ClinicalTrials.gg
RecruitingNCT04273061CAPTIV-8Updated Sep 16, 2026

Investigating the Effects of Atezolizumab in People Whose Tumour DNA or RNA Indicates Possible Sensitivity

A Phase 2 interventional study of Atezolizumab in Breast Cancer, Lung Cancer and Gastrointestinal Cancer, sponsored by British Columbia Cancer Agency. Recruiting at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by British Columbia Cancer Agency · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2020; still recruiting 6 years 4 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study will investigate the effects of atezolizumab on select cancer types in people whose analysis of tumour DNA and RNA indicates they may be sensitive to atezolizumab. This study aims to determine if the information from the cancer genome analysis corresponds with the effects of atezolizumab on individuals and their cancer.

This is a Phase 2 study, which is undertaken after preliminary safety testing on a drug is completed, and will involve approximately 50 participants. Participants are assigned to one of 3 cohorts based on their primary tumour type: gastrointestinal (GI), sarcoma, and 'other' cancer types. Participants in all cohorts will receive the same dose of atezolizumab (1200 mg every 3 weeks). Participants continue on treatment until they no longer may benefit from the treatment or they decide to stop treatment.

02

Conditions studied

  • Breast Cancer
  • Lung Cancer
  • Gastrointestinal Cancer
  • Genitourinary Cancer
  • Gynecologic Cancer
  • Sarcoma
  • Unknown Primary Tumors
  • Head and Neck Cancer
  • Skin Cancer

Keywords

  • Genomic analysis
  • Atezolizumab
  • Whole genome and transcriptome analysis
  • Immune Burden Variant score
  • Immune checkpoint inhibition
  • Personalized OncoGenomics
  • Phase 2
  • Precision targeting
03

In context

Breast Neoplasms

14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.

This study's planned enrollment of 50 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

British Columbia Cancer Agency is the lead sponsor of 152 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age greater than or equal to 18 years at the time of signature of .
  • Participants with an incurable solid tumour who have undergone whole genome and transcriptome analysis (WGTA) as part of Personalized OncoGenomics (POG) or equivalent program.

    a. Participants must have had successful sequencing of their tumour, been formally reviewed by the POG (or POG-approved) 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) (or site equivalent), and allocated to a specific tumour-defined cohort (that is open for enrolment) with a final opinion documented.

  • (ECOG) performance status 0-2.
  • Participants must have , as defined by 1.1.
  • of at least 12 weeks.
  • Adequate hematologic and end-organ function, as defined by the following laboratory results obtained within 28 days prior to the first study treatment:

    1. (ANC) ≥ 1500 cells/µL without granulocyte colony- stimulating factor support.
    2. White blood cell (WBC) counts > 2500/µL.
    3. Lymphocyte count ≥ 500/µL.
    4. Serum albumin ≥ 2.5 g/dL.
    5. count ≥ 100,000/µL without transfusion (without transfusion within 2 weeks of laboratory test used to determine eligibility).
    6. ≥ 9.0 g/dL, participants may be transfused or receive erythropoietic treatment to meet this criterion.
    7. (INR) or activated partial thromboplastin time (aPTT) ≤ 1.5 × (ULN). This applies only to participants who are not receiving therapeutic anticoagulation; participants receiving therapeutic anticoagulation must have an INR or aPTT within therapeutic limits for at least 1 week prior to enrolment.
    8. (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 × ULN with the following exceptions: i) Participants with documented liver : AST and/or ALT ≤ 5 × ULN. ii) Participants with documented liver or bone metastases: ALP ≤ 5 × ULN.
    9. Serum ≤ 1.5 × ULN. Participants with known Gilbert's syndrome who have serum bilirubin level ≤ 3 × ULN may be enrolled.
    10. Serum creatinine ≤ 1.5 × ULN.
  • For women of : agreement to remain abstinent (refrain from heterosexual intercourse) or use methods that result in a failure rate of less than 1% (one percent) per year during the treatment period and for at least 5 months after the last dose of atezolizumab.
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse with a female partner of childbearing potential or who is pregnant) or use contraceptive measures that result in a failure rate of less than 1% (one percent) per year, and agreement to refrain from donating sperm, during the treatment period and for at least 5 months after the last dose of atezolizumab.
  • Asymptomatic participants with treated or untreated CNS lesions are eligible provided that all of the following criteria are met:

    1. Measurable disease, per RECIST 1.1, must be present.
    2. The participant has no history of intracranial hemorrhage or spinal cord hemorrhage.
    3. The participant has not undergone stereotactic radiotherapy within 7 days prior to the initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, or neurosurgical resection within 28 days prior to initiation of study treatment.
    4. The participant has no ongoing requirement for as therapy for CNS disease. Anticonvulsant therapy at a stable dose is permitted.
  • Ability to give informed consent for the study procedures defined in this protocol.

