Sitravatinib (MGCD516) and Nivolumab in Oral Cavity Cancer Window Opportunity Study (SNOW)
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|ClinicalTrials.gov Identifier: NCT03575598|
Recruitment Status : Active, not recruiting
First Posted : July 2, 2018
Last Update Posted : April 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Carcinoma, Head And Neck Squamous Cell Carcinoma Mouth Squamous Cell Carcinoma of the Oral Cavity||Drug: Sitravatinib Biological: Nivolumab||Early Phase 1|
This is a single center, open-label, non-randomized, pre-operative 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 Sitravatinib and Nivolumab. A total of 12 patients who are evaluable for correlative studies, are planned for enrollment.
This study will involve treatment with Sitravatinib and Nivolumab, tests and procedures done for safety and the collection of blood samples for biomarker research. Tissue samples (fresh biopsy or archival tissue) will also be collected for biomarker research and evaluation.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sitravatinib (MGCD516) and Nivolumab in Oral Cavity Cancer Window Opportunity Study (SNOW)|
|Actual Study Start Date :||August 30, 2018|
|Estimated Primary Completion Date :||August 30, 2020|
|Estimated Study Completion Date :||August 30, 2020|
Experimental: Sitravatinib and Nivolumab
Patients will start therapy with sitravatinib within 10 days of study enrollment. Sitravatinib will be given at 120mg once daily on a continuous basis until 48 hours before planned surgery, or for a maximum period of 28 days.
Nivolumab will be given as a single infusion at a dose of 240mg, over a period of 30 minutes on Day 15 of the study.
Sitravatinib (MGCD516) is an orally-available, potent small molecule inhibitor of a closely related spectrum of tyrosine kinases, which has shown antitumor activity in a variety of in vitro and in vivo model systems.
Other Name: MGCD516
Nivolumab (OPDIVO®) is a human IgG4 kappa immunoglobulin that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.
Other Name: OPDIVO®
- Pharmacodynamic effects with biomarker analyses [ Time Frame: 2 years ]Tumor PD-L1 expression by IHC
- Immune effects with biomarker analyses [ Time Frame: 2 years ]Density of immune cell population in the tumor and/or peripheral blood, including T-cell subsets, NK cells and myeloid-derived cell subsets
- Toxicities as per NCI CTCAE v5.0 [ Time Frame: 2 years ]
- Rate of completion of surgery within the initially planned window [ Time Frame: 2 years ]
- Rate of post-operative complications [ Time Frame: 2 years ]
- Rate of disease progression as per RECIST v1.1 during the pre-operative treatment period [ Time Frame: 2 years ]
- Pathologic treatment effect in tumor and/ or lymph nodes [ Time Frame: 2 years ]
- Rate of nodal extracapsular extension and positive margins [ Time Frame: 2 years ]
- Analysis of plasma Sitravatinib concentration before and after Nivolumab therapy [ Time Frame: 2 years ]
- Dynamic changes in immune cell activation and/or suppression using flow cytometry, DNA/RNA sequencing, and FACS sorting [ Time Frame: 2 years ]Tumor and immune cell genome and trascriptome analysis
- Dynamic changes in intratumoral hypoxia with pre-operative Sitravatinib and Nivolumab therapy using 18FAZA PET [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03575598
|Princess Margaret Cancer Centre|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Lillian Siu, MD||University Health Network, Toronto|