NCT03575598: SNOW

Sitravatinib (MGCD516) and Nivolumab in Oral Cavity Cancer Window Opportunity Study

Completed EARLY_PHASE1 Last updated 27 July 2023

What this trial tests

EARLY_PHASE1 trial testing Sitravatinib in Squamous Cell Carcinoma, Head And Neck in 10 participants. Completed in 18 February 2020.

Timeline

30 August 2018

Primary endpoint
18 February 2020

18 February 2020

Quick facts

Lead sponsor	University Health Network, Toronto
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	30 August 2018
Primary completion	18 February 2020
Estimated completion	18 February 2020
Sites	1 location across Canada

Drugs / interventions tested

• Sitravatinib (sitravatinib) — full drug profile →
• Nivolumab (nivolumab) — full drug profile →

Conditions studied

• Squamous Cell Carcinoma, Head And Neck — all drugs for Squamous Cell Carcinoma, Head And Neck →
• Squamous Cell Carcinoma Mouth — all drugs for Squamous Cell Carcinoma Mouth →
• Squamous Cell Carcinoma of the Oral Cavity — all drugs for Squamous Cell Carcinoma of the Oral Cavity →

Sponsor

University Health Network, Toronto

Who can join

18 and older, any sex, with Squamous Cell Carcinoma, Head And Neck or Squamous Cell Carcinoma Mouth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a window of opportunity study for patients with resectable squamous cell carcinoma of the oral cavity who are considered suitable for curative-intent surgical resection, with pre-operative drugs, Sitravatinib and Nivolumab.

Publications & conference data

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

1. Dissecting the Role of AXL in Cancer Immune Escape and Resistance to Immune Checkpoint Inhibition.
   Engelsen AST, Lotsberg ML, Abou Khouzam R, Thiery JP, et al · · 2022 · cited 74× · PMID 35572601 · DOI 10.3389/fimmu.2022.869676
2. Immune Evasion by Head and Neck Cancer: Foundations for Combination Therapy.
   Horton JD, Knochelmann HM, Day TA, Paulos CM, et al · · 2019 · cited 65× · PMID 30961829 · DOI 10.1016/j.trecan.2019.02.007
3. The Role of the Receptor Tyrosine Kinase Axl in Carcinogenesis and Development of Therapeutic Resistance: An Overview of Molecular Mechanisms and Future Applications.
   Wium M, Ajayi-Smith AF, Paccez JD, Zerbini LF. · · 2021 · cited 56× · PMID 33806258 · DOI 10.3390/cancers13071521
4. Exosome derived from tumor-associated macrophages: biogenesis, functions, and therapeutic implications in human cancers.
   Zhou M, He X, Mei C, Ou C. · · 2023 · cited 53× · PMID 37981718 · DOI 10.1186/s40364-023-00538-w
5. Antitumor immune effects of preoperative sitravatinib and nivolumab in oral cavity cancer: SNOW window-of-opportunity study.
   Oliva M, Chepeha D, Araujo DV, Diaz-Mejia JJ, et al · · 2021 · cited 47× · PMID 34599023 · DOI 10.1136/jitc-2021-003476
6. Addressing CPI resistance in NSCLC: targeting TAM receptors to modulate the tumor microenvironment and future prospects.
   Peters S, Paz-Ares L, Herbst RS, Reck M. · · 2022 · cited 43× · PMID 35858709 · DOI 10.1136/jitc-2022-004863
7. AXL signaling in cancer: from molecular insights to targeted therapies.
   Yadav M, Sharma A, Patne K, Tabasum S, et al · · 2025 · cited 42× · PMID 39924521 · DOI 10.1038/s41392-024-02121-7
8. Comprehending the crosstalk between Notch, Wnt and Hedgehog signaling pathways in oral squamous cell carcinoma - clinical implications.
   Patni AP, Harishankar MK, Joseph JP, Sreeshma B, et al · · 2021 · cited 38× · PMID 33704672 · DOI 10.1007/s13402-021-00591-3