Clinical Trials for Melanoma

A Phase 1/2 Study of Tegavivint (NSC#826393) in Children, Adolescents, and Young Adults With Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors

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.

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.

HealthScout AI summary: This trial enrolls children, adolescents, and young adults with recurrent or refractory solid tumors (including lymphomas and desmoid tumors), treating them with intravenous tegavivint, a small molecule inhibitor targeting TBL1 to disrupt Wnt/beta-catenin signaling. Expansion cohorts focus on specific tumor types and Wnt pathway–driven malignancies.

ClinicalTrials.gov ID: NCT04851119

A Multicenter Phase 1-2A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of LNS8801 in Patients with Advanced Cancer with and Without Pembrolizumab

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.

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.

HealthScout AI summary: Adults with advanced/metastatic solid tumors lacking standard options—including cohorts for pancreatic, gastric, NSCLC, colorectal, metastatic uveal melanoma (≤2 prior lines), PD‑1/L1–refractory cutaneous melanoma, and PD‑1/L1–relapsed solid tumors—receive oral LNS8801, a selective GPER agonist, as monotherapy or combined with pembrolizumab. Key exclusions include ERα‑positive malignancies, active CNS disease for combo, prior severe PD‑1/L1 irAEs (for combo), recent estrogen/ER‑directed therapy, and strong CYP modulators or PPIs.

ClinicalTrials.gov ID: NCT04130516

A Phase 1/2 Study of IDE196 in Patients with Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions

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.

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.

HealthScout AI summary: Adults with metastatic uveal melanoma or other solid tumors harboring GNAQ/GNA11 mutations or PRKC fusions (ECOG 0–1) receive the oral pan–PKC inhibitor darovasertib (IDE196) as monotherapy or combined with binimetinib (MEK inhibitor) or crizotinib (MET/ALK/ROS1 inhibitor). Key exclusions include prior PKC inhibitor use and, for crizotinib cohorts, prior ALK/MET/ROS1 inhibitors and ILD/pneumonitis; HLA-A*02:01–positive uveal melanoma patients should have considered tebentafusp first line.

ClinicalTrials.gov ID: NCT03947385

Evaluating Length of Treatment With PD-1/PD-L1 Inhibitor in Advanced Solid Tumors

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to 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.

HealthScout AI summary: Adults with advanced solid tumors (e.g., NSCLC, melanoma, RCC, urothelial, HNSCC, MSI-H/dMMR cancers, TNBC, HCC, gastric/GEJ, cervical, anal, Merkel cell) who have at least stable disease after ~12 months of PD-1/PD-L1 therapy (pembrolizumab, nivolumab, atezolizumab, durvalumab, or avelumab) are randomized to discontinue therapy versus continue until progression. Compares de-escalation after 1 year to ongoing checkpoint blockade to evaluate disease control, time to next treatment, and safety.

ClinicalTrials.gov ID: NCT04157985

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.

HealthScout 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

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

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.

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.

HealthScout 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 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

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.

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.

HealthScout 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

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.

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.

HealthScout 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

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.

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.

HealthScout 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.

HealthScout 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