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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.
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
CAPTIV-8 Trial 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.Check my eligibility
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.See study design
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.
CAPTIV-8 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My tumor has been sequenced, reviewed, and fits specific genetic criteria for a study.
Select...
I agree to use highly effective birth control or remain abstinent during and for 5 months after treatment.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I am able to care for myself and perform daily activities.
Select...
My cancer is incurable and has been analyzed through a personalized genomics program.
Select...
My white blood cell count is healthy without needing medication to boost it.
Select...
I am 18 years old or older.
Select...
My cancer is incurable and has been analyzed through a genome program like POG.
CAPTIV-8 Trial 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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (ORR) in each tumour-defined cohort, as defined by RECIST 1.1
Secondary outcome measures
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 moreOther outcome measures
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 moreSide effects data
From 2019 Phase 3 trial • 1225 Patients • NCT0200822736%
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%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Peripheral sensory neuropathy
7%
Pain in extremity
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
CAPTIV-8 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
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860
Find a Location
Who is running the clinical trial?
British Columbia Cancer AgencyLead Sponsor
171 Previous Clinical Trials
90,311 Total Patients Enrolled
Hoffmann-La RocheIndustry Sponsor
2,431 Previous Clinical Trials
1,089,868 Total Patients Enrolled
Janessa Laskin, MDPrincipal InvestigatorBC Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of lung scarring or inflammation but not from radiation treatment.I am not on steroids for brain disease but may be on stable anticonvulsants.I am 18 years old or older.My tumor has been sequenced, reviewed, and fits specific genetic criteria for a study.My condition is stable with only mild creams needed.I have an autoimmune thyroid condition but am on a stable thyroid medication.I have Type I diabetes managed with a stable insulin dose.I haven't taken any experimental drugs or joined another clinical trial for treatment in the last 14 days or longer.I agree to use highly effective birth control or remain abstinent during and for 5 months after treatment.I am able to care for myself and perform daily activities.I have not had severe infections or been hospitalized for infection complications in the last 2 weeks.I have brain lesions but no symptoms, and meet all required health criteria.I agree to use highly effective birth control or abstain from sex, and not donate sperm, for 5 months after my last dose.I can take care of myself and am up and about more than half of my waking hours.My cancer can be measured and is not in my brain or spinal cord.My rash covers less than 10% of my body.I haven't had specific brain treatments in the last month before starting the study treatment.I have skin conditions like eczema or psoriasis but no psoriatic arthritis.I have not received a live vaccine in the last 4 weeks and do not plan to during or within 5 months after treatment.I haven't taken any steroids or immune-suppressing drugs in the last 2 weeks.My tumor has been genetically sequenced and approved for a specific treatment group.I have active hepatitis B or C.My cancer is incurable and has been analyzed through a personalized genomics program.I have never had bleeding in my brain or spinal cord.My white blood cell count is healthy without needing medication to boost it.I have active tuberculosis.I do not have serious heart conditions like recent heart attacks or unstable heart disease.My blood clotting tests are within normal limits, and if on blood thinners, they've been stable for a week.I am 18 years old or older.I haven't needed strong medication for flare-ups in the past year.My recent blood and organ function tests are within normal ranges.My cancer is incurable and has been analyzed through a genome program like POG.I am a man and agree to use highly effective contraception or abstain from sex, and not donate sperm, for 5 months after my last dose.I haven't taken any immune-boosting drugs in the last 6 weeks.My hemoglobin level is at least 9.0 g/dL, possibly after treatment.I have an autoimmune or inflammatory condition.I agree to use highly effective birth control or remain abstinent during and for 5 months after treatment.I haven't had major surgery in the last 21 days and don't expect to need one during the study.I have had a previous transplant of stem cells or an organ.I have never been treated with drugs targeting PD-1/PD-L1 for cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Breast Cohort
- Group 2: Lung Cohort
- Group 3: GI Cohort
- Group 4: GU Cohort
- Group 5: Gyne Cohort
- Group 6: Sarcoma Cohort
- Group 7: Primary Unknown Cohort
- Group 8: Other Cohort
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this investigation still available?
"Affirmative. According to clinicaltrials.gov, this medical research which was initially posted on June 17th 2020 is open for enrollment and recently updated on 4th of June 2022. The trial aims at recruiting 200 participants across two centres."
Answered by AI
What is the upper limit of individuals participating in this clinical investigation?
"Affirmative. Clinicaltrials.gov indicates that this medical investigation, which was originally posted June 17th 2020, is actively seeking participants. A total of 200 people are required to be enrolled from two separate sites."
Answered by AI
Does this research present new information?
"At present, 351 trials related to Atezolizumab are taking place in 74 countries and across 1645 cities. The first experiment of its kind began in 2008 with Roche-Hoffmann sponsoring the clinical study having 720 participants, which concluded Phase 2 successfully. Since then, 80 more studies have reached completion."
Answered by AI
Has Atezolizumab been examined through scientific experimentation in the past?
"Atezolizumab was initially developed in 2008 by the SCRI Tennessee Oncology Chattanooga. As of now, there are 80 successfully completed studies and an additional 351 clinical trials currently enrolling patients; many situated within Toronto, Ontario."
Answered by AI
How has Atezolizumab been employed to support patient care?
"Atezolizumab is a regular intervention for small cell lung carcinoma. It can also be utilized to treat non-small cell lung carcinomas and other malignant neoplasms, both pre- and postoperatively."
Answered by AI
Has the regulatory body given its seal of approval to Atezolizumab?
"Atezolizumab's safety is supported by some data, leading to a score of 2 on our scale. No efficacy studies have been conducted yet in this Phase 2 trial."
Answered by AI
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