Clinical Trials for