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A Study of Tisotumab Vedotin for Patients With Platinum-Resistant Ovarian Cancer With a Safety Run-in of a Dose-Dense Regimen (innovaTV 208)

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ClinicalTrials.gov Identifier: NCT03657043
Recruitment Status : Recruiting
First Posted : September 3, 2018
Last Update Posted : March 6, 2019
Sponsor:
Collaborator:
Genmab
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Brief Summary:
This trial will study tisotumab vedotin to find out what its side effects are and to see if it works for platinum-resistant ovarian cancer (PROC). We will be testing different doses of tisotumab vedotin that are given at different times. We will compare the side effects and ability to treat tumors of these different doses and schedules. In this study, there will be a safety run-in group of up to 12 patients that will look at a dose-dense treatment schedule. In a dose-dense schedule, smaller doses are given more frequently. After the run-in period is over, there will be two groups in the study. One group will get tisotumab vedotin once every 3 weeks (21 day cycles). The other group will get tisotumab vedotin once a week for 3 weeks followed by 1 week off (28-day cycles).

Condition or disease Intervention/treatment Phase
Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer Drug: tisotumab vedotin Phase 2

Detailed Description:
The study objectives are to evaluate the safety, antitumor activity, and pharmacokinetics of tisotumab vedotin (TV) administered every 3 weeks or on Days 1, 8, and 15 of every 4-week cycle (dose-dense regimen) for patients with epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that has relapsed within 6 months of the completion of platinum-based treatment. All patients must have platinum-resistant ovarian cancer (PROC) and be eligible for single agent chemotherapy. Additionally, patients must have previously received a bevacizumab-containing treatment regimen for ovarian cancer, if eligible.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Phase 2 Study of Tisotumab Vedotin for Patients With Platinum-Resistant Ovarian Cancer With a Safety Run-in of a Dose-Dense Regimen
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021


Arm Intervention/treatment
Experimental: Safety Run-In (Dose-dense Schedule)
28 day, 3 dose cycle
Drug: tisotumab vedotin
Intravenous (IV) infusion

Experimental: Tisotumab Vedotin
21 day, single dose cycle
Drug: tisotumab vedotin
Intravenous (IV) infusion

Experimental: Tisotumab Vedotin (Dose-dense Schedule)
28 day, 3 dose cycle
Drug: tisotumab vedotin
Intravenous (IV) infusion




Primary Outcome Measures :
  1. Incidence of Dose Limiting Toxicities (DLTs) - Safety Run-In Phase [ Time Frame: Up to 60 days ]
  2. Confirmed Objective Response Rate (ORR) - Phase 2 [ Time Frame: Up to 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 that are Grade 3+, treatment-related, or serious - Phase 2 [ Time Frame: Up to 3 years ]
  2. Confirmed and unconfirmed ORR - Phase 2 [ Time Frame: Up to 3 years ]
    Proportion of patients who achieve a CR or PR according to RECIST v1.1 as assessed by the investigator

  3. Cancer Antigen 125 (CA-125) response rate according to Gynecologic Cancer Intergroup (GCIG) criteria - Phase 2 [ Time Frame: Up to 3 years ]
    Proportion of patients who have at least a 50% reduction in CA-125 value from baseline

  4. Overall response according to the Gynecological Cancer Intergroup (GCIG) combined RECIST and CA-125 criteria - Phase 2 [ Time Frame: Up to 3 years ]
    Proportion of patients whose best response is a CR or PR according to the GCIG combined RECIST and CA-125 criteria

  5. Duration of response (DOR) - Phase 2 [ Time Frame: Up to 3 years ]
    Time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of PD or death due to any cause, whichever comes first

  6. Disease control rate (DCR) - Phase 2 [ Time Frame: Up to 3 years ]
    Proportion of patients with complete response (CR), partial response (PR), or stable disease (SD)

  7. Time to response (TTR) - Phase 2 [ Time Frame: Up to 3 years ]
    Time from the start of study treatment to the first documentation of objective response (CR or PR that is subsequently confirmed)

  8. Progression-free survival (PFS) - Phase 2 [ Time Frame: Up to 3 years ]
    Time from the start of study treatment to the first documentation of PD or death due to any cause, whichever comes first

  9. Overall survival (OS) - Phase 2 [ Time Frame: Up to 3 years ]
    Time from the start of study treatment to date of death due to any cause

  10. Pharmacokinetic (PK) parameter: Cmax - Phase 2 [ Time Frame: Up to 3 years ]
    Maximum observed concentration

  11. PK parameter: AUClast - Phase 2 [ Time Frame: Up to 3 years ]
    Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration

  12. Incidence of antitherapeutic antibodies (ATA) - Phase 2 [ Time Frame: Up to 3 years ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Histologic documentation of epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
  • If eligible, patients must have received previous treatment with a bevacizumab-containing regimen for ovarian cancer.
  • Safety run-in only: Patients with platinum-resistant ovarian cancer (PROC) who have received up to 5 prior systemic treatment regimens for ovarian cancer
  • Phase 2 only: Patients with PROC who have received at most 1 prior cytotoxic chemotherapy regimen in the PROC setting
  • Measureable disease according to RECIST v1.1 as assessed by the investigator
  • An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
  • Life expectancy of at least 3 months
  • Able to provide fresh tissue for biomarker analysis from a newly obtained core or excisional biopsy of a tumor lesion. Some exceptions may apply, in which case archival tissue will be used.

Exclusion Criteria:

  • Primary platinum-refractory disease, defined as disease progression within 2 months of completion of first line platinum-based therapy
  • Patients with clinical symptoms or signs of gastrointestinal obstruction with the past 6 months or who currently require parenteral nutrition
  • Hematological: Known past or current coagulation defects leading to an increased risk of bleeding, diffuse alveolar hemorrhage from vasculitis, known bleeding diathesis, ongoing major bleeding, or trauma with increased risk of life-threatening bleeding within 8 weeks of trial entry
  • Cardiovascular: Clinically significant cardiac disease including uncontrolled hypertension, unstable angina, acute myocardial infarction with 6 months of screening, serious cardiac arrhythmia requiring medication, medical history of congestive heart failure, or medical history of decreased cardiac ejection fraction of <45%
  • Ophthalmological: Active ocular surface disease at baseline or prior episode of cicatricial conjunctivitis or Steven Johnson syndrome
  • Prior treatment with MMAE-derived drugs
  • Inflammatory bowel disease including Crohn's disease and ulcerative colitis
  • Ongoing, acute, or chronic inflammatory skin disease
  • Uncontrolled tumor-related pain
  • Inflammatory lung disease requiring chronic medical therapy
  • Grade 3 or higher pulmonary disease unrelated to underlying malignancy
  • Uncontrolled pleural or pericardial effusions
  • Grade >1 peripheral neuropathy
  • Patients who are pregnant or breastfeeding

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): NCT03657043


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

Locations
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United States, Colorado
Poudre Valley Hospital-University of Colorado Recruiting
Fort Collins, Colorado, United States, 80528
Contact: Jill Wood    970-297-6163    jill.wood2@uchealth.org   
Principal Investigator: Steven Schuster         
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Thomas Stone    813-745-4673    Thomas.Stone@moffitt.org   
Principal Investigator: Hye Sook Chon         
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Aretha DiSalvo    551-996-8258    Aretha.disalvo@hackensackmeridian.org   
Principal Investigator: Donna McNamara         
United States, Ohio
Ohio State University Clinical Trials Management Office Recruiting
Columbus, Ohio, United States, 43210
Contact: Sarah Hwang    614-247-7793    Sarah.Hwang@osumc.edu   
Principal Investigator: David O'Malley         
United States, Texas
Renovatio Clinical Recruiting
The Woodlands, Texas, United States, 77380
Contact: Alice Mouton    713-703-2398    Alice.mouton@renovatioclinical.com   
Principal Investigator: Mary Crow         
Sponsors and Collaborators
Seattle Genetics, Inc.
Genmab
Investigators
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Study Director: Leonardo Nicacio, MD Seattle Genetics, Inc.

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Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT03657043     History of Changes
Other Study ID Numbers: SGNTV-002
First Posted: September 3, 2018    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019

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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 Seattle Genetics, Inc.:
Platinum-resistant
Antibody drug conjugate
Tisotumab vedotin
PROC

Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fallopian Tube Diseases