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Checkpoint Inhibitor

Sitravatinib + Immunotherapy for Renal Cell Carcinoma

Phase 1
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
Confirmed diagnosis of Clear-Cell Renal Cell Carcinoma (for initial cohorts under consideration)
No prior treatment with systemic therapy (for initial cohorts under consideration)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 12 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug (sitravatinib) in combination with two other drugs (nivolumab and ipilimumab) to see if it is safe and effective.

Who is the study for?
This trial is for adults with advanced or metastatic clear-cell renal cell carcinoma (ccRCC) or other solid tumors who haven't had systemic therapy. They must have a confirmed diagnosis, good bone marrow and organ function, and no heart issues, other cancers, brain metastases, carcinomatous meningitis, immunocompromising conditions or autoimmune diseases.Check my eligibility
What is being tested?
The study tests the combination of Sitravatinib with Nivolumab and Ipilimumab in treating ccRCC. It's an open-label Phase 1 trial that looks at safety, how well it works against cancer (clinical activity), and how the body processes these drugs (pharmacokinetics).See study design
What are the potential side effects?
Possible side effects include immune-related reactions like inflammation in organs; skin rash; liver enzyme changes; endocrine disorders such as thyroid dysfunction; fatigue; gastrointestinal symptoms like diarrhea; and potential infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Clear-Cell Renal Cell Carcinoma.
Select...
I have not had any systemic therapy for my condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of patients experiencing treatment-emergent AEs
Secondary outcome measures
Duration of Response (DOR)
Objective Response Rate (ORR) in accordance with RECIST v1.1
Progression-free Survival (PFS)

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

3Treatment groups
Experimental Treatment
Group I: Phase 1b Dose Escalation Cohort BExperimental Treatment3 Interventions
Patients with favorable-risk RCC with clear cell component for first-line treatment.
Group II: Phase 1b Dose Escalation Cohort AExperimental Treatment3 Interventions
Patients with poor- or intermediate-risk RCC with clear cell component for first-line treatment
Group III: Phase 1: Dose EscalationExperimental Treatment3 Interventions
Patients with poor- or intermediate-risk RCC with clear cell component for first-line treatment.
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
Ipilimumab
2014
Completed Phase 3
~2620

Find a Location

Who is running the clinical trial?

Mirati Therapeutics Inc.Lead Sponsor
70 Previous Clinical Trials
8,113 Total Patients Enrolled
Curtis Chin, MDStudy DirectorMirati Therapeutics Inc.
4 Previous Clinical Trials
121 Total Patients Enrolled
Hirak Der-Torossian, MDStudy DirectorMirati Therapeutics Inc.
3 Previous Clinical Trials
1,107 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 common benefits of Sitravatinib?

"Sitravatinib can be used to target previous anti-angiogenic therapy, malignant neoplasms, and unresectable melanoma."

Answered by AI

Is patient recruitment open for this clinical trial?

"The clinicaltrials.gov website indicates that this study is not currently looking for participants. This study was originally posted on August 11th, 2020 and was edited most recently on October 7th, 2020. Although this study is not actively enrolling patients, there are 3465 other trials that are."

Answered by AI

Has the Federal Drug Administration given the green light to Sitravatinib?

"Sitravatinib's safety is not well understood because it is still in Phase 1 of clinical trials."

Answered by AI

Does Sitravatinib have a history of being studied in other medical trials?

"There are currently 811 active clinical trials studying Sitravatinib. Of those, 88 have reached Phase 3. The majority of these trials are based in Pittsburgh, but there are a total of 43685 locations worldwide where studies are taking place."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
How old are they?
18 - 65
What site did they apply to?
MD Anderson
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Study of Sitravatinib, Nivolumab and Ipilimumab in Advanced or Metastatic Clear-Cell Renal Cell Carcinoma or Other Solid Malignancies
2020. "Study of Sitravatinib, Nivolumab and Ipilimumab in Advanced or Metastatic Clear-Cell Renal Cell Carcinoma or Other Solid Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04518046.
All > Renal Cell Carcinoma
~20 spots leftby Apr 2025
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