Clinical Trials for Melanoma

An Open-label, Multicenter, Dose Escalation and Expansion Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics, and Anti-tumor Activity of GI-102, a CD80-IgG4 Fc-IL-2v Bispecific Fusion Protein, As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced or Metastatic Solid Tumors (KEYNOTE-G08)

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 (ECOG 0-1, no active CNS metastases) to receive GI-102, a bispecific CD80–IL-2 variant fusion protein designed to selectively activate CD8+ T and NK cells, as monotherapy or combined with standard regimens, including pembrolizumab and trastuzumab deruxtecan (for HER2+ disease).

ClinicalTrials.gov ID: NCT05824975

A Phase 1a/1b Multicenter, Open-label Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of PLN-101095 as Monotherapy and in Combination With Pembrolizumab in Adult Participants With Advanced or Metastatic Solid Tumors Who Have Disease Progression While on Pembrolizumab

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 that have progressed on at least three months of pembrolizumab, evaluating the investigational oral integrin αvβ8/αvβ1 inhibitor PLN-101095 as monotherapy or combined with pembrolizumab. Eligible patients must have no other effective treatment options and prior pembrolizumab resistance (primary or secondary).

ClinicalTrials.gov ID: NCT06270706

A Phase I/II, Open-label, Adaptive Two-part Trial to Evaluate the Safety, Efficacy, Optimal Dose and Pharmacokinetics of BNT326 as Monotherapy and in Combination With Cancer Immunotherapies in Participants With Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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/metastatic solid tumors (select cohorts: 2L+ cutaneous melanoma, EGFR-mutated or EGFR/ALK/ROS1–negative NSCLC, rare melanomas, other solid tumors; and in combination: 2L+ melanoma and HER2‑negative metastatic breast cancer) receive the HER3-targeting antibody–drug conjugate BNT326 (topoisomerase I payload) as monotherapy or combined with BNT327, a bispecific anti–PD-L1/anti–VEGF-A antibody. Includes a dedicated drug–drug interaction cohort with CYP inhibitors (itraconazole or paroxetine).

ClinicalTrials.gov ID: NCT07070232

A Phase I/II Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6750, a CD8 Guided IL-2 Agent Alone and in Combination With Other Anti-cancer Agents in Participants With Select Advanced or Metastatic Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 select advanced/metastatic solid tumors after standard therapy (melanoma, cSCC, Merkel cell, NSCLC, HNSCC, gastric/GEJ, RCC, HGSOC, TNBC) receive AZD6750, an investigational CD8-guided IL-2 designed to preferentially activate CD8+ T cells; a separate module enrolls NSCLC (including 1L PD-L1 ≥1%) to receive AZD6750 plus rilvegostomig, a bispecific PD-1/TIGIT antibody. Key exclusions include uncontrolled CNS disease, active autoimmune disease, prior severe I/O toxicities, and in the NSCLC module prior anti-TIGIT or targetable driver-positive 1L disease.

ClinicalTrials.gov ID: NCT07115043

Phase I Randomized Open Label Trial Investigating Adoptive Transfer of CD39+CD103+CD8+ Tumor-isolated T Cells (AGX148) Alone or Combined With siRNA Modulation of PD-1 (AGX148/PH-762) in Patients With Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 unresectable/metastatic solid tumors (post–standard therapy; prior ICI required for melanoma/HNSCC) undergo tumor harvest for autologous CD39+CD103+ CD8+ TIL therapy after cyclophosphamide/fludarabine lymphodepletion and IL-2 support. Patients are randomized to standard enriched TILs (AGX148) or the same product with ex vivo PD‑1 knockdown via self‑delivering siRNA PH‑762 (AGX148/PH‑762) to enhance effector function and persistence, with varying durations of low‑dose IL‑2 post-infusion.

ClinicalTrials.gov ID: NCT05902520

A Phase 1, Multicenter, Open-label, 2-stage, Single-arm Study to Evaluate the Safety and Tolerability of an Autologous Tumor-infiltrating Lymphocytes (TIL) Regimen and Preliminary Antitumor Activity of TIL in Pediatric, Adolescent, and Young Adult Participants With Relapsed or Refractory Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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: Single-arm TIL therapy (lifileucel-based autologous tumor-infiltrating lymphocytes expanded ex vivo with IL-2) for children, adolescents, and young adults (≤21 years) with relapsed/refractory solid tumors lacking effective options, including sarcomas, primary CNS tumors, and melanoma. Patients undergo tumor resection for TIL manufacture, nonmyeloablative lymphodepletion, then a single TIL infusion with supportive care (typically IL-2); outcomes include safety and preliminary antitumor activity.

ClinicalTrials.gov ID: NCT06566092

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

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 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 I/IIa, First-In-Human, Multi-Center, Monotherapy and Combination-Therapy With Nivolumab, Dose-Escalation and Dose-Expansion Study of [212Pb]VMT01 Melanocortin-1 Receptor-Targeted, Image-Guided Alpha-Particle Therapy in Subjects With Previously Treated Unresectable or Metastatic Melanoma

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 unresectable stage III/IV melanoma that has progressed after at least one prior systemic regimen and shows MC1R positivity on 68Ga‑VMT02 PET or 203Pb‑VMT01 SPECT receive [212Pb]VMT01, an MC1R-targeted peptide alpha-emitting radiopharmaceutical, as monotherapy or combined with nivolumab. Up to three [212Pb]VMT01 cycles are given about 8 weeks apart, with nivolumab dosed Q4W in combo cohorts; patients need ECOG 0–1 and adequate organ function, and key exclusions apply for prior radiopharmaceuticals and immune-related contraindications.

ClinicalTrials.gov ID: NCT05655312

An Open-Label, Multicenter, Phase 1B/2 Study of RP1 in Solid Organ and Hematopoietic Cell Transplant Recipients With Advanced Cutaneous Malignancies

Active drug

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

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

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.

HealthScout AI summary: Transplant recipients (solid-organ or hematopoietic cell) with recurrent, locally advanced, or metastatic cutaneous malignancies confined to skin/soft tissue/lymph nodes and with measurable injectable disease receive intratumoral RP1. RP1 is a modified HSV-1 oncolytic immunotherapy (ICP34.5/ICP47-deleted; expresses GM‑CSF and fusogenic GALV‑GP R‑) given every 2 weeks to induce tumor-selective lysis and antitumor immunity; patients with visceral/CNS metastases, recent rejection, active HSV, or uncontrolled viral infections are excluded.

ClinicalTrials.gov ID: NCT04349436

A Randomized, Double-Blind Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Treatment-Naïve Unresectable or Metastatic Melanoma

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

No known activity

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

HealthScout AI summary: Adults with treatment‑naïve unresectable or metastatic melanoma (ECOG 0–1) are randomized to ABP 206, an investigational nivolumab biosimilar (anti–PD‑1), or reference nivolumab, given IV until progression or 24 months. Excludes prior systemic therapy for advanced disease, prior PD‑1/PD‑L1 or CTLA‑4 inhibitors, active untreated CNS metastases, ocular melanoma, and significant immune‑mediated disorders.

ClinicalTrials.gov ID: NCT06054555