Melanoma Clinical Trials

The melanoma clinical trials being conducted at Moffitt Cancer Center provide patients with novel opportunities to try exciting new treatments and be among the first to benefit from them. Through these important research studies, physicians are able to evaluate innovative treatment options and compare them with the current best practices. As a result, the standard of care, which is the best treatment currently available based on past research, improves continually for the benefit of all patients.

A patient’s eligibility for participating in melanoma clinical trials is carefully determined by considering several factors for each particular study. To ensure accuracy and help researchers achieve meaningful results, potential participants are screened based on characteristics like age, gender, type and stage of cancer, past treatments and overall health and wellness.

Once a patient qualifies for a clinical trial, he or she must then decide whether to participate. At Moffitt, we work carefully with our patients to make sure they have all the information they need to make informed choices. With regard to clinical trials for melanoma, our team will explain:

  • What the study will entail and how it might affect the patient’s daily life
  • How the proposed treatment compares with the standard of care
  • The risks and benefits associated with the treatment under study
  • Potential side effects
  • The requirements of participation, including testing, hospitalization and physician visits
  • Other available treatment options
  • Whether long-term follow-up care will be needed

Moffitt is the only National Cancer Institute-designated Comprehensive Cancer Center based in Florida, and we continue to lead the way in cancer research. Our multispecialty team of melanoma experts works collaboratively to ensure that each patient receives highly individualized, supportive care, whether that includes a clinical trial or other advanced treatment option.

If you would like to learn about the melanoma clinical trials currently underway at Moffitt Cancer Center, you do not need a referral to consult with our cancer experts. Please call 1-813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form online.

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Open Clinical Trials:

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CLINICAL TRIAL 19441

Pilot Study of Adaptive BRAF-MEK Inhibitor Therapy for Advanced BRAF Mutant Melanoma

Disease Site: Melanoma, skin

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CLINICAL TRIAL 19868

First in Human Phase I Study of 225Actinium-DOTA-Ahx-MC1RL (225Ac-MTI-201) in Metastatic Melanoma

Disease Site: Eye and Orbit, Melanoma, skin

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CLINICAL TRIAL 20162

Phase 1 Trial of Intralesional Immunotherapy with IFx-Hu2.0 Vaccine in Patients with Advanced Merkel Cell Carcinoma or Cutaneous Squamous Cell Carcinoma

Disease Site: Melanoma, skin, Merkel cell carcinoma, Other Skin, Skin, Squamous Cell Carcinoma (SCC)

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CLINICAL TRIAL 20270

A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-144 or LN-145) in Patients with Solid Tumors (IOV-COM-202)

Disease Site: Lung, Melanoma, skin, Non small cell lung cancer

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CLINICAL TRIAL 20313

Neoadjuvant Immunotherapy with Intratumoral Tavokinogene Telseplasmid (Tavo) plus Electroporation in Combination with Intravenous Nivolumab in Patients with Operable Locally- Regionally Advanced Melanoma

Disease Site: Melanoma, skin

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CLINICAL TRIAL 20494

A Phase II Study of High Dose Bolus IL2 in Combination with Low Dose Ipilimumab Followed Sequentially by Nivolumab in Patients with Inoperable Stage III or Stage IV Melanoma Who Have Failed Prior Anti-PD1 Immunotherapy

Disease Site: Melanoma, skin

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CLINICAL TRIAL 20641

A Randomized Pilot Trial of Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib and Binimetinib in Advanced Melanoma

Disease Site: Melanoma, skin

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CLINICAL TRIAL 20854

Exercise to Boost Response to Checkpoint Blockade Immunotherapy

Disease Site: Melanoma, skin, Other Skin

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CLINICAL TRIAL 20904

A Randomized Phase 2 Trial of Encorafenib + Binimetinib + Nivolumab vs Ipilimumab + Nivolumab in Braf-V600 Mutant Melanoma with Brain Metastases

Disease Site: Melanoma, skin

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CLINICAL TRIAL 21080

A Phase 1, Open-Label, Dose-Escalation, and Dose-Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SRK-181 Administered Alone or in Combination with a Checkpoint Inhibitor in Patients with Locally Advanced or Metastatic Solid Tumors (DRAGON)

Disease Site: Any Site, Lung, Melanoma, skin, Urinary Bladder

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CLINICAL TRIAL 21112

Phase 2 Study of Axitinib + Ipilimumab in Advanced Melanoma

Disease Site: Melanoma, skin

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CLINICAL TRIAL 21180

A First-in-Human, Two-Part, Open-Label, Clinical Study to Assess the Safety, Tolerability and Activity of Intravenous Doses of ICT01 as Monotherapy and in Combination with an Immune Checkpoint Inhibitor, in Patients with Advanced-Stage, Relapsed/Refractory Cancer (EVICTION Study)

Disease Site: Any Site, Breast, Colon, Larynx, Leukemia, other, Lip, Oral Cavity and Pharynx, Lung, Melanoma, skin, Ovary, Prostate, Stomach, Urinary Bladder

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CLINICAL TRIAL 21239

Randomized Phase II/III Study of Nivolumab plus Ipilimumab plus Sargramostim versus Nivolumab plus Ipilimumab in Patients with Unresectable Stage III or Stage IV Melanoma

Disease Site: Melanoma, skin

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CLINICAL TRIAL 21273

A Randomized, Pilot Study to Evaluate the Molecular and Cellular Response to Treatment with Nivolumab with either Adjuvant Ipilimumab or Relatlimab in Adult Patients with Surgically Resectable Melanoma Brain Metastases

Disease Site: Melanoma, skin

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CLINICAL TRIAL 21344

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients with Melanoma (Morpheus-Melanoma)

Disease Site: Melanoma, skin

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CLINICAL TRIAL 21553

A Multicenter, Randomized, Double-Blind Phase 3 Study of HBI-8000 Combined with Nivolumab versus Placebo with Nivolumab in Patients with Unresectable or Metastatic Melanoma Not Previously Treated with PD-1 or PD-L1 Inhibitors

Disease Site: Melanoma, skin

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CLINICAL TRIAL 21573

An Open-Label Expanded Access Study of the Melphalan/Hepatic Delivery System (HDS) in Patients with Hepatic Dominant Ocular Melanoma

Disease Site: Melanoma, skin

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CLINICAL TRIAL 21707

A Proof of Concept Study of TBio-4101 (an autologous selected and expanded tumor infiltrating lymphocyte [TIL] therapy) using Short-Term Cultured, Selected Autologous TIL Following a Lymphodepleting Chemotherapy Regimen and Followed by IL-2 for Patients with Relapsed or Refractory Melanoma (Phase 1)

Disease Site: Melanoma, skin

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CLINICAL TRIAL 21731

A Phase II Trial of Olaparib in Combination with Pembrolizumab for Advanced Uveal Melanoma

Disease Site: Melanoma, skin

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CLINICAL TRIAL 21125

MElanoma Research Lymph Node Prediction Implementation National_001 (MERLIN_001)

Disease Site: Melanoma, skin

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CLINICAL TRIAL 21942

Characterization of Lymphoid Aggregates in Desmoplastic Melanoma

Disease Site: Melanoma, skin

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CLINICAL TRIAL 50401

Creation of Cell Lines and Corresponding DNA and RNA Analysis from Acral Lentiginous Malignant Melanoma

Disease Site: Melanoma, skin

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