Melanoma Clinical Trials
Melanoma clinical trials at Moffitt Cancer Center offer patients novel opportunities to try exciting new treatments and the chance to be among the first to benefit from them. Through important research studies, physicians evaluate innovative treatment options and compare them with the current best practices. As a result, the standard of care improves continually for the benefit of all patients.
Who is Eligible for Melanoma Clinical Trials?
A patient’s eligibility for 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
The End of Cancer Begins Here®
Find a Clinical TrialMoffitt 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.
-
Clinical Trials
CLINICAL TRIAL 19868
First in Human Phase I Study of 225Actinium-DOTA-Ahx-MC1RL (225Ac-MTI-201) in Metastatic Melanoma
Condition: Cutaneous
Intervention: 225Ac-MTI-201 ()
CLINICAL TRIAL 19868
First in Human Phase I Study of 225Actinium-DOTA-Ahx-MC1RL (225Ac-MTI-201) in Metastatic Melanoma
Condition: Cutaneous
Intervention: 225Ac-MTI-201 ()
CLINICAL TRIAL 20490
Keystroke: A Randomized Phase II Study of Pembrolizumab (Keytruda) Plus Stereotactic Re-irradiation versus SBRT Alone For Locoregionally Recurrent or Second Primary Head and Neck Carcinoma
Condition: Head & Neck
Intervention: Pembrolizumab (Keytruda)
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
Condition: Cutaneous
Intervention: Aldesleukin (Interleukin-2); BMS-936558 (Nivolumab); IL-2 (Interleukin-2); Interleukin-2 (); Ipilimumab (); Nivolumab (Opdivo); Proleukin (Interleukin-2); Yervoy (Ipilimumab)
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
Condition: Cutaneous
Intervention: Aldesleukin (Interleukin-2); BMS-936558 (Nivolumab); IL-2 (Interleukin-2); Interleukin-2 (); Ipilimumab (); Nivolumab (Opdivo); Proleukin (Interleukin-2); Yervoy (Ipilimumab)
CLINICAL TRIAL 20641
A Randomized Pilot Trial of Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib and Binimetinib in Advanced Melanoma
Condition: Cutaneous
Intervention: BMS-936558 (Nivolumab); Binimetinib (); Encorafenib (); Nivolumab (Opdivo); Not Applicable ()
CLINICAL TRIAL 20641
A Randomized Pilot Trial of Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib and Binimetinib in Advanced Melanoma
Condition: Cutaneous
Intervention: BMS-936558 (Nivolumab); Binimetinib (); Encorafenib (); Nivolumab (Opdivo); Not Applicable ()
CLINICAL TRIAL 20731
Phase 2 Study of Afatinib in Advanced Cutaneous Squamous Cell Carcinoma
Condition: Cutaneous
Intervention: Afatinib (); BIBW 2992 (Afatinib)
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
Condition: Cutaneous
Intervention: BMS-936558 (Nivolumab); Ipilimumab (); Nivolumab (Opdivo); Sargramostim (); Yervoy (Ipilimumab)
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
Condition: Cutaneous
Intervention: BMS-936558 (Nivolumab); Ipilimumab (); Nivolumab (Opdivo); Sargramostim (); Yervoy (Ipilimumab)
CLINICAL TRIAL 21731
A Phase II Trial of Olaparib in Combination with Pembrolizumab for Advanced Uveal Melanoma
Condition: Cutaneous
Intervention: Olaparib (Lynparza); Pembrolizumab (Keytruda)
CLINICAL TRIAL 21731
A Phase II Trial of Olaparib in Combination with Pembrolizumab for Advanced Uveal Melanoma
Condition: Cutaneous
Intervention: Olaparib (Lynparza); Pembrolizumab (Keytruda)
CLINICAL TRIAL 23460
A Multicenter Phase I/Ib Dose Escalation Study of WTX-124 as Monotherapy and in Combination with Pembrolizumab in Patients with Selected Advanced or Metastatic Solid Tumors
Condition: Cutaneous
Intervention: Pembrolizumab (Keytruda)
