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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

Must not have

Known cardiac history including: History of unstable or deteriorating cardiac disease within the previous 12 months prior to screening including but not limited to the following: Unstable angina or myocardial infarction, Transient ischemic attack (TIA)/Cerebrovascular accident (CVA), Congestive heart failure (New York Heart Association [NYHA] Class III or IV), Uncontrolled clinically significant arrhythmias.

Serum creatinine > 1.5 x ULN, unless creatinine clearance ≥ 40 mL/min (measured or calculated using the Cockroft-Gault formula).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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 below

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I have stage III or IV melanoma and know my BRAF status.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had serious heart problems in the last year.

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My kidney function is within the required range for the trial.

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My cancer is not uveal melanoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of dose limiting toxicity

Occurrence of one or more grade 3 or higher adverse event in a given patient (Cohort 1)

Secondary study objectives

Best overall response

Overall survival (OS)

Progression-free survival (PFS)

Side effects data

From 2017 Phase 4 trial • 59 Patients • NCT02034474

11%

Low ANC

nausea

agranulocytosis

Inpatient admission

fatigue

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Tocilizumab

Awards & Highlights

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.

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

Nivolumab

FDA approved

Tocilizumab

FDA approved

0 / 4Eligibility criteria met