Squamous Cell Carcinoma, Head And NeckEarly Phase 1SNOWNCT03575598
Sitravatinib (MGCD516) and Nivolumab in Oral Cavity Cancer Window Opportunity Study
A Early Phase 1 study testing Sitravatinib and Nivolumab in people with Squamous Cell Carcinoma, Head And Neck and Squamous Cell Carcinoma Mouth, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma, Head And Neck, Squamous Cell Carcinoma Mouth, Squamous Cell Carcinoma of the Oral Cavity
- What is being tested?
- Sitravatinib and Nivolumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 30 Aug 2018to 18 Feb 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written and voluntary informed consent.
- Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- Age > 18 years, male or female.
- Patient must be diagnosed with histologically confirmed squamous cell carcinoma of the oral cavity (SCCOC) (floor of mouth, anterior 2/3 tongue, buccal mucosa, upper and lower gingiva, retromolar trigone and hard palate) previously untreated, considered resectable by the head and neck treating surgeon (T2-4a, N0-2, or T1 - greater than 1 cm - N2, M0; without evidence of distant metastasis).
- Patient must be willing and able to provide 2 fresh tumor biopsies for histopathological and biomarker evaluation: one at baseline and one after treatment with Sitravatinib but prior to treatment with Nivolumab. Archival tissue sample will be requested if available.
- No anti-neoplastic treatment is allowed between the time from obtaining baseline tumor specimen and enrollment.
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- ECOG performance status 0-1.
- Patient must have adequate organ function as determined by the following:
- Renal function: i. Serum creatinine < 1.5 ULN (upper limit of normal range) or a calculated creatinine clearance of > 50mL/min using the following formula:
- Creatinine clearance = [(140-age) x wt (kg) x Constant] / creatinine (umol/L)
- Constant = 1.23 for men, and 1.04 for women
- Bone marrow function (without hematopoietic growth factors or transfusion): i. Absolute neutrophil count (ANC) > 1.0 x 109/L ii. Leukocytes > 2.0 x 109/L iii. Hemoglobin > 90 g/L or > 9g/dL iv. Platelets > 100 x 109/L
- Liver function: i. Total bilirubin ≤ 1.5 x ULN or ≤ 3 x ULN for patients with Gilbert Syndrome. ii. Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) < 2.5 x ULN
- Cardiac function: i. A normal left ventricular ejection fraction (LVEF) of ≥50% by a MUGA scan performed within 4 weeks of the study commencement.
- Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
- Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
- Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy). Women of child-bearing potential (WOCBP) or men whose partner is a WOCBP agrees to use contraception while participating in this study, and for a period of 6 months following termination of study treatment.
- Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Who cannot join
- Primary site of head and neck carcinoma unknown, lip, skin, or outside the oral cavity.
- Patients with tumors that invade major vessels or are within ≤ 3 mm of the carotid artery as shown unequivocally by imaging studies.
- Patients with any prior history of clinically significant bleeding related to the current head and neck cancer.
- Patients with a history of gross hemoptysis (bright red blood of ½ teaspoon or more per episode of coughing) < 3 months prior to enrollment.
- Prior or concurrent radiation therapy to tumor at site of planned resection.
- Any concurrent chemotherapy, biologic, immunologic or hormonal therapy for cancer treatment.
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- Concurrent use of hormones for non-cancer-related conditions (eg, insulin for diabetes and hormone replacement therapy) is acceptable.
- Current or prior use of immunosuppressive medication within 14 days prior to starting dosing. The following are exceptions to this criteria:
- Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection).
- Adrenal replacement steroid > 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease.
- Steroids as premedication for hypersensitivity reactions (eg, computed tomography scan premedication).
- Active or documented history of autoimmune disease within 2 years before screening, including:
- Active or prior documented inflammatory bowel disease (eg. Crohn's disease, ulcerative colitis).
- Patients with vitiligo, resolved childhood asthma/atopy, type I diabetes mellitus, Grave's disease, Hashimoto's disease, or psoriasis not requiring systemic steroids and/or immunosuppressive agents within the past 2 years, are not excluded.
- History of primary immune deficiency.
- History of stroke or transient ischemic attack within the previous 6 months.
- History of uncontrolled hypertension (> 150 mm Hg systolic or > 100 mm Hg diastolic) on multiple observations despite standard of care treatment.
- Any of the following cardiac abnormalities:
- Unstable angina pectoris,
- Congestive heart failure ≥ NYHA Class 3,
- QTc >480 milliseconds,
- Left ventricular ejection fraction (LVEF) < 50.
- Concomitant medication known to cause prolonged QT that cannot be discontinued or changed to a different medication prior to enrollment.
- History of organ transplant that requires use of immunosuppressive medications.
- Known allergy or reaction to any components of Sitravatinib and/or Nivolumab formulation.
- Subjects who are known to be human immunodeficiency (HIV) positive.
- Has a known history of or is positive for active hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (defined as HCV RNA [qualitative] is detected).
- HBV DNA must be undetectable and HBsAg negative at Screening Visit.
- Participants who have had definitive treatment for HCV are permitted if HCV RNA is undetectable at Screening Visit.
- Female patients who are pregnant or breast-feeding.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active clinically significant infection requiring parenteral antibiotics, unstable cardiac arrhythmia, active peptic ulcer disease or gastritis, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events from Sitravatinib or Nivolumab, or compromise the ability of the subject to give written informed consent.
- Any condition that, in the opinion of the Investigator, would interfere with evaluation of the study regimen or interpretation of patient safety or study results.
- Any previous treatment with a PD1 or PD-L1 inhibitor, including Nivolumab.
- History of another primary malignancy, except for:
- Malignancy treated with curative intent and with no known active disease ≥3 years before the first dose of study drug and of low potential risk for recurrence,
- Adequately treated non-melanoma skin cancer without evidence of disease,
- Adequately treated carcinoma in situ without evidence of disease.
- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of study medications.
- Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sitravatinib (MGCD516) and Nivolumab in Oral Cavity Cancer Window Opportunity Study (SNOW)
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.
Read the detailed description
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.
- Conditions
- Squamous Cell Carcinoma, Head And Neck, Squamous Cell Carcinoma Mouth, Squamous Cell Carcinoma of the Oral Cavity
- Being tested
- Sitravatinib, Nivolumab
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitravatinibDrug
Also called MGCD516
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.
NivolumabBiological
Also called OPDIVO®
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.
| Study group | Role | What they receive |
|---|---|---|
| Sitravatinib and Nivolumab | Experimental | 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. Receives: Drug: Sitravatinib; Biological: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamic and immune effects of pre-operative therapy with Sitravatinib and Nivolumab in patients with SCCOC
Tumor PD-L1 expression by IHC
Measured: 2 years
Pharmacodynamic and immune effects of pre-operative therapy with Sitravatinib and Nivolumab in patients with SCCOC
Density of immune cell population in the tumor and/or peripheral blood, including circulating tumor DNA (ctDNA), T-cell subsets, NK cells and myeloid-derived cell subsets
Measured: 2 years
Pharmacodynamic and immune effects of pre-operative therapy with Sitravatinib and Nivolumab in patients with SCCOC
Serum pro-inflammatory cytokines and chemokines
Measured: 2 years
Secondary outcomes (7)
Safety and tolerability of pre-operative therapy with Sitravatinib and Nivolumab on patients with SCCOC
Toxicities as per NCI CTCAE v5.0
Measured: 2 years
Safety and tolerability of pre-operative therapy with Sitravatinib and Nivolumab on patients with SCCOC
Rate of completion of surgery within the initially planned window
Measured: 2 years
Safety and tolerability of pre-operative therapy with Sitravatinib and Nivolumab on patients with SCCOC
Rate of post-operative complications
Measured: 2 years
Pre-operative clinical activity of the combination of Sitravatinib and Nivolumab in patients with SCCOC
Rate of disease progression as per RECIST v1.1 during the pre-operative treatment period
Measured: 2 years
Pre-operative clinical activity of the combination of Sitravatinib and Nivolumab in patients with SCCOC
Pathologic treatment effect in tumor and/ or lymph nodes
Measured: 2 years
Pre-operative clinical activity of the combination of Sitravatinib and Nivolumab in patients with SCCOC
Rate of nodal extracapsular extension and positive margins
Measured: 2 years
Sitravatinib plasma levels alone and in combination with Nivolumab.
Analysis of plasma Sitravatinib concentration before and after Nivolumab therapy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start30 Aug 2018
- Primary completion18 Feb 2020
- Study completion18 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Squamous Cell Carcinoma, Head And NeckStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Mirati Therapeutics Inc.
- Responsible party
- Sponsor
- Investigators
- Lillian Siu, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575598
- Sponsor's protocol ID
- SNOW-001
- Acronym
- SNOW
- Status last verified
- Jul 2023
- First submitted
- 11 Jun 2018
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oliva M, Chepeha D, Araujo DV, Diaz-Mejia JJ, Olson P, Prawira A, Spreafico A, Bratman SV, Shek T, de Almeida J, R Hansen A, Hope A, Goldstein D, Weinreb I, Smith S, Perez-Ordonez B, Irish J, Torti D, Bruce JP, Wang BX, Fortuna A, Pugh TJ, Der-Torossian H, Shazer R, Attanasio N, Au Q, Tin A, Feeney J, Sethi H, Aleshin A, Chen I, Siu L. Antitumor immune effects of preoperative sitravatinib and nivolumab in oral cavity cancer: SNOW window-of-opportunity study. J Immunother Cancer. 2021 Oct;9(10):e003476. doi: 10.1136/jitc-2021-003476.
PubMed 34599023
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sitravatinib (MGCD516) and Nivolumab in Oral Cavity Cancer Window Opportunity Study (SNOW)
- ClinicalTrials.gov ID
- NCT03575598
- Acronym / sponsor ID
- SNOW / SNOW-001
- Conditions
- Squamous Cell Carcinoma, Head And Neck, Squamous Cell Carcinoma Mouth, Squamous Cell Carcinoma of the Oral Cavity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Mirati Therapeutics Inc.
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 18 Feb 2020 (actual)
- Study completion
- 18 Feb 2020 (actual)
- First posted
- 2 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sitravatinib and Nivolumab | Experimental | Drug: Sitravatinib, Biological: NivolumabPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Signed written and voluntary informed consent.
- Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- Age > 18 years, male or female.
- Patient must be diagnosed with histologically confirmed squamous cell carcinoma of the oral cavity (SCCOC) (floor of mouth, anterior 2/3 tongue, buccal mucosa, upper and lower gingiva, retromolar trigone and hard palate) previously untreated, considered resectable by the head and neck treating surgeon (T2-4a, N0-2, or T1 - greater than 1 cm - N2, M0; without evidence of distant metastasis).
- Patient must be willing and able to provide 2 fresh tumor biopsies for histopathological and biomarker evaluation: one at baseline and one after treatment with Sitravatinib but prior to treatment with Nivolumab. Archival tissue sample will be requested if available.
Key exclusion criteria (39 listed)
- Primary site of head and neck carcinoma unknown, lip, skin, or outside the oral cavity.
- Patients with any prior history of clinically significant bleeding related to the current head and neck cancer.
- Patients with a history of gross hemoptysis (bright red blood of ½ teaspoon or more per episode of coughing) < 3 months prior to enrollment.
- Prior or concurrent radiation therapy to tumor at site of planned resection.
- Any concurrent chemotherapy, biologic, immunologic or hormonal therapy for cancer treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SitravatinibAlso: MGCD516Sitravatinib (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. | Drug | Sitravatinib and Nivolumab |
| NivolumabAlso: OPDIVO®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. | Biological | Sitravatinib and Nivolumab |
Primary outcome
Pharmacodynamic and immune effects of pre-operative therapy with Sitravatinib and Nivolumab in patients with SCCOC
Time frame: 2 years
Tumor PD-L1 expression by IHC
Pharmacodynamic and immune effects of pre-operative therapy with Sitravatinib and Nivolumab in patients with SCCOC
Time frame: 2 years
Density of immune cell population in the tumor and/or peripheral blood, including circulating tumor DNA (ctDNA), T-cell subsets, NK cells and myeloid-derived cell subsets
Pharmacodynamic and immune effects of pre-operative therapy with Sitravatinib and Nivolumab in patients with SCCOC
Time frame: 2 years
Serum pro-inflammatory cytokines and chemokines
7 secondary outcomes
Safety and tolerability of pre-operative therapy with Sitravatinib and Nivolumab on patients with SCCOC
Time frame: 2 years
Safety and tolerability of pre-operative therapy with Sitravatinib and Nivolumab on patients with SCCOC
Time frame: 2 years
Safety and tolerability of pre-operative therapy with Sitravatinib and Nivolumab on patients with SCCOC
Time frame: 2 years
Pre-operative clinical activity of the combination of Sitravatinib and Nivolumab in patients with SCCOC
Time frame: 2 years
Pre-operative clinical activity of the combination of Sitravatinib and Nivolumab in patients with SCCOC
Time frame: 2 years
Pre-operative clinical activity of the combination of Sitravatinib and Nivolumab in patients with SCCOC
Time frame: 2 years
Sitravatinib plasma levels alone and in combination with Nivolumab.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Derived from this study: PubMed 34599023Oliva M, Chepeha D, Araujo DV, Diaz-Mejia JJ, Olson P, Prawira A, Spreafico A, Bratman SV, Shek T, de Almeida J, R Hansen A, Hope A, Goldstein D, Weinreb I, Smith S, Perez-Ordonez B, Irish J, Torti D, Bruce JP, Wang BX, Fortuna A, Pugh TJ, Der-Torossian H, Shazer R, Attanasio N, Au Q, Tin A, Feeney J, Sethi H, Aleshin A, Chen I, Siu L. Antitumor immune effects of preoperative sitravatinib and nivolumab in oral cavity cancer: SNOW window-of-opportunity study. J Immunother Cancer. 2021 Oct;9(10):e003476. doi: 10.1136/jitc-2021-003476.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lillian Siu, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sitravatinib and Nivolumab in people with Squamous Cell Carcinoma, Head And Neck and Squamous Cell Carcinoma Mouth, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacodynamic and immune effects of pre-operative therapy with Sitravatinib and Nivolumab in patients with SCCOC (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03575598, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.