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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
Refractory to at least one and no more than two lines of therapy, with progression on last line of therapy. Neoadjuvant or adjuvant therapy completed more than one year prior does not count towards these two lines of therapy. Individuals with alveolar soft part sarcoma may enroll without being refractory to at least one line of chemotherapy. Any inappropriate therapies (ie hormonal therapies) should be discussed with the PI to determine if they are to be counted toward the two lines of therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years from end of treatment
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My condition worsened after 1-2 treatments.
Select...
My cancer has not improved after 1-2 treatments, but it's been over a year since my initial therapy.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years from end of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years from end of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Radiographic response rate by RECIST 1.1
Secondary outcome measures
Change in quality of life as measured by FACT-G7
Clinical benefit rate
Overall survival
+3 moreSide effects data
From 2022 Phase 2 trial • 45 Patients • NCT0210173695%
HYPOTHYROIDISM
73%
DIARRHEA
55%
WEIGHT LOSS
50%
FATIGUE
41%
VOMITING
41%
NAUSEA
41%
ASPARTATE AMINOTRANSFERASE INCREASED
41%
ANOREXIA
41%
ALANINE AMINOTRANSFERASE INCREASED
41%
Neutrophil Count Decreased
36%
HEADACHE
36%
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
36%
PAIN IN EXTREMITY
36%
HYPERTENSION
32%
PAIN
32%
PROTEINURIA
27%
ABDOMINAL PAIN
27%
White Blood Cell Count Decreased
23%
Platelet Count Decreased
23%
Skin Hypopigmentation
23%
HAIR COLOR CHANGE
23%
Renal & Urinary Disorders - Other, Ketonuria
23%
PLATELET COUNT DECREASE
23%
HYPONATREMIA
23%
Decreased Platelet Count
18%
HYPOPHOSPHATEMIA
18%
HYPOKALEMIA
18%
Alopecia
18%
Hyperkalemia
18%
Upper Respiratory Infection
18%
HEMOGLOBIN INCREASED
14%
DIZZINESS
14%
BILIRUBIN INCREASED
14%
Pruritis
14%
ACNEIFORM RASH
14%
Fever
14%
Rash Maculopapular
14%
CONSTIPATION
14%
HYPERGLYCEMIA
14%
HYPOGLYCEMIA
14%
Blood Bilirubin Increased
14%
Cough
14%
Rash Acneiform
14%
Skin And Subcutaneous Disorders - Other, Achromotricia
9%
TUMOR PAIN
9%
ORAL PAIN
9%
ALKALINE PHOSPHATASE INCREASED
9%
WEIGHT GAIN
9%
NASAL CONGESTION
9%
Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified
9%
ABSOLUTE NEUTROPHIL COUNT DECREASED
9%
LIPASE INCREASED
9%
LYMPHOCYTE COUNT DECREASED
9%
HYPOCALCEMIA
9%
DRY SKIN
9%
Back Pain
9%
Creatinine Increased
9%
Papulopustular Rash
9%
Paresthesia
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
RASH
5%
INSOMNIA
5%
Peripheral Sensory Neuropathy
5%
HYPERTHYROIDISM
5%
SINUS BRADYCARDIA
5%
Hypertension
5%
ANXIETY
5%
Sore Throat
5%
Myalgia
5%
SPINAL CORD COMPRESSION
5%
Gastrointestinal Disorders - Other, Stomatitis
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Hoarseness
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Peripheral Motor Neuropathy
5%
Investigations - Other, Eosinophilia
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
Stomach Pain
5%
TENDONITIS
5%
HEMATURIA
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps
5%
Facial Pain
5%
HYPOMAGNESEMIA
5%
Allergic Rhinitis
5%
Activated Partial Thromboplastin Time Prolonged
5%
Leg Pain
5%
Muscle Weakness Lower Limb
5%
Muscle Weakness Upper Limb
5%
Psychiatric Disorders - Other, Mood Swings
5%
Scalp Lesion
5%
Scalp Pain
5%
Sinus Tachycardia
5%
Sinusitis
5%
Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger
5%
Skin And Subcutaneous Tissue Disorders- Other, Erythema
5%
Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips
5%
Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema
5%
Syncope
5%
Tachycardia
5%
Urine Discoloration
5%
JOINT RANGE OF MOTION DECREASED
5%
ANEMIA
5%
PARONYCHIA
5%
BRUISING
5%
SERUM AMYLASE INCREASED
5%
SKIN INFECTION
5%
HYPOALBUMINEMIA
5%
URINARY FREQUENCY
5%
URINARY URGENCY
5%
Behaviour Disturbance
5%
Breast Pain
5%
Conjunctivitis
5%
Creatine Phosphokinase Increased
5%
Ear And Labyrinth Disorders - Other, Impacted Cerumen
5%
Ear Pain
5%
Elevated Amylase
5%
Hypermagnesemia
5%
Hypotension
5%
Infections And Infestations - Other, Covid-19
5%
Infections And Infestations - Other, Gi Viral Infection
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%
Investigations - Other, International Normalized Ration Increased
5%
Laryngitis
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
5%
Neuropathy
5%
Periodontal Disease
5%
Rash Ezcematoid
5%
Skin And Subcutaneous Disorders - Other, Dry Skin Patches
5%
Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change
5%
Skin And Subcutaneous Tissue Disorders - Other: Blue Lips (Not Cyanosis)
5%
Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles
5%
Tooth Infection
5%
Joint Range Of Motion Decreased
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
Ipilimumab
2014
Completed Phase 3
~2620
Nivolumab
2014
Completed Phase 3
~4750
Cabozantinib
2020
Completed Phase 2
~1080
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,604 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,409 Total Patients Enrolled
ExelixisIndustry Sponsor
117 Previous Clinical Trials
19,446 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of lung scarring or inflammation not caused by infections.I am currently being treated for an infection.I haven't had cancer treatment in the last 4 weeks.You have tumors that can be measured and are at least 10mm in size on CT scan or 20mm on chest x-ray, or can be measured using calipers during a clinical exam.Your platelet count is at least 100,000 per cubic millimeter of blood without any transfusion.I have had a solid organ or bone marrow transplant.You have other medical conditions that could make it unsafe for you to participate in the study.I have a serious illness that is not under control.My condition worsened after 1-2 treatments.I have had cancer before, but it fits the exceptions.My sarcoma is caused by a genetic change, but it's not ASPS.I haven't had radiation for bone metastasis in the last 2 weeks or any other radiation in the last 4 weeks.I have cancer that has spread to my brain.My cancer has not improved after 1-2 treatments, but it's been over a year since my initial therapy.You are currently pregnant or breastfeeding.I have been treated with cabozantinib or drugs targeting PD-1, PD-L1, or CTLA-4.I haven't taken any kinase inhibitor medication in the last 2 weeks.I haven't taken steroids or immunosuppressants in the last 14 days.I require dialysis.I have not had major surgery in the last 2 weeks.I have not received a live vaccine in the last 30 days.Your hemoglobin level must be at least 9.0 grams per deciliter.I have an autoimmune disease.My sarcoma cannot be surgically removed and has spread.I cannot swallow pills.I am 18 years old or older.My blood tests and organ functions are normal.My cancer can be biopsied to test for PD-L1 if there's no old tissue sample.I have recovered from side effects of previous treatments.I agree to use birth control during the study.I am 18 years old or older.You need to have a minimum of 2,000 white blood cells per cubic millimeter of blood.You are currently taking any experimental drugs as part of another study.I am currently taking blood thinners.My white blood cell count is healthy without needing medication to boost it.I am fully active and can carry on all my pre-disease activities without restriction.My sarcoma is confirmed by tests and cannot be surgically removed or has spread.I have a condition that prevents my body from absorbing nutrients properly.Your bilirubin levels must be within certain limits, unless you have a condition called Gilbert's disease.
Research Study Groups:
This trial has the following groups:- Group 1: Crossover from Cohort A to Cohort B: Cabozantinib + Nivolumab + Ipilimumab
- Group 2: Cohort A: Cabozantinib
- Group 3: Cohort B: Cabozantinib + Nivolumab + Ipilimumab
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are we currently able to sign people up for this clinical trial?
"That is right, the clinical trial is ongoing and currently recruiting patients. It was first posted on January 5th, 2021 with the most recent update being March 8th, 2022. The study wants to enroll 105 patients from 4 different locations."
Answered by AI
Are there any negative side effects associated with Cabozantinib?
"This is a Phase 2 trial, so cabozantinib's safety is only supported by preliminary data."
Answered by AI
At how many research facilities is this investigation being conducted?
"Multiple locations are recruiting patients for this clinical trial, such as Stanford University Medical Center in Stanford, the University of Colorado in Aurora, Abramson Cancer Center at Pennsylvania Hospital in Philadelphia, and 4 other centres."
Answered by AI
Are there any ongoing or previous clinical trials that have studied Cabozantinib?
"In total, there are 879 active clinical trials studying the efficacy of Cabozantinib. Out of these medical studies, 96 are in Phase 3. Additionally, while many of the tests for this medication are being conducted out of Pittsburgh, Pennsylvania, there are 46889 locations running these sorts of trials."
Answered by AI
What are the common indications for Cabozantinib?
"Cabozantinib is commonly used to treat unresectable melanoma. Cabozantinib can also be effective at treating other cancers such as squamous cell carcinoma, high risk of recurrence, and disease."
Answered by AI
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