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Protein Kinase Inhibitor

Pharmacological Study for Melanoma

Phase 2

Waitlist Available

Led By Hussein A Tawbi

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

Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula) (within one week prior to registration)

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial is testing two different combinations of drugs to treat patients with stage III-IV melanoma that has spread or can't be removed by surgery. The first combination is nivolumab with trametinib and dabrafenib. The second combination is encorafenib with binimetinib. The trial will compare how well the two combinations work and what side effects they cause.

Who is the study for?

This trial is for adults with stage III-IV melanoma that's spread or can't be surgically removed, specifically those with a BRAF V600 mutation. It includes patients who've had prior treatments except for BRAFi/MEKi and requires stable brain metastases if present. Participants must have good organ function, not need high steroid doses, and agree to contraception.Check my eligibility

What is being tested?

The study tests how well nivolumab (an immunotherapy drug) works with trametinib and dabrafenib or encorafenib and binimetinib (targeted therapies) in treating advanced melanoma. The goal is to see which combination better inhibits tumor growth by blocking enzymes needed for cell growth.See study design

What are the potential side effects?

Possible side effects include immune system changes leading to inflammation in various organs, potential skin reactions, fatigue, liver enzyme elevation indicating liver stress, blood-related issues like anemia or clotting problems, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function, measured by creatinine levels, is within the normal range.

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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Upper arm

Secondary outcome measures

Complete response

Incidence of adverse events assessed using National Cancer Institute's Common Terminology Criteria for Adverse Events version 4.0

Disease

+3 more

Other outcome measures

Circulating and tumor markers

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm C (NEB)Experimental Treatment5 Interventions

Patients receive nivolumab IV over 30 minutes on day 1 and 15, encorafenib PO QD on days 1-28, and binimetinib PO BID on days 1-28. Cycles repeats every 28 days for up to 3 years in the absence of disease progression or unacceptable toxicity.

Group II: Arm B (NT, closed to accrual)Experimental Treatment4 Interventions

Patients receive nivolumab IV over 30 minutes on day 1 and 15, and trametinib PO QD on days 1-28. Cycles repeats every 28 days for up to 3 years in the absence of disease progression or unacceptable toxicity.

Group III: Arm A (NDT, CLOSED)Experimental Treatment5 Interventions

Patients receive nivolumab IV over 30 minutes on day 1, dabrafenib PO BID on days 1-28, and trametinib PO QD on days 1-28. Cycles repeats every 28 days for up to 3 years in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trametinib

2014

Completed Phase 2

~1550

Binimetinib

2018

Completed Phase 3

~1100

Nivolumab

2014

Completed Phase 3

~4750

Dabrafenib

2011

Completed Phase 3

~4120

Encorafenib

2021

Completed Phase 3

~960

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,729 Total Patients Enrolled

102 Trials studying Melanoma

25,283 Patients Enrolled for Melanoma

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,101 Total Patients Enrolled

557 Trials studying Melanoma

193,181 Patients Enrolled for Melanoma

Hussein A TawbiPrincipal InvestigatorM.D. Anderson Cancer Center

4 Previous Clinical Trials

431 Total Patients Enrolled

3 Trials studying Melanoma

131 Patients Enrolled for Melanoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the primary indications for Nivolumab?

"Nivolumab is used to treat patients with unresectable melanoma, squamous cell carcinoma, and a high risk of cancer recurrence."

Answered by AI

How many participants can join this research project?

"Although this trial is not currently enrolling patients, it was last edited on September 22nd, 2022. There are presently 3215 trials actively searching for participants with cancer and 888 trials for Nivolumab that are still recruiting patients."

Answered by AI

What are the potential dangers of Nivolumab?

"While there is some data gathered from Phase 2 clinical trials supporting the safety of Nivolumab, there is currently no evidence to suggest that it is an effective medication."

Answered by AI

Has this clinical trial been done before?

"888 clinical trials involving the use of Nivolumab are currently ongoing in 53 countries and 2640 cities. The first-ever trial for Nivolumab was conducted by Medarex back in 2010 with 127 patients. That study completed Phase 1 of drug approval, and since then 937 similar studies have taken place."

Answered by AI

Is there still room for more participants in this test program?

"Although this study is not looking for new patients at the moment, information hosted on clinicaltrials.gov shows that it was most recently updated on September 22nd, 2022. There are 4103 other trials currently underway that may be seeking candidates."

Answered by AI

What is the global clinical experience with Nivolumab?

"There are 888 active clinical trials looking into nivolumab with 90 of them being in Phase 3. Many research centres for this drug are based in Cambridge, England, but there are a total of 45247 locations running these type of investigations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Nivolumab With Trametinib and Dabrafenib, or Encorafenib and Binimetinib in Treating Patients With BRAF Mutated Metastatic or Unresectable Stage III-IV Melanoma

2016. "Nivolumab With Trametinib and Dabrafenib, or Encorafenib and Binimetinib in Treating Patients With BRAF Mutated Metastatic or Unresectable Stage III-IV Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02910700.

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