Reading and Resources

The lists below include information about melanoma evidence-based guidelines, ongoing clinical trials, and online resources.

Treatment Guidelines 

Websites

ResourceAddress
AIM at Melanoma Foundationhttps://www.aimatmelanoma.org/
American Academy of Dermatology Association.https://www.aad.org/
American Cancer Society (ACS). Melanoma Skin Cancerhttps://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 Communityhttps://www.cancersupportcommunity.org/
Caregiver Action Networkhttps://www.caregiveraction.org/
MedlinePlus. Melanomahttps://medlineplus.gov/melanoma.html
Melanoma Research Foundationhttps://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 Cancerhttps://www.sitcancer.org/home/
The University of Texas MD Anderson cancer Center. Survivorship-Cutaneous Melanomahttps://www.mdanderson.org/documents/for-physicians/algorithms/survivorship/survivorship-cutaneous-melanoma-web-algorithm.pdf
US National Library of Medicine. Clinical Trialshttps://clinicaltrials.gov

Selected Ongoing Phase 3 Studies of Systemic Therapy for Melanoma

Investigational Agent(s)Study TitleNCT NumberAcronymStudy Status*
ABP 206A Study to Evaluate ABP 206 Compared With Nivolumab (Nivolumab) in Subjects With Unresectable or Metastatic MelanomaNCT06054555Recruiting
ABP 206A Study to Evaluate Similarity of ABP 206 Compared With Nivolumab in Subjects With Resected MelanomaNCT05907122Ongoing
Anti-PD-1 TherapyDuration of Anti-PD-1 Therapy in Metastatic MelanomaNCT02821013STOP-GAPRecruiting
AtezolizumabDETERMINE 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) DispositionNCT05770102DETERMINERecruiting
BCD-201Clinical Study of the Efficacy and Safety of BCD-201 and Pembrolizumab in Subjects With Advanced MelanomaNCT05986331Ongoing
BCD-217 (Nurulimab + Prolgolimab)A Study of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) in Patients With Resectable Stage III Skin MelanomaNCT05751928NEO-MIMAJORRecruiting
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 MelanomaNCT05732805OCTAVAOngoing
BCD-263 + NivolumabClinical Study of the Efficacy and Safety of BCD-263 and Nivolumab As Monotherapy in Subjects with Advanced Melanoma of the SkinNCT06640530UNIVERSERecruiting
Cemiplimab + FianlimabA Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic MelanomaNCT06246916Recruiting
Cemiplimab + FianlimabA 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 MelanomaNCT06190951Recruiting
Cemiplimab + FianlimabA 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 SurgeryNCT05608291Recruiting
Cemiplimab + FianlimabClinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic MelanomaNCT05352672Recruiting
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 MelanomaNCT02224781Ongoing
EIK1001-006 + PembrolizumabSafety and Efficacy of EIK1001-006 in Combo With Pembro Versus Placebo and Pembro as First-Line Therapy in Patients With Advanced Melanoma.NCT06697301Recruiting
Encorafenib + BimitenibAdjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation.NCT05270044COLUMBUS-ADOngoing
Encorafenib, Binimetinib,
and Pembrolizumab
A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic MelanomaNCT04657991Ongoing
EntrectinibDETERMINE Trial Treatment Arm 03: Entrectinib in Adult, Teenage/Young Adults and Paediatric Patients With ROS1 Gene Fusion-positive Cancers.NCT05770544DETERMINERecruiting
HBI-8000 + NivolumabStudy Comparing Investigational Drug HBI-8000 + Nivolumab vs. Placebo + Nivolumab in Patients With Advanced MelanomaNCT04674683Ongoing
High-Dose Interferon AlfaHigh-Dose Interferon Alfa in Treating Patients With Stage II or Stage III MelanomaNCT00003641Ongoing
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 SurgeryNCT02506153Ongoing
IMC-F106CIMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced MelanomaNCT06112314PRISM-MEL-301Recruiting
Immune Checkpoint Inhibitors
+ Chemotherapy
Trans-Artery/Intra-Tumor Infusion of Checkpoint Inhibitors Plus Chemodrug for Immunotherapy of Advanced Solid TumorsNCT03755739Recruiting
Immunotherapy +
Stereotactic Radiosurgery
Immunotherapy or Targeted Therapy with or Without Stereotactic Radiosurgery for Patients with Brain Metastases from Melanoma or Non-small Cell Lung CancerNCT05522660USZ-STRIKERecruiting
IO102-IO103 + PembrolizumabIO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced MelanomaNCT05155254IOB-013 / KN-D18Ongoing
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 SurgeryNCT01274338Ongoing
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 IpilimumabNCT06587451Recruiting
Lifileucel + PembrolizumabStudy to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.NCT05727904Recruiting
Naporafenib (ERAS-254) + TrametinibA Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With NRAS-mutant MelanomaNCT06346067SEACRAFT-2Recruiting
NivolumabAdjuvant Nivolumab Treatment in Stage II (IIA, IIB, IIC) High-risk MelanomaNCT04309409NivoMelaNADINA
NivolumabEffectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C MelanomaNCT04099251CheckMate76KOngoing
Nivolumab + IpilimumabNeoadjuvant Ipilimumab Plus Nivolumab Versus Standard Adjuvant Nivolumab in Macroscopic Stage III MelanomaNCT04949113NADINAOngoing
Nivolumab + RelatlimabA Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable MelanomaNCT05625399RELATIVITY-127Ongoing
Nivolumab + RelatlimabA Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV MelanomaNCT05002569RELATIVITY-098Ongoing
Nivolumab + RelatlimabA Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced MelanomaNCT03470922RELATIVITY-047Ongoing
Nivolumab, Ipilimumab, and GM-CSFA Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced MelanomaNCT02339571Recruiting
OH2 InjectionOH2 Injection in MelanomaNCT05868707Recruiting
PD-1/PD-L1 InhibitorEvaluating Length of Treatment With PD-1/PD-L1 Inhibitor in Advanced Solid TumorsNCT04157985Recruiting
PembrolizumabSafety and Efficacy of Pembrolizumab Compared to Placebo in Resected High-risk Stage II MelanomaNCT03553836KEYNOTE-716Ongoing
PembrolizumabStudy of Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-Risk Stage III MelanomaNCT02362594Ongoing
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 MelanomaNCT05665595KEYVIBE-010Ongoing
RPH-075Study сomparing the Efficacy and Safety of RPH-075 and Pembrolizumab in Patients With Unresectable or Metastatic Skin MelanomaNCT06320353Ongoing
SUPRAME-ACTengine IMA203SUPRAME-ACTengine IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous MelanomaNCT06743126SUPRAMERecruiting
TebentafuspTebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced MelanomaNCT05549297TEBE-AMRecruiting
Tranexamic AcidPerioperative Treatment with Tranexamic Acid in MelanomaNCT05899465PRIMERecruiting
TunlametinibComparing Tunlametinib Capsules and Combination Chemotherapy in Advanced NRAS-mutant MelanomaNCT06008106Recruiting
V940 + PembrolizumabA Clinical Study of V940 Plus Pembrolizumab in People With High-Risk Melanoma V940-001NCT05933577V940-001Ongoing
Vemurafenib + CobimetinibDETERMINE Trial Treatment Arm 05: Vemurafenib in Combination With Cobimetinib in Adult Patients With BRAF Positive Cancers.NCT05768178DETERMINERecruiting
Vusolimogene oderparepvec
+ Nivolumab
Vusolimogene oderparepvec and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 DrugsNCT06264180IGNYTE-3Recruiting

Glossary of FDA approved drugs for Advanced Melanoma

Generic nameTrade nameLink to prescribing information
AtezolizumabTecentriq®https://www.tecentriq.com/melanoma.html
BinimetinibMektovi®https://www.braftovimektovi.com/
CobimetinibCotellic®https://www.cotellic.com/
DabrafenibTafinlar®https://www.us.tafinlarmekinist.com/
EncorafenibBraftovi®https://www.braftovimektovi.com/
Entrectinib*RozlytrekTMhttps://www.rozlytrek.com/
Interleukin-2Proleukin® (Aldesleukin)https://proleukin.com/
IpilimumabYervoy®https://www.yervoy.com/
Larotectinib*Vitrakvi®https://hcp.vitrakvi-us.com/
NivolumabOpdivo®https://www.opdivo.com/
Nivolumab plus RelatlimabOpdualagTMhttps://www.opdualag.com/
PembrolizumabKeytruda®https://www.keytruda.com/melanoma/
Talimogene laherparepvecImlygic®https://www.imlygic.com/
TrametinibMekinist®https://www.us.tafinlarmekinist.com/
VemurafenibZelboraf®https://www.gene.com/patients/medicines/zelboraf

Ongoing clinical trials and new therapeutics for advanced cutaneous melanoma1

AgentPhaseStudy
Atezolizumab + Bevacizumab2NCT04356729
Atezolizumab + Cobimetinib + Vemurafenib3NCT02908672
Botensilimab2NCT05529316
Dabrafenib + Trametinib followed by Ipilimumab + Nivolumab -or- Ipilimumab + Nivolumab followed by Dabrafenib + Trametinib3NCT02224781
Dabrafenib and/or Trametinib Rollover study4NCT03340506
Encorafenib + Binimetinib3NCT05270044
Encorafenib + Binimetinib + Pembrolizumab3NCT04657991
Fianlimab + Cemiplimab3

3
NCT05352672

NCT05608291
Imiquimod + Pembrolizumab1NCT03276832
Ipilimumab4NCT02068196
Ipilimumab + Imatinib mesylate1NCT01738139
Nivolumab + Ipilimumab3

3

3

3

3
NCT04949113

NCT03068455

NCT02388906

NCT01844505

NCT02599402
Nivolumab + Ipilimumab + GM-CSF2/3NCT02339571
Nivolumab/CMP-001 + Nivolumab2/3NCT04695977
Nivolumab/HBI-8000 + Nivolumab3NCT04674683
Nivolumab + Relatlimab3

3

2/3
NCT05002569

NCT05625399

NCT03470922
Panobinostat + Ipilimumab1NCT02032810
PDR001 + Dabrafenib + Trametinib3NCT02967692
Pembrolizumab + Infliximab2NCT05034536
Pembrolizumab + Lenvatinib3NCT03820986
Pembrolizumab/IO102-IO103 + Pembrolizumab3NCT05155254
PeptiCRAd-1 + Pembrolizumab1NCT05492682
Talimogene laherparepvec (T-VEC) + Nivolumab2NCT04330430
Talimogene laherparepvec (T-VEC) + Pembrolizumab2NCT02965716
Tebentafusp/Tebentafusp + Pembrolizumab2/3NCT05549297
Tislelizumab + Dacarbazine2NCT05466474

References

  1. US National Library of Medicine. Clinical Trials. https://clinicaltrials.gov/ct2/home Accessed 05/01/2025.
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