NCT03543358 is a Phase 2 clinical trial of rovalpituzumab tesirine in Cancer, sponsored by AbbVie.

Who is sponsoring NCT03543358?

NCT03543358 is sponsored by AbbVie.

What drugs are being tested in NCT03543358?

Interventions in NCT03543358: rovalpituzumab tesirine, rovalpituzumab tesirine.

Is NCT03543358 still recruiting?

NCT03543358 is currently completed. Last updated 5 January 2021.

Are results published for NCT03543358?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-01-05 · How we verify

NCT03543358

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Long-Term Study of Rovalpituzumab Tesirine

Completed Phase 2 Results posted Last updated 5 January 2021

What this trial tests

Phase 2 trial testing rovalpituzumab tesirine in Cancer in 3 participants. Completed in 26 November 2019.

Timeline

10 September 2018

Primary endpoint
26 November 2019

26 November 2019

Quick facts

Lead sponsor	AbbVie
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	10 September 2018
Primary completion	26 November 2019
Estimated completion	26 November 2019
Sites	3 locations across United States

Drugs / interventions tested

rovalpituzumab tesirine — full drug profile →
rovalpituzumab tesirine — full drug profile →

Conditions studied

Cancer — all drugs for Cancer →

Sponsor

AbbVie — full company profile →

Who can join

18 and older, any sex, with Cancer. Patients with the condition only — healthy volunteers not accepted.

Adverse events — posted to ClinicalTrials.gov

Time frame: up to 13.6 months (maximum time on study). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

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

Serious: 0/3 (0%)

Deaths: 1/3

Other adverse events (3 terms — click to expand)

Reaction	System	Arm A: Post-Treatment Foll…
Insomnia	Psychiatric disorders	—
Nausea	Gastrointestinal disorders	—
Constipation	Gastrointestinal disorders	—

Data from ClinicalTrials.gov NCT03543358 adverse events section.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

New Approaches to SCLC Therapy: From the Laboratory to the Clinic.
Poirier JT, George J, Owonikoko TK, Berns A, et al · · 2020 · cited 141× · PMID 32018053 · DOI 10.1016/j.jtho.2020.01.016
The Notch signaling pathway: a potential target for cancer immunotherapy.
Li X, Yan X, Wang Y, Kaur B, et al · · 2023 · cited 114× · PMID 37131214 · DOI 10.1186/s13045-023-01439-z
Exploration of the antibody-drug conjugate clinical landscape.
Maecker H, Jonnalagadda V, Bhakta S, Jammalamadaka V, et al · · 2023 · cited 90× · PMID 37639687 · DOI 10.1080/19420862.2023.2229101
The role of Hedgehog and Notch signaling pathway in cancer.
Xia R, Xu M, Yang J, Ma X. · · 2022 · cited 39× · PMID 36517618 · DOI 10.1186/s43556-022-00099-8
Drug conjugates for the treatment of lung cancer: from drug discovery to clinical practice.
Zhou L, Lu Y, Liu W, Wang S, et al · · 2024 · cited 27× · PMID 38429828 · DOI 10.1186/s40164-024-00493-8

Verify or expand the search:

Other trials of rovalpituzumab tesirine

Trials testing the same drug.

NCT03503890 — Expanded Access to Rovalpituzumab Tesirine · no longer available

Other recruiting trials for Cancer

Currently open trials in the same condition.

NCT07390045 — Exercise and Cognitive Rehabilitation Interventions for Older Cancer Survivors · NA · recruiting
NCT07528547 — Hypersight and Ethos In Pediatric Radiotherapy · NA · recruiting
NCT07481890 — Feasibility and Efficacy of the EMDR Toolbox Method in Cancer Patients. · NA · recruiting
NCT07402057 — Implementation and Evaluation of a Program Aimed at Facilitating Palliative Care Conversations · NA · recruiting
NCT07305740 — On-Trac: An Online Intervention for Cancer Survivors Managing Anxiety · NA · recruiting

Other AbbVie trials

Trials by the same sponsor.

NCT07219017 — A Study to Assess the Mass Balance of Oral ABBV-1354 in Healthy Adult Male Participants · Phase 1 · completed
NCT05316220 — A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years W · Phase 3 · withdrawn
NCT07024797 — Study to Assess the Adverse Events, Tolerability, and How Oral Doses of ABBV-932 Moves Through the Body in Healthy Adult · Phase 1 · completed
NCT07058051 — Cross-sectional Study to Characterize Real World Burden of Disease in Patients With Vitiligo in China · completed
NCT07007091 — A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03543358 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AbbVie
Last refreshed: 5 January 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03543358.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing