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Reading and Resources
The lists below include information about melanoma evidence-based guidelines, ongoing clinical trials, and online resources.
Treatment Guidelines
| Guidelines | Link to guidelines |
|---|---|
| ASCO Clinical Practice Guidelines (2023) | https://www.asco.org/guidelines?categories=Melanoma |
| NCCN Clinical Practice Guidelines. (V2.2025) | https://www.nccn.org/professionals/physician_gls/pdf/cutaneous_melanoma.pdf |
| ESMO Clinical Practice Guidelines. (2025) | https://www.esmo.org/guidelines/guidelines-by-topic/melanoma-and-skin-cancers/clinical-practice-guidelines-cutaneous-melanoma |
Websites
| Resource | Address |
|---|---|
| AIM at Melanoma Foundation | https://www.aimatmelanoma.org/ |
| American Academy of Dermatology Association. | https://www.aad.org/ |
| American Cancer Society (ACS). Melanoma Skin Cancer | https://cancer.org/cancer/melanoma-skin-cancer.html |
| American Joint Committee on Cancer. | https://www.facs.org/quality-programs/cancer-programs/american-joint-committee-on-cancer/ |
| American Society of Clinical Oncology (ASCO) Education Book. Beyond Checkpoint Inhibition: Keeping Therapeutic Options Open. (Joshi UM, et al. 2025) | https://pubmed.ncbi.nlm.nih.gov/40233298/ |
| ASCO Education Book. Curing Stage IV Melanoma: Where Have We Been and Where Are We? (Chan PY, et al. 2024) | https://pubmed.ncbi.nlm.nih.gov/40233298/ |
| Cancer Support Community | https://www.cancersupportcommunity.org/ |
| Caregiver Action Network | https://www.caregiveraction.org/ |
| MedlinePlus. Melanoma | https://medlineplus.gov/melanoma.html |
| Melanoma Research Foundation | https://melanoma.org |
| National Cancer Institute. Drugs Approved for Melanoma. | https://www.cancer.gov/about-cancer/treatment/drugs/melanoma |
| National Comprehensive Cancer Network. | https://www.nccn.org/home/ |
| Society for Immunotherapy of Cancer | https://www.sitcancer.org/home/ |
| The University of Texas MD Anderson cancer Center. Survivorship-Cutaneous Melanoma | https://www.mdanderson.org/documents/for-physicians/algorithms/survivorship/survivorship-cutaneous-melanoma-web-algorithm.pdf |
| US National Library of Medicine. Clinical Trials | https://clinicaltrials.gov |
Selected Ongoing Phase 3 Studies of Systemic Therapy for Melanoma
| Investigational Agent(s) | Study Title | NCT Number | Acronym | Study Status* |
|---|---|---|---|---|
| ABP 206 | A Study to Evaluate ABP 206 Compared With Nivolumab (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma | NCT06054555 | Recruiting | |
| ABP 206 | A Study to Evaluate Similarity of ABP 206 Compared With Nivolumab in Subjects With Resected Melanoma | NCT05907122 | Ongoing | |
| Anti-PD-1 Therapy | Duration of Anti-PD-1 Therapy in Metastatic Melanoma | NCT02821013 | STOP-GAP | Recruiting |
| Atezolizumab | DETERMINE Trial Treatment Arm 02: Atezolizumab in Adult, Teenage/Young Adults and Paediatric Patients With Cancers With High Tumour Mutational Burden (TMB) or Microsatellite Instability-high (MSI-high) or Proven Constitutional Mismatch Repair Deficiency (CMMRD) Disposition | NCT05770102 | DETERMINE | Recruiting |
| BCD-201 | Clinical Study of the Efficacy and Safety of BCD-201 and Pembrolizumab in Subjects With Advanced Melanoma | NCT05986331 | Ongoing | |
| BCD-217 (Nurulimab + Prolgolimab) | A Study of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) in Patients With Resectable Stage III Skin Melanoma | NCT05751928 | NEO-MIMAJOR | Recruiting |
| BCD-217 (Nurulimab + Prolgolimab) + Anti-PD-1 | A Clinical Study of BCD-217 (Nurulimab + Prolgolimab) Followed by Anti-PD-1 Compared to Anti-PD-1 Monotherapy as First-Line Treatment in Subjects With Unresectable/Metastatic Melanoma | NCT05732805 | OCTAVA | Ongoing |
| BCD-263 + Nivolumab | Clinical Study of the Efficacy and Safety of BCD-263 and Nivolumab As Monotherapy in Subjects with Advanced Melanoma of the Skin | NCT06640530 | UNIVERSE | Recruiting |
| Cemiplimab + Fianlimab | A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma | NCT06246916 | Recruiting | |
| Cemiplimab + Fianlimab | A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma | NCT06190951 | Recruiting | |
| Cemiplimab + Fianlimab | A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery | NCT05608291 | Recruiting | |