Exclusion criteria

Exclusion Criteria:

  • Any prior treatment with monoclonal antibodies targeting the Programmed Death 1/Ligand (/PD-L1) axis, including antibody-drug conjugates and other experimental agents.
  • Treatment with any approved or agent or participation in another clinical trial with therapeutic intent within 14 days or five half-lives of the drug, whichever is longer, prior to enrollment. Participants receiving gonadotropin releasing hormone (GnRH) analogues may continue to receive treatment while participating in CAPTIV-8.
  • Pregnancy or breastfeeding.
  • History of severe allergic, anaphylactic, or other reactions to chimeric or humanized antibodies or fusion proteins.
  • Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation.
  • Active disease at any point within the last 2 years prior to enrollment including but not limited to:

    1. Myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
    2. Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid-replacement hormone may be eligible for this study.
    3. Participants with controlled Type I diabetes mellitus on a stable dose of insulin regimen are eligible for this study.
  • Participants with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., participants with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:

    1. Rash must cover less than 10% (ten percent) of body surface area (BSA).
    2. Disease is well controlled at baseline and only requiring low potency topical .
    3. No acute exacerbations of underlying condition within the last 12 months requiring treatment with either psoralen plus ultraviolet radiation (PUVA), methotrexate, retinoids, biologic agents, oral calcineurin inhibitors or high potency or oral steroids.
  • 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.
  • Positive test for (participants with a history of/or symptoms of HIV are eligible only if serological tests are negative).
  • Participants with virus (HBV) are excluded if one of the following conditions is met:

    1. Positive hepatitis B surface antigen (HBsAg) test at screening; or
    2. Negative or positive hepatitis B surface antibody (HBsAb) test at screening accompanied by a positive total hepatitis B core antibody (HBcAb) test followed by a positive (per local laboratory definition) HBV DNA test.
  • Positive virus (HCV) antibody test followed by a positive HCV RNA test at screening.
  • Active tuberculosis.
  • Severe infections within 2 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
  • Significant cardiovascular disease, such as cardiac disease (Class II or greater), myocardial infarction within the previous 3 months, unstable arrhythmias, or unstable angina.
  • Major surgical procedure within 21 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study.
  • Prior allogeneic stem cell or solid organ transplant.
  • Treatment with systemic immunostimulatory agents (including but not limited to interferons, interleukin-2 (IL-2)) within 6 weeks or five half-lives of the drug, whichever is shorter, prior to Cycle 1, Day 1.
  • Treatment with systemic corticosteroids or other systemic medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumour necrosis factor [anti-TNF] agents) within 2 weeks prior to Cycle 1, Day 1, or anticipated requirement for systemic immunosuppressive medications during the trial.
  • Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab.
  • Participants who are otherwise felt by the treating clinician to be unfit to proceed with this protocol.
Terms in these criteria, in plain language(25)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    GI Cohort

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

    Drug: Atezolizumab

  • Experimental
    Sarcoma Cohort

    Cohort of participants whose primary tumour type is sarcoma.

    Drug: Atezolizumab

  • Experimental
    Other Cohort

    Cohort of participants whose primary tumour type is not classified as one of the other study arms. This cohort includes participants with head and neck, breast, lung, genitourinary (GU), gynecological, skin, primary unknown, or rare cancers.

    Drug: Atezolizumab

Interventions

  • 1200 mg by intravenous infusion every 3 weeks as tolerated

    Also known as: TECENTRIQ

06

What researchers measure

Primary outcomes

  1. Overall response rate (ORR) for the study cohort, as defined by RECIST 1.1

    The proportion of participants in the study cohort who have a complete response (CR) or partial response (PR) to treatment, as defined by RECIST 1.1.

    Time frame: From the date of the screening scan (within 28 days of first dose) until the date of confirmed progression, withdrawal, or date of death, whichever comes first, assessed up to 54 months.

Secondary outcomes

  1. Progression-free survival (PFS) for the study cohort from the initiation of atezolizumab

    The length of time from the first dose of atezolizumab until participants in the study cohort have progressive disease (PD), as defined by RECIST 1.1.

    Time frame: From the date of first dose until the date of confirmed progression, withdrawal, or date of death, whichever comes first, assessed up to 54 months.

  2. Clinical benefit rate (CBR) for the study cohort at the 18-week follow-up scan

    The percentage of participants in the study cohort who have a complete response (CR), partial response (PR), or stable disease (SD) response to treatment, as defined by RECIST 1.1, at the 18-week follow-up scan.

