Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dexamethasone

Dexamethasone acetate

Rovalpituzumab tesirine

Immunoconjugates

Immunologic Factors

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.

Arm B includes participants who enter the extension study while receiving ongoing rovalpituzumab tesirine treatment plus dexamethasone in the parent study.

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

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.

AbbVie Inc.

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.

A Long-Term Study of Rovalpituzumab Tesirine

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

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.

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.

AbbVie

Participants who entered the extension study while in post-treatment follow-up of parent study. Participants may receive 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 (retreatment may be repeated).

Arm A: Post-Treatment Follow-Up/Optional Retreatment

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Global Medical Services

No participants received treatment or retreatment in this study.

Number of Participants Receiving Treatment or Retreatment Who Experience a Treatment-Emergent Adverse Event (TEAE)

Participants who entered the extension study while receiving ongoing rovalpituzumab tesirine treatment plus dexamethasone in the parent study. Participants receive rovalpituzumab tesirine (0.3 mg/kg or previously adjusted dose) on Day 1 of each 6-week cycle, omitting every third cycle until disease progression or study drug discontinuation.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Long-Term Study of Rovalpituzumab Tesirine	NCT03543358	Cancer	rovalpituzumab ... rovalpituzumab ...	18 Years -	AbbVie
A Long-Term Study of Rovalpituzumab Tesirine	NCT03543358	Cancer	rovalpituzumab ... rovalpituzumab ...	18 Years -	AbbVie

Spots Global Cancer Trial Database for rollover study