| Cemiplimab + Fianlimab | Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma | NCT05352672 | Recruiting | |
| Dabrafenib + Trametinib With Ipilimumab + Nivolumab | Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma | NCT02224781 | Ongoing | |
| EIK1001-006 + Pembrolizumab | Safety and Efficacy of EIK1001-006 in Combo With Pembro Versus Placebo and Pembro as First-Line Therapy in Patients With Advanced Melanoma. | NCT06697301 | Recruiting | |
| Encorafenib + Bimitenib | Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation. | NCT05270044 | COLUMBUS-AD | Ongoing |
| Encorafenib, Binimetinib, and Pembrolizumab | A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma | NCT04657991 | Ongoing | |
| Entrectinib | DETERMINE Trial Treatment Arm 03: Entrectinib in Adult, Teenage/Young Adults and Paediatric Patients With ROS1 Gene Fusion-positive Cancers. | NCT05770544 | DETERMINE | Recruiting |
| HBI-8000 + Nivolumab | Study Comparing Investigational Drug HBI-8000 + Nivolumab vs. Placebo + Nivolumab in Patients With Advanced Melanoma | NCT04674683 | Ongoing | |
| High-Dose Interferon Alfa | High-Dose Interferon Alfa in Treating Patients With Stage II or Stage III Melanoma | NCT00003641 | Ongoing | |
| High-Dose Recombinant Interferon Alfa-2B or Ipilimumab | Physician/Patient Choice of Either High-Dose Recombinant Interferon Alfa-2B or Ipilimumab, Versus Pembrolizumab in Treating Patients With Stage III-IV High Risk Melanoma That Has Been Removed by Surgery | NCT02506153 | Ongoing | |
| IMC-F106C | IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma | NCT06112314 | PRISM-MEL-301 | Recruiting |
| Immune Checkpoint Inhibitors + Chemotherapy | Trans-Artery/Intra-Tumor Infusion of Checkpoint Inhibitors Plus Chemodrug for Immunotherapy of Advanced Solid Tumors | NCT03755739 | Recruiting | |
| Immunotherapy + Stereotactic Radiosurgery | Immunotherapy or Targeted Therapy with or Without Stereotactic Radiosurgery for Patients with Brain Metastases from Melanoma or Non-small Cell Lung Cancer | NCT05522660 | USZ-STRIKE | Recruiting |
| IO102-IO103 + Pembrolizumab | IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma | NCT05155254 | IOB-013 / KN-D18 | Ongoing |
| Ipilimumab or High-Dose Interferon Alfa-2b | Ipilimumab or High-Dose Interferon Alfa-2b in Treating Patients With High-Risk Stage III-IV Melanoma That Has Been Removed by Surgery | NCT01274338 | Ongoing | |
| JPB898 (Nivolumab Biosimilar) | Integrated Pharmacokinetics (PK)/Efficacy, Safety, and Immunogenicity Study to Demonstrate Similarity of JPB898, a Proposed Biosimilar to Nivolumab, to Nivolumab in Combination With Ipilimumab | NCT06587451 | Recruiting | |
| Lifileucel + Pembrolizumab | Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma. | NCT05727904 | Recruiting | |
| Naporafenib (ERAS-254) + Trametinib | A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With NRAS-mutant Melanoma | NCT06346067 | SEACRAFT-2 | Recruiting |
| Nivolumab | Adjuvant Nivolumab Treatment in Stage II (IIA, IIB, IIC) High-risk Melanoma | NCT04309409 | NivoMela | NADINA |
| Nivolumab | Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma | NCT04099251 | CheckMate76K | Ongoing |
| Nivolumab + Ipilimumab | Neoadjuvant Ipilimumab Plus Nivolumab Versus Standard Adjuvant Nivolumab in Macroscopic Stage III Melanoma | NCT04949113 | NADINA | Ongoing |
| Nivolumab + Relatlimab | A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma | NCT05625399 | RELATIVITY-127 | Ongoing |
| Nivolumab + Relatlimab | A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma | NCT05002569 | RELATIVITY-098 | Ongoing |
| Nivolumab + Relatlimab | A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma | NCT03470922 | RELATIVITY-047 | Ongoing |
| Nivolumab, Ipilimumab, and GM-CSF | A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma | NCT02339571 | Recruiting | |
| OH2 Injection | OH2 Injection in Melanoma | NCT05868707 | Recruiting | |
| PD-1/PD-L1 Inhibitor | Evaluating Length of Treatment With PD-1/PD-L1 Inhibitor in Advanced Solid Tumors | NCT04157985 | Recruiting | |
| Pembrolizumab | Safety and Efficacy of Pembrolizumab Compared to Placebo in Resected High-risk Stage II Melanoma | NCT03553836 | KEYNOTE-716 | Ongoing |