    Time frame: From the date of the screening scan (within 28 days of first dose) until the date of the 18-week follow-up scan.

  3. Overall survival (OS) for the study cohort from the initiation of atezolizumab

    The length of time from the initiation of atezolizumab that participants in the study cohort survive.

    Time frame: From the date of first dose until the date of death, assessed up to 54 months.

  4. Quality-adjusted survival for the study cohort from the initiation of atezolizumab

    Survival time (from the initiation of atezolizumab) multiplied by quality of life. Participants' responses to health-related quality of life questions on the EQ-5D-3L questionnaire will be converted to utility weights using existing conversion scales that are based on patient and public valuations of the health states described by the EQ-5D-3L questionnaire.

    Time frame: From the date of first dose until the treatment discontinuation visit (within 30 days of last dose), withdrawal, or date of death, whichever comes first, assessed up to 54 months.

  5. Duration of response (DoR) for the study cohort

    The length of time from the first response to treatment (CR or PR) until participants in the study cohort have progressive disease (PD), as defined by RECIST 1.1.

    Time frame: From the date of the scan that shows the first response to treatment until the date of progression, withdrawal, or date of death, whichever comes first, assessed up to 54 months.

Other outcomes

  1. Putative markers of sensitivity to atezolizumab for the study cohort

    From blood and tissue samples collected throughout the study, identify putative markers of sensitivity to atezolizumab based on the response to treatment of the participants in the study cohort.

    Time frame: From the date of screening sample collection until the date of progression, withdrawal, or date of death, whichever comes first, assessed up to 54 months.

  2. Putative primary and secondary resistance markers to atezolizumab in the study cohort

    From blood and tissue samples collected throughout the study, identify putative primary and secondary resistance markers to atezolizumab based on the response to treatment of the participants in the study cohort.

    Time frame: From the date of screening sample collection until the date of progression, withdrawal, or date of death, whichever comes first, assessed up to 54 months.

  3. Putative germline predictors of adverse events or toxicities of interest in the study cohort

    From blood and tissue samples collected throughout the study, identify putative germline predictors of adverse events or toxicities of interest to atezolizumab based on the response to treatment of the participants in the study cohort.

    Time frame: From the date of screening sample collection until the date of progression, withdrawal, or date of death, whichever comes first, assessed up to 54 months.

  4. Compare the utility of iRECIST for response assessment to RECIST 1.1 in the study cohort

    Participant response to treatment as per RECIST 1.1. compared to the response to treatment as per the modified response evaluation criteria in solid tumours for immunotherapy trials (iRECIST) from screening until progression in the study cohort.

    Time frame: From the date of the screening scan (within 28 days of first dose) until the date of progression, withdrawal, or date of death, whichever comes first, assessed up to 54 months.

