Clinical Trials for Melanoma

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

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.

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/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 1/2 Open Label, Safety and Preliminary Efficacy Study of a Live Biotherapeutic Product (CJRB-101) in Combination With Pembrolizumab in Subjects With Selected Types of Advanced or Metastatic Cancer

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

TrialFetch AI summary: Adults with unresectable locally advanced or metastatic NSCLC (EGFR/ALK–, PD-L1 TPS ≥50%), HNSCC (PD-L1 CPS ≥20), or melanoma (any PD-L1/BRAF) who are either ICI-naive or have progressed on prior PD‑1/PD‑L1 therapy receive pembrolizumab plus CJRB‑101, an oral live biotherapeutic (Leuconostoc mesenteroides) designed to modulate the tumor-immune microenvironment (macrophage repolarization, APC activation, ↑CD8+ infiltration) to enhance PD‑1 blockade. Key exclusions include EGFR/ALK+ NSCLC, nasopharyngeal carcinoma, uncontrolled brain mets, significant autoimmune disease/IBD, key infections, and inability to take oral capsules.

ClinicalTrials.gov ID: NCT05877430

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.

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: 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 II Study of Binimetinib in Combination With Imatinib in Patients With Advanced KIT-Mutant 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.

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 stage III/IV KIT-mutant melanoma (including controlled brain mets), after progression on or ineligible for standard therapy, receive binimetinib (MEK1/2 inhibitor) plus imatinib (KIT/ABL/PDGFR TKI) given continuously in 28‑day cycles. Prior immune checkpoint inhibitors are allowed with washout; key exclusions include significant cardiac/ocular risks and malabsorption.

ClinicalTrials.gov ID: NCT04598009