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Neoadjuvant Sitravatinib in Combination With Nivolumab in Patients With Clear Cell Renal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT03680521
Recruitment Status : Recruiting
First Posted : September 21, 2018
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Mirati Therapeutics Inc.

Brief Summary:
The study will evaluate the clinical activity of nivolumab in combination with the investigational agent sitravatinib in patients with locally-advanced clear cell renal cell carcinoma (ccRCC) in the pre-surgical setting.

Condition or disease Intervention/treatment Phase
Clear Cell Renal Cell Carcinoma Drug: Sitravatinib Drug: Nivolumab Phase 2

Detailed Description:
Sitravatinib is a receptor tyrosine kinase inhibitor (TKI) that targets multiple closely related receptor tyrosine kinase pathways including VEGFR, PDGF receptor (PDGFR), c-KIT, MET, and the TAM family of receptors (TYRO3, AXL, and MER). Nivolumab is a monoclonal antibody directed against PD-1 and blocks the interaction between PD-1 and its ligands, thereby releasing PD-1-mediated inhibition of T-cell proliferation (including cytotoxic CD8+ T-cells) and cytokine production. Together, sitravatinib and nivolumab may cooperate to elicit greater anti-tumor activity than either agent alone, as sitravatinib is predicted to enhance several steps in the cancer immunity cycle that may augment the efficacy of nivolumab.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Sitravatinib in Combination With Nivolumab in Patients Undergoing Nephrectomy for Locally-Advanced Clear Cell Renal Cell Carcinoma
Actual Study Start Date : September 24, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: Sitravatinib and nivolumab
Sitravatinib oral capsule administered daily 2 weeks alone then in combination with nivolumab administered as 240 mg IV every 2 weeks. Total treatment duration: 6-8 weeks.
Drug: Sitravatinib
Sitravatinib oral capsule administered daily for 6-8 weeks.

Drug: Nivolumab
Nivolumab administered as 240 mg IV every 2 weeks for 4-6 weeks.




Primary Outcome Measures :
  1. Percentage of patients achieving a point in time objective response (either complete or partial response [CR or PR]) prior to surgery. [ Time Frame: 6-8 weeks ]

Secondary Outcome Measures :
  1. Number of patients experiencing adverse events (number and percent of patients reporting AEs) [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Imaging results consistent with locally-advanced RCC
  2. Candidate for partial or complete nephrectomy as part of treatment plan.
  3. Measurable disease as per RECIST version 1.1.
  4. ECOG performance status 0 or 1.
  5. Adequate bone marrow and organ function.

Exclusion Criteria:

  1. Prior systemic anti-tumor treatment for RCC.
  2. Patients who are receiving any other investigational agents.
  3. Clinical status indicating that immediate surgery (within 6 weeks) is warranted regardless of whether neoadjuvant therapy is to be administered, as assessed by the treating surgeon.
  4. Inability to undergo baseline tumor biopsy.
  5. Active or prior documented autoimmune or immunocompromising conditions.
  6. Uncontrolled hypertension.

Information from the National Library of Medicine

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): NCT03680521


Contacts
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Contact: Mirati Therapeutics 844-893-5530 mirati516002@mirati.com

Locations
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United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Jose A Karam, MD    713-792-3250    jakaram@mdanderson.org   
Sponsors and Collaborators
Mirati Therapeutics Inc.

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Responsible Party: Mirati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03680521     History of Changes
Other Study ID Numbers: 516-002
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mirati Therapeutics Inc.:
ccRCC
MGCD516
Antineoplastic Agents
Immunologic factors
nivolumab
Tyrosine Kinase Inhibitor
VEGFR
TAM RTKs
PD-1
PD-L1

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents