Clinical Trials for Melanoma

A PHASE 1A/B OPEN-LABEL MASTER STUDY OF PF-07799544 AS A SINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED AGENTS IN PARTICIPANTS WITH ADVANCED SOLID TUMORS

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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 or metastatic solid tumors, including primary brain tumors, who have exhausted standard therapies, with dedicated cohorts for BRAF-mutant melanoma and other BRAF-mutated solid tumors; patients receive PF-07799544, a novel oral brain-penetrant MEK inhibitor, alone or in combination with a pan-mutant BRAF inhibitor (PF-07799933) or encorafenib, depending on tumor type and molecular profile.

ClinicalTrials.gov ID: NCT05538130

A Phase 1a/1b Dose Escalation/Expansion Study of TTX-080, an HLA-G Antagonist, as Monotherapy and in Combination With Pembrolizumab, Cetuximab or FOLFIRI Plus Cetuximab in Patients With Advanced Solid Refractory/Resistant Malignancies

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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 or metastatic solid tumors (including HNSCC, NSCLC, colorectal, TNBC, RCC, and acral melanoma) that are refractory or resistant to standard therapies, testing the investigational HLA-G antagonist monoclonal antibody TTX-080 alone or combined with pembrolizumab, cetuximab, or FOLFIRI plus cetuximab. Control arms include standard regimens for comparison in metastatic colorectal cancer.

ClinicalTrials.gov ID: NCT04485013

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

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 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

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 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

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 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

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

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: 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 Pilot Trial of Autologous Tumor Infiltrating Lymphocytes (LN-144 or LN-145) for Patients With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, or Dedifferentiated Liposarcoma

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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 uveal melanoma (any prior therapy) or unresectable/metastatic UPS or DDLPS refractory to ≥1 systemic regimen receive autologous tumor-infiltrating lymphocyte therapy lifileucel (LN-144/LN-145) after nonmyeloablative lymphodepleting chemotherapy and followed by IL-2. Lifileucel consists of ex vivo–expanded, tumor-specific T cells (adoptive cell therapy) and is being studied here for safety/feasibility in these populations.

ClinicalTrials.gov ID: NCT05607095

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

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 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

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 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

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 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