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

ConditionsBreast CancerLung CancerGastrointestinal CancerGenitourinary CancerGynecologic CancerSarcomaUnknown Primary TumorsHead and Neck CancerSkin Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBritish Columbia Cancer Agency

About this trial

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 200 participants. Participants are assigned to one of 8 cohorts based on their primary tumour type: breast, lung, gastrointestinal (GI), primary unknown, genitourinary (GU), sarcoma, gynecological, and 'other' cancer types. Participants in all cohorts will receive the same dose of atezolizumab (1200 mg every 3 weeks). In the first stage for each cohort, 8 participants will be enrolled and if no participants respond to treatment, enrollment to that cohort will be closed. If 1 or more participants respond to treatment, up to 16 additional participants will be enrolled to that cohort. Participants continue on treatment until they no longer may benefit from the treatment or they decide to stop treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Participants with an incurable solid tumour who have undergone whole genome and transcriptome analysis (WGTA) as part of Personalized OncoGenomics (POG) or equivalent program.

Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

Participants must have measurable disease, as defined by RECIST 1.1.

Disqualifiers

Any prior treatment with monoclonal antibodies targeting the Programmed Death 1/Ligand (PD-1/PD-L1) axis, including antibody-drug conjugates and other experimental agents.

Treatment with any approved or investigational 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 hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Atezolizumab

    Drug

    1200 mg by intravenous infusion every 3 weeks as tolerated

Treatment groups

200 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Breast CohortExperimental treatment 1 intervention
Group B: Lung CohortExperimental treatment 1 intervention
Group C: GI CohortExperimental treatment 1 intervention
Group D: GU CohortExperimental treatment 1 intervention
Group E: Gyne CohortExperimental treatment 1 intervention
Group F: Sarcoma CohortExperimental treatment 1 intervention
Group G: Primary Unknown CohortExperimental treatment 1 intervention
Group H: Other CohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall response rate (ORR) in each tumour-defined cohort, as defined by RECIST 1.1

The proportion of participants in each tumour-defined 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) in each tumour-defined cohort from the initiation of atezolizumab

The length of time from the first dose of atezolizumab until participants in each tumour-defined 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) in each tumour-defined cohort at the 18-week follow-up scan

The percentage of participants in each tumour-defined 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) in each tumour-defined cohort from the initiation of atezolizumab

The length of time from the initiation of atezolizumab that participants in each tumour-defined cohort survive.

Time frame
From the date of first dose until the date of death, assessed up to 54 months.
4

Quality-adjusted survival in each tumour-defined 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.

Other outcomes

1

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

British Columbia Cancer Agency

Lead sponsor

Hoffmann-La Roche

Collaborator

Source ClinicalTrials.gov
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