Clinical Trials for Melanoma

A Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ARV-806 in Participants With KRAS G12D Mutated 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: Adults with previously treated unresectable or metastatic KRAS G12D–mutated solid tumors are eligible for dose escalation; dose expansion is limited to pancreatic ductal adenocarcinoma after at least one prior systemic therapy. All receive IV ARV-806, an investigational PROTAC designed to degrade mutant KRAS G12D, weekly or every two weeks.

ClinicalTrials.gov ID: NCT07023731

Phase 1 Study of X-PACT (X-ray Psoralen Activated Cancer Therapy) for Intra-tumoral Injection of Superficial Tumors in Patients With Advanced Head and Neck Cancer, Breast Cancer, Soft Tissue Sarcoma or Melanoma

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 enrolls adults with advanced, superficial, and injectable head and neck cancer, breast cancer, soft tissue sarcoma, or melanoma that has progressed on or is ineligible for standard therapy. Patients receive intra-tumoral X-PACT, a novel approach using methoxsalen and a phosphor device activated by local X-ray to induce tumor cell death.

ClinicalTrials.gov ID: NCT04389281

Phase 1 Dose Escalation Study of Systemically Administered IL13Ra2 Chimeric Antigen Receptor (CAR) T Cells After a Nonmyeloablative Conditioning Regimen in Patients With Metastatic Melanoma and Other 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.

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 metastatic melanoma (including prior brain metastases) or other relapsed/refractory, IL13Ralpha2-expressing solid tumors to receive lymphodepleting chemotherapy followed by systemic infusion of autologous CAR T cells targeting IL13Ralpha2, a tumor-associated antigen. Patients must have good performance status and tumors confirmed to express IL13Ralpha2 by immunohistochemistry.

ClinicalTrials.gov ID: NCT04119024

A Phase I/II Study Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to Patients With CD70-Expressing 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.

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 metastatic or unresectable CD70-expressing cancers (including clear cell renal cell carcinoma and other solid tumors) who have progressed after at least one prior therapy, to receive a lymphodepleting regimen followed by infusion of autologous T cells genetically engineered with an anti-CD70 chimeric antigen receptor targeting CD70-positive tumor cells, plus high-dose aldesleukin (IL-2) post-infusion.

ClinicalTrials.gov ID: NCT02830724

A Phase 1 Dose Escalation and Expansion Study of the c-Kit Specific Antibody-Drug Conjugate NN3201 in Subjects With Advanced and/or Metastatic Solid Tumors Known to Express c-Kit

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 unresectable locally advanced or metastatic GIST after imatinib, extensive-stage SCLC, or selected c-Kit–associated tumors after standard therapy or when standard therapy is not an option receive intravenous NN3201 every three weeks. NN3201 is an investigational antibody–drug conjugate targeting c-Kit that delivers the cytotoxic payload MMAE.

ClinicalTrials.gov ID: NCT06805825

An Open-label, Phase I/IIa First-in-human, Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic and Antitumour Activity of ERK1/2 Inhibitor IPN01194 as Single Agent in Adult Participants With Advanced Solid Tumours

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 measurable metastatic melanoma, colorectal cancer, pancreatic ductal adenocarcinoma, or head and neck squamous cell carcinoma harboring selected MAPK-pathway mutations, ECOG 0–1, and no suitable standard therapy receive oral IPN01194 monotherapy. IPN01194 inhibits ERK1/2, downstream components of MAPK signaling.

ClinicalTrials.gov ID: NCT06305247

A Phase I/II Study of Ex-Vivo Expanded Allogeneic Universal Donor (UD) TGFbi NK Cell Infusions in Combination With Temozolomide as a Lymphodepleting Agent in Patients With Melanoma Metastatic to the Brain

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: Adults with progressive melanoma brain metastases (measurable ≥10 mm, ECOG 0–2) receive temozolomide lymphodepletion followed by IV infusions of ex vivo–expanded allogeneic TGF-β–inhibited NK cells, which are designed to resist TGF-β–mediated immunosuppression and enhance NK cytotoxicity in the CNS. Key exclusions include leptomeningeal disease and need for immediate stereotactic radiotherapy; corticosteroids allowed if stable/minimal.

ClinicalTrials.gov ID: NCT05588453

Phase I Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases

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: Adolescents and adults (12–50) with histologically confirmed solid tumors metastatic to the lungs, ECOG ≤2 and adequate organ/pulmonary function, receive on‑site aerosolized gemcitabine via nebulizer twice weekly in 28‑day cycles, including those previously treated with systemic gemcitabine. Gemcitabine is a nucleoside analog prodrug that inhibits ribonucleotide reductase and DNA synthesis; trial excludes active asthma or significant pulmonary symptoms and seeks to define pulmonary MTD and preliminary activity.

ClinicalTrials.gov ID: NCT03093909

Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma

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: Adults with metastatic/unresectable melanoma (PD‑1–refractory or PD‑1–naïve) or metastatic clear‑cell RCC refractory to PD‑1/PD‑L1–based therapy receive pembrolizumab (PD‑1 blockade) combined with high‑dose aldesleukin/IL‑2 (T‑cell activation) given inpatient. Single‑arm design aims to improve objective response; excludes significant autoimmune disease, prior severe irAEs, active infection, or major cardiopulmonary compromise.

ClinicalTrials.gov ID: NCT05155033

A Phase 1/2a, Open-Label, Dose-Escalation and Dose-Expansion First-In-Human Study of the Safety, Tolerability, Activity, and Pharmacokinetics of REGN10597 (Anti PD-1-IL2RA-IL2 Fusion Protein) in Patients With Advanced Solid Organ 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 locally advanced or metastatic solid tumors that have progressed on standard therapy receive REGN10597 in dose escalation; expansion cohorts enroll patients with melanoma or clear-cell renal cell carcinoma. REGN10597 is an investigational PD-1–targeting fusion protein designed to deliver masked IL-2 activity to PD-1–positive T cells.

ClinicalTrials.gov ID: NCT06413680