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Checkpoint Inhibitor
Triple Immunotherapy for Advanced Cancers
Phase 2
Waitlist Available
Led By Adi Diab
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Cohort 1: Melanoma (n=35 patients) - Histologically confirmed stage III (unresectable) or stage IV melanoma, as per American Joint Committee on Cancer (AJCC) Version 8 staging system. Patients must consent to BRAF testing or have documented BRAF status as per regionally acceptable V600 mutational status testing.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is investigating the side effects of a combination of immunotherapy drugs to see if they are effective in treating locally advanced melanoma, non-small cell lung cancer, or urothelial carcinoma.
Who is the study for?
This trial is for adults with advanced melanoma, non-small cell lung cancer (NSCLC), or urothelial carcinoma. Participants must consent to specific testing and comply with study requirements. Exclusions include autoimmune diseases, certain heart conditions, active infections, recent use of immunosuppressants or live vaccines, and some other health issues.Check my eligibility
What is being tested?
The trial tests tocilizumab combined with ipilimumab and nivolumab in treating locally advanced cancers. It aims to see if this combination can enhance the immune system's ability to fight cancer while managing side effects better than current treatments.See study design
What are the potential side effects?
Possible side effects include immune-related reactions that could affect various organs, infusion-related symptoms like fever or chills, fatigue, potential liver enzyme elevations indicating liver stress, blood count changes increasing infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have stage III or IV melanoma and know my BRAF status.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of dose limiting toxicity
Occurrence of one or more grade 3 or higher adverse event in a given patient (Cohort 1)
Secondary outcome measures
Best overall response
Overall survival (OS)
Progression-free survival (PFS)
Side effects data
From 2017 Phase 4 trial • 59 Patients • NCT0203447411%
Low ANC
5%
nausea
5%
Inpatient admission
5%
fatigue
5%
agranulocytosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tocilizumab
Placebo
Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort 3 (ipilimumab,, nivolumab, tocilizumab)Experimental Treatment3 Interventions
Patients with NSCLC receive ipilimumab IV over 90 minutes every 6 weeks and nivolumab IV over 30 minutes every 2 weeks for up to 2 years. Patients also receive tocilizumab SC every 2 weeks for up to 12 weeks (6 doses). Treatment continues in the absence of disease progression or unacceptable toxicity.
Group II: Cohort 2 (ipilimumab, nivolumab, tocilizumab)Experimental Treatment3 Interventions
Patients with urothelial cancer will receive ipilimumab IV over 90 minutes and nivolumab IV over 30 minutes on day 1. Treatment with ipilimumab and nivolumab repeats every 3 weeks for 4 doses, then treatment with nivolumab repeats every 4 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Starting on week 1, patients also receive tocilizumab SC every 2 weeks for up to 12 weeks (6 doses) in the absence of disease progression or unacceptable toxicity.
Group III: Cohort 1 (ipilimumab, nivolumab, tocilizumab)Experimental Treatment3 Interventions
Patients with melanoma will receive ipilimumab IV over 90 minutes and nivolumab IV over 30 minutes on day 1. Treatment with ipilimumab and nivolumab repeats every 3 weeks for 4 doses, then treatment with nivolumab repeats every 4 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Cohort 1 will be divided into 2 sub-groups: sub-group 1 of 25 patients, and subgroup 2 of 10 patients that will consist of varying Tocilizumab administration doses. For sub-group 1, Tocilizumab 162mg will be administered subcutaneously every 2 weeks starting week 0, up to 12 weeks for a total of 6 doses. For sub-group 2 , Tocilizumab 162mg will be administered subcutaneously once every week starting at week 0 up to week 6 followed by Tocilizumab administered subcutaneously every 2 weeks starting at week 6 up to 12 weeks for a total of 9 doses.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
FDA approved
Tocilizumab
FDA approved
Nivolumab
FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,767 Total Patients Enrolled
102 Trials studying Melanoma
25,300 Patients Enrolled for Melanoma
Adi DiabPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
36 Total Patients Enrolled
2 Trials studying Melanoma
36 Patients Enrolled for Melanoma
Adi Diab, MDPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
53 Total Patients Enrolled
3 Trials studying Melanoma
53 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have NSCLC with a specific EGFR mutation and have had one prior EGFR TKI treatment.I have advanced urothelial carcinoma and cannot receive cisplatin.I have stage III or IV melanoma and know my BRAF status.I haven't taken high-dose steroids or other immune-weakening drugs in the last 14 days.I have had serious heart problems in the last year.My kidney function is within the required range for the trial.I have not received a live vaccine in the last 30 days.Your white blood cell count, neutrophil count, platelet count, or hemoglobin level are too low.You have a current autoimmune disease.I have signed the consent form for this study.You are being held against your will for treatment of a mental or physical illness.Your liver enzymes (AST/ALT) and total bilirubin levels are too high, except if you have Gilbert Syndrome, in which case only your total bilirubin can be slightly elevated.My cancer is not uveal melanoma.I haven't had any cancer except for certain skin, bladder, prostate, cervix, or breast cancers in the last 3 years.I have not had an infection needing treatment in the last 14 days.I have lung disease that could affect my treatment's safety monitoring.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1 (ipilimumab, nivolumab, tocilizumab)
- Group 2: Cohort 2 (ipilimumab, nivolumab, tocilizumab)
- Group 3: Cohort 3 (ipilimumab,, nivolumab, tocilizumab)
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
How many participants are involved in this research endeavor?
"Affirmative. According to clinicaltrials.gov, this research project is currently recruiting and began on the 23rd of September 2021. The last amendment was made on 11th October 2022 and there are 55 spaces available at 1 medical site."
Answered by AI
To what conditions is tocilizumab typically prescribed?
"Tocilizumab has proven to be a successful treatment for unresectable melanoma and other conditions such as squamous cell carcinoma, high risk of recurrence, and disease."
Answered by AI
Are recruitments for this trial still being accepted?
"Affirmative. According to clinicaltrials.gov, this research is open for recruitment with the initial posting on September 23rd 2021 and the latest update recorded October 11th 2022. At present, 55 volunteers must be recruited from a single location."
Answered by AI
Is Tocilizumab an officially sanctioned pharmaceutical?
"The safety rating of tocilizumab, as assessed by Power is a 2. This reflects the current status at Phase 2 and that there are some data available regarding its efficacy but none confirming it."
Answered by AI
Could you elucidate the other experiments involving Tocilizumab that have taken place?
"As of now, 834 medical studies are currently exploring the potentials of tocilizumab with 94 trials in their final stage. While many such clinical tests originate from Pittsburgh, Pennsylvania there is a total number of 44205 sites conducting experiments for this drug."
Answered by AI
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