Clinical Trials for Melanoma

A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab Versus Relatlimab and Nivolumab in Participants With Unresectable or Metastatic Melanoma

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with untreated unresectable stage III or metastatic cutaneous melanoma (ECOG 0–1, measurable disease; excludes uveal/acral/mucosal melanoma, active brain mets, and significant autoimmune disease) are randomized to fixed-dose fianlimab (anti–LAG-3) plus cemiplimab (anti–PD-1) versus the approved relatlimab (anti–LAG-3) plus nivolumab (anti–PD-1) first-line. Primary endpoint is BICR-assessed ORR, with key secondary PFS/OS and safety.

ClinicalTrials.gov ID: NCT06246916

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

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with unresectable/metastatic cutaneous melanoma that has progressed on prior anti–PD-1 therapy, ECOG 0–1, and homozygous consensus GPER genotype (C/C) are randomized to LNS8801 (oral GPER agonist) plus pembrolizumab, LNS8801 alone, or physician’s choice therapy (dacarbazine/temozolomide or standard immunotherapy options). Aims to test whether GPER activation, which may promote melanocytic differentiation and enhance PD‑1 responsiveness, improves PFS versus standard options.

ClinicalTrials.gov ID: NCT06624644

A Phase 1B/2 Pan-Tumor, Open-Label Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: This trial enrolls adults with recurrent or metastatic solid tumors—including endometrial, head and neck, pancreatic, colorectal, hepatocellular, gastric, urothelial, ovarian, cervical, biliary tract, certain subtypes of breast cancer, and cutaneous melanoma—whose disease has progressed after standard therapy and who have measurable, biopsiable disease. All patients receive ifinatamab deruxtecan, an investigational B7-H3-directed antibody-drug conjugate delivering a topoisomerase I inhibitor, administered intravenously every three weeks.

ClinicalTrials.gov ID: NCT06330064

A Double-blind, Phase II Randomized Study of Brain-directed Stereotactic Radiation With or Without AGuIX Gadolinium-based Nanoparticles in the Management of Brain Metastases at Higher Risk of Local Recurrence With Radiation Alone

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with solid tumors and high-risk brain metastases (e.g., melanoma refractory to immunotherapy, GI primaries, HER2+ breast cancer, cystic or large lesions, or local recurrence after prior brain radiation) are randomized to stereotactic radiation with or without intravenous AGuIX gadolinium-based nanoparticles, which act as tumor-targeted radiosensitizers and MRI contrast agents.

ClinicalTrials.gov ID: NCT04899908

HERTHENA-PanTumor01 (U31402-277): A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects With Locally Advanced or Metastatic Solid Tumors

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with measurable, unresectable locally advanced or metastatic solid tumors that have progressed after standard therapies, enrolled in tumor-specific refractory cohorts (e.g., melanoma post–PD-(L)1, SCCHN post platinum/PD-(L)1, HER2-negative gastric/GEJ, HGS ovarian, cervical, endometrial, urothelial, ESCC, pancreatic, mCRPC, nonsquamous NSCLC without drivers, and HR+/HER2– breast cancer after CDK4/6 and chemo). Single-arm therapy is patritumab deruxtecan (HER3-DXd) 5.6 mg/kg IV q3w, an HER3-targeted antibody–drug conjugate delivering a topoisomerase I inhibitor (DXd).

ClinicalTrials.gov ID: NCT06172478

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)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with unresectable or metastatic cutaneous (including acral) melanoma who are HLA‑A*02:01 positive and have progressed after PD‑1 therapy (and BRAF‑directed therapy if mutated) are randomized to autologous PRAME‑targeted TCR‑T cells (IMA203) after lymphodepletion with short-course low‑dose IL‑2 support versus investigator’s choice of approved therapies (e.g., nivolumab/relatlimab, anti‑PD‑1, ipilimumab, lifileucel, or chemotherapy). Key exclusions include mucosal/uveal melanoma, active CNS disease, significant autoimmune/cardiac comorbidities, active infections, and LDH >2× ULN.

ClinicalTrials.gov ID: NCT06743126

Phase II Study of PD-1 Inhibitor Zimberelimab (AB122) With TIGIT Inhibitor Domvanalimab (AB154) in PD-1 Relapsed/Refractory Melanoma

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with cutaneous melanoma (non-mucosal/ocular/acral) that has progressed on prior anti–PD-1/L1 therapy receive zimberelimab (anti–PD-1) plus domvanalimab (Fc-silent anti-TIGIT) every 3 weeks, with continuation for disease control up to 24 months. Prior CTLA-4 and, if BRAF-mutant, BRAF/MEK therapy allowed; requires ECOG 0–1, excludes active autoimmune disease, prior TIGIT therapy, and uncontrolled/active CNS disease (treated, stable brain mets allowed).

ClinicalTrials.gov ID: NCT05130177

Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion Before Tumor-Infiltrating Lymphocyte Therapy With Lifileucel in Metastatic Melanoma

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with unresectable stage IIIc/IV melanoma after 1–3 prior therapies (must include anti–PD‑1; BRAF/MEK if BRAF V600+) receive one-time autologous TIL therapy (lifileucel, polyclonal tumor-reactive T cells) following a reduced-dose fludarabine/cyclophosphamide lymphodepletion and up to 6 doses of IL‑2. Excludes uveal melanoma and active/untreated CNS disease; requires a resectable lesion for TIL harvest and ECOG 0–1.

ClinicalTrials.gov ID: NCT06151847

A Multicenter, Phase II Trial of Relatlimab, Nivolumab, and Ipilimumab in Patients With Asymptomatic and Symptomatic Melanoma Brain Metastases

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with non-uveal melanoma and measurable untreated brain metastases (including asymptomatic ECOG 0–1 and symptomatic ECOG 0–2 with limited steroids) receive triple checkpoint blockade: nivolumab (PD-1 inhibitor) plus relatlimab (LAG-3 inhibitor) combined with ipilimumab (CTLA-4 inhibitor). Prior adjuvant/neoadjuvant PD-1/CTLA-4/LAG-3 allowed if >6 months; excludes leptomeningeal disease, prior whole-brain RT, active autoimmune disease requiring systemic therapy, and significant cardiac comorbidity.

ClinicalTrials.gov ID: NCT06712927

A Phase II, Multicenter, Open-Label Trial of DB-1311 in Combination With BNT327 or DB-1305 in Participants With Advanced/Metastatic Solid Tumors

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Enrolls adults with advanced/metastatic solid tumors—HCC (Child-Pugh A), cervical, melanoma, recurrent/metastatic HNSCC, platinum‑resistant high‑grade serous ovarian, and nonsquamous NSCLC without actionable drivers—ECOG 0–1 and measurable disease. Investigational therapy pairs the B7‑H3–targeted topoisomerase‑I ADC DB‑1311 with either BNT327 (PD‑L1/VEGF‑A bispecific) for HCC/cervical/melanoma/HNSCC or with the TROP2‑directed topoisomerase‑I ADC DB‑1305 for NSCLC.

ClinicalTrials.gov ID: NCT06953089