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PD-L1 Inhibitor

Atezolizumab + Cabozantinib for Osteosarcoma

Phase 2
Recruiting
Led By John A Livingston
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) of 0, 1 or 2. Use Karnofsky >= 50 for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age
Platelet count >= 100 x 10^9/L (100,000/uL) without transfusion (obtained within 14 days prior to initiation of study treatment)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is studying giving atezolizumab and cabozantinib to see how well it works in treating adolescents and young adults with osteosarcoma that has come back or has spread to other places in the body.

Who is the study for?
Adolescents and young adults aged 12 or older with recurrent or metastatic osteosarcoma, who have tried conventional therapies without success. Participants must have measurable disease, be able to provide a tumor specimen for research, and meet specific health criteria including organ function tests. They should not be HIV positive and must agree to use effective contraception.Check my eligibility
What is being tested?
The trial is testing the combination of Atezolizumab (an immunotherapy drug) and Cabozantinib (a drug that blocks tumor growth enzymes) in patients with advanced osteosarcoma. The study aims to see if this drug combo can control cancer better than current treatments.See study design
What are the potential side effects?
Possible side effects include immune-related reactions, liver issues, high blood pressure, fatigue, diarrhea, mouth sores, hand-foot syndrome (redness and pain on palms or soles), decreased appetite, weight loss, nausea/vomiting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am mostly active and can care for myself despite my illness.
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My platelet count is at least 100,000 without needing a transfusion.
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My diagnosis of bone cancer is confirmed by tissue examination.
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My cancer did not respond or has returned after treatment with specific chemotherapy drugs.
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I am 12 years old or older.
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My cancer has spread and cannot be removed by surgery.
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My body surface area is at least 1 square meter.
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My kidney function, measured by creatinine clearance, is sufficient.
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My white blood cell count is healthy without needing medication.
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My liver tests, AST and ALT, are within normal limits.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
Incidence of adverse events
Objective response rate
Overall survival (OS)
+1 more

Side effects data

From 2022 Phase 2 trial • 45 Patients • NCT02101736
95%
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%
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%
Hoarseness
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Peripheral Motor Neuropathy
5%
Investigations - Other, Eosinophilia
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
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

1Treatment groups
Experimental Treatment
Group I: Treatment (atezolizumab, cabozantinib)Experimental Treatment2 Interventions
Patients receive atezolizumab IV over 60 minutes on day 1 and cabozantinib PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860
Cabozantinib
2020
Completed Phase 2
~1080

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,276 Total Patients Enrolled
14 Trials studying Osteosarcoma
467 Patients Enrolled for Osteosarcoma
John A LivingstonPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
31 Total Patients Enrolled
1 Trials studying Osteosarcoma
31 Patients Enrolled for Osteosarcoma

Media Library

Atezolizumab (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05019703 — Phase 2
Osteosarcoma Research Study Groups: Treatment (atezolizumab, cabozantinib)
Osteosarcoma Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT05019703 — Phase 2
Atezolizumab (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05019703 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research a precedent-setting endeavor?

"Research on cabozantinib has been ongoing since 2008. To date, Hoffmann-La Roche alone has conducted 135 trials of the medication across 75 countries and 1911 cities. Currently, there are 447 active studies that involve cabozantinib in some capacity."

Answered by AI

How can we be sure that Cabozantinib is secure to use?

"Cabozantinib's safety is rated at 2, as it has only undergone a Phase 2 trial with limited evidence backing its efficacy."

Answered by AI

Are there vacancies available for anyone interested in participating in this research?

"The current study is not currently recruiting. As of August 31st, 2022, it has been posted for 8 months since December 1st, 2022. Other studies pertaining to refractory osteosarcoma and Cabozantinib are actively accepting patients with 1114 and 447 trials respectively."

Answered by AI

To what uses is Cabozantinib commonly allocated?

"Cabozantinib is an effective treatment for small cell lung cancer (SCLC) that has previously been treated with anti-VEGF and malignant neoplasms."

Answered by AI

To what extent is this research being conducted with participants?

"Unfortunately, the recruitment period for this trial has now come to an end. It was first posted on December 1st 2022 and last amended August 31st 2022. However, prospective participants may be interested to know that there are still 1114 trials searching for those with refractory osteosarcoma and 447 trials actively recruiting patients taking Cabozantinib."

Answered by AI
~27 spots leftby Dec 2027