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PD-L1 Inhibitor

Atezolizumab + Bevacizumab for Melanoma

Phase 2

Recruiting

Research Sponsored by Elizabeth Buchbinder, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have normal organ and marrow function as defined below

Age ≥ 18 years

Must not have

History of leptomeningeal disease

History of idiopathic pulmonary fibrosis, organizing pneumonia, or evidence of active pneumonitis on screening chest computed tomography (CT) scan

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trial is researching whether or not a combination of two drugs that change the immune system and tumor could be a possible treatment for people with metastatic or unresectable stage III or IV cutaneous melanoma.

Who is the study for?

This trial is for adults with stage III or IV cutaneous melanoma that can't be removed by surgery. Participants must not have used certain cancer drugs before, agree to use effective contraception, and provide a tumor sample. They should have normal organ function and no history of severe allergies to the drugs being tested or other major health issues.

What is being tested?

The study tests combining Atezolizumab (which helps the immune system fight cancer) with Bevacizumab (which stops tumors from making new blood vessels) as a treatment for advanced skin cancer. The goal is to see if this drug duo works better together.

What are the potential side effects?

Possible side effects include high blood pressure, bleeding problems, allergic reactions similar to those caused by other antibodies or proteins in the drugs' family, infections due to weakened immune response, and potential heart or lung complications.

Eligibility Criteria

Inclusion Criteria

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

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My organ and bone marrow functions are normal.

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I am 18 years old or older.

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I agree to not have unprotected sex or donate sperm.

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My melanoma is at an advanced stage and cannot be removed with surgery.

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My cancer biopsy shows no PD-L1 protein.

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I can take care of myself but might not be able to do active work.

Exclusion Criteria

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

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I have had leptomeningeal disease.

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I have a history of specific lung conditions or signs of lung inflammation on a CT scan.

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I have high calcium levels in my blood that are causing symptoms.

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I haven't taken any immune-boosting drugs in the last 4 weeks or before their effects wore off.

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I have not had major surgery in the last 4 weeks.

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I have a serious wound, ulcer, or untreated bone fracture that is not healing.

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My high blood pressure is not well controlled.

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I haven't had any major abdominal issues like fistulas or abscesses in the last 6 months.

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I have previously been treated with bevacizumab or PD-L1 targeted therapy.

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I have or had an autoimmune disease or immune deficiency.

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I haven't had major surgery in the last 4 weeks.

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I am currently taking or have recently taken aspirin or blood thinners.

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I have brain metastases that are untreated or getting worse.

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I am allergic to ingredients in the bevacizumab medication.

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

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My cancer pain is not managed with current treatments.

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I take NSAIDs every day for a chronic condition.

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I have an active hepatitis B infection.

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I have active tuberculosis.

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I have had a previous transplant of stem cells or an organ.

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

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I have a serious heart condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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

Overall Response Rate in PD-L1 negative melanoma

Secondary study objectives

Change tumor-infiltrating lymphocytes (TILs)

Duration of response

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE 5.

+2 more

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

Headache

Dysgeusia

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.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Atezolizumab and BevacizumabExperimental Treatment2 Interventions

The research study procedures include screening for eligibility, study treatment including evaluations, a biopsy, and follow up visits. * Atezolizumab will be administered intravenously at a fixed predetermined dose every three weeks * Bevacizumab will be administered intravenously at a fixed predetermined dose every three weeks, with 21 consecutive days defined as a treatment cycle. Treatment will be administered on an outpatient basis Study treatment will continue until study doctors decide to stop therapy due to criteria which may include disease progression, adverse events or changes in condition. Participants will be followed for survival health information following treatment until the study ends, which could be approximately 5 years from start of treatment

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

FDA approved

Bevacizumab

FDA approved

0 / 28Eligibility criteria met