Clinical Trials for Melanoma

A Phase II Trial for Metastatic Melanoma Using Adoptive Cell Therapy With Tumor-Infiltrating Lymphocytes Plus IL-2 Either Alone or Following the Administration of Pembrolizumab

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: Adults with metastatic cutaneous melanoma, including those refractory to prior PD-1/PD-L1 therapy and with at least one resectable lesion for TIL harvest, receive non-myeloablative lymphodepletion followed by autologous TIL infusion and high-dose IL-2, with most eligible patients also receiving pembrolizumab (anti–PD-1) given peri- and post-infusion. Patients with controlled small asymptomatic brain metastases may enroll; key exclusions include significant autoimmune disease, active infections, major cardiopulmonary compromise, and prior severe immune-related toxicities to PD-1/PD-L1 agents for the pembrolizumab arm.

ClinicalTrials.gov ID: NCT02621021

A First-in-human, Phase I, Multi-center, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Evidence of Antitumor Activity of IDOV-Immune in Adult 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: Adults with advanced solid tumors refractory to standard therapy (ECOG 0–1, measurable disease) receive a single intravenous infusion of IDOV-Immune (VM-002), a genetically engineered oncolytic vaccinia virus designed for tumor-selective replication and lysis with immune-stimulating transgenes to enhance antitumor immunity. Key exclusions include prior oncolytic virus therapy, recent vaccinia/smallpox vaccination, active autoimmune disease requiring systemic therapy, significant cardiopulmonary disease, uncontrolled infection, and unstable/untreated CNS metastases.

ClinicalTrials.gov ID: NCT06910657

An Open-Label, Multicenter, First-in-Human, Dose-Escalation, Multicohort, Phase 1/2 Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab in Subjects With Locally Advanced or Metastatic Solid Tumors

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.

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 evaluates the safety and maximum tolerated dose of INBRX-106, a hexavalent OX40 agonist antibody, both alone and in combination with pembrolizumab, in adult patients with locally advanced or metastatic solid tumors, including NSCLC, melanoma, and head and neck squamous cell carcinoma, who have progressed on standard therapies.

ClinicalTrials.gov ID: NCT04198766

A Phase 1-2 Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents in Subjects With Advanced Malignancies

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.

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 targets adult patients with advanced solid tumors, including NSCLC, melanoma, liposarcoma, leiomyosarcoma, and SCCHN, who have exhausted standard treatments. It evaluates OR2805, a monoclonal antibody targeting CD163 to modulate tumor-associated macrophages, administered alone or with cemiplimab or docetaxel.

ClinicalTrials.gov ID: NCT05094804

A First-In-Human Phase 1/2 Open-Label Study of Intravenous ST-067, Subcutaneous ST-067 with or Without Obinutuzumab Pre-Treatment, and ST-067 in Combination with Pembrolizumab in Subjects with Advanced Solid Malignancies

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.

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 involves adult patients with advanced or metastatic solid tumors such as melanoma and non-small cell lung cancer who have relapsed after standard treatments, testing the investigational agent ST-067 alone or with pembrolizumab and obinutuzumab to enhance immune response against tumor cells.

ClinicalTrials.gov ID: NCT04787042

A Phase 1/1b, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF6002 as a Monotherapy and in Combination With Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications

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.

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 melanoma, lung, head and neck, urothelial, gastric, esophageal, cervical, hepatocellular, and other select cancers) who have exhausted or are not candidates for standard therapy may receive DF6002, a novel IL-12 Fc fusion protein designed to enhance anti-tumor immunity, as monotherapy or in combination with nivolumab. Both subcutaneous and intravenous DF6002 dosing routes are under investigation.

ClinicalTrials.gov ID: NCT04423029

A Phase 1/2, Open-label Study of PD-1 Knockout Tumor-infiltrating Lymphocytes (IOV-4001) in Participants With Unresectable or Metastatic Melanoma or Stage III or IV 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.

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 melanoma or advanced non-small-cell lung cancer who have progressed after at least anti-PD-1/PD-L1 therapy, using an autologous tumor-infiltrating lymphocyte product (IOV-4001) genetically edited to knock out PD-1 via TALEN technology, administered after lymphodepleting chemotherapy and followed by high-dose IL-2. PD-1 knockout aims to enhance TIL antitumor activity by reducing exhaustion.

ClinicalTrials.gov ID: NCT05361174

A Phase 1a, Dose Escalation, Safety and Tolerability Study of NX-1607, a Casitas B-lineage Lymphoma Proto-oncogene (CBL-B) Inhibitor, in Adults With Advanced Malignancies, With Phase 1b Expansion in Select Tumor Types

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.

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 or metastatic solid tumors or diffuse large B-cell lymphoma who have exhausted standard therapies, evaluating the investigational oral CBL-B inhibitor NX-1607 (which enhances antitumor immunity by blocking a negative regulator of immune cell activation) as monotherapy or in combination with paclitaxel. Eligible tumor types include ovarian, gastric, head and neck, melanoma, NSCLC, prostate, mesothelioma, triple-negative breast, urothelial, cervical, microsatellite-stable colorectal cancer, and DLBCL/Richter transformation.

ClinicalTrials.gov ID: NCT05107674

A Phase I, Open-label, Multi-center Study of KFA115 as a Single Agent and in Combination With Pembrolizumab in Patients With Select Advanced Cancers

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.

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 selected advanced solid tumors—including NSCLC, renal cell carcinoma, melanoma, platinum-resistant ovarian cancer, nasopharyngeal carcinoma, and triple negative breast cancer—who have progressed after specific prior therapies, to evaluate the safety and dosing of KFA115 (a novel immunomodulatory small molecule, presumed to enhance anti-tumor immunity) as monotherapy and in combination with pembrolizumab. Exclusion criteria include significant cardiac, autoimmune, and interstitial lung diseases, as well as history of severe hypersensitivity to study drugs.

ClinicalTrials.gov ID: NCT05544929

A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Checkpoint Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors

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.

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 incurable, locally advanced or metastatic solid tumors (e.g., NSCLC, HNSCC, melanoma, TNBC, GI, cervical, CRC, urothelial, clear cell RCC, HCC) receive RO7502175, an afucosylated anti-CCR8 IgG1 designed to deplete intratumoral Tregs via enhanced ADCC, as monotherapy or combined with PD-(L)1 inhibitors (atezolizumab or pembrolizumab). Eligible patients have ECOG 0–1, measurable disease, and no active infections, autoimmune disease, or untreated CNS metastases.

ClinicalTrials.gov ID: NCT05581004