Study Details

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Ulixertinib/Palbociclib in Patients With Advanced Melanoma

This research study is designed to estimate overall survival after treatment with ulixertinib in combination with palbociclib in an expansion cohort of patients with metastatic PD1 inhibitor-refractory RAS mutated and NF1-mutant (no concurrent BRAFV600 mutations) melanoma.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Visits can be combined with regular clinical appointments

Location

North Carolina

What will be asked of you

During the screening process you will receive an MD visit, blood tests, an echocardiogram (echo), an electrocardigoram (EKG), eye exam, imaging scan, and biopsy (optional). During treatment you will receive MD visits, blood tests, treatment with study drugs, imaging scans, biopsy (optional) and the need to complete drug diaries.

Incentives

In-person visits:
If on study treatment for six months, up to fifteen visits.

Total length of participation:
Up to two years of follow-up following treatment (for roughly six months) for a total of two and a half years.

Looking for Specific Volunteers

Able to participate:

Participants must have advanced melanoma that cannot be resected
Participant must have genetic testing that shows one of the following mutations: NRASG12/G13/Q61, KRASG12/G13, HRASG12/G13, any amplifications of the NRAS, KRAS, or HRAS genes
Participant must have progressed on a scan after at least two infusions of a drug known as a PD1/PD-L1 inhibitor.
Participant must have previously received the drug ipilimumab.

Not eligible if:

Participant had any cancer treatments within 28 days of starting study treatment.
Participant has a history or current evidence/risk of eye disorders known as retinal vein occlusion or central serous retinopathy.
Participant had major surgery within 28 days of starting study treatment.
Participant has another type of active cancer (some exceptions can be made).

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Trials Office
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Hanna Sanoff
Medicine- Oncology

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Melanoma)

IRB Number

17-2338

ClinicalTrials.gov

NCT03454035