CLINICAL TRIAL 23460
A Multicenter Phase I/Ib Dose Escalation Study of WTX-124 as Monotherapy and in Combination with Pembrolizumab in Patients with Selected Advanced or Metastatic Solid Tumors
Condition: Cutaneous
Intervention: Pembrolizumab (Keytruda)
CLINICAL TRIAL 21996
An Open-Label, Multicenter, Phase 1b/2 Study of RP1 in Solid Organ Transplant Recipients with Advanced Cutaneous Malignancies
Condition: Cutaneous
Intervention: RP1 ()
CLINICAL TRIAL 21997
Adaptive Therapy of Vismodegib in Advanced Basal Cell Carcinoma
Condition: Cutaneous
Intervention: Not Applicable (); Vismodegib (Erivedge)
CLINICAL TRIAL 22079
A Phase 1/2, Open-Label Study of PD-1 Knockout Tumor-Infiltrating Lymphocytes (IOC-4001) in Participants with Unresectable or Metastatic Melanoma or Stage III or IV Non-Small-Cell Lung Cancer
Condition: Cutaneous
Intervention: IL-2 (Interleukin-2); IOV-4001 (); MESNA (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)
CLINICAL TRIAL 22079
A Phase 1/2, Open-Label Study of PD-1 Knockout Tumor-Infiltrating Lymphocytes (IOC-4001) in Participants with Unresectable or Metastatic Melanoma or Stage III or IV Non-Small-Cell Lung Cancer
Condition: Cutaneous
Intervention: IL-2 (Interleukin-2); IOV-4001 (); MESNA (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)
CLINICAL TRIAL 22279
A phase 1a/b open-label master study of pf-07799544 as a Single-agent and in combination with other targeted agents In participants with braf-mutant melanoma and other solid Tumors
Condition: Cutaneous
Intervention: PF-07284890 (); PF-07799544 (); PF-0779993 (); PF-07799933 ()
CLINICAL TRIAL 22279
A phase 1a/b open-label master study of pf-07799544 as a Single-agent and in combination with other targeted agents In participants with braf-mutant melanoma and other solid Tumors
Condition: Cutaneous
Intervention: PF-07284890 (); PF-07799544 (); PF-0779993 (); PF-07799933 ()
CLINICAL TRIAL 22505
Cutaneous Adverse Events (irCAEs) Associated with Immunotherapy in Patients with Melanoma
Condition: Cutaneous
Intervention:
CLINICAL TRIAL 22505
Cutaneous Adverse Events (irCAEs) Associated with Immunotherapy in Patients with Melanoma
Condition: Cutaneous
Intervention:
CLINICAL TRIAL 22536
Immune Profiling of Relatlimab and Nivolumab Combination Immunotherapy for Advanced Stage Metastatic Melanoma
Condition: Cutaneous
Intervention:
CLINICAL TRIAL 22536
Immune Profiling of Relatlimab and Nivolumab Combination Immunotherapy for Advanced Stage Metastatic Melanoma
Condition: Cutaneous
Intervention:
CLINICAL TRIAL 22554
A prospective, multicenter, open-label, randomized, actively controlled, parallel-group Phase 3 clinical trial to evaluate efficacy, safety, and tolerability of IMA203 versus investigator's choice of treatment in patients with previously treated, unresectable or metastatic cutaneous melanoma (ACTengine® IMA203-301)
Condition: Cutaneous
Intervention: Albumin-Bound Paclitaxel (); BMS-936558 (Nivolumab); BMS-986016 (Relatlimab); DTIC (Dacarbazine); Dacarbazine (); IL-2 (Interleukin-2); IMA203 (); Ipilimumab (); Lifileucel (); Nivolumab (Opdivo); Paraplatin (carboplatin); Pembrolizumab (Keytruda); Relatlimab (); Taxol (paclitaxel); Temodal (Temozolomide); Temozolomide (); Yervoy (Ipilimumab); carboplatin (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate); paclitaxel ()
CLINICAL TRIAL 22554
A prospective, multicenter, open-label, randomized, actively controlled, parallel-group Phase 3 clinical trial to evaluate efficacy, safety, and tolerability of IMA203 versus investigator's choice of treatment in patients with previously treated, unresectable or metastatic cutaneous melanoma (ACTengine® IMA203-301)
