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Checkpoint Inhibitor

Sitravatinib for Renal Cell Carcinoma

Phase 1 & 2
Waitlist Available
Led By Nizar M Tannir
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights

Study Summary

This trial is testing the side effects of a new drug, sitravatinib, when used with nivolumab to treat patients with kidney cancer.

Eligible Conditions
  • Renal Cell Carcinoma
  • Kidney Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy (defined as achieving complete remission, partial remission or stable disease)
Incidence of adverse events
Secondary outcome measures
Objective response rate
Overall survival time
Progression free survival time
+1 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%
Hypothyroidism
29%
Hypotension
29%
Myalgia
29%
Diarrhoea
29%
Urinary tract infection
29%
Vomiting
29%
Pain
29%
Amylase increased
14%
Arthralgia
14%
Cough
14%
Abdominal pain
14%
Acute respiratory failure
14%
Weight decreased
14%
Nasal congestion
14%
Epistaxis
14%
Flank pain
14%
Alanine aminotransferase increased
14%
Hyperuricaemia
14%
Memory impairment
14%
Musculoskeletal pain
14%
Night sweats
14%
Urinary retention
14%
Nausea
14%
Rash
14%
Decreased appetite
14%
Dizziness
14%
Haematuria
14%
Nail discolouration
14%
Hypoglycaemia
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
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sitravatinib 120 mg
Sitravatinib 80 mg

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (sitravatinib, nivolumab)Experimental Treatment5 Interventions
Patients receive sitravatinib PO QD on days 1-14 and receive nivolumab IV over 60 minutes on day 1 starting cycle 2. Cycles repeat every 14 days for cycles 1-6 and then every 28 days for subsequent cycles in the absence of disease progression or unacceptable toxicity. Patients who receive at least 6 infusions of nivolumab with no DLTs related to nivolumab, may then receive nivolumab every 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sitravatinib
2021
Completed Phase 2
~490
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,354 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,667 Previous Clinical Trials
40,926,124 Total Patients Enrolled
Nizar M TannirPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
100 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Sitravatinib and Nivolumab in Treating Patients With Advanced or Metastatic Kidney Cancer
2017. "Sitravatinib and Nivolumab in Treating Patients With Advanced or Metastatic Kidney Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03015740.
~5 spots leftby Apr 2025
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