Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumors (innovaTV 207)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    532
  • sponsor
    Seagen Inc.
Updated on 18 September 2022
cancer
tyrosine
systemic therapy
measurable disease
kinase inhibitor
oxaliplatin
carboplatin
fluoropyrimidine
gemcitabine
pembrolizumab
irinotecan
bevacizumab
adenocarcinoma
solid tumour

Summary

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 four 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.
  • 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

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 or tisotumab vedotin in combination with other agents. 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).

Details
Condition Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Exocrine Pancreatic Cancer, Carcinoma, Squamous Cell of Head and Neck
Treatment cisplatin, carboplatin, Pembrolizumab, Tisotumab Vedotin
Clinical Study IdentifierNCT03485209
SponsorSeagen Inc.
Last Modified on18 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Relapsed, locally-advanced or metastatic colorectal or pancreatic cancer, squamous NSCLC, or SCCHN patients who are not candidates for standard therapy
Parts A, B, and C
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 3 lines of systemic therapy in the metastatic setting
Patients eligible for a tyrosine kinase inhibitor should have received such therapy. These patients should have received no more than 4 lines of systemic therapy 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/or a checkpoint inhibitor (CPI), if eligible, and must have experienced disease progression following such therapy. Participants should have received no more than 3 systemic lines of therapy in the recurrent or metastatic setting
Part D
Participants with SCCHN must have received no previous systemic therapy in the recurrent or metastatic disease setting
Participants with NSCLC must have histologically or cytologically documented squamous cell NSCLC and must have received no previous systemic therapy for metastatic disease or radiation therapy to the lung that is > 30 Gy within 6 months of the first dose of study treatment
PD-L1 biomarker expression as determined by a PD-L1 IHC assay should be available
Able to provide fresh or archival tissue for biomarker analysis

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)
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
Participants with primary neuroendocrine or sarcomatoid histologies. For SCCHN, participants may not have a primary site of nasopharynx
Inflammatory lung disease. Participants with pulmonary disease are allowed if systemic steroids and long-term oxygen are not required
Part D Only: Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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