Melanoma and Skin Cancer Clinical Trials
When appropriate, we also offer our patients the option to participate in clinical trials to try a promising new medical drug or other treatment. New treatments through clinical trials are expected to be at least as effective as — or possibly more effective than — current treatments.
Clinical trials test new treatment options only after they have first been researched in the laboratory, where they are carefully studied in the test tube and in laboratory animals. Only the treatments most likely to work are further evaluated in humans during clinical trials. For any new drug or treatment to receive approval by the U.S. Food and Drug Administration (FDA) and become available to the public, it must pass through three phases of clinical trials to show that it is safe and effective in treating the disease. If the FDA approves the drug, it will continue to be monitored for safety and effectiveness in what is known as a Phase 4 study.
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A Phase 3, Randomized, Multicenter, Open-Label Study of IDRX-42 (GSK6042981) versus Sunitinib in Participants with Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) after Imatinib Therapy (StrateGIST 3) +
A Phase 3, Randomized, Multicenter, Open-Label Study of IDRX-42 (GSK6042981) versus Sunitinib in Participants with Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) after Imatinib Therapy (StrateGIST 3)
Protocol No: 300383
Age Group: Adult
Disease Sites: Soft Tissue
NCT Id: NCT07218926
Phase: III
Principal Investigators: Jacobo Hincapie-Echeverri, MD
Objective
To compare the efficacy of IDRX-42 to that of sunitinib in participants with metastatic and/or unresectable GIST after failure of imatinib therapy, as evidenced by PFS
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Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination with Pembrolizumab Versus Investigator's Choice in HLA-A*02:01-Positive Participants with Previously Treated Advanced Melanoma (TEBE-AM) +
Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination with Pembrolizumab Versus Investigator's Choice in HLA-A*02:01-Positive Participants with Previously Treated Advanced Melanoma (TEBE-AM)
Protocol No: IMCGP100-203
Age Group: Adult
Disease Sites: Melanoma, Skin
NCT Id: NCT05549297
Phase: II/III
Principal Investigators: Tirrell Johnson, MD
Eligibility Document -
Attachment Id: 14448
File Name: Subject Eligibility _Screening Checklist Version 19JUL2024 (1).docx
URL:
Objective
To study if the drug tebentafusp, alone or with another therapy, can help people with advanced melanoma live longer and reduce cancer activity in their blood.
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A Phase 1/2, Open-label Study of PD-1 Knockout Tumor-infiltrating Lymphocytes (IOV-4001) in Participants with Unresectable or Metastatic Melanoma or Stage III or IV Non-Small-Cell Lung Cancer +
A Phase 1/2, Open-label Study of PD-1 Knockout Tumor-infiltrating Lymphocytes (IOV-4001) in Participants with Unresectable or Metastatic Melanoma or Stage III or IV Non-Small-Cell Lung Cancer
Protocol No: IOV-GM1-201
Age Group: Adult
Disease Sites: Lung, Melanoma, Skin
NCT Id: NCT05361174
Phase: II/III
Principal Investigators: Juan Varela MD, PhD
Eligibility Document -
Attachment Id: 11553
File Name: Subject Eligibility _Baseline Checklist GM1.docx
URL:
Objective
This study is testing a new type of immune cell therapy called IOV-4001. It's being used in people with advanced melanoma or lung cancer to see if it is safe and whether it can help shrink tumors.
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A Phase 3, Multicenter, Randomized, Open-Label, Parallel Group, Treatment Study to Assess the Efficacy and Safety of the Lifileucel (LN-144, Autologous Tumor Infiltrating Lymphocytes [TIL]) Regimen in Combination with Pembrolizumab Compared with Pembrolizumab Monotherapy in Participants with Untreated, Unresectable or Metastatic Melanoma +
A Phase 3, Multicenter, Randomized, Open-Label, Parallel Group, Treatment Study to Assess the Efficacy and Safety of the Lifileucel (LN-144, Autologous Tumor Infiltrating Lymphocytes [TIL]) Regimen in Combination with Pembrolizumab Compared with Pembrolizumab Monotherapy in Participants with Untreated, Unresectable or Metastatic Melanoma
Protocol No: IOV-MEL-301
Age Group: Adult
Disease Sites: Melanoma, Skin
NCT Id: NCT05727904
Phase: III
Principal Investigators: Juan Varela MD, PhD
Eligibility Document -
Attachment Id: 21212
File Name: Subject Eligibility _Screening Checklist IOV-MEL-301.docx
URL:
Objective
This study is looking at whether combining lifileucel with pembrolizumab helps patients more than pembrolizumab alone by measuring how many people respond to treatment and how long their cancer stays stable over five years.
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Phase 1/2 Study of mRNA-4359 Administered Alone and in Combination with Immune Checkpoint Blockade in Participants with Advanced Solid Tumors +
Phase 1/2 Study of mRNA-4359 Administered Alone and in Combination with Immune Checkpoint Blockade in Participants with Advanced Solid Tumors
Protocol No: MRNA-4359-P101
Age Group: Adult
Disease Sites: Lung, Melanoma, Skin
NCT Id: NCT05533697
Phase: I/II
Principal Investigators: Yuanbin Chen, MD
Eligibility Document -
Attachment Id: 20312
File Name: Subject Eligibility _Screening Checklist Version 28JUL2025 MRNA-4359-P101.docx
URL:
Objective
The main goal of this study is to find the safest dose of the study drug and see how well it works against solid tumors. We will also check for any side effects and how the cancer responds to treatment. This helps us learn if the drug can be used safely and effectively.
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A Phase 1/2, Open-Label Study to Investigate the Safety and Efficacy of Membrane Bound IL15 Expressing Tumor-Infiltrating Lymphocytes (OBX-115) in Participants with Advanced Solid Tumors +
A Phase 1/2, Open-Label Study to Investigate the Safety and Efficacy of Membrane Bound IL15 Expressing Tumor-Infiltrating Lymphocytes (OBX-115) in Participants with Advanced Solid Tumors
Protocol No: OBX115-23-01
Age Group: Adult
Disease Sites: Multiple Myeloma
NCT Id: NCT06060613
Phase: I/II
Principal Investigators: Tirrell Johnson, MD
Eligibility Document -
Attachment Id: 19652
File Name: OBX Subject Eligibility _Baseline Checklist Version 19MAR2025 2.docx
URL:
Objective
This study is testing a new kind of cell therapy called OBC-115 to see if it is safe and effective in people with advanced sold tumors.
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