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Tiragolumab and Atezolizumab in Advanced Pan-cancer Patients
This phase II study will explore the effect of 2 monoclonal antibodies, tiragolumab and atezolizumab, in patients with locally advanced solid cancers which cannot be removed by surgery or have spread. Their cancers will have characteristics which may predict immune response to the study treatment. PD-L1 and TIGIT are immune receptors which can help cancers grow by evading the immune response and inhibiting the action of some immune cells.
By blocking these receptors, tiragolumab and atezolizumab may work together to re-activate the body's anti-tumour immune response and kill cancer cells.
Study details:
Patients who are enrolled in the MoST or CaSP cancer screening programs, and whose tumour is assessed as amenable to tiragolumab and atezolizumab treatment, will be recommended for participation in the study. After being informed about the study, and the potential risks, patients who consent to participate undergo a 21-day screening period to determine study eligibility. Patients will be prospectively selected into subgroups based on their tumour characteristics.
Once eligibility is confirmed, tiragolumab alone is administered at Cycle 1 Day 1 (day 1 of study). Commencing from Cycle 2 Day 1, tiragolumab and atezolizumab are administered at 21-day cycles until treatment discontinuation, with or without disease progression. Participants undergo a biopsy at cycle 2 prior to commencement of atezolizumab treatment.
Standard imaging scans (usually computed tomography (CT)) are performed throughout the trial. Patients also undergo blood, urine and stool sample collection on study. Once participants discontinue treatment, a study visit is performed within 30 days of the end of the final treatment cycle.
If treatment cessation is not contemporaneous with disease progression, follow-up calls are conducted every 9 weeks until disease progression. Once disease progression occurs, a study visit is performed within 30 days of disease progression and then every 3 months until 12 months after the final participant discontinues study treatment. Active follow-up of all participants will continue until death or 12 months after the last participant discontinues study treatment, whichever occurs first.
Subsequently, survival data will be obtained through MoST or CaSP until death.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-12-15
Primary completion: 2026-05-01
Study completion finish: 2028-11-01
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT06003621
Intervention or treatment
BIOLOGICAL: Tiragolumab
BIOLOGICAL: Atezolizumab
Conditions
- • Solid Tumor, Adult
Find a site
Closest Location:
Border Medical Oncology Research Unit
Research sites nearby
Select from list below to view details:
Border Medical Oncology Research Unit
Albury, New South Wales, Australia
Coffs Harbour Health Campus
Coffs Harbour, New South Wales, Australia
Cairns Hospital
Cairns, Queensland, Australia
Rockhampton Hospital
Rockhampton, Queensland, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Tiragolumab and atezolizumab
| BIOLOGICAL: Tiragolumab
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Progression Free Survival (PFS) rate at 6 Months | The primary outcome, PFS rate at 6 months, is defined as the proportion of participants who are alive and progression free at 6 months from start of study treatment Radiological disease progression is defined according to modified Response Evaluation Criteria in Solid Tumours version 1.1 for immune-based therapeutics (iRECIST) or Response Assessment in Neuro-Oncology criteria (RANO). Clinical progression is defined as the development of: 1. Symptoms attributable to cancer progression; or 2. Initiation of other anticancer treatment for cancer; or 3. Significant deterioration of performance status not explained by treatment toxicities, co-morbidities, or radiological evidence of progression; or 4. Unequivocal development of new non-measurable disease that is not assessable according to iRECIST or RANO criteria. | 6 months |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Objective tumour response rate (OTRR) as per iRECIST or RANO criteria | The objective tumour response rate is defined as the proportion of participants who achieved an objective response at any time point. Participants with an objective tumour response are defined as those assessed as having a complete or partial response according to iRECIST or RANO. Investigator assessed response status (i.e. complete response, partial response, stable disease or progressive disease) will be assessed by using iRECIST or RANO at each assessment time point. Confirmation of progressive disease will be undertaken in accordance to the iRECIST criteria. | iRECIST/RANO every 9 weeks from study entry to objective disease progression, up to 18 months |
