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Checkpoint Inhibitor
Autogene Cevumeran + Pembrolizumab for Melanoma (IMCODE001 Trial)
Phase 2
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
Histologically confirmed metastatic (recurrent or de novo Stage IV) or unresectable locally advanced (Stage IIIC or IIID) cutaneous, acral, or mucosal melanoma
Tumor specimen availability
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 24 months
Awards & highlights
IMCODE001 Trial Summary
This trial will test if adding RO7198457 to pembrolizumab helps people with previously untreated advanced melanoma compared to pembrolizumab alone.
Who is the study for?
This trial is for adults with advanced melanoma that hasn't been treated before. They should have a certain level of physical fitness (ECOG 0 or 1), a life expectancy of at least 12 weeks, and their major organs must be functioning well. People can't join if they've had organ transplants, significant heart disease, liver problems, eye melanoma, untreated brain metastases, autoimmune diseases, HIV/AIDS, hepatitis B or C.Check my eligibility
What is being tested?
The study is testing the combination of Autogene cevumeran (RO7198457) with Pembrolizumab versus using Pembrolizumab alone in patients who haven't received treatment for their advanced melanoma. It aims to see which approach works better and how safe it is.See study design
What are the potential side effects?
Possible side effects include immune system reactions affecting various organs; infusion-related symptoms like fever or chills; fatigue; skin issues; hormonal gland problems such as thyroid disorders; and an increased risk of infections.
IMCODE001 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My melanoma is advanced and cannot be removed with surgery.
Select...
I can provide a sample of my tumor for testing.
Select...
I am fully active or can carry out light work.
IMCODE001 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECISTv.1.1) After Randomization
Secondary outcome measures
Duration of Response (DOR) According to RECISTv.1.1 After Randomization
Mean Change in Global Health Status (GHS)/Health-related Quality of Life (HRQoL) Score After Randomization
Objective Response Rate (ORR) According to RECISTv.1.1 After Cross Over
+3 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
IMCODE001 Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Safety Run-in Period: Autogene Cevumeran + PembrolizumabExperimental Treatment2 Interventions
Participants will receive at least one cycle of 200 mg pembrolizumab monotherapy by intravenous (IV) infusion followed by 200 mg pembrolizumab IV infusion every 3 weeks (Q3W) plus a recommended dose of autogene cevumeran.
Group II: Randomized Period: Arm B: Autogene Cevumeran + PembrolizumabExperimental Treatment2 Interventions
Participants will receive at least one cycle of 200 mg pembrolizumab monotherapy by IV infusion followed by 200 mg pembrolizumab IV infusion Q3W plus a recommended dose of autogene cevumeran.
Group III: Randomized Period: Arm A: PembrolizumabActive Control1 Intervention
Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W. Participants in Arm A have the option to cross over to combination treatment with autogene cevumeran plus pembrolizumab (Arm B) after confirmed disease progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Genentech, Inc.Lead Sponsor
1,539 Previous Clinical Trials
567,558 Total Patients Enrolled
34 Trials studying Melanoma
1,556 Patients Enrolled for Melanoma
BioNTech SEIndustry Sponsor
64 Previous Clinical Trials
109,050 Total Patients Enrolled
4 Trials studying Melanoma
1,862 Patients Enrolled for Melanoma
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
888,371 Total Patients Enrolled
50 Trials studying Melanoma
42,788 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had my spleen removed.I have active hepatitis B, C, or tuberculosis.I have not had any cancer treatment except those allowed in the study.Your disease can be measured using a specific method called RECIST v1.1.I have advanced melanoma and haven't received systemic anti-cancer treatments, with some exceptions.My blood and organs are functioning well.You have a positive test for HIV.I have a significant liver condition.I have been diagnosed with eye melanoma.My melanoma is advanced and cannot be removed with surgery.I have a serious heart condition.You have had a bone marrow or solid organ transplant in the past.You have a history of autoimmune disease.You are expected to live for at least 12 more weeks.I can provide a sample of my tumor for testing.I am fully active or can carry out light work.I have brain metastases that are untreated or getting worse.
Research Study Groups:
This trial has the following groups:- Group 1: Randomized Period: Arm B: Autogene Cevumeran + Pembrolizumab
- Group 2: Safety Run-in Period: Autogene Cevumeran + Pembrolizumab
- Group 3: Randomized Period: Arm A: Pembrolizumab
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.
To what extent does Pembrolizumab pose a risk to patients?
"After assessing the available clinical data, our team at Power assigned Pembrolizumab a score of 2. This is due to Phase 2 trial results indicating some safety but no efficacy information."
Answered by AI
What primary ailments is Pembrolizumab utilized to address?
"Pembrolizumab has a range of applications, including the treatment of malignant tumours. It is also used to treat resistant cases of melanoma, microsatellite instability high conditions, and chemotherapy-resistant cancer progression."
Answered by AI
Has Pembrolizumab been studied in past clinical experiments?
"Pembrolizumab's research was kick-started in 2010 by City of Hope and since then, 251 trials have been concluded. Currently, there are 961 ongoing studies taking place mainly in Jacksonville, Florida."
Answered by AI
What is the aggregate figure for individuals participating in this research?
"This medical trial is no longer recruiting participants. It was initially launched on the 8th of January 2019 and last updated 11th November 2022. For those still looking for studies, there are 754 trials actively enrolling patients with melanoma while 961 clinical experiments are seeking individuals to use Pembrolizumab."
Answered by AI
Is it possible to enlist in this medical experiment at the present moment?
"Clinicaltrials.gov does not indicate that this particular trial is actively recruiting, as it was last updated on November 11th of 2022 and first posted on August 1st 2019. Despite being inactive right now, there are 1715 other clinical trials looking for participants at the moment."
Answered by AI
At how many locales is this experiment operating presently?
"At the moment, 21 different medical facilities in various cities such as Jacksonville, Cleveland and Saint George are currently enrolling patients for this trial. For convenience of participants, it is recommended to pick a site that is closest to their residence in order to reduce travel expenses."
Answered by AI
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