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

Proffered paper session - Immunotherapy of Cancer

2717 - Stage 2 enrollment complete: Sitravatinib in Combination with Nivolumab in NSCLC Patients Progressing on Prior Checkpoint Inhibitor Therapy


22 Oct 2018


Proffered paper session - Immunotherapy of Cancer



Tumour Site


Ticiana Leal


Annals of Oncology (2018) 29 (suppl_8): viii400-viii441. 10.1093/annonc/mdy288


T.A. Leal1, A.I. Spira2, C. Blakely3, K. He4, D. Berz5, D. Richards6, J. Uyeki7, A. Savage8, T. Roque9, E. Massarelli10, R.M. Jotte11, I. Chen12, J. Christensen13, P. Olson13, V. Tassell14, L. Horn15

Author affiliations

  • 1 Medical Oncology, University of Wisconsin School of Medicine and Public Health, 53711 - Madison/US
  • 2 ,, Virginia Cancer Specialists, Fairfax/US
  • 3 Thoracic Medical Oncology, University of California San Francisco, 94115 - San Francisco/US
  • 4 Research, The Ohio State University Comprehensive Cancer Center, 43202 - Columbus/US
  • 5 Research, Beverly Hills Cancer Center, 90211 - Beverly Hill/US
  • 6 Research, Texas Oncology P.A., 77074 - Houston/US
  • 7 Research, Texas Oncology - Austin Midtown, 78745 - Austin/US
  • 8 Research, Hematology Oncology Associates - Barnett Office, 97504 - Medford/US
  • 9 Research, USO, 75090 - Sherman/US
  • 10 Medical Oncology, City of Hope, 91010 - Duarte/US
  • 11 Medical Oncology / Hematology, Rocky Mountain Cancer Centers, Denver/US
  • 12 Clinical Development, Mir, 92121 - San Diego/US
  • 13 Translational Research, Mirati Therapeutics, Inc., 92121 - San Diego/US
  • 14 Clinical Development, Mirati Therapeutics, Inc., 92121 - San Diego/US
  • 15 Research, Vanderbilt Ingram Cancer Center, 37232-6307 - Nashville/US


Login to access the resources on OncologyPRO.

If you do not have an ESMO account, please create one for free.

Abstract 2717


Sitravatinib is a spectrum-selective TKI which targets TAM receptors (Axl, MER), split family receptors (VEGFR2 and KIT), and MET. Inhibition of these receptor tyrosine kinases may enhance antitumor activity by reducing Type 2 tumor-associated macrophages, regulatory T cells and myeloid-derived suppressor cells and enhancing a T cell-mediated anti-tumor immune response. Thus, this combination is a rational approach to enhancing or restoring the clinical activity of checkpoint inhibitor therapy (CIT) in pts with immunotherapy resistant NSCLC.


Study objectives include evaluation of safety and efficacy in pts with non-squamous NSCLC who have progression of disease (PD) on or after treatment with CIT. Sitravatinib is administered orally in continuous 28-Day cycles; nivolumab is administered via IV, 240 mg every 2 weeks. Treatment arms are stratified by prior clinical benefit (PCB) vs no prior clinical benefit (NPCB [PD in ≤ 12 weeks]). A predictive probability design is used for assessment of enrollment expansion in each stage. Other objectives include PK and correlative biomarkers.


Enrollment in Stage 2 of the CIT-experienced cohorts is complete and enrollment is ongoing. As of April 13, 2018, the CIT-experienced cohorts enrolled 46 pts and 25/46 have had at least one on-study tumor assessment. Twenty-one out of 25 pts have demonstrated tumor reductions. Seven pts out of the 25 have achieved a partial response (PR); 4 confirmed and 3 unconfirmed (1 PR/3 uPR in PCB; 3 PRs in NPCB cohorts, respectively); with the longest treatment duration exceeding 50 weeks. Sitravatinib-related AEs (>10% of pts; all grades) included diarrhea, nausea, vomiting, decreased appetite, fatigue, mucosal inflammation, dysphonia, AST/ALT increase, weight decrease, hypertension, and palmar-plantar erythrodysaesthesia syndrome. Updated safety and efficacy data will be presented.


The combination of sitravatinib with nivolumab is clinically active with manageable side effects. Correlation of clinical activity with molecular analyses, including specific gene alterations and tumor mutation burden, is underway and will be presented.

Clinical trial identification


Legal entity responsible for the study

Mirati Therapeutics, Inc.


Mirati Therapeutics, Inc.

Editorial Acknowledgement


T.A. Leal: Advisory board (consulting): Takeda, AstraZeneca, Novartis, AbbVie, BMS. A.I. Spira: Consulting and research support (to institution): Mirati Therapeutics. C. Blakely: Research funding: Mirati, Novartis, Ignyta, Medimmune, Clovis; Consulting: Jazz Pharmaceuticals. E. Massarelli: Speakers bureau: AstraZeneca, Merck; Consultant: Genetech; Grants and research support: BMS, Genetech, I. Chen: Employment: Mirati Therapeutics. J. Christensen, P. Olson: Employment and stock ownership: Mirati Therapeutics. V. Tassell: Employment and stock ownership: Mirati Therapeutics; Stock ownership: Pfizer. L. Horn: Consulting: Abbvie, AstraZeneca, BMS, Genentech, Merck, Incyte, Xcovery. All other authors have declared no conflicts of interest.

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.