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PD-L1 Inhibitor
Autogene Cevumeran + Atezolizumab for Cancer
Phase 1
Waitlist Available
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Measured or calculated creatinine clearance >=50 milliliters per minute (mL/min) on the basis of the Cockcroft-Gault glomerular filtration rate estimation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to end of study (up to approximately 3 years)
Awards & highlights
Study Summary
This trial is testing a new drug, RO7198457, to see if it is safe and works well against cancer.
Who is the study for?
This trial is for adults with certain advanced cancers (like melanoma, lung, bladder, colorectal) that have worsened after standard treatment or where such treatments aren't suitable. Participants should be relatively healthy otherwise (ECOG 0-1), have a life expectancy of at least 12 weeks, and not have had recent major surgeries or immune system issues.Check my eligibility
What is being tested?
The study is testing Autogene Cevumeran alone and combined with Atezolizumab in patients with various advanced cancers. It's an early-phase trial to check the safety and how well these treatments work together while monitoring the body's immune response.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system like inflammation in different organs, infusion-related reactions which can occur during or after receiving a drug intravenously, fatigue, digestive problems, changes in blood counts leading to increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My kidneys are functioning well, with a creatinine clearance rate of at least 50 mL/min.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to end of study (up to approximately 3 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to end of study (up to approximately 3 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline in ECGs
Change from Baseline in Targeted Clinical Laboratory Test Results
Change from Baseline in Targeted Vital Signs
+6 moreSecondary outcome measures
DoR According to Immune-Modified RECIST
Duration of Response (DoR) According to RECIST v1.1
Overall Survival (OS)
+4 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%
Pain in extremity
7%
Peripheral sensory neuropathy
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
Trial Design
5Treatment groups
Experimental Treatment
Group I: Phase Ib: Dose Exploration: Autogene Cevumeran + AtezolizumabExperimental Treatment2 Interventions
Non-small cell lung cancer (NSCLC) or melanoma cancer immunotherapy (CIT)-treated participants will receive autogene cevumeran (at dosage lower than maximum tolerated dose [MTD] based on available safety data) along with atezolizumab at a fixed dose of 1200 mg.
Group II: Phase 1b Flat Dose Escalation: Autogene Cevumeran + AtezolizumabExperimental Treatment2 Interventions
Participants will receive autogene cevumeran at escalated dosages along with atezolizumab at a fixed dose of 1200 milligrams (mg)
Group III: Phase 1b Expansion: Autogene Cevumeran + Atezolizumab (Serial Biopsy)Experimental Treatment2 Interventions
CIT-naive patients with selected tumor types who consent to optional serial biopsies will receive autogene cevumeran (at multiple dose levels below MTD based on available safety data) along with atezolizumab at a dixed dose of 1200 mg.
Group IV: Phase 1b Expansion: Autogene Cevumeran + AtezolizumabExperimental Treatment2 Interventions
Participants with different indications as per inclusion criteria will receive autogene cevumeran (at multiple dose levels below MTD based on available safety data) along with atezolizumab at a fixed dose of 1200 mg.
Group V: Phase 1a Flat Dose Escalation: Autogene CevumeranExperimental Treatment1 Intervention
Participants will receive autogene cevumeran at escalated dosages.
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?
Genentech, Inc.Lead Sponsor
1,539 Previous Clinical Trials
567,417 Total Patients Enrolled
BioNTech SEIndustry Sponsor
64 Previous Clinical Trials
108,909 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
888,230 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received neoantigen-specific or whole-tumor cancer vaccines, except as allowed.I am fully active or restricted in physically strenuous activity but can do light work.My kidneys are functioning well, with a creatinine clearance rate of at least 50 mL/min.I do not have an active brain tumor or untreated brain metastases.I have advanced NSCLC and haven't been treated with specific immune therapies.I have had my spleen removed.I have had a severe immune reaction to previous cancer immunotherapy, not including manageable hormone issues or minor enzyme increases.All my side effects from previous immune therapy, except stable hormone issues or vitiligo, have gone away.My cancer has spread to the lining of my brain and spinal cord.I have pain from my cancer that isn't relieved by treatment.I haven't had any cancers other than my current one in the last 5 years.I have high calcium levels in my blood that aren't managed.I haven't taken MAOI drugs in the last 3 weeks.I have active hepatitis B or C.My blood and organs are functioning well.You have had a bone marrow or solid organ transplant in the past.You are allergic to the vaccine or any of its ingredients.I do not have any health conditions that would make it unsafe for me to take a new drug.I have a known immune system deficiency.My cancer is advanced and didn't respond to standard treatments or they were unsuitable for me.My cancer tissue samples are available for testing.My cancer type matches those listed in the study's protocol.I have a type of advanced or metastatic solid tumor that can be biopsied.My side effects from previous cancer treatments are mild, except for hair loss, skin color changes, or hormone issues treated with medication.You have tested positive for HIV.My spinal cord compression hasn't been fully treated, or it was treated but hasn't been stable for 2 weeks.I had cytokine treatment, but it's been over 6 weeks or 5 half-lives since my last dose.I frequently need procedures to remove excess fluid from my chest or abdomen.I haven't had any cancer except for skin cancer in the last 5 years.I have an active or latent tuberculosis infection.I haven't had a severe infection in the last 2 weeks.I have had a condition where my lymphocytes grow abnormally.I have not had severe infections in the last 4 weeks.You have a history of autoimmune disease, with some exceptions mentioned in the study plan.I have not received a live vaccine in the last 4 weeks and do not plan to during the study.You are expected to live for at least 12 more weeks.I haven't had any cancer treatment, including chemo, hormone therapy, or radiation, in the last 3 weeks.You have had serious allergic reactions to certain types of medications or ingredients in the study drug.I do not have significant liver disease or a history of heavy alcohol use.I haven't had major surgery in the last 28 days and don't expect to need one during the study.I've had immune therapy but it's been weeks since my last dose.I haven't taken any immune-weakening medications in the last 2 weeks.I had a severe reaction to previous immune therapy, not including manageable thyroid issues.You have a disease that can be measured using specific guidelines.I have a history of lung scarring or inflammation.
Research Study Groups:
This trial has the following groups:- Group 1: Phase Ib: Dose Exploration: Autogene Cevumeran + Atezolizumab
- Group 2: Phase 1b Expansion: Autogene Cevumeran + Atezolizumab
- Group 3: Phase 1b Expansion: Autogene Cevumeran + Atezolizumab (Serial Biopsy)
- Group 4: Phase 1b Flat Dose Escalation: Autogene Cevumeran + Atezolizumab
- Group 5: Phase 1a Flat Dose Escalation: Autogene Cevumeran
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.
Are there any other investigations which have looked into the effects of Autogene cevumeran?
"Autogene cevumeran was first experimented with at SCRI Tennessee Oncology Chattanooga in 2008, and so far 80 trials have been completed. Currently there are 350 active clinical studies being conducted, many of which originate from Scottsdale, Arizona."
Answered by AI
Has there ever been a similar research endeavor conducted before?
"Autogene cevumeran has been under research since 2008 when Hoffmann-La Roche sponsored the first clinical trial involving 720 patients. Upon successful completion of phase 2, 350 active studies on this drug can now be found in 1646 cities and 74 countries around the world."
Answered by AI
Is enrollment currently open for this investigation?
"At this time, no additional participants are being taken in for this clinical trial. The study was initially published on December 21st 2017 and the last update occurred September 29th 2022. If you would like to search for other trials, there are currently 3231 studies actively searching for patients with melanoma and 350 investigations that accept Autogene cevumeran enrollees."
Answered by AI
To which medical conditions is Autogene cevumeran most frequently applied?
"Autogene cevumeran is typically used to combat the effects of small cell lung cancer (sclc). However, this medication can also be deployed in treating multiple other malignancies such as non-small cell lung carcinoma and postoperative cases."
Answered by AI
What sort of risks do patients face when taking Autogene cevumeran?
"Autogene cevumeran's safety profile has been assessed as a 1 since this is an early stage trial, meaning that the data supporting both efficacy and security are limited."
Answered by AI
How widespread is the implementation of this research endeavor?
"The HonorHealth Research Institute - Bisgrove in Scottsdale, Arizona, The Ottawa Hospital Cancer Centre; Oncology in Ottawa, Nevada, and Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley in Las Vegas are all running this trial. Additionally there are 14 other sites across the United States hosting it as well."
Answered by AI
How many individuals are currently participating in this clinical exploration?
"This specific clinical trial is no longer open for enrolment. It was initially launched on December 21st, 2017 and was last updated on September 29th 2022. If you are searching for other medical studies involving melanoma, there are 3231 active trials while 350 can be found targeting Autogene cevumeran specifically."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
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