A Long-Term Study of Rovalpituzumab Tesirine

A Multicenter, Long-Term, Rollover Extension Study of Rovalpituzumab Tesirine

The purpose of this long-term, extension study is to provide ongoing safety and efficacy follow-up of subjects who participated in a rovalpituzumab tesirine study that has completed the primary analysis and that is closing.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Drug: rovalpituzumab tesirine; Drug: rovalpituzumab tesirine

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 2

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85704
      • Arizona Oncology Associates, PC-HOPE (Rudasill) /ID# 204818
  • California
    • Duarte, California, United States, 91010-3012
      • City of Hope National Medical Center /ID# 204885
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • Univ of Pittsburgh Med Ctr /ID# 204763

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject had enrolled, participated in, and received at least 1 dose of rovalpituzumab tesirine in a parent study.
• Additional eligibility criterion for Arm A: subjects who discontinued the study drug in the parent study have completed the treatment emergent adverse event reporting window.

For subjects who elect optional retreatment in Arm A, must meet additional criteria before receiving rovalpituzumab tesirine retreatment including:

• Tolerated their initial 2 doses of rovalpituzumab tesirine.
• Achieved clinical benefit as defined by stable disease or better, and is determined that the subject would potentially benefit from additional treatment.
• Experienced radiographic disease progression at least 12 weeks after the second dose of rovalpituzumab tesirine.
• Received no other systemic anti-cancer therapy after rovalpituzumab tesirine treatment.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate hematologic, kidney, and liver function, per protocol.
• In subjects with central nervous system (CNS) metastases, documentation of stable or improved status as described in the protocol.

Exclusion Criteria:

• Subjects not previously enrolled in a rovalpituzumab tesirine study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm A: Post-Treatment Follow-Up/Optional Retreatment; Arm A includes participants who enter the extension study while in post-treatment follow-up. This arm includes optional rovalpituzumab tesirine retreatment plus dexamethasone per participant per retreatment period.	Drug: rovalpituzumab tesirine; Optional retreatment with rovalpituzumab tesirine (0.3 mg/kg or previously adjusted dose) administered intravenously once every 6 weeks beginning on Day 1 (day of dosing) for 2 dose cycles; Other Names: SC16LD6.5; Drug: rovalpituzumab tesirine; Rovalpituzumab tesirine (0.3 mg/kg or previously adjusted dose) administered intravenously once every 6 weeks beginning on Day 1 (day of dosing). Subjects will receive rovalpituzumab tesirine on Day 1 of each 6-week cycle, omitting every third cycle until disease progression or study drug discontinuation.; Other Names: SC16LD6.5
EXPERIMENTAL: Arm B: Continued Treatment; Arm B includes participants who enter the extension study while receiving ongoing rovalpituzumab tesirine treatment plus dexamethasone in the parent study.	Drug: rovalpituzumab tesirine; Optional retreatment with rovalpituzumab tesirine (0.3 mg/kg or previously adjusted dose) administered intravenously once every 6 weeks beginning on Day 1 (day of dosing) for 2 dose cycles; Other Names: SC16LD6.5; Drug: rovalpituzumab tesirine; Rovalpituzumab tesirine (0.3 mg/kg or previously adjusted dose) administered intravenously once every 6 weeks beginning on Day 1 (day of dosing). Subjects will receive rovalpituzumab tesirine on Day 1 of each 6-week cycle, omitting every third cycle until disease progression or study drug discontinuation.; Other Names: SC16LD6.5

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Receiving Treatment or Retreatment Who Experience a Treatment-Emergent Adverse Event (TEAE)	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either a reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. TEAEs and serious TEAEs are defined as any event that began or worsened in severity after the first dose of study drug. For more details on AEs, please see the Adverse Event section.	From first dose of study drug until 70 days following last dose of study drug; up to approximately 5 years.

Collaborators and Investigators

• Sponsor: AbbVie

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 10, 2018
• Primary Completion (ACTUAL): November 26, 2019
• Study Completion (ACTUAL): November 26, 2019

Study Registration Dates

• First Submitted: May 21, 2018
• First Submitted That Met QC Criteria: May 21, 2018
• First Posted (ACTUAL): June 1, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 10, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: cancer; rollover study; rovalpituzumab tesirine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Immunoconjugates
• Other Study ID Numbers: M16-291

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No