Clinical Trials for Melanoma

B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR)

Active drug

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

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.

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: Pediatric and young adult patients (≤21 years) with measurable, relapsed/refractory B7‑H3 (CD276)–positive solid tumors, including CNS involvement, receive lymphodepleting fludarabine/cyclophosphamide followed by a single IV infusion of autologous B7‑H3–targeted CAR T cells. The investigational therapy uses second‑generation CAR T cells engineered to recognize B7‑H3 to mediate antigen-directed cytotoxicity, with dose escalation to define safety and preliminary activity.

ClinicalTrials.gov ID: NCT04897321

A Pilot Trial of Autologous Tumor Infiltrating Lymphocytes (LN-144 or LN-145) for Patients With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, or Dedifferentiated Liposarcoma

Active drug

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

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.

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 metastatic uveal melanoma (any prior therapy) or unresectable/metastatic UPS or DDLPS refractory to ≥1 systemic regimen receive autologous tumor-infiltrating lymphocyte therapy lifileucel (LN-144/LN-145) after nonmyeloablative lymphodepleting chemotherapy and followed by IL-2. Lifileucel consists of ex vivo–expanded, tumor-specific T cells (adoptive cell therapy) and is being studied here for safety/feasibility in these populations.

ClinicalTrials.gov ID: NCT05607095

A Phase 1/2a, Open-Label, Dose Escalation and Expansion Study of the Safety and Tolerability of T3011 Administered Via Intratumoral Injection as a Single Agent and in Combination With Intravenous Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors

Active drug

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

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.

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 advanced/metastatic solid tumors requiring at least one injectable lesion (ECOG 0–1) receive intratumoral T3011—an engineered oncolytic HSV‑1 expressing IL‑12 and an anti‑PD‑1 antibody—either as monotherapy in melanoma, HNSCC post‑platinum/PD‑(L)1, sarcoma, or cSCC, or combined with IV pembrolizumab in previously treated metastatic NSCLC without EGFR/ALK alterations. Excludes patients with uninjectable disease, high‑risk injection sites, active autoimmune disease requiring immunosuppression, active HSV, significant cardiopulmonary disease, CNS metastases, or active viral infections.

ClinicalTrials.gov ID: NCT04370587

Ulixertinib (BVD-523) in Combination With Palbociclib in Patients With Advanced Solid Tumors With Expansion Cohort in Previously Treated Metastatic Pancreatic Cancer and Metastatic RAS-mutant and NF1-mutant (no BRAFV600 Mutations) Melanoma

Active drug

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

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.

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 advanced solid tumors in dose escalation and expansion cohorts of previously treated metastatic pancreatic cancer or unresectable stage III/IV melanoma harboring RAS mutations or NF1 loss (excluding BRAFV600), treated with oral ulixertinib (ERK1/2 inhibitor targeting MAPK) plus palbociclib (CDK4/6 inhibitor). Melanoma cohort generally requires prior PD‑1/PD‑L1 therapy; measurable disease is required and controlled brain metastases are allowed only in the RAS/NF1‑mutant melanoma cohort under specified conditions.

ClinicalTrials.gov ID: NCT03454035

Phase 1 Study Evaluating Genetically Modified Autologous T Cells Expressing a TCR Recognizing a Cancer/Germline Antigen as Monotherapy or in Combination With Nivolumab in Patients With Recurrent and/or Refractory Solid Tumors

Active drug

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

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.

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 PRAME-expressing, recurrent/refractory solid tumors (HLA‑A*02:01+, ECOG 0–1) receive autologous PRAME‑specific TCR‑T therapy (IMA203 or IMA203CD8) after cyclophosphamide/fludarabine lymphodepletion, with low‑dose IL‑2 support and an arm combining IMA203 with nivolumab. IMA203 targets a PRAME peptide via engineered TCR, while IMA203CD8 co‑expresses CD8αβ to enable CD4/CD8 T‑cell tumor killing; nivolumab (PD‑1 inhibitor) is tested for potential synergy.

