Clinical Trials for Melanoma

A Phase I/II Study of Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab in Advanced Solid Tumors (PNeoVCA)

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.

TrialFetch AI summary: This trial involves adults with unresectable or metastatic advanced solid tumors who have progressed on prior treatments or are candidates for pembrolizumab, combining pembrolizumab, which targets the PD-1 receptor to enhance immune response, with a personalized neoantigen peptide vaccine designed to stimulate an individualized immune attack against tumor-associated proteins.

ClinicalTrials.gov ID: NCT05269381

A Phase 1b/2a Multi-Center, Dose Escalation and Reference Regimen-Controlled, Multi-Cohort Study to Determine the Safety and Efficacy of Oral 7HP349 (Alintegimod) in Combination with Ipilimumab Followed by Nivolumab Monotherapy in Patients with Locally Advanced or Metastatic Cancers Following One or More Prior Therapies

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.

TrialFetch AI summary: This trial involves patients with advanced or metastatic solid tumors, such as melanoma and non-small cell lung cancer, who have had prior therapies, evaluating the safety and efficacy of Alintegimod, an integrin-targeting agent, combined with ipilimumab and nivolumab.

ClinicalTrials.gov ID: NCT06362369

A Phase 1, First-in-Human, Open-Label, Multi-Center, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LB-LR1109 for the Treatment of Advanced 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.

TrialFetch AI summary: The trial is for adult patients with advanced or metastatic non-small cell lung cancer, head and neck squamous cell carcinoma, renal cell carcinoma, urothelial carcinoma, or malignant melanoma who have no remaining standard treatment options, and it evaluates the safety, tolerability, and dosing of the investigational drug LB-LR1109, administered intravenously.

ClinicalTrials.gov ID: NCT06332755

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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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 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.

TrialFetch 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.

TrialFetch 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