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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
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
No Placebo-Only Group
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 belowSelect...
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 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
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 moreSide effects data
From 2022 Phase 2 trial • 45 Patients • NCT0210173695%
HYPOTHYROIDISM
73%
DIARRHEA
55%
WEIGHT LOSS
50%
FATIGUE
41%
ALANINE AMINOTRANSFERASE INCREASED
41%
Neutrophil Count Decreased
41%
ASPARTATE AMINOTRANSFERASE INCREASED
41%
VOMITING
41%
ANOREXIA
41%
NAUSEA
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%
PLATELET COUNT DECREASE
23%
HYPONATREMIA
23%
Decreased Platelet Count
23%
Platelet Count Decreased
23%
Skin Hypopigmentation
23%
Renal & Urinary Disorders - Other, Ketonuria
23%
HAIR COLOR CHANGE
18%
Upper Respiratory Infection
18%
HEMOGLOBIN INCREASED
18%
HYPOKALEMIA
18%
HYPOPHOSPHATEMIA
18%
Alopecia
18%
Hyperkalemia
14%
Rash Acneiform
14%
Pruritis
14%
Rash Maculopapular
14%
HYPOGLYCEMIA
14%
HYPERGLYCEMIA
14%
BILIRUBIN INCREASED
14%
ACNEIFORM RASH
14%
Cough
14%
Blood Bilirubin Increased
14%
DIZZINESS
14%
Skin And Subcutaneous Disorders - Other, Achromotricia
14%
CONSTIPATION
14%
Fever
9%
TUMOR PAIN
9%
Papulopustular Rash
9%
ALKALINE PHOSPHATASE INCREASED
9%
LIPASE INCREASED
9%
Creatinine Increased
9%
Back Pain
9%
ABSOLUTE NEUTROPHIL COUNT DECREASED
9%
Paresthesia
9%
Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified
9%
ORAL PAIN
9%
LYMPHOCYTE COUNT DECREASED
9%
NASAL CONGESTION
9%
WEIGHT GAIN
9%
HYPOCALCEMIA
9%
DRY SKIN
5%
Muscle Weakness Lower Limb
5%
Allergic Rhinitis
5%
Hypotension
5%
Hypertension
5%
SERUM AMYLASE INCREASED
5%
Investigations - Other, Eosinophilia
5%
Sore Throat
5%
ANXIETY
5%
Hypermagnesemia
5%
Rash Ezcematoid
5%
Scalp Pain
5%
Neuropathy
5%
Psychiatric Disorders - Other, Mood Swings
5%
URINARY URGENCY
5%
Sinus Tachycardia
5%
Periodontal Disease
5%
Peripheral Sensory Neuropathy
5%
Myalgia
5%
Tooth Infection
5%
RASH
5%
Peripheral Motor Neuropathy
5%
Tachycardia
5%
URINARY FREQUENCY
5%
Conjunctivitis
5%
Sinusitis
5%
Syncope
5%
Activated Partial Thromboplastin Time Prolonged
5%
Breast Pain
5%
JOINT RANGE OF MOTION DECREASED
5%
INSOMNIA
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Skin And Subcutaneous Disorders - Other, Dry Skin Patches
5%
HEMATURIA
5%
Investigations - Other, International Normalized Ration Increased
5%
Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps
5%
Joint Range Of Motion Decreased
5%
Behaviour Disturbance
5%
Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips
5%
Infections And Infestations - Other, Gi Viral Infection
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Scalp Lesion
5%
Stomach Pain
5%
TENDONITIS
5%
SKIN INFECTION
5%
HYPOMAGNESEMIA
5%
Muscle Weakness Upper Limb
5%
Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
Skin And Subcutaneous Tissue Disorders- Other, Erythema
5%
Infections And Infestations - Other, Covid-19
5%
Investigations - Other, Increased Mean Corpuscular Volume
5%
Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
Injury, Poisoning And Procedural Complications - Other, Ankle Injury
5%
Injury, Poisoning And Procedural Complications- Other, Scalp Laceration
5%
Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles
5%
SINUS BRADYCARDIA
5%
HYPERTHYROIDISM
5%
Creatine Phosphokinase Increased
5%
Skin And Subcutaneous Tissue Disorders - Other: Blue Lips (Not Cyanosis)
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
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: 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
2015
Completed Phase 3
~4010
Ipilimumab
2015
Completed Phase 3
~3070
Cabozantinib
2020
Completed Phase 2
~1760
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,991 Previous Clinical Trials
2,295,779 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,682 Previous Clinical Trials
4,129,464 Total Patients Enrolled
ExelixisIndustry Sponsor
120 Previous Clinical Trials
20,025 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.
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