Clinical Trials for Melanoma

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 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 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.

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 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

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

Phase I Study of Memory-Like Natural Killer Cells With Nivolumab and Relatlimab in Advanced or Metastatic Melanoma After Progression on Checkpoint Inhibitors

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 III/IV melanoma that has progressed on prior PD-1/PD-L1 therapy receive lymphodepletion followed by a single infusion of cytokine-induced memory-like NK cells (autologous or haploidentical donor), then nivolumab (PD-1 inhibitor) plus relatlimab (LAG-3 antibody). Allows treated/stable brain metastases; excludes active autoimmune disease requiring immunosuppression, prior severe irAEs leading to permanent ICI discontinuation, TIL therapy, organ allograft, and active viral infections.

ClinicalTrials.gov ID: NCT05629546

A Randomized Phase 2 Trial of Ipilumumab and Nivolumab With or Without Hypofractionated Radiotherapy in Patients With Metastatic 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 metastatic melanoma (ECOG 0–1) with at least two measurable lesions and one lesion amenable to hypofractionated radiotherapy are randomized to receive standard ipilimumab (anti–CTLA-4) plus nivolumab (anti–PD-1) with or without HFRT (8 Gy × 3 to a single lesion). Excludes active CNS disease requiring urgent therapy, prior checkpoint inhibitors in the metastatic setting, significant autoimmune disease/immunosuppression, active infections, or HFRT contraindications.

ClinicalTrials.gov ID: NCT03646617

Phase II Study of Binimetinib With Encorafenib in Patients With Metastatic Melanoma and CNS 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 BRAFV600-mutant metastatic melanoma with active CNS involvement (parenchymal and/or leptomeningeal) receive high-dose encorafenib (BRAF inhibitor) plus binimetinib (MEK1/2 inhibitor); includes two cohorts: prior BRAF/MEK–treated with progressive CNS disease and BRAF/MEK–naive, with prior immunotherapy allowed. Aims to evaluate intracranial disease control and PFS with continuous oral therapy; key exclusions include significant cardiovascular disease, recent thromboembolism, and strong CYP3A modulators.

ClinicalTrials.gov ID: NCT05026983

Phase 2 Study of Axitinib + PD-1 Blockade in Mucosal Melanoma With Pilot Addition of Stereotactic Body Radiotherapy or Ipilimumab in Select Progressors

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 or metastatic mucosal melanoma (head/neck including conjunctival, GI, or GU), treatment-naive, ECOG 0–2, including selected patients with brain metastases, receive nivolumab (PD-1 inhibitor) plus axitinib (VEGFR1–3 TKI); at progression, patients may continue doublet with SBRT for oligoprogression or add ipilimumab (CTLA-4 inhibitor) for multifocal/non-SBRT-amenable progression. Primary endpoint is objective response by RECIST 1.1 within 1 year.

ClinicalTrials.gov ID: NCT05384496

A Phase II Trial of Olaparib in Combination With Pembrolizumab for Advanced Uveal 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 metastatic uveal melanoma (ECOG 0–1) receive pembrolizumab (anti–PD‑1) plus olaparib (PARP1/2 inhibitor) until progression or toxicity; prior liver-directed therapy allowed, but prior PD‑1/PD‑L1 or PARP inhibitors for uveal melanoma are excluded. Aims to test whether PARP inhibition can potentiate PD‑1 blockade in this population; key exclusions include uncontrolled CNS metastases and active autoimmune disease requiring systemic therapy.

ClinicalTrials.gov ID: NCT05524935