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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 below
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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 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
Disease control rate
Objective response rate
Secondary outcome measures
Duration of response
Health-related quality-of-life (QOL)
Incidence of adverse events
+2 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%
Hypotension
29%
Hypothyroidism
29%
Blood thyroid stimulating hormone increased
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
2021
Completed Phase 2
~700

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,693 Total Patients Enrolled
Pavlos MsaouelPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
30 Total Patients Enrolled

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04904302 — Phase 2
Renal Cell Carcinoma Research Study Groups: Treatment (sitravatinib, nivolumab)
Renal Cell Carcinoma Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT04904302 — Phase 2
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04904302 — Phase 2

Frequently Asked Questions

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

What ailments is Sitravatinib commonly employed to ameliorate?

"Sitravatinib can be utilized to treat malignant tumors, non-operable melanomas and squamous cell carcinoma."

Answered by AI

Does this investigation currently have any openings for participants?

"The latest information on clinicaltrials.gov reveals that recruiting for this medical study is still in progress, with the first post appearing on May 3rd and the most recent update occurring June 29th 2022."

Answered by AI

How many participants are partaking in this experiment?

"Affirmative. Clinicaltrials.gov's records demonstrate that this medical experiment, which was first displayed on May 3rd 2022, is currently recruiting candidates. Approximately 88 volunteers are sought from a single clinical site."

Answered by AI

Is this experimental research new to the medical field?

"Currently, there are 728 live Sitravatinib trials being conducted in 2366 cities across 49 countries. Ono Pharmaceutical Co. Ltd was the first to sponsor this drug's trial back in 2012 with 659 participants and completed Phase 1 & 2 approval stages. In total, 483 studies have been run since then."

Answered by AI

What is the ultimate aim of this medical experiment?

"The primary outcome measure of this 24 week clinical trial is the Objective Response Rate, while secondary outcomes include Progression Free Survival (assessed with Kaplan-Meier survival curves and Cox regression models), Duration of response (also assessed with Kaplan-Meier survival curves and Cox regression models) as well as Adverse Events which will be recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 using descriptive statistics such a frequency and 95% confidence intervals)."

Answered by AI

Has Sitravatinib been greenlit by the FDA?

"The safety profile of Sitravatinib has been evaluated as a 2 on our scale, since it is only in Phase 2 testing and thus far there are no efficacy data available."

Answered by AI

What other research endeavors have included Sitravatinib as a focus?

"Currently, there are 728 active clinical trials researching Sitravatinib, with 83 of these encompassing Phase 3. Though the primary location for investigating this treatment is Basel, BE; 40412 sites worldwide are running studies related to it."

Answered by AI
~25 spots leftby Jan 2025