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Checkpoint Inhibitor
Sitravatinib + Nivolumab for Advanced Kidney Cancer
Phase 2
Waitlist Available
Led By Pavlos Msaouel
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
Patients with histologically or cytologically confirmed metastatic/advanced clear cell RCC, or RCC with a clear cell component, who have received 1 or 2 prior lines of treatment in the advanced or metastatic setting, and the most recent treatment must include a PD-1 or PD-L1 CPI, cabozantinib, or lenvatinib
For patients with Gilbert's disease, total bilirubin should =< 3 mg/dL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights
Study Summary
This trial is testing sitravatinib & nivolumab to treat patients with metastatic clear cell renal cell cancer. Sitravatinib may stop growth by blocking enzymes & nivolumab may help the body's immune system attack the cancer.
Who is the study for?
This trial is for adults with advanced or metastatic clear cell renal cell cancer who've had 1-2 previous treatments including specific therapies like PD-1/PD-L1 CPI. They must have measurable disease, be in good physical condition, and not pregnant. Exclusions include other recent cancers, certain medical conditions, and those on conflicting medications.Check my eligibility
What is being tested?
The trial tests sitravatinib combined with nivolumab against advanced kidney cancer. Sitravatinib may halt tumor growth by blocking enzymes needed for cell growth while nivolumab boosts the immune system to fight cancer cells.See study design
What are the potential side effects?
Potential side effects include immune-related reactions that can affect organs, fatigue, digestive issues, skin problems, hormonal gland changes (like thyroid), and possible infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have advanced kidney cancer treated with specific drugs.
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My total bilirubin level is 3 mg/dL or less, even with Gilbert's disease.
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I am able to care for myself but may not be able to do active work.
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I am 18 years old or older.
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I am a woman who can have children and have a negative pregnancy test.
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My cancer progressed after my last treatment with a PD-1/PD-L1 inhibitor within the past 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease control rate
Objective response rate
Secondary outcome measures
Duration of response
Health-related quality-of-life (QOL)
Incidence of adverse events
+2 moreSide effects data
From 2023 Phase 2 trial • 25 Patients • NCT0368052186%
Hypertension
71%
Dysphonia
57%
Headache
43%
Fatigue
43%
Constipation
43%
Lipase increased
43%
Oral dysaesthesia
29%
Hypothyroidism
29%
Blood thyroid stimulating hormone increased
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 Treatment4 Interventions
Patients receive sitravatinib PO QD and nivolumab IV over 30 minutes on day 1. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Sitravatinib
2017
Completed Phase 2
~490
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,986 Previous Clinical Trials
1,789,426 Total Patients Enrolled
Pavlos MsaouelPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your hemoglobin level is at least 9 grams per deciliter.I have or had an autoimmune disease.I have not had major surgery or significant injury within the last 28 days.I am not on medications that affect heart rhythm significantly.You have a weakened immune system.I am currently receiving treatment for kidney cancer.Your total bilirubin level should be less than or equal to 1.5 mg/dL.I have not had any live vaccines in the week before or during the study.I am not pregnant, breastfeeding, and if capable of having children, I am using effective birth control.I have untreated brain or spinal cord cancer spread.My kidney function is normal and I don't need dialysis.I have advanced kidney cancer treated with specific drugs.You must have at least one place in your body where the disease can be measured.Your platelet count is at least 75,000 per microliter.My total bilirubin level is 3 mg/dL or less, even with Gilbert's disease.My heart's pumping ability is below 40%.Your liver enzyme levels should not be too high, unless you have known cancer spread to your liver.Your blood clotting tests (INR and PTT) should be within a certain range before joining the study.I am not currently on cancer treatment and haven't been for the last 2 weeks.I have had severe side effects from previous immunotherapy.I haven't had any cancer in the past 2 years, except for certain skin cancers or early-stage cervical cancer.I am able to care for myself but may not be able to do active work.I am 18 years old or older.I am a woman who can have children and have a negative pregnancy test.My cancer progressed after my last treatment with a PD-1/PD-L1 inhibitor within the past 6 months.You have enough infection-fighting white blood cells in your body.My brain cancer was treated with surgery or targeted radiation and has not worsened in the last month.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (sitravatinib, nivolumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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