| Pembrolizumab | Study of Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-Risk Stage III Melanoma | NCT02362594 | Ongoing | |
| Pembrolizumab/Vibostolimab (MK-7684A) | A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma | NCT05665595 | KEYVIBE-010 | Ongoing |
| RPH-075 | Study Ñomparing the Efficacy and Safety of RPH-075 and Pembrolizumab in Patients With Unresectable or Metastatic Skin Melanoma | NCT06320353 | Ongoing | |
| SUPRAME-ACTengine IMA203 | SUPRAME-ACTengine IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma | NCT06743126 | SUPRAME | Recruiting |
| Tebentafusp | Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma | NCT05549297 | TEBE-AM | Recruiting |
| Tranexamic Acid | Perioperative Treatment with Tranexamic Acid in Melanoma | NCT05899465 | PRIME | Recruiting |
| Tunlametinib | Comparing Tunlametinib Capsules and Combination Chemotherapy in Advanced NRAS-mutant Melanoma | NCT06008106 | Recruiting | |
| V940 + Pembrolizumab | A Clinical Study of V940 Plus Pembrolizumab in People With High-Risk Melanoma V940-001 | NCT05933577 | V940-001 | Ongoing |
| Vemurafenib + Cobimetinib | DETERMINE Trial Treatment Arm 05: Vemurafenib in Combination With Cobimetinib in Adult Patients With BRAF Positive Cancers. | NCT05768178 | DETERMINE | Recruiting |
| Vusolimogene oderparepvec + Nivolumab | Vusolimogene oderparepvec and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs | NCT06264180 | IGNYTE-3 | Recruiting |
Glossary of FDA approved drugs for Advanced Melanoma
| Generic name | Trade name | Link to prescribing information |
|---|---|---|
| Atezolizumab | Tecentriq® | https://www.tecentriq.com/melanoma.html |
| Binimetinib | Mektovi® | https://www.braftovimektovi.com/ |
| Cobimetinib | Cotellic® | https://www.cotellic.com/ |
| Dabrafenib | Tafinlar® | https://www.us.tafinlarmekinist.com/ |
| Encorafenib | Braftovi® | https://www.braftovimektovi.com/ |
| Entrectinib* | RozlytrekTM | https://www.rozlytrek.com/ |
| Interleukin-2 | Proleukin® (Aldesleukin) | https://proleukin.com/ |
| Ipilimumab | Yervoy® | https://www.yervoy.com/ |
| Larotectinib* | Vitrakvi® | https://hcp.vitrakvi-us.com/ |
| Nivolumab | Opdivo® | https://www.opdivo.com/ |
| Nivolumab plus Relatlimab | OpdualagTM | https://www.opdualag.com/ |
| Pembrolizumab | Keytruda® | https://www.keytruda.com/melanoma/ |
| Talimogene laherparepvec | Imlygic® | https://www.imlygic.com/ |
| Trametinib | Mekinist® | https://www.us.tafinlarmekinist.com/ |
| Vemurafenib | Zelboraf® | https://www.gene.com/patients/medicines/zelboraf |
Ongoing clinical trials and new therapeutics for advanced cutaneous melanoma1
| Agent | Phase | Study |
|---|---|---|
| Atezolizumab + Bevacizumab | 2 | NCT04356729 |
| Atezolizumab + Cobimetinib + Vemurafenib | 3 | NCT02908672 |
| Botensilimab | 2 | NCT05529316 |
| Dabrafenib + Trametinib followed by Ipilimumab + Nivolumab -or- Ipilimumab + Nivolumab followed by Dabrafenib + Trametinib | 3 | NCT02224781 |
| Dabrafenib and/or Trametinib Rollover study | 4 | NCT03340506 |
| Encorafenib + Binimetinib | 3 | NCT05270044 |
| Encorafenib + Binimetinib + Pembrolizumab | 3 | NCT04657991 |
| Fianlimab + Cemiplimab | 3 3 | NCT05352672 NCT05608291 |
| Imiquimod + Pembrolizumab | 1 | NCT03276832 |
| Ipilimumab | 4 | NCT02068196 |
| Ipilimumab + Imatinib mesylate | 1 | NCT01738139 |
| Nivolumab + Ipilimumab | 3 3 3 3 3 | NCT04949113 NCT03068455 NCT02388906 NCT01844505 NCT02599402 |
| Nivolumab + Ipilimumab + GM-CSF | 2/3 | NCT02339571 |
| Nivolumab/CMP-001 + Nivolumab | 2/3 | NCT04695977 |
| Nivolumab/HBI-8000 + Nivolumab | 3 | NCT04674683 |
| Nivolumab + Relatlimab | 3 3 2/3 | NCT05002569 NCT05625399 NCT03470922 |
| Panobinostat + Ipilimumab | 1 | NCT02032810 |
| PDR001 + Dabrafenib + Trametinib | 3 | NCT02967692 |
| Pembrolizumab + Infliximab | 2 | NCT05034536 |
| Pembrolizumab + Lenvatinib | 3 | NCT03820986 |
| Pembrolizumab/IO102-IO103 + Pembrolizumab | 3 | NCT05155254 |
| PeptiCRAd-1 + Pembrolizumab | 1 | NCT05492682 |
| Talimogene laherparepvec (T-VEC) + Nivolumab | 2 | NCT04330430 |
| Talimogene laherparepvec (T-VEC) + Pembrolizumab | 2 | NCT02965716 |
| Tebentafusp/Tebentafusp + Pembrolizumab | 2/3 | NCT05549297 |
| Tislelizumab + Dacarbazine | 2 | NCT05466474 |
References
- US National Library of Medicine. Clinical Trials. https://clinicaltrials.gov/ct2/home Accessed 05/01/2025.
