← Back to Search

Tyrosine Kinase Inhibitor

Cabozantinib + Nivolumab + Ipilimumab for Soft Tissue Sarcoma

Phase 2
Waitlist Available
Led By Brian A Van Tine, M.D. Ph.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Refractory to at least one and no more than two lines of therapy, with progression on last line of therapy
Histologically or cytologically confirmed soft tissue sarcoma that is metastatic or unresectable
Must not have
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or evidence of active pneumonitis on screening chest CT scan
Active infection requiring systemic treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years from end of treatment
Awards & highlights

Summary

This trial is testing whether adding PD-1 and CTLA-4 inhibitors to cabozantinib will improve the response rate in patients with soft tissue sarcoma, and whether cabozantinib priming will increase the response to nivolumab and ipilimumab.

Who is the study for?
Adults with advanced soft tissue sarcoma, who have tried at least one but no more than two previous treatments without success. They must be able to measure their cancer, have normal organ and bone marrow function, and not be on certain medications or have specific health conditions like brain metastases or active infections.
What is being tested?
The trial is testing if combining Cabozantinib (a drug that targets tumor growth) with Nivolumab and Ipilimumab (drugs that boost the immune system) can better treat soft tissue sarcoma compared to current therapies.
What are the potential side effects?
Possible side effects include fatigue, diarrhea, skin rash, liver issues, hormonal gland problems (like thyroid dysfunction), high blood pressure, bleeding or clotting disorders. There may also be risks of severe immune system reactions affecting various organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My condition worsened after 1-2 treatments.
Select...
My sarcoma cannot be surgically removed and has spread.
Select...
I am 18 years old or older.
Select...
My blood tests and organ functions are normal.
Select...
I am 18 years old or older.
Select...
My white blood cell count is healthy without needing medication to boost it.
Select...
I am fully active and can carry on all my pre-disease activities without restriction.
Select...
My sarcoma is confirmed by tests and cannot be surgically removed or has spread.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of lung scarring or inflammation not caused by infections.
Select...
I am currently being treated for an infection.
Select...
I have had a solid organ or bone marrow transplant.
Select...
I have a serious illness that is not under control.
Select...
My sarcoma is caused by a genetic change, but it's not ASPS.
Select...
I have cancer that has spread to my brain.
Select...
I have been treated with cabozantinib or drugs targeting PD-1, PD-L1, or CTLA-4.
Select...
I haven't taken steroids or immunosuppressants in the last 14 days.
Select...
I require dialysis.
Select...
I have not had major surgery in the last 2 weeks.
Select...
I have an autoimmune disease.
Select...
I cannot swallow pills.
Select...
I am currently taking blood thinners.
Select...
I have a condition that prevents my body from absorbing nutrients properly.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years from end of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years from end of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Radiographic response rate by RECIST 1.1
Secondary study objectives
Change in quality of life as measured by FACT-G7
Clinical benefit rate
Overall survival
+3 more

