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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)
Must not have
Known or suspected presence of other cancer
Brain metastases (for initial cohorts under consideration)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug combination of sitravatinib, nivolumab, and ipilimumab in patients with certain types of cancer. The goal is to see if this combination can effectively stop cancer growth and help the immune system fight the cancer.

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.
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).
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
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I have been diagnosed with Clear-Cell Renal Cell Carcinoma.
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I have not had any systemic therapy for my condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I may have another type of cancer besides the one being treated.
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My cancer has spread to my brain.
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I have cancer cells in the fluid around my brain and spinal cord.
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My heart does not function properly.
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I have or had an autoimmune disease.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Frequency of patients experiencing treatment-emergent AEs
Secondary study objectives
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%
Pain
29%
Hypothyroidism
29%
Vomiting
29%
Diarrhoea
29%
Hypotension
29%
Myalgia
29%
Urinary tract infection
29%
Amylase increased
14%
Acute respiratory failure
14%
Flank pain
14%
Cough
14%
Alanine aminotransferase increased
14%
Epistaxis
14%
Night sweats
14%
Weight decreased
14%
Abdominal pain
14%
Arthralgia
14%
Hyperuricaemia
14%
Memory impairment
14%
Musculoskeletal pain
14%
Nasal congestion
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Ipilimumab
2014
Completed Phase 3
~3140
Sitravatinib
2017
Completed Phase 2
~510
Nivolumab
2014
Completed Phase 3
~5220

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Renal Cell Carcinoma (RCC) include Tyrosine Kinase Inhibitors (TKIs), PD-1 inhibitors, and CTLA-4 inhibitors. TKIs, such as sitravatinib, block enzymes involved in the growth and spread of cancer cells by inhibiting pathways like VEGF, which is crucial for tumor angiogenesis. PD-1 inhibitors, like nivolumab, enhance the immune system's ability to detect and destroy cancer cells by blocking the PD-1 pathway, which tumors use to evade immune detection. CTLA-4 inhibitors, such as ipilimumab, further boost the immune response by blocking CTLA-4, a checkpoint that downregulates immune activity. These mechanisms are vital for RCC patients as they target both the tumor's growth and its ability to hide from the immune system, offering a comprehensive approach to treatment.
First-line Nivolumab plus Ipilimumab Versus Sunitinib in Patients Without Nephrectomy and With an Evaluable Primary Renal Tumor in the CheckMate 214 Trial.

Find a Location

Who is running the clinical trial?

Mirati Therapeutics Inc.Lead Sponsor
70 Previous Clinical Trials
8,107 Total Patients Enrolled
Hirak Der-Torossian, MDStudy DirectorMirati Therapeutics Inc.
3 Previous Clinical Trials
1,107 Total Patients Enrolled
Curtis Chin, MDStudy DirectorMirati Therapeutics Inc.
4 Previous Clinical Trials
121 Total Patients Enrolled
~4 spots leftby Oct 2025