07

Study locations

1 of 2 sites recruiting
08

References and documents

Publications

  • Ayers M, Lunceford J, Nebozhyn M, Murphy E, Loboda A, Kaufman DR, Albright A, Cheng JD, Kang SP, Shankaran V, Piha-Paul SA, Yearley J, Seiwert TY, Ribas A, McClanahan TK. IFN-gamma-related mRNA profile predicts clinical response to PD-1 blockade. J Clin Invest. 2017 Aug 1;127(8):2930-2940. doi: 10.1172/JCI91190. Epub 2017 Jun 26. PubMed 28650338 ↗
  • Balachandran VP, Luksza M, Zhao JN, Makarov V, Moral JA, Remark R, Herbst B, Askan G, Bhanot U, Senbabaoglu Y, Wells DK, Cary CIO, Grbovic-Huezo O, Attiyeh M, Medina B, Zhang J, Loo J, Saglimbeni J, Abu-Akeel M, Zappasodi R, Riaz N, Smoragiewicz M, Kelley ZL, Basturk O; Australian Pancreatic Cancer Genome Initiative; Garvan Institute of Medical Research; Prince of Wales Hospital; Royal North Shore Hospital; University of Glasgow; St Vincent's Hospital; QIMR Berghofer Medical Research Institute; University of Melbourne, Centre for Cancer Research; University of Queensland, Institute for Molecular Bioscience; Bankstown Hospital; Liverpool Hospital; Royal Prince Alfred Hospital, Chris O'Brien Lifehouse; Westmead Hospital; Fremantle Hospital; St John of God Healthcare; Royal Adelaide Hospital; Flinders Medical Centre; Envoi Pathology; Princess Alexandria Hospital; Austin Hospital; Johns Hopkins Medical Institutes; ARC-Net Centre for Applied Research on Cancer; Gonen M, Levine AJ, Allen PJ, Fearon DT, Merad M, Gnjatic S, Iacobuzio-Donahue CA, Wolchok JD, DeMatteo RP, Chan TA, Greenbaum BD, Merghoub T, Leach SD. Identification of unique neoantigen qualities in long-term survivors of pancreatic cancer. Nature. 2017 Nov 23;551(7681):512-516. doi: 10.1038/nature24462. Epub 2017 Nov 8. PubMed 29132146 ↗
  • Bolotin DA, Shugay M, Mamedov IZ, Putintseva EV, Turchaninova MA, Zvyagin IV, Britanova OV, Chudakov DM. MiTCR: software for T-cell receptor sequencing data analysis. Nat Methods. 2013 Sep;10(9):813-4. doi: 10.1038/nmeth.2555. Epub 2013 Jul 28. No abstract available. PubMed 23892897 ↗
  • Bolotin DA, Poslavsky S, Mitrophanov I, Shugay M, Mamedov IZ, Putintseva EV, Chudakov DM. MiXCR: software for comprehensive adaptive immunity profiling. Nat Methods. 2015 May;12(5):380-1. doi: 10.1038/nmeth.3364. No abstract available. PubMed 25924071 ↗
  • Brown SD, Warren RL, Gibb EA, Martin SD, Spinelli JJ, Nelson BH, Holt RA. Neo-antigens predicted by tumor genome meta-analysis correlate with increased patient survival. Genome Res. 2014 May;24(5):743-50. doi: 10.1101/gr.165985.113. Epub 2014 Apr 29. PubMed 24782321 ↗
  • Brown SD, Raeburn LA, Holt RA. Profiling tissue-resident T cell repertoires by RNA sequencing. Genome Med. 2015 Nov 30;7:125. doi: 10.1186/s13073-015-0248-x. PubMed 26620832 ↗
  • Cibulskis K, Lawrence MS, Carter SL, Sivachenko A, Jaffe D, Sougnez C, Gabriel S, Meyerson M, Lander ES, Getz G. Sensitive detection of somatic point mutations in impure and heterogeneous cancer samples. Nat Biotechnol. 2013 Mar;31(3):213-9. doi: 10.1038/nbt.2514. Epub 2013 Feb 10. PubMed 23396013 ↗
  • Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026. PubMed 19097774 ↗
  • Freeman JD, Warren RL, Webb JR, Nelson BH, Holt RA. Profiling the T-cell receptor beta-chain repertoire by massively parallel sequencing. Genome Res. 2009 Oct;19(10):1817-24. doi: 10.1101/gr.092924.109. Epub 2009 Jun 18. PubMed 19541912 ↗
  • Gogvadze E, Buzdin A. Retroelements and their impact on genome evolution and functioning. Cell Mol Life Sci. 2009 Dec;66(23):3727-42. doi: 10.1007/s00018-009-0107-2. Epub 2009 Aug 2. PubMed 19649766 ↗
  • Hugo W, Zaretsky JM, Sun L, Song C, Moreno BH, Hu-Lieskovan S, Berent-Maoz B, Pang J, Chmielowski B, Cherry G, Seja E, Lomeli S, Kong X, Kelley MC, Sosman JA, Johnson DB, Ribas A, Lo RS. Genomic and Transcriptomic Features of Response to Anti-PD-1 Therapy in Metastatic Melanoma. Cell. 2016 Mar 24;165(1):35-44. doi: 10.1016/j.cell.2016.02.065. Epub 2016 Mar 17. PubMed 26997480 ↗
  • Hugo W, Zaretsky JM, Sun L, Song C, Moreno BH, Hu-Lieskovan S, Berent-Maoz B, Pang J, Chmielowski B, Cherry G, Seja E, Lomeli S, Kong X, Kelley MC, Sosman JA, Johnson DB, Ribas A, Lo RS. Genomic and Transcriptomic Features of Response to Anti-PD-1 Therapy in Metastatic Melanoma. Cell. 2017 Jan 26;168(3):542. doi: 10.1016/j.cell.2017.01.010. No abstract available. PubMed 28129544 ↗
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09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04273061
Collaborators
Hoffmann-La Roche, BC Cancer Foundation, Genome British Columbia, Terry Fox Research Institute
Responsible party
Sponsor
First posted
Feb 17, 2020
Start date
Jun 17, 2020
Primary completion
Oct 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Sep 16, 2026

Study contacts

Janessa Laskin, MD
Contact
jlaskin@bccancer.bc.ca
800-663-3333
Daniel Renouf, MD, MPH
Contact
drenouf@bccancer.bc.ca
800-663-3333
Janessa Laskin, MD
principal investigator · BC Cancer

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Atezolizumab

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