Side effects data

From 2022 Phase 2 trial • 45 Patients • NCT02101736
95%
HYPOTHYROIDISM
73%
DIARRHEA
55%
WEIGHT LOSS
50%
FATIGUE
41%
ALANINE AMINOTRANSFERASE INCREASED
41%
Neutrophil Count Decreased
41%
ASPARTATE AMINOTRANSFERASE INCREASED
41%
VOMITING
41%
NAUSEA
41%
ANOREXIA
36%
HEADACHE
36%
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
36%
PAIN IN EXTREMITY
36%
HYPERTENSION
32%
PROTEINURIA
32%
PAIN
27%
White Blood Cell Count Decreased
27%
ABDOMINAL PAIN
23%
Skin Hypopigmentation
23%
PLATELET COUNT DECREASE
23%
HYPONATREMIA
23%
Renal & Urinary Disorders - Other, Ketonuria
23%
Platelet Count Decreased
23%
Decreased Platelet Count
23%
HAIR COLOR CHANGE
18%
Upper Respiratory Infection
18%
HEMOGLOBIN INCREASED
18%
HYPOKALEMIA
18%
HYPOPHOSPHATEMIA
18%
Alopecia
18%
Hyperkalemia
14%
Skin And Subcutaneous Disorders - Other, Achromotricia
14%
Pruritis
14%
HYPERGLYCEMIA
14%
BILIRUBIN INCREASED
14%
DIZZINESS
14%
ACNEIFORM RASH
14%
Cough
14%
Blood Bilirubin Increased
14%
CONSTIPATION
14%
HYPOGLYCEMIA
14%
Rash Acneiform
14%
Rash Maculopapular
14%
Fever
9%
Papulopustular Rash
9%
ALKALINE PHOSPHATASE INCREASED
9%
Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified
9%
Back Pain
9%
ABSOLUTE NEUTROPHIL COUNT DECREASED
9%
LIPASE INCREASED
9%
Creatinine Increased
9%
Paresthesia
9%
ORAL PAIN
9%
LYMPHOCYTE COUNT DECREASED
9%
TUMOR PAIN
9%
NASAL CONGESTION
9%
WEIGHT GAIN
9%
HYPOCALCEMIA
9%
DRY SKIN
5%
Skin And Subcutaneous Disorders - Other, Dry Skin Patches
5%
Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
Hypertension
5%
SERUM AMYLASE INCREASED
5%
Behaviour Disturbance
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Investigations - Other, Eosinophilia
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Rash Ezcematoid
5%
Muscle Weakness Lower Limb
5%
Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps
5%
Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger
5%
Sore Throat
5%
HYPOMAGNESEMIA
5%
Activated Partial Thromboplastin Time Prolonged
5%
Investigations - Other, International Normalized Ration Increased
5%
Myalgia
5%
Scalp Pain
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
Hypermagnesemia
5%
Hypotension
5%
Infections And Infestations - Other, Gi Viral Infection
5%
Psychiatric Disorders - Other, Mood Swings
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
TENDONITIS
5%
INSOMNIA
5%
URINARY URGENCY
5%
Allergic Rhinitis
5%
Injury, Poisoning And Procedural Complications - Other, Ankle Injury
5%
Injury, Poisoning And Procedural Complications- Other, Scalp Laceration
5%
Investigations - Other, Increased Mean Corpuscular Volume
5%
Sinus Tachycardia
5%
Periodontal Disease
5%
Peripheral Sensory Neuropathy
5%
Scalp Lesion
5%
Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change
5%
Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips
5%
Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema
5%
Tachycardia
5%
Infections And Infestations - Other, Covid-19
5%
Peripheral Motor Neuropathy
5%
Tooth Infection
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
ANXIETY
5%
JOINT RANGE OF MOTION DECREASED
5%
URINARY FREQUENCY
5%
Conjunctivitis
5%
Muscle Weakness Upper Limb
5%
Neuropathy
5%
Sinusitis
5%
Skin And Subcutaneous Tissue Disorders- Other, Erythema
5%
Stomach Pain
5%
Syncope
5%
RASH
5%
HEMATURIA
5%
Breast Pain
5%
Joint Range Of Motion Decreased
5%
SINUS BRADYCARDIA
5%
HYPERTHYROIDISM
5%
Creatine Phosphokinase Increased
5%
Skin And Subcutaneous Tissue Disorders - Other: Blue Lips (Not Cyanosis)
5%
SKIN INFECTION
5%
Urine Discoloration
5%
SPINAL CORD COMPRESSION
5%
ANEMIA
5%
PARONYCHIA
5%
BRUISING
5%
HYPOALBUMINEMIA
5%
Ear And Labyrinth Disorders - Other, Impacted Cerumen
5%
Ear Pain
5%
Elevated Amylase
5%
Facial Pain
5%
Gastrointestinal Disorders - Other, Stomatitis
5%
Hoarseness
5%
Laryngitis
5%
Leg Pain
5%
Localized Edema
5%
Lung Infection
5%
Metabolism And Nutrition Disorders - Other, Decreased Oral Intake
5%
Metabolism Other - Decreased Vitamin D
5%
Metbolism And Nutrition Disorders - Other, Hyperchloremia
5%
Mucositis Oral
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort B
Cohort A

Trial Design

3Treatment groups
Experimental Treatment
Group I: Crossover from Cohort A to Cohort B: Cabozantinib + Nivolumab + IpilimumabExperimental Treatment3 Interventions
-Participants who cross-over from Cohort A into Cohort B will initiate treatment with nivolumab at a dose of 3 mg/kg IV over approximately 30 minutes and ipilimumab at a dose of 1 mg/kg IV over approximately 30 minutes. Nivolumab and ipilimumab will be given every 3 weeks for 4 doses. Nivolumab will then be continued at a dose of 480 mg IV over approximately 30 minutes every 4 weeks, with cabozantinib to continue at 40 mg every day. Treatment may continue for up to 2 years.
Group II: Cohort B: Cabozantinib + Nivolumab + IpilimumabExperimental Treatment3 Interventions
-Patients randomized to Cohort B will take cabozantinib at a dose of 40 mg by mouth once each day. Nivolumab will given IV at a dose of 3 mg/kg over approximately 30 minutes every 3 weeks for 4 doses, followed by 480 mg over approximately 30 minutes every 4 weeks until treatment discontinuation. Ipilimumab will be given IV at a dose of 1 mg/kg over approximately 30 minutes every 3 weeks for 4 doses. Treatment may continue for up to 2 years.
Group III: Cohort A: CabozantinibExperimental Treatment1 Intervention
Patients randomized to Cohort A will take cabozantinib at a dose of 60 mg by mouth once each day of each 28-day cycle. Treatment may continue indefinitely. At time of progression, patients will continue on cabozantinib daily but will reduce their dose to 40 mg. They will cross over into Cohort B and initiate treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~5220
Ipilimumab
2014
Completed Phase 3
~3140
Cabozantinib
2020
Completed Phase 2
~1760

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,970 Previous Clinical Trials
2,308,518 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,678 Previous Clinical Trials
4,125,540 Total Patients Enrolled
ExelixisIndustry Sponsor
119 Previous Clinical Trials
19,814 Total Patients Enrolled

Media Library

Cabozantinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04551430 — Phase 2
Soft Tissue Sarcoma Research Study Groups: Crossover from Cohort A to Cohort B: Cabozantinib + Nivolumab + Ipilimumab, Cohort A: Cabozantinib, Cohort B: Cabozantinib + Nivolumab + Ipilimumab
Soft Tissue Sarcoma Clinical Trial 2023: Cabozantinib Highlights & Side Effects. Trial Name: NCT04551430 — Phase 2
Cabozantinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04551430 — Phase 2
~16 spots leftby Jun 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top