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Checkpoint Inhibitor

Atezolizumab for Cancer (CAPTIV-8 Trial)

Phase 2

Recruiting

Led By Janessa Laskin, MD

Research Sponsored by British Columbia Cancer Agency

Eligibility Criteria Checklist

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

Must have

Age greater than or equal to 18 years at the time of signature of informed consent.

a. Participants must have had successful sequencing of their tumour, been formally reviewed by the POG genome analysts and found to have CAPTIV-8 factors identified (including Immune, Burden, Variant (IBV) score ≥ 5), been reviewed at the Molecular Tumour Board (MTB), and allocated to a specific tumour-defined cohort (that is open for enrolment) with a final opinion documented.

Must not have

History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted

The participants has no ongoing requirement for corticosteroids as therapy for CNS disease. Anticonvulsant therapy at a stable dose is permitted

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of first dose until the date of death, assessed up to 54 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial is investigating whether atezolizumab, a cancer immunotherapy drug, is effective for treating various types of cancer in people whose tumor DNA and RNA indicates they may be sensitive to the drug.

Who is the study for?

Adults with incurable solid tumors who've had genome analysis suggesting sensitivity to Atezolizumab can join. They must have measurable disease, a life expectancy of at least 12 weeks, and good organ function. Women and men must agree to effective contraception. Exclusions include recent other treatments, certain health conditions like severe allergies or autoimmune diseases, active infections or HIV/HBV, significant heart issues, and prior PD-1/PD-L1 axis treatment.

What is being tested?

The trial tests Atezolizumab's effectiveness on various cancers (like breast, lung) in patients selected by tumor DNA/RNA analysis. It's a Phase 2 study with around 200 participants divided into cohorts based on cancer type. Each receives the same dose every three weeks until no longer beneficial or they choose to stop.

What are the potential side effects?

Atezolizumab may cause immune-related reactions affecting organs, infusion reactions similar to allergic responses during drug administration, fatigue, digestive problems such as nausea or diarrhea; blood disorders that could affect clotting or immunity; increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My tumor has been sequenced, reviewed, and fits specific genetic criteria for a study.

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I agree to use highly effective birth control or remain abstinent during and for 5 months after treatment.

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I can take care of myself and am up and about more than half of my waking hours.

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I am able to care for myself and perform daily activities.

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My cancer is incurable and has been analyzed through a personalized genomics program.

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My white blood cell count is healthy without needing medication to boost it.

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I am 18 years old or older.

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My cancer is incurable and has been analyzed through a genome program like POG.

Exclusion Criteria

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

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I have a history of lung scarring or inflammation but not from radiation treatment.

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I am not on steroids for brain disease but may be on stable anticonvulsants.

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My condition is stable with only mild creams needed.

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I have Type I diabetes managed with a stable insulin dose.

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I have not had severe infections or been hospitalized for infection complications in the last 2 weeks.

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My cancer can be measured and is not in my brain or spinal cord.

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My rash covers less than 10% of my body.

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I haven't had specific brain treatments in the last month before starting the study treatment.

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I have not received a live vaccine in the last 4 weeks and do not plan to during or within 5 months after treatment.

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I haven't taken any steroids or immune-suppressing drugs in the last 2 weeks.

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I have active hepatitis B or C.

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I have never had bleeding in my brain or spinal cord.

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I have active tuberculosis.

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I do not have serious heart conditions like recent heart attacks or unstable heart disease.

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I haven't needed strong medication for flare-ups in the past year.

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I haven't taken any immune-boosting drugs in the last 6 weeks.

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I have an autoimmune or inflammatory condition.

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I haven't had major surgery in the last 21 days and don't expect to need one during the study.

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

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I have never been treated with drugs targeting PD-1/PD-L1 for cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of first dose until the date of death, assessed up to 54 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of first dose until the date of death, assessed up to 54 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of first dose until the date of death, assessed up to 54 months. 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 (ORR) in each tumour-defined cohort, as defined by RECIST 1.1

Secondary study objectives

Clinical benefit rate (CBR) in each tumour-defined cohort at the 18-week follow-up scan

Duration of response (DoR) in each tumour-defined cohort

Overall survival (OS) in each tumour-defined cohort from the initiation of atezolizumab

+2 more

Other study objectives

Compare the utility of iRECIST for response assessment to RECIST 1.1 in each tumour-defined cohort

Putative germline predictors of adverse events or toxicities of interest in each tumour-defined cohort

Putative markers of sensitivity to atezolizumab in each tumour-defined cohort

+1 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

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

8Treatment groups

Experimental Treatment

Group I: Sarcoma CohortExperimental Treatment1 Intervention

Cohort of participants whose primary tumour type is sarcoma.

Group II: Primary Unknown CohortExperimental Treatment1 Intervention

Cohort of participants whose primary tumour type is unknown.

Group III: Other CohortExperimental Treatment1 Intervention

Cohort of participants whose primary tumour type is not classified as one of the other study arms. This cohort includes participants with cancers from the head and neck, skin, or rare cancers.

Group IV: Lung CohortExperimental Treatment1 Intervention

Cohort of participants whose primary tumour type is lung.

Group V: Gyne CohortExperimental Treatment1 Intervention

Cohort of participants whose primary tumour type is gynecological.

Group VI: GU CohortExperimental Treatment1 Intervention

Cohort of participants whose primary tumour type is genitourinary.

Group VII: GI CohortExperimental Treatment1 Intervention

Cohort of participants whose primary tumour type is gastrointestinal (including pancreas and hepatobiliary).

Group VIII: Breast CohortExperimental Treatment1 Intervention

Cohort of participants whose primary tumour type is breast.

Treatment

First Studied