Condition: Cutaneous
Intervention: Albumin-Bound Paclitaxel (); BMS-936558 (Nivolumab); BMS-986016 (Relatlimab); DTIC (Dacarbazine); Dacarbazine (); IL-2 (Interleukin-2); IMA203 (); Ipilimumab (); Lifileucel (); Nivolumab (Opdivo); Paraplatin (carboplatin); Pembrolizumab (Keytruda); Relatlimab (); Taxol (paclitaxel); Temodal (Temozolomide); Temozolomide (); Yervoy (Ipilimumab); carboplatin (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate); paclitaxel ()
CLINICAL TRIAL 22574
Neoadjuvant and Adjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma
Condition: Cutaneous
Intervention: BMS-936558 (Nivolumab); BMS-986016 (Relatlimab); Ipilimumab (); Nivolumab (Opdivo); Relatlimab (); Yervoy (Ipilimumab)
CLINICAL TRIAL 22574
Neoadjuvant and Adjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma
Condition: Cutaneous
Intervention: BMS-936558 (Nivolumab); BMS-986016 (Relatlimab); Ipilimumab (); Nivolumab (Opdivo); Relatlimab (); Yervoy (Ipilimumab)
CLINICAL TRIAL 23082
Phase I/II Clinical Trial of CD40L-augmented Tumor Infiltrating Lymphocytes (TIL) for Patients with Advanced Melanoma
Condition: Cutaneous
Intervention: Aldesleukin (Interleukin-2); IL-2 (Interleukin-2); Interleukin-2 (); Proleukin (Interleukin-2); TIL (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)
CLINICAL TRIAL 23082
Phase I/II Clinical Trial of CD40L-augmented Tumor Infiltrating Lymphocytes (TIL) for Patients with Advanced Melanoma
Condition: Cutaneous
Intervention: Aldesleukin (Interleukin-2); IL-2 (Interleukin-2); Interleukin-2 (); Proleukin (Interleukin-2); TIL (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)
CLINICAL TRIAL 23318
Pembrolizumab for Advanced Cutaneous Sarcomas Not Including Angiosarcoma
Condition: Sarcoma
Intervention: Pembrolizumab (Keytruda)
CLINICAL TRIAL 23341
A Randomized, Controlled, Multicenter, Phase 3 Clinical Study Comparing Vusolimoqene Oderparepvec in Combination with Nivolumab Versus Treatment of Physician's Choice in Patients with Advanced Melanoma that Has Progressed on an Anti-PD-1 and an Anti-CTLA-4 Containing Treatment Regimen
Condition: Cutaneous
Intervention: Albumin-Bound Paclitaxel (); BMS-936558 (Nivolumab); BMS-986016 (Relatlimab); DTIC (Dacarbazine); Dacarbazine (); Nivolumab (Opdivo); Pembrolizumab (Keytruda); Relatlimab (); Taxol (paclitaxel); Temodal (Temozolomide); Temozolomide (); Vusolimogene Oderparepvec (); paclitaxel ()
CLINICAL TRIAL 23341
A Randomized, Controlled, Multicenter, Phase 3 Clinical Study Comparing Vusolimoqene Oderparepvec in Combination with Nivolumab Versus Treatment of Physician's Choice in Patients with Advanced Melanoma that Has Progressed on an Anti-PD-1 and an Anti-CTLA-4 Containing Treatment Regimen
Condition: Cutaneous
Intervention: Albumin-Bound Paclitaxel (); BMS-936558 (Nivolumab); BMS-986016 (Relatlimab); DTIC (Dacarbazine); Dacarbazine (); Nivolumab (Opdivo); Pembrolizumab (Keytruda); Relatlimab (); Taxol (paclitaxel); Temodal (Temozolomide); Temozolomide (); Vusolimogene Oderparepvec (); paclitaxel ()
CLINICAL TRIAL 23360
IFx-Hu2.0 as an Adjunctive Therapy to Pembrolizumab in Checkpoint Inhibitor Naïve Subjects with Advanced or Metastatic Merkel Cell Carcinoma
Condition: Cutaneous
Intervention: IFx-Hu2.0 (); Pembrolizumab (Keytruda)
CLINICAL TRIAL 23377
A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab versus Relatlimab and Nivolumab in Participants with Unresectable or Metastatic Melanoma.
