
single agent tisotumab vedotin. Patients who meet eligibility criteria will be enrolled into
cohorts based on tumor type. Tumor types to be evaluated include colorectal cancer, squamous
non-small cell lung cancer (NSCLC), exocrine pancreatic adenocarcinoma, and squamous cell
carcinoma of the head and neck (SCCHN).
Trial Arms
Name | Type | Description | Interventions |
---|
Tisotumab Vedotin - Q3W Schedule | Experimental | Tisotumab Vedotin every 3 weeks | |
Tisotumab Vedotin - 3Q4W Schedule | Experimental | Tisotumab Vedotin on Days 1, 8, and 15 of 28-day cycle | |
Tisotumab Vedotin - 3Q4W/2Q4W Schedule | Experimental | Tisotumab Vedotin on Days 1, 8, and 15 of a 28-day cycle and Tisotumab Vedotin on Days 1 and 15 of every 28-day cycle | |
Eligibility Criteria
Inclusion Criteria:
- Relapsed, locally-advanced or metastatic colorectal or pancreatic cancer, squamous
NSCLC, or SCCHN patients who are not candidates for standard therapy.
- All patients must have experienced disease progression on or after their most recent
systemic therapy.
- Baseline measurable disease as measured by RECIST v1. 1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- Colorectal cancer patients must have received prior therapy with each of following
agents, if eligible: a fluoropyrimidine, oxaliplatin, irinotecan, and/or bevacizumab.
Patients should have received no more than 3 systemic regimens in the metastatic
setting.
- Patients with NSCLC must have predominant squamous histology. Patients must have
received prior therapy with a platinum-based treatment and a checkpoint inhibitor
(CPI), if eligible. Patients should have received no more than 2 systemic regimens in
the metastatic setting.
- Patients eligible for a tyrosine kinase inhibitor should have received such
therapy. These patients should have received no more than 3 systemic regimens in
the metastatic setting.
- Patients with exocrine pancreatic adenocarcinoma must have predominant adenocarcinoma
histology. Patients must have received prior therapy with a gemcitabine-based or
5FU-based regimen, if eligible, and should have received no more than 1 systemic
regimen in the unresectable or metastatic setting.
- Patients with SCCHN must have received prior therapy with a platinum-based regimen and
a checkpoint inhibitor (CPI), if eligible, and should have received no more than 3
systemic regimens in the recurrent/metastatic setting.
Exclusion Criteria:
- Active bleeding conditions
- Ocular surface disease at the time of enrollment (Note: cataract is not considered
active ocular surface disease for this protocol)
- Pulmonary disease requiring chronic medical therapy, unrelated to underlying cancer
- Uncontrolled tumor-related pain
- Peripheral neuropathy greater than or equal to Grade 2
- History of another malignancy within 3 years of the first dose of study drug, or any
evidence of residual disease from a previously diagnosed malignancy.
- Active brain metastasis
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) |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | Proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the investigator |
Secondary Outcome Measures
Measure: | Incidence of Adverse Events |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | Type, severity, and relatedness of adverse events. An AE is any untoward medical occurrence in a subject or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. |
Measure: | Confirmed and Unconfirmed ORR |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | Proportion of patients who achieve a CR or PR according to RECIST v1.1 as assessed by the investigator |
Measure: | Disease Control Rate (DCR) |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | Proportion of patients who achieve a CR or PR according to RECIST v1.1 as assessed by the investigator, or meet the SD criteria at least once after start of study treatment |
Measure: | Duration of Response (DOR) |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | Time from the first documentation of objective response to the first documentation of PD or death due to any cause, whichever comes first |
Measure: | Time to Response (TTR) |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | Time from the start of study treatment to the first documentation of objective response |
Measure: | Progression-free survival (PFS) |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | Time from the start of study treatment to the first documentation of PD or death due to any cause, whichever comes first |
Measure: | Overall Survival (OS) |
Time Frame: | Up to approximately 4 years |
Safety Issue: | |
Description: | Time from the start of study treatment to date of death due to any cause |
Measure: | Cmax |
Time Frame: | Through 8 days after dosing |
Safety Issue: | |
Description: | Maximum observed plasma concentration |
Measure: | Ctrough |
Time Frame: | Through 8 days after dosing |
Safety Issue: | |
Description: | Observed plasma concentration at the end of the dosing interval |
Measure: | Incidence of ATAs |
Time Frame: | Through 8 days after dosing |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Seagen Inc. |
Trial Keywords
- Colorectal cancer
- NSCLC
- SCCHN
- CRC
- Pancreatic cancer
- Head and neck cancer
- Seattle Genetics
- HNSCC
Last Updated
August 3, 2021