Clinical Trials for Melanoma

Phase 1b/2 Trial of Defactinib and Avutometinib, With or Without Encorafenib, for the Treatment of Patients With Brain Metastases From Cutaneous Melanoma

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.

TrialFetch AI summary: Adults with cutaneous melanoma brain metastases progressing after immunotherapy and at least one untreated, measurable brain lesion receive defactinib (a FAK/PYK2 inhibitor) plus avutometinib (a RAF/MEK clamp). Patients with BRAF V600E/K-mutant disease also receive encorafenib, a BRAF inhibitor.

ClinicalTrials.gov ID: NCT06194929

A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors

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.

TrialFetch AI summary: Adults with measurable, locally advanced or metastatic solid tumors and ECOG performance status 0–1 receive MDNA11 alone or with pembrolizumab. MDNA11 is a long-acting IL-2 agonist designed to favor IL-2 receptor β signaling in CD8-positive T cells and natural killer cells while limiting regulatory T-cell stimulation; pembrolizumab blocks PD-1.

ClinicalTrials.gov ID: NCT05086692

A Phase 1/2 Study of OR502 Alone and in Combination With Other Anti-cancer Agents in Subjects With Advanced Malignancies

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.

TrialFetch AI summary: Adults with progressive advanced or metastatic solid tumors may receive intravenous OR502, an investigational LILRB2-blocking antibody intended to reduce myeloid immune suppression, alone or with the PD-1 inhibitor cemiplimab. The currently recruiting cohorts are for melanoma and non-small cell lung cancer previously treated with PD-(L)1-based therapy.

ClinicalTrials.gov ID: NCT06090266

A Phase 1/1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 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.

TrialFetch AI summary: Adults with relapsed or refractory, unresectable locally advanced or metastatic solid tumors, including metastatic castration-resistant prostate cancer, receive MGC026 intravenously every 21 days in dose-escalation or expansion cohorts. MGC026 is a B7-H3–targeting antibody–drug conjugate carrying an exatecan-based topoisomerase I inhibitor payload.

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

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.

TrialFetch AI summary: Adults with ECOG 0–1, an injectable tumor lesion, and previously treated advanced solid tumors may receive intratumoral STX-001 alone or with pembrolizumab; combination expansion cohorts focus on unresectable triple-negative breast cancer and advanced nonuveal melanoma. STX-001 is a lipid nanoparticle containing self-replicating mRNA encoding interleukin-12, designed to stimulate local antitumor immunity.

ClinicalTrials.gov ID: NCT06249048

A Phase 1/2, Open-Label Study to Investigate the Safety and Efficacy of Membrane Bound IL15 Expressing Tumor-Infiltrating Lymphocytes (OBX-115) 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.

TrialFetch AI summary: Adults with advanced or metastatic melanoma progressing after PD-1/PD-L1 blockade, or relapsed/refractory metastatic NSCLC after approved therapies, receive conditioning followed by OBX-115, an autologous tumor-infiltrating lymphocyte therapy engineered to express membrane-bound IL-15. Acetazolamide regulates IL-15 expression to support TIL expansion and persistence without high-dose IL-2.

ClinicalTrials.gov ID: NCT06060613

A Phase 1, Open-Label, Multiple-Ascending Dose Study of the Safety and Tolerability of CTX-8371 in Patients With Advanced Malignancies

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.

TrialFetch AI summary: Adults with previously treated, locally advanced unresectable or metastatic melanoma, head and neck squamous cell carcinoma, non-small-cell lung cancer, triple-negative breast cancer, or classical Hodgkin lymphoma receive intravenous CTX-8371 monotherapy every 2 weeks. CTX-8371 is a bispecific antibody targeting PD-1 and PD-L1; most solid-tumor cohorts require progression after prior PD-1/PD-L1 therapy.

ClinicalTrials.gov ID: NCT06150664

Phase III Trial of Single Fraction Stereotactic Radiosurgery (SRS) Versus Fractionated SRS (FSRS) for Intact Brain Metastases

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to standard of care.

TrialFetch AI summary: Adults with 1-8 intact (unresected), non-brainstem brain metastases from solid tumors (such as NSCLC, melanoma, breast, renal, or GI cancers), good performance status, and no prior brain radiotherapy are randomized to receive either single-session stereotactic radiosurgery (SRS) or fractionated SRS (three sessions). Both approaches are non-invasive, high-precision outpatient radiotherapy options for brain metastases.

ClinicalTrials.gov ID: NCT06500455

Phase I/II Trial of Autologous Rapamycin-Resistant Th1/Tc1 (RAPA-201) Cell Therapy of PD-(L)1 Resistant Solid Tumors

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.

TrialFetch AI summary: Adults with advanced or unresectable melanoma, small-cell or non-small-cell lung cancer, or head and neck squamous cell carcinoma whose most recent anti-PD-(L)1–containing regimen failed to produce a response or was followed by relapse within 12 months receive carboplatin–paclitaxel plus autologous RAPA-201 cells. RAPA-201 is a rapamycin-resistant, Th1/Tc1-polarized CD4+/CD8+ T-cell product without a single tumor-antigen target; the expanded cohort also receives pembrolizumab maintenance.

ClinicalTrials.gov ID: NCT05144698

A Phase 1, Open-label, Multi-center Study of the Safety, Tolerability, and Efficacy of IPH4502 as a Single Agent in 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.

TrialFetch AI summary: Adults with previously treated, unresectable locally advanced or metastatic Nectin-4–expressing solid tumors, measurable disease, and no remaining therapy with demonstrated benefit receive IPH4502 monotherapy. IPH4502 is an investigational Nectin-4–targeted antibody–drug conjugate that delivers the topoisomerase I inhibitor exatecan.

ClinicalTrials.gov ID: NCT06781983