Protocol Summary

Protocol No.: OCR17458

Sponsor Protocol No.: SGNTV-001; innovaTV 207

Protocol Title.: Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors

Principal Investigator: George, Thomas

Objective: 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 two 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.

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).

Phase: Phase II

Age Group: Adult

Age: 18 Years - N/A

Gender: All

Scope: National

Treatment:

Experimental: Tisotumab Vedotin - Q3W Regimen
Tisotumab Vedotin [2.0 mg/kg] every 3 weeks

Experimental: Tisotumab Vedotin - 3Q4W Regimen
Tisotumab Vedotin [0.9 mg/kg or 1.2 mg/kg] on Days 1, 8, and 15 of 28-day cycle

Detailed Eligibility:

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 or previous brain metastasis
- Patients who are breastfeeding, pregnant, or planning to become pregnant from the time of informed consent until 6 months after the final study dose is administered
- For patients with SCCHN or NSCLC, ongoing anticoagulant therapy

Applicable Conditions:

  • Bladder Cancer
  • Brain and Nervous System
  • Breast Cancer
  • Colon Cancer
  • Gastrointestinal Cancer
  • Gynecologic Cancer
  • Head & Neck Cancer
  • Kidney Cancer (Renal Cell)
  • Liver Cancer
  • Melanoma
  • Ovarian Cancer
  • Pancreatic Cancer
  • Prostate Cancer
  • Sarcoma
  • Skin Cancer
  • Urologic Cancer
  • Participation Institution:

  • UF Gainesville : Melissa Lynn
  • Contact:
    Melissa Lynn
    Email: melissa.lynn@ufl.edu

    More Information: View study listing on ClinicialTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT03485209