The median duration of objective tumour response | Median duration of objective tumour response is defined as the time interval from documentation of an objective tumour response to date of first evidence of radiological disease progression. | iRECIST/RANO every 9 weeks from study entry to objective disease progression, up to 18 months |
Median PFS | PFS is defined as the interval from the start date of study treatment to the date of first evidence of disease progression (clinical or radiological) or death from any cause, whichever occurs first. Median PFS will be calculated. Participants who did not progress or who are still alive will be censored on the date of their last clinical assessment or tumour assessment. | iRECIST/RANO every 9 weeks from study entry to objective disease progression, up to 60 months |
To evaluate the duration of clinical benefit (DCB) | DCB is defined as the time interval from date of start of study treatment to date of first evidence of radiological disease progression. | iRECIST/RANO every 9 weeks from study entry to objective disease progression, up to 60 months |
To evaluate the overall survival (OS) rate at 12 months | OS is defined as the interval from the start date of study treatment to date of death from any cause. Participants who did not die will be censored at the date of last known follow-up alive. OS rate at 12 months is defined as the proportion of participants who are alive at 12 months, from start date of study treatment to date of death from any cause (or the date of last known vital status during follow up within 12 months from start date of study treatment). | Cycle 1 Day 1 to 12 months |
To calculate the median overall survival | Median OS will be calculated | Cycle 1 Day 1 to death, up to 5 years |
To evaluate the time to progression (TTP) | TTP is defined as the time interval from the start date of study treatment to the date of first evidence of disease progression on the MoST-TAP trial or death due to cancer. | iRECIST/RANO every 9 weeks from study entry to objective disease progression, up to 60 months |
To calculate the median Growth Modulation Index (GMI) | To assess clinical benefit while taking into account the disease tempo of individual patients, GMI, defined as the ratio of TTP using tiragolumab and atezolizumab in the MoST-TAP trial with the TTP in the period prior to MoST-TAP, will be calculated. GMI estimates the duration of clinical benefit normalised against the disease tempo, as estimated by the TTP before enrolment onto the MoST-TAP trial. If GMI is ≥1.3, then the study therapy will be defined as having benefit for the participant. The median GMI will be calculated. | iRECIST/RANO every 9 weeks from study entry to objective disease progression, up to 60 months |
The incidence and rates of AEs and serious AEs (SAEs) | The safety and tolerability of tiragolumab and atezolizumab treatment will be assessed by the incidence and rates of AEs and serious AEs (SAEs). AEs will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Tolerability is defined as the time from commencement of study treatment until interruption of treatment due to toxicity. Interruption of treatment includes treatment discontinuation or a pause in treatment. Toxicity is defined as a treatment-related AE equal to or above Grade 3 as graded by CTCAE v5.0. An AE is deemed to be due to treatment if the causal relationship between the event and tiragolumab or atezolizumab treatment is judged by the Investigator to be definitely, probably or possibly related. | From Cycle 1 Day 1 to 90 days after cessation of study drug |
To evaluate the health related quality of life (HRQOL) over the course of the trial | HRQOL will be measured by the EORTC Quality of Life of Cancer Patients (QLQ-C30 v3). The questionnaire includes functional, symptom and global health status / QoL scales. Patients rate items on the questionnaire from 1 (not at all) to 4 (very much) or from 1 (very poor) to 7 (excellent). Questionnaires are administered at Cycle 1 Day 1 (baseline, Week 1), Cycle 4 Day 1 (Week 10) and then every 3 cycles until disease progression. Questionnaires are also administered at the Treatment Discontinuation Visit and the Progressive Disease Visit. | Cycle 1 Day 1, Cycle 4 Day 1 and then every third cycle until disease progression (cycles length 21 days). Also administered at the Treatment Discontinuation Visit and the Progressive Disease Visit. |
Frequently Asked Questions
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