Clinical Trials for Melanoma

Phase Ib Study of AlpeliSib With PEmbroLizumab in Patients With mEtastatic Breast caNcer or melanomA (SELENA)

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 advanced or metastatic melanoma (including those with untreated brain metastases) or triple-negative breast cancer with brain metastases who have progressed after standard therapy, testing the combination of alpelisib (a PI3Kα inhibitor) and pembrolizumab (a PD-1 inhibitor).

ClinicalTrials.gov ID: NCT06545682

Phase 2 Study of Avapritinib in Patients With CKIT or PDGFRA Mutation-Positive Malignant Solid Tumors

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: This trial enrolls adults with locally advanced or metastatic non-GIST solid tumors (such as melanoma, sarcoma, or primary CNS tumors) harboring activating mutations in CKIT or PDGFRA, who have no effective standard therapy options. Patients receive avapritinib, an oral tyrosine kinase inhibitor selective for CKIT and PDGFRA mutations.

ClinicalTrials.gov ID: NCT04771520

RAdiation comBined With BIspecific T-Cell Engager in DLL3 Expressing Tumors (RABBIT) Study: A Phase I/II Study of AMG757 / Tarlatamab and Concurrent Radiation Therapy in Tumors With High Prevalence of DLL3

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 relapsed/refractory DLL3-expressing or DLL3-prevalent tumors (including SCLC, LCNEC, high-grade neuroendocrine tumors, and select NSCLC/other histologies) receive the DLL3-directed bispecific T‑cell engager tarlatamab plus external-beam radiation, given concurrently or sequentially depending on safety. Key risks include CRS/ICANS; includes extracranial and cranial RT cohorts with allowance for treated/stable brain mets and selected brain lesions.

ClinicalTrials.gov ID: NCT06814496

Phase II Study of Nivolumab in Combination With Relatlimab in Patients With Active Melanoma Brain Metastases

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 melanoma and at least one measurable, untreated brain metastasis (0.5–3 cm), ECOG 0–1, and no steroid-requiring neurologic symptoms receive fixed-dose nivolumab (PD-1 inhibitor) plus relatlimab (LAG-3 inhibitor) IV every 28 days. Prior limited SRT/excision allowed if non-irradiated measurable disease remains; excludes leptomeningeal disease, lesions >3 cm, prior metastatic PD-1 therapy, and significant autoimmune/infectious comorbidities.

ClinicalTrials.gov ID: NCT05704647

A Phase I/II Study of Ex-Vivo Expanded Allogeneic Universal Donor (UD) TGFbi NK Cell Infusions in Combination With Temozolomide as a Lymphodepleting Agent in Patients With Melanoma Metastatic to the Brain

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 progressive melanoma brain metastases (measurable ≥10 mm, ECOG 0–2) receive temozolomide lymphodepletion followed by IV infusions of ex vivo–expanded allogeneic TGF-β–inhibited NK cells, which are designed to resist TGF-β–mediated immunosuppression and enhance NK cytotoxicity in the CNS. Key exclusions include leptomeningeal disease and need for immediate stereotactic radiotherapy; corticosteroids allowed if stable/minimal.

ClinicalTrials.gov ID: NCT05588453

A Randomized Phase 2 Trial of Encorafenib + Binimetinib + Nivolumab vs Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases

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 BRAF V600–mutant melanoma and active, measurable brain metastases (including leptomeningeal disease), no prior systemic therapy for metastatic disease, are randomized to encorafenib (BRAF inhibitor) + binimetinib (MEK1/2 inhibitor) plus nivolumab (PD-1 antibody) versus standard ipilimumab (CTLA-4 antibody) + nivolumab. Allows limited steroids, extracranial disease, and prior adjuvant/neoadjuvant therapy; excludes uveal melanoma and significant autoimmune or recent radiation contraindications.

ClinicalTrials.gov ID: NCT04511013

High Dose-Rate Brachytherapy for the Treatment of Both Primary and Secondary Unresectable Liver Malignancies

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 unresectable primary or metastatic liver tumors (up to 5 lesions), including those ≥3 cm or adjacent to major vessels/critical structures, adequate hepatic function (not Child-Pugh C), and no active infection receive percutaneous, image-guided high dose-rate brachytherapy using iridium-192. The therapy delivers conformal ablative radiation via temporary intratumoral catheters and is compared to a matched historical cohort for local control and survival outcomes.

ClinicalTrials.gov ID: NCT05053555

Phase 2, Single Arm Study of Tebentafusp and Radioembolization in the Treatment of Metastatic Uveal Melanoma

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 HLA-A*02:01–positive metastatic uveal melanoma predominantly confined to the liver receive Y-90 transarterial radioembolization followed by weekly tebentafusp. Tebentafusp is a bispecific gp100–HLA-A*02:01–targeted TCR/anti-CD3 ImmTAC that redirects T cells to melanoma cells; key exclusions include large (>8 cm) dominant liver lesions, significant hepatic dysfunction, vascular shunting precluding TARE, and active CNS metastases requiring steroids.

ClinicalTrials.gov ID: NCT06627244

A Phase II Clinical Trial of Anti-PD-1 mAb Therapy Alone or With Metabolic Modulators to Reverse Tumor Hypoxia and Immune Dysfunction in Solid Tumor Malignancies

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 advanced solid tumors eligible for standard anti–PD-1 monotherapy (e.g., melanoma, RCC, NSCLC, HCC Child-Pugh A, MSI-H tumors, urothelial, GEJ/gastric adenocarcinoma, HNSCC) are randomized to nivolumab or pembrolizumab alone versus combined with metformin (mitochondrial complex I inhibitor/AMPK activator) or rosiglitazone (PPAR-γ agonist) to reduce tumor hypoxia and improve immune function. Requires measurable disease, ECOG 0–2, and mandatory pre/post-treatment biopsies; excludes prior PD-1/PD-L1 therapy and significant cardiopulmonary/autoimmune contraindications.

ClinicalTrials.gov ID: NCT04114136

A Phase 2 Study of Nivolumab and Ipilimumab in Combination With Sirolimus and Prednisone in Kidney Transplant Recipients With Selected Unresectable or Metastatic Cutaneous Cancers

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 functioning kidney transplants and unresectable or metastatic cutaneous melanoma (non-uveal), cSCC, BCC, or Merkel cell carcinoma receive nivolumab (PD‑1 inhibitor) plus ipilimumab (CTLA‑4 inhibitor) with concurrent sirolimus (mTOR inhibitor) and prednisone, followed by nivolumab maintenance. Designed to balance antitumor activity with graft preservation; prior PD-(L)1 exposure allowed, with re-induction permitted at progression.

ClinicalTrials.gov ID: NCT05896839