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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
Must not have
Primary central nervous system (CNS) malignancy, untreated CNS metastases, or active CNS metastases (progressing or requiring corticosteroids for symptomatic control)
Previous splenectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a personalized cancer vaccine and an immune-boosting drug in cancer patients. The vaccine teaches the body to attack cancer, while the drug helps immune cells find and kill hidden cancer cells. This approach aims to induce strong anti-tumor responses by selecting suitable vaccines based on the patient's existing immune system.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have an active brain tumor or untreated brain metastases.
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I have had my spleen removed.
Select...
All my side effects from previous immune therapy, except stable hormone issues or vitiligo, have gone away.
Select...
My cancer has spread to the lining of my brain and spinal cord.
Select...
I have pain from my cancer that isn't relieved by treatment.
Select...
I have high calcium levels in my blood that aren't managed.
Select...
I haven't taken MAOI drugs in the last 3 weeks.
Select...
I have active hepatitis B or C.
Select...
I have a known immune system deficiency.
Select...
I had cytokine treatment, but it's been over 6 weeks or 5 half-lives since my last dose.
Select...
I frequently need procedures to remove excess fluid from my chest or abdomen.
Select...
I have an active or latent tuberculosis infection.
Select...
I haven't had a severe infection in the last 2 weeks.
Select...
I have had a condition where my lymphocytes grow abnormally.
Select...
I have not had severe infections in the last 4 weeks.
Select...
I have not received a live vaccine in the last 4 weeks and do not plan to during the study.
Select...
I haven't had any cancer treatment, including chemo, hormone therapy, or radiation, in the last 3 weeks.
Select...
I do not have significant liver disease or a history of heavy alcohol use.
Select...
I haven't had major surgery in the last 28 days and don't expect to need one during the study.
Select...
I haven't taken any immune-weakening medications in the last 2 weeks.
Select...
I have a history of lung scarring or inflammation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side 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%
Stomatitis
11%
Vomiting
11%
Neuropathy peripheral
10%
Arthralgia
9%
Neutrophil count decreased
9%
Rash
8%
Headache
8%
Dysgeusia
8%
Paraesthesia
7%
Pain in extremity
7%
Mucosal inflammation
7%
Back pain
7%
Peripheral sensory neuropathy
7%
Insomnia
6%
Pneumonia
6%
Abdominal pain
6%
Febrile neutropenia
6%
Lacrimation increased
6%
Dry skin
6%
Dizziness
5%
Malaise
5%
Urinary tract infection
5%
Weight decreased
5%
Haemoptysis
5%
Nail disorder
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
4%
Productive cough
3%
Upper respiratory tract infection
3%
Pruritus
2%
Influenza like illness
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
1%
Syncope
1%
Dehydration
1%
Atrial fibrillation
1%
Lower respiratory tract infection
1%
Lung infection
1%
Respiratory tract infection
1%
Acute kidney injury
1%
Chronic obstructive pulmonary disease
1%
Pleural effusion
1%
Depression
1%
Musculoskeletal chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~5850
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Head and Neck Cancers include immune response modulation and PD-L1 inhibition. Immune response modulation, such as with Autogene Cevumeran, involves enhancing the body's immune system to recognize and attack cancer cells more effectively.
PD-L1 inhibitors like Atezolizumab work by blocking the PD-L1 protein on cancer cells, which normally helps them evade immune detection. By inhibiting this pathway, the immune system can better identify and destroy cancer cells.
These mechanisms are crucial for patients with Head and Neck Cancers as they offer targeted approaches that can improve treatment efficacy and potentially reduce side effects compared to traditional therapies.
Immunotherapeutic Approaches to Head and Neck Cancer.The promise of immunotherapy in head and neck squamous cell carcinoma.
Immunotherapeutic Approaches to Head and Neck Cancer.The promise of immunotherapy in head and neck squamous cell carcinoma.
Find a Location
Who is running the clinical trial?
Genentech, Inc.Lead Sponsor
1,554 Previous Clinical Trials
568,682 Total Patients Enrolled
BioNTech SEIndustry Sponsor
70 Previous Clinical Trials
110,115 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,217 Previous Clinical Trials
894,583 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.
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