A Study of Autogene Cevumeran (RO7198457) as a Single Agent and in Combination With Atezolizumab … (NCT03289962) | Clinical Trial Compass
CompletedPhase 1
A Study of Autogene Cevumeran (RO7198457) as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumors
United States, Belgium, Canada273 participantsStarted 2017-12-21
Plain-language summary
This is a Phase 1a/1b, open-label, multicenter, global, dose-escalation study designed to evaluate the safety, tolerability, immune response, and pharmacokinetics of autogene cevumeran (RO7198457) as a single agent and in combination with atezolizumab (MPDL3280A, an engineered anti-programmed death-ligand 1 \[anti-PD-L1\] antibody).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy greater than or equal to (\>=12 weeks)
* Adequate hematologic and end-organ function
* Measured or calculated creatinine clearance \>=50 milliliters per minute (mL/min) on the basis of the Cockcroft-Gault glomerular filtration rate estimation
Cancer-Specific Inclusion Criteria:
* Participants with histologic documentation of locally advanced, recurrent, or metastatic incurable malignancy that has progressed after at least one available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable, or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized standard of care
* Participants with confirmed availability of representative tumor specimens in formalin-fixed, paraffin-embedded (FFPE) blocks (preferred), or sectioned tissue
* Participants with measurable disease per RECIST v1.1
Additional Inclusion Criteria for Participants in Each Indication-Specific Exploration/Expansion Cohort of Phase 1b:
* NSCLC Cohorts (CIT-Naive): Participants with histologically confirmed incurable, advanced NSCLC not previously treated with anti-PD-L1/PD-1 and/or with anti-CTLA-4 (investigational or approved), for whom a clinical trial of an investigational agent in combination with an anti-PD-L1/PD-1 antibody is considered an acceptable treatment option (if CIT \[including anti-PD-L1/PD-1 agents\] is appro…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants with Dose-Limiting Toxicities (DLTs)
Timeframe: Phase 1a: Days 1 to 14 / Phase 1b: Days 1 to 21
2
MTD/Recommended Phase 2 Dose (RP2D) of Autogene Cevumeran
Timeframe: Phase 1a: Days 1 to 14 / Phase 1b: Days 1 to 21
3
Percentage of Participants with Adverse Events (AEs)
Timeframe: Baseline up to end of the study (up to approximately 3 years)
4
Percentage of Participants with Immune-Mediated Adverse Events (imAEs)
Timeframe: Baseline up to end of the study (up to approximately 3 years)
5
Percentage of Participants by Number of Treatment Cycles Received
Timeframe: Baseline up to end of the study (up to approximately 3 years)
6
Dose Intensity of Autogene Cevumeran
Timeframe: Baseline up to end of the study (up to approximately 3 years)