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Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors (innovaTV 207)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03485209
Recruitment Status : Recruiting
First Posted : April 2, 2018
Last Update Posted : August 26, 2022
Sponsor:
Collaborators:
Genmab
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Seagen Inc.

Brief 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

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Carcinoma, Non-Small-Cell Lung Exocrine Pancreatic Cancer Carcinoma, Squamous Cell of Head and Neck Drug: tisotumab vedotin Drug: pembrolizumab Drug: carboplatin Drug: cisplatin Phase 2

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 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 532 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumors
Actual Study Start Date : June 25, 2018
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part A: Tisotumab Vedotin - Q3W Schedule
Tisotumab Vedotin every 3 weeks
Drug: tisotumab vedotin
Given into the vein (IV; intravenously)
Other Name: TIVDAK

Experimental: Part B: Tisotumab Vedotin - 3Q4W Schedule
Tisotumab Vedotin on Days 1, 8, and 15 of 28-day cycle
Drug: tisotumab vedotin
Given into the vein (IV; intravenously)
Other Name: TIVDAK

Experimental: Part C: Tisotumab Vedotin - 3Q4W/2Q4W Schedule
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
Drug: tisotumab vedotin
Given into the vein (IV; intravenously)
Other Name: TIVDAK

Experimental: Part D: Tisotumab Vedotin Combination Therapy - Q3W Schedule
Tisotumab vedotin + pembrolizumab + (carboplatin or cisplatin). Given on Day 1 of every 21-day cycle.
Drug: tisotumab vedotin
Given into the vein (IV; intravenously)
Other Name: TIVDAK

Drug: pembrolizumab
200mg given by IV
Other Name: Keytruda

Drug: carboplatin
AUC 5mg/mL per minute given by IV

Drug: cisplatin
100mg/m^2 given by IV




Primary Outcome Measures :
  1. Confirmed Objective Response Rate (ORR) [ Time Frame: Up to approximately 3 years ]
    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 :
  1. Incidence of Adverse Events (AEs) [ Time Frame: Up to approximately 3 years ]
    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.

  2. Confirmed and Unconfirmed ORR [ Time Frame: Up to approximately 3 years ]
    Proportion of patients who achieve a CR or PR according to RECIST v1.1 as assessed by the investigator

  3. Disease Control Rate (DCR) [ Time Frame: Up to approximately 3 years ]
    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

  4. Duration of Response (DOR) [ Time Frame: Up to approximately 3 years ]
    Time from the first documentation of objective response to the first documentation of PD or death due to any cause, whichever comes first

  5. Time to Response (TTR) [ Time Frame: Up to approximately 3 years ]
    Time from the start of study treatment to the first documentation of objective response

  6. Progression-free survival (PFS) [ Time Frame: Up to approximately 3 years ]
    Time from the start of study treatment to the first documentation of PD or death due to any cause, whichever comes first

  7. Overall Survival (OS) [ Time Frame: Up to approximately 4 years ]
    Time from the start of study treatment to date of death due to any cause

  8. Cmax [ Time Frame: Through 30-37 days following the last dose; up to approximately 3 years ]
    Maximum observed plasma concentration

  9. Ctrough [ Time Frame: Through 30-37 days following the last dose; up to approximately 3 years ]
    Observed plasma concentration at the end of the dosing interval

  10. Incidence of anti-therapeutic antibodies (ATAs) [ Time Frame: Through 30-37 days following the last dose; up to approximately 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parts A, B, and C

    • 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.
    • 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
  • Baseline measurable disease as measured by RECIST v1. 1.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.

Exclusion Criteria:

  • Participants with primary neuroendocrine or sarcomatoid histologies. For SCCHN, participants may not have a primary site of nasopharynx.
  • Active bleeding conditions
  • Ocular surface disease at the time of enrollment (Note: cataract is not considered active ocular surface disease for this protocol)
  • 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.
  • Uncontrolled tumor-related pain
  • Inflammatory lung disease. Participants with pulmonary disease are allowed if systemic steroids and long-term oxygen are not required
  • Peripheral neuropathy greater than or equal to Grade 2
  • Active brain metastasis
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03485209


Contacts
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Contact: Seagen Trial Information Support 8663337436 clinicaltrials@seagen.com

Locations
Show Show 40 study locations
Sponsors and Collaborators
Seagen Inc.
Genmab
Merck Sharp & Dohme LLC
Investigators
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Study Director: Francisco Beca, MD, PhD Seagen Inc.
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Responsible Party: Seagen Inc.
ClinicalTrials.gov Identifier: NCT03485209    
Other Study ID Numbers: SGNTV-001
2017-005076-26 ( EudraCT Number )
KEYNOTE-E02 ( Other Identifier: Merck Sharp & Dohme Corp. )
First Posted: April 2, 2018    Key Record Dates
Last Update Posted: August 26, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seagen Inc.:
Colorectal cancer
NSCLC
SCCHN
CRC
Pancreatic cancer
Head and neck cancer
Seattle Genetics
HNSCC
Additional relevant MeSH terms:
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Carcinoma
Pancreatic Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Squamous Cell
Head and Neck Neoplasms