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PD-L1 Inhibitor

Atezolizumab + Cabozantinib for Glioblastoma

Phase 1 & 2

Recruiting

Led By Shiao-Pei S Weathers

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

Have a performance status of >= 60 on the Karnofsky performance status (KPS)

Patients must be at least 12 weeks out from completion of concurrent chemoradiation

Must not have

Has received radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment, or systemic treatment with radionuclides within 6 weeks before first dose of study treatment

Evidence of tumor invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (e.g., Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and side effects of two drugs, atezolizumab and cabozantinib, in patients with recurrent glioblastoma. The drugs may help to shrink tumors by interfering with the ability of tumor cells to grow and spread.

Who is the study for?

Adults (18+) with recurrent glioblastoma previously treated with radiation and temozolomide, who have a Karnofsky performance status of >=60. Must not be pregnant or breastfeeding, agree to use contraception, and have adequate organ function as indicated by specific lab values. Cannot join if they've had certain other cancer treatments, serious medical conditions that interfere with the study, or known allergies to trial medications.

What is being tested?

The safety and effectiveness of combining Atezolizumab (an immunotherapy drug) with Cabozantinib (a drug that blocks tumor growth enzymes) in shrinking tumors for patients whose glioblastoma has returned after treatment.

What are the potential side effects?

Potential side effects include immune system reactions leading to inflammation in various organs, fatigue, liver issues reflected in blood tests, high blood pressure problems from Cabozantinib; plus typical chemotherapy-related side effects like nausea and low blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am mostly able to care for myself but may need occasional help.

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It has been at least 12 weeks since I finished my combined chemotherapy and radiation treatment.

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I have been treated with radiation and temozolomide before.

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I am 18 years old or older.

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My kidney function is within the normal range or slightly above.

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My condition has returned for the first or second time.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had radiation for bone metastasis in 2 weeks or any radiation in 4 weeks.

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I have a tumor affecting my digestive system or a serious digestive condition.

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I have a history of HIV or active hepatitis B or C.

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I am experiencing side effects from previous radiation therapy.

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I have had cancer treatments directly in the tumor area but not Gliadel wafers or Optune device.

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I am currently being treated for an infection.

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I have not had severe infections or been hospitalized for infection complications in the last 4 weeks.

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I have a lung condition not caused by an infection.

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I have or am at risk for an autoimmune disease.

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I have not received a live vaccine in the last 4 weeks and do not plan to during the study.

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I don't have any upcoming surgeries and have healed from past ones.

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My rash covers less than 10% of my body.

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I have not had signs of infection in the last 2 weeks.

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I have not taken any antibiotics in the last 2 weeks.

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I have not received a live flu vaccine within the last 4 weeks and won't during the study.

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I have been treated with drugs targeting PD-1 or PD-L1.

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I have previously been treated with medication targeting blood vessel growth in cancer.

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I cannot swallow pills.

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I have or had nephrotic syndrome.

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I have had a severe hypertension crisis or brain issues due to high blood pressure.

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I have heart failure that affects my daily activities.

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I have not had a stroke or TIA in the last 6 months.

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I haven't had significant bleeding, like coughing up or vomiting blood, in the last 3 months.

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I haven't taken any immune-weakening medications in the last 2 weeks.

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My heart's electrical activity (QTcF) is not over 500 ms.

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I have a history of lung scarring or inflammation.

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I have lung lesions with cavities or disease in my airways.

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I tested positive for hepatitis C but do not currently have the virus in my blood.

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I have active tuberculosis.

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I do not have a bleeding disorder or blood clotting problem that isn't treated with medication.

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I am not in any other cancer treatment trials since finishing chemoradiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Objective response rate

Progression-free survival (PFS)

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227

36%

Fatigue

35%

Alopecia

24%

Diarrhoea

23%

Nausea

23%

Decreased appetite

22%

Anaemia

20%

Asthenia

19%

Cough

19%

Dyspnoea

16%

Myalgia

15%

Neutropenia

14%

Constipation

14%

Oedema peripheral

12%

Pyrexia

11%

Stomatitis

11%

Vomiting

11%

Neuropathy peripheral

10%

Arthralgia

Neutrophil count decreased

Rash

Dysgeusia

Headache

Paraesthesia

Pain in extremity

Mucosal inflammation

Back pain

Peripheral sensory neuropathy

Insomnia

Febrile neutropenia

Pneumonia

Lacrimation increased

Abdominal pain

Dry skin

Dizziness

Malaise

Urinary tract infection

Weight decreased

Haemoptysis

Nail disorder

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Productive cough

Upper respiratory tract infection

Pruritus

Influenza like illness

Alanine aminotransferase increased

Aspartate aminotransferase increased

Syncope

Dehydration

Atrial fibrillation

Lower respiratory tract infection

Lung infection

Respiratory tract infection

Acute kidney injury

Chronic obstructive pulmonary disease

Pleural effusion

Depression

Musculoskeletal chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (atezolizumab, cabozantinib)Experimental Treatment2 Interventions

Patients receive atezolizumab IV over 30-60 minutes on day 1 and cabozantinib PO on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2016

Completed Phase 3

~5860

Cabozantinib

2020

Completed Phase 2

~2360