Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster display session

2478 - A Phase 1/2 Study on Safety of Rovalpituzumab Tesirine in Combination with Nivolumab or Nivolumab + Ipilimumab in Small Cell Lung Cancer


09 Sep 2017


Poster display session


Immunotherapy;  Small Cell Lung Cancer


Charity Scripture


Annals of Oncology (2017) 28 (suppl_5): v539-v542. 10.1093/annonc/mdx386


C. Scripture1, G. Selvaggi2, I. Lakatos1, K. Boynton1, S. Lally1, T.H. Han1, S.L. Peng1, S.J. Dylla1

Author affiliations

  • 1 Clinical Development, AbbVie Stemcentrx LLC, 94080 - South San Francisco/US
  • 2 Oncology Clinical Development, Bristol-Myers Squibb, 08648 - Lawrenceville/US


Abstract 2478


Small cell lung cancer (SCLC) is an unmet medical need, representing ∼15% of lung cancer diagnosed/year. Two-thirds of patients (pts) are diagnosed with extensive stage (ES) SCLC with a 2-year survival rate of 5%. Delta-like protein 3 (DLL3), an atypical Notch receptor family ligand, is highly expressed in SCLC and other neuroendocrine tumors with little to no expression in normal tissue. Rovalpituzumab tesirine (Rova-T™) is an antibody-drug conjugate composed of a humanized DLL3-specific IgG1 monoclonal antibody tethered to a toxic DNA cross-linking agent. A Phase 1 study of Rova-T in SCLC pts showed encouraging progression-free and overall survival and a manageable safety profile1. Studies show that nivolumab (nivo, anti-PD-1 antibody) +/- ipilimumab (ipi, anti-CTLA-4 antibody) has antitumor activity and is well-tolerated in 2nd line SCLC. Given the complementary mechanisms of action and non-overlapping toxicities, futher study is warranted to evaluate if a combination of Rova-T and nivo, or all 3 agents leads to more pts with long-term responses and prolonged survival.

Trial design

This Phase 1/2 study (NCT03026166) will enroll ∼90 pts in 3 cohorts. Each cohort will receive Rova-T 0.3 mg/kg IV on Day 1 of the 1st and 3rd 3-week cycle in combination with: nivo 360 mg/kg IV q3wk x 2 cycles (cohort 1) or nivo 1 mg/kg q3wk + ipi 1 mg/kg (cohort 2) or 3mg/kg (cohort 3) IV q3wk x 4 cycles. Maintenance nivo will be administered in all cohorts at 480 mg IV q4wk. The dose limiting toxicity (DLT) evaluation period is 12 weeks. Pt eligibility: ≥ 18 years; histologically or cytologically confirmed 2nd line or later ES SCLC; confirmed DLL3-positive status based on immunohistochemistry of baseline tumor tissue (for DLT evaluable pts); ECOG 0-1; no autoimmune disease; no prior exposure to immuno-oncology or pyrrolobenzodiazepine-based drugs. Primary and secondary objectives: assess safety and efficacy of Rova-T in combination with nivo or nivo + ipi. Exploratory objectives: assess expression of DLL3 and PD-L1 and their relationship to clinical outcome, pharmacokinetics, incidence of neutralizing antibodies, and effects on pharmacodynamic biomarkers. 1. Rudin et al., Lancet Oncol, 2016.

Clinical trial identification


Legal entity responsible for the study

AbbVie Stemcentrx


AbbVie Stemcentrx


C. Scripture, I. Lakatos, K. Boynton, S. Lally, T.H. Han, S.L. Peng, S.J. Dylla: Employee of AbbVie Stemcentrx and may own stock. G. Selvaggi: Employee of Bristol-Myers Squibb.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.