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Sitravatinib for Renal Cell Carcinoma

Phase 2
Waitlist Available
Research Sponsored by Mirati Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate bone marrow and organ function.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 until 28 days after last dose of study drug or surgery, whichever occurred last (up to a maximum of 13 weeks)
Awards & highlights

Study Summary

This trial will study if the combination of sitravatinib and nivolumab is effective in treating patients with locally-advanced clear cell renal cell carcinoma before surgery.

Eligible Conditions
  • Clear Cell Renal Cell Carcinoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Your bone marrow and organs are working properly.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 until 28 days after last dose of study drug or surgery, whichever occurred last (up to a maximum of 13 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 until 28 days after last dose of study drug or surgery, whichever occurred last (up to a maximum of 13 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Who Achieved a Point in Time Objective Response (Either Complete or Partial Response [CR or PR]) Prior to Surgery
Point in Time Objective Response Prior to Surgery
Secondary outcome measures
Blood Plasma Concentrations of Sitravatinib
Change From Baseline in CD4+ T-cells in the Tumor
Change From Baseline in CD8+ T-cells in the Tumor
+8 more

Side effects data

From 2023 Phase 2 trial • 25 Patients • NCT03680521
86%
Hypertension
71%
Dysphonia
57%
Headache
43%
Fatigue
43%
Constipation
43%
Lipase increased
43%
Oral dysaesthesia
29%
Blood thyroid stimulating hormone increased
29%
Hypotension
29%
Urinary tract infection
29%
Myalgia
29%
Hypothyroidism
29%
Diarrhoea
29%
Vomiting
29%
Pain
29%
Amylase increased
14%
Hyperuricaemia
14%
Nasal congestion
14%
Abdominal pain
14%
Alanine aminotransferase increased
14%
Weight decreased
14%
Night sweats
14%
Urinary retention
14%
Nausea
14%
Rash
14%
Decreased appetite
14%
Dizziness
14%
Haematuria
14%
Nail discolouration
14%
Arthralgia
14%
Hypoglycaemia
14%
Memory impairment
14%
Musculoskeletal pain
14%
Oral herpes
14%
Pain in jaw
14%
Pneumonitis
14%
Procedural pain
14%
Pyrexia
14%
Rhinitis allergic
14%
Rhinorrhoea
14%
Sinus congestion
14%
Somnolence
14%
Thrombocytopenia
14%
Tinnitus
14%
Tooth abscess
14%
Herpes zoster
14%
Chills
14%
Urosepsis
14%
Atrial fibrillation
14%
Acute respiratory failure
14%
Cough
14%
Epistaxis
14%
Flank pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sitravatinib 120 mg
Sitravatinib 80 mg

Trial Design

1Treatment groups
Experimental Treatment
Group I: Sitravatinib and nivolumabExperimental Treatment2 Interventions
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 prior to planned nephrectomy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sitravatinib
Not yet FDA approved
Nivolumab
FDA approved

Find a Location

Who is running the clinical trial?

Mirati Therapeutics Inc.Lead Sponsor
69 Previous Clinical Trials
7,960 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the deleterious effects associated with Sitravatinib in patients?

"Sitravatinib attained a safety rating of 2, as the Phase 2 trial has been able to provide proof that it is relatively safe but there is no evidence yet showing its efficacy."

Answered by AI

Is this trial a pioneering effort in its field?

"Since 2012, the pharmaceutical industry has been conducting research into sitravatinib. Initially sponsored by Ono Pharmaceutical Co Ltd., an initial trial was conducted in 2012 involving 659 people which followed with Phase 1 and 2 drug approval. Presently, there are 728 clinical trials for sitravatinib spread across 2366 cities in 49 countries worldwide."

Answered by AI

What conditions is Sitravatinib typically used to treat?

"Sitravatinib is typically used to combat malignant neoplasms, but it has also been proven effective in treating conditions such as metastatic esophageal adenocarcinoma, squamous cell carcinoma, and unresectable melanoma."

Answered by AI

Could you summarize any other research efforts surrounding Sitravatinib?

"Currently, the number of active studies related to Sitravatinib stands at 728 with 83 in Phase 3. Basel, BE is home to many trials for this medication and globally there are 40,413 sites conducting research on its efficacy."

Answered by AI

Are there any openings available for prospective participants in this clinical trial?

"Unfortunately, this medical trial is no longer actively accepting participants; the last update was on April 27th 2021. However, there are currently 2580 trials looking for individuals with carcinoma and 728 studies recruiting patients that require Sitravatinib treatment."

Answered by AI

What is the cap on participants for this clinical research?

"This clinical trial is no longer actively seeking participants. Originally registered on October 10th 2018, the study was last updated April 27th 2021. Carcinoma and renal cell patients have a multitude of other options with 2580 active trials while those searching for Sitravatinib can join one of 728 studies currently recruiting."

Answered by AI
~4 spots leftby Mar 2025