Condition: Cutaneous
Intervention: BMS-936558 (Nivolumab); BMS-986016 (Relatlimab); Cemiplimab (); Fianlimab (); Nivolumab (Opdivo); REGN2810 (Cemiplimab); Relatlimab ()
CLINICAL TRIAL 23377
A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab versus Relatlimab and Nivolumab in Participants with Unresectable or Metastatic Melanoma.
Condition: Cutaneous
Intervention: BMS-936558 (Nivolumab); BMS-986016 (Relatlimab); Cemiplimab (); Fianlimab (); Nivolumab (Opdivo); REGN2810 (Cemiplimab); Relatlimab ()
CLINICAL TRIAL 23474
A Multicenter, Open-Label, Randomized, Controlled Study to Assess the Antitumor Activity of LNS8801 With and Without Pembrolizumab in Patients With Treatment-Refractory, Unresectable Melanoma
Condition: Cutaneous
Intervention: BMS-936558 (Nivolumab); BMS-986016 (Relatlimab); DTIC (Dacarbazine); Dacarbazine (); Ipilimumab (); LNS8801 (); Nivolumab (Opdivo); Pembrolizumab (Keytruda); Relatlimab (); Temodal (Temozolomide); Temozolomide (); Yervoy (Ipilimumab)
CLINICAL TRIAL 23474
A Multicenter, Open-Label, Randomized, Controlled Study to Assess the Antitumor Activity of LNS8801 With and Without Pembrolizumab in Patients With Treatment-Refractory, Unresectable Melanoma
Condition: Cutaneous
Intervention: BMS-936558 (Nivolumab); BMS-986016 (Relatlimab); DTIC (Dacarbazine); Dacarbazine (); Ipilimumab (); LNS8801 (); Nivolumab (Opdivo); Pembrolizumab (Keytruda); Relatlimab (); Temodal (Temozolomide); Temozolomide (); Yervoy (Ipilimumab)
CLINICAL TRIAL 23475
A Phase 1/2 Study of OR502 Alone and in Combination with other Anti-cancer Agents in Subjects with Advanced Malignancies
Condition: Cutaneous
Intervention: Cemiplimab (); OR502 (); REGN2810 (Cemiplimab)
CLINICAL TRIAL 23475
A Phase 1/2 Study of OR502 Alone and in Combination with other Anti-cancer Agents in Subjects with Advanced Malignancies
Condition: Cutaneous
Intervention: Cemiplimab (); OR502 (); REGN2810 (Cemiplimab)
CLINICAL TRIAL 23590
Randomized Phase III Trial of Neoadjuvant Immunotherapy with Response-Adapted Treatment versus Standard-Of-Care Treatment for Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma
Condition: Multiple
Intervention: Cemiplimab (); REGN2810 (Cemiplimab); Radiotherapy ()
CLINICAL TRIAL 23697
A Phase 1/1b, Open-label, Multicenter, First-in-human Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of VVD-159642, a RAS-PI3KA Inhibitor, as a Single Agent and in Combination in Participants With Advanced Solid Tumors
Condition: Multiple
Intervention: AMG 510 (Sotorasib); GSK1120212 (Trametinib); Sotorasib (); Trametinib (); VVD-159642 ()
CLINICAL TRIAL 23697
A Phase 1/1b, Open-label, Multicenter, First-in-human Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of VVD-159642, a RAS-PI3KA Inhibitor, as a Single Agent and in Combination in Participants With Advanced Solid Tumors
Condition: Multiple
Intervention: AMG 510 (Sotorasib); GSK1120212 (Trametinib); Sotorasib (); Trametinib (); VVD-159642 ()