Clinical Trials for Melanoma

PNV21-001: A Phase I Study of a Personalized Multi-Peptide Neo-Antigen Vaccine in Breast Cancer, PD1/PD-L1 Inhibitor-Refractory Melanoma, and Pretreated Non-Small Cell Lung Cancer

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.

HealthScout AI summary: This trial evaluates a personalized multi-peptide neo-antigen vaccine combined with poly ICLC and the PD-1 inhibitor nivolumab in adult patients with advanced, treatment-resistant stage IIIC-IV melanoma, hormone receptor positive HER2-negative metastatic breast cancer, and stage III-IV non-small cell lung cancer, focusing on safety and immune response.

ClinicalTrials.gov ID: NCT05098210

A Phase I/Ib, First-In-Human, Multi-Part, Open-Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of DF6215 Monotherapy and in Combination Therapy in Patients with Advanced (Unresectable, Recurrent, or Metastatic) Solid Tumors

No known activity

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

HealthScout AI summary: This trial enrolls adults with unresectable, recurrent, or metastatic solid tumors (including dedicated cohorts for melanoma post anti-PD-1 therapy and platinum-resistant ovarian cancer) to receive DF6215—a novel, half-life extended monovalent IL-2 agonist designed to selectively activate CD8+ T cells and NK cells—either alone or in combination with pembrolizumab. Participants must have ECOG 0-1, adequate organ function, and meet strict cardiac and infection criteria.

ClinicalTrials.gov ID: NCT06108479

A Phase 1/1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors

No known activity

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

HealthScout AI summary: This trial enrolls adults with unresectable, locally advanced or metastatic solid tumors—including a wide range such as head and neck, lung, bladder, prostate, breast, colorectal, and others—who have progressed on or are intolerant to standard therapies. Patients receive MGC026, a B7-H3-targeted antibody-drug conjugate delivering a topoisomerase I inhibitor (exatecan), with cohorts in both dose escalation and expansion phases.

ClinicalTrials.gov ID: NCT06242470

A Phase 1/2, Open-label, Multi-center, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of STX-001 Delivered by Intratumoral Injection in Patients With Advanced Solid Tumors as a Monotherapy or in Combination With Pembrolizumab

No known activity

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

HealthScout AI summary: Eligible adult patients with advanced or metastatic solid tumors (including dedicated cohorts for TNBC and melanoma) whose disease is refractory or progressed after standard therapy may receive intratumoral STX-001, a self-replicating mRNA encoding IL-12, as monotherapy or combined with pembrolizumab. Enrollment requires an accessible lesion for injection/biopsy and ECOG 0-1.

ClinicalTrials.gov ID: NCT06249048

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule, in Subjects with Unresectable, Locally Advanced, or Metastatic Solid Tumors That Are Antigen-rich (START-001)

No known activity

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

HealthScout AI summary: This study enrolls adults with unresectable, locally advanced, or metastatic antigen-rich solid tumors—including TMB-H, MSI-H/dMMR, virally associated, metastatic colorectal, triple negative breast, platinum-resistant ovarian, metastatic castration-resistant prostate, and NSCLC—who lack standard treatment options. Patients receive STAR0602 (invikafusp alfa), a bifunctional bispecific antibody that selectively activates and expands Vβ6/Vβ10 T cell subsets to enhance antitumor immunity.

ClinicalTrials.gov ID: NCT05592626

A Phase 1a/1b, Open-Label, Multi-Center, Dose Escalation and Expansion Study of HFB200603 (Anti-BTLA Antibody) as a Single Agent and in Combination With Tislelizumab (Anti-PD-1 Antibody) in Adult Patients With Advanced Solid Tumors

No known activity

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

HealthScout AI summary: This trial enrolls adults with advanced/metastatic renal cell carcinoma, non-small cell lung cancer, melanoma, gastric cancer, or colorectal cancer who have received multiple prior lines of therapy, and treats them with HFB200603, a BTLA (B and T lymphocyte attenuator) antagonist monoclonal antibody, as monotherapy or in combination with the anti-PD-1 antibody tislelizumab. Patients must have measurable disease, ECOG 0-1, and a tumor site amenable to biopsy.

ClinicalTrials.gov ID: NCT05789069

A Phase 1 Basket Study Evaluating the Safety and Feasibility of T-Plex, Autologous Customized T Cell Receptor-Engineered T Cells Targeting Multiple Peptide/HLA Antigens in Participants With Antigen-positive Locally Advanced (Unresectable) or Metastatic Solid Tumors

No known activity

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

HealthScout AI summary: This trial enrolls adults with unresectable or metastatic solid tumors expressing MAGE-A1, MAGE-A4, MAGE-C2, PRAME, or HPV16 antigens and specified HLA types, who have exhausted standard treatments. Participants receive autologous TCR-engineered T cells (TCR-T) targeting these antigens, as monotherapy or in combination, following lymphodepleting chemotherapy.

ClinicalTrials.gov ID: NCT05973487

A Phase 1, Open-Label, Multiple-Ascending Dose Study of the Safety and Tolerability of CTX-8371 in Patients With Advanced Malignancies

No known activity

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

HealthScout AI summary: Adults with advanced unresectable or metastatic melanoma (non-uveal/mucosal), head and neck squamous cell carcinoma, non-small cell lung cancer, triple negative breast cancer, or classical Hodgkin lymphoma who have progressed on prior PD-1/PD-L1 therapy are eligible to receive CTX-8371, an investigational bispecific antibody targeting PD-1 and PD-L1 designed to overcome checkpoint inhibitor resistance, as monotherapy.

ClinicalTrials.gov ID: NCT06150664

A Phase 1/1b Study of VET3-TGI Administered Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors

No known activity

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

HealthScout AI summary: Eligible patients have advanced, unresectable, or metastatic solid tumors of multiple types that are refractory to standard therapy and have a tumor accessible for intratumoral injection or biopsy. This trial evaluates the investigational oncolytic immunotherapy VET3-TGI (a vaccinia-derived agent engineered to kill tumor cells and modulate the tumor microenvironment via CXCR3, IL-12, and TGF-β inhibition) given by intratumoral or intravenous administration, alone or with pembrolizumab.

ClinicalTrials.gov ID: NCT06444815

Phase I/Ib Study of Concurrent Intravenous and Intrathecal Nivolumab for Melanoma and Lung Cancer Patients With Leptomeningeal Disease (LMD)

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.

HealthScout AI summary: This trial enrolls adults with leptomeningeal disease from melanoma (all subtypes, including primary CNS) or non-small cell lung cancer, allowing prior therapies, who receive escalating intrathecal nivolumab (anti-PD-1 immune checkpoint inhibitor) combined with standard intravenous nivolumab. The study tests concurrent intrathecal and intravenous administration to increase CNS drug levels for this population.

ClinicalTrials.gov ID: NCT03025256