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Ipilimumab and All-Trans Retinoic Acid Combination Treatment of Stage IV Melanoma

Information source: University of Colorado, Denver
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Melanoma

Intervention: All-Trans Retinoic Acid (Drug); Ipilimumab (Drug)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: University of Colorado, Denver

Official(s) and/or principal investigator(s):
Martin McCarter, MD, Principal Investigator, Affiliation: University of Colorado, Denver

Overall contact:
Martin McCarter, MD, Phone: (720) 724-2728, Email: Martin.Mccarter@ucdenver.edu

Summary

The purpose of this study is to assess the safety and efficacy of combined treatment with Ipilimumab and all-trans retinoic acid (ATRA) in melanoma patients.

Clinical Details

Official title: Ipilimumab and All-Trans Retinoic Acid Combination Treatment of Stage IV Melanoma

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Number of Adverse Events

MDSC frequency

MDSC suppressive function

Secondary outcome: Changes in the frequency of tumor-specific T cell responses

Detailed description: The successful treatment of melanoma with immune checkpoint inhibitors, such as anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) and Programmed cell death protein 1 (PD-1) antibodies, has altered our thinking and approach to immunotherapy for solid tumors. Despite these advances, only a portion of patients experience a durable response suggesting that there is room for improvement via enhanced immunomodulatory approaches. Anti-CTLA-4 (Ipilimumab) significantly improves overall survival and achieves long-lasting complete responses in some melanoma patients, the number of patients that achieve durable clinical benefit is limited and could be improved by a combined immunomodulatory approach. The objectives of this study are to assess the safety and efficacy of combined treatment with Ipilimumab and all-trans retinoic acid (ATRA) in melanoma patients. We hypothesize that combined treatment with Ipilimumab and ATRA will improve patient responses, increase tumor antigen-specific T cell responses, and decrease immunosuppressive myeloid-derived suppressor cells (MDSCs) in melanoma patients compared to patients treated with Ipilimumab alone.

Eligibility

Minimum age: 18 Years. Maximum age: 89 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients over the age of 18 year.

- Patients diagnosed with Stage IV melanoma.

- Patients that are considered candidates for ipilimumab therapy.

- Patients able to understand and willing to sign a written informed consent documents.

- Patients willing to have regular blood draws, one before treatment and four during or

after treatment. Exclusion Criteria:

- Patients under the age of 18.

- Patients with Stage I, II, or III melanoma.

- Patients that have received systemic treatments within four weeks prior to the

beginning of treatment.

- Women that are pregnant or nursing.

- Patients with ocular melanoma.

- Patients taking immunosuppressive medications.

- Patients with active autoimmune disease.

- Patients with known sensitivity to retinoic acid derivatives.

Locations and Contacts

Martin McCarter, MD, Phone: (720) 724-2728, Email: Martin.Mccarter@ucdenver.edu

Additional Information

Starting date: March 2015
Last updated: March 25, 2015

Page last updated: August 23, 2015

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