ClinicalTrials.gov ID: NCT03686124

Biomarker Stratified CaboZantinib (NSC#761968) and NivOlumab (NSC#748726) (BiCaZO) - A Phase II Study of Combining Cabozantinib and Nivolumab in Participants With Advanced Solid Tumors (IO Refractory Melanoma or HNSCC) Stratified by Tumor Biomarkers - an immunoMATCH Pilot Study

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 non-uveal melanoma or recurrent/metastatic HNSCC that progressed on or within 12 weeks of prior anti–PD-1 therapy receive nivolumab plus daily cabozantinib, with enrollment stratified by tumor mutational burden and Tumor Inflammation Score. Cabozantinib is a multikinase inhibitor (MET/VEGFR2/AXL) intended to disrupt angiogenesis and the immunosuppressive microenvironment to synergize with PD-1 blockade.

ClinicalTrials.gov ID: NCT05136196

Phase 1/2a Open-Label, Dose-Escalation, Multicenter, FIH, Consecutive-Cohort, Clinical Trial of BI-1808, a Monoclonal Antibody to TNFR 2 As a Single Agent and in Combination with Pembrolizumab (MK-3475-D20) in Subjects with Advanced Malignancies

Active drug

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

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.

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 advanced solid tumors or T‑cell lymphomas (including CTCL) after failure/intolerance of standard therapy, ECOG 0–1, measurable disease, and biopsy‑amenable tumors receive BI‑1808, a human IgG1 anti‑TNFR2 antibody that blocks TNF‑α/TNFR2 signaling and may deplete TNFR2+ Tregs, given IV every 3 weeks as monotherapy or combined with pembrolizumab. Excludes active CNS metastases, significant autoimmune disease, recent anticancer therapy, or active infections; expansion cohorts include ovarian cancer, melanoma, and T‑cell lymphomas.

ClinicalTrials.gov ID: NCT04752826

Phase II Open-label, Multi-center Study of Tebentafusp in HLA-A*0201 Positive Previously Untreated Metastatic Uveal Melanoma (mUM) With Integrated Circulating Tumor DNA (ctDNA) Biomarker (TARGET-tebe)

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: HLA-A*02:01–positive adults with previously untreated metastatic uveal melanoma receive weekly tebentafusp (step-up to 68 mcg), a bispecific gp100–HLA-directed ImmTAC that redirects T cells via anti-CD3 to melanoma cells. The trial integrates serial Signatera ctDNA monitoring to correlate early molecular response with clinical outcomes.

ClinicalTrials.gov ID: NCT06070012

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)

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: HLA-A*02:01–positive adults with unresectable stage III/IV non-ocular melanoma who have progressed after anti–PD-(L)1 (and received anti–CTLA-4; BRAF V600+ must have had BRAF/MEK) are randomized to tebentafusp alone, tebentafusp plus pembrolizumab, or investigator’s choice. Tebentafusp is an ImmTAC TCR–bispecific targeting gp100/HLA-A*02:01 and engaging CD3 to redirect T cells; the study excludes uveal melanoma and patients with active CNS metastases or significant autoimmune disease.

ClinicalTrials.gov ID: NCT05549297

A Phase I Study to Evaluate the Safety of Naltrexone and Propranolol in Combination With Standard of Care Ipilimumab and Nivolumab in Patients With Advanced Melanoma

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 stage III/IV melanoma eligible for ipilimumab 3 mg/kg plus nivolumab 1 mg/kg, ECOG 0–1, measurable disease, and no unstable brain mets or active autoimmune disease receive standard IPI+NIVO with propranolol (nonselective beta-adrenergic blocker) and escalating-dose naltrexone (opioid receptor antagonist) to test safety and define the recommended naltrexone dose. Prior systemic therapy is allowed with washout; patients requiring opioids are excluded from naltrexone cohorts.

ClinicalTrials.gov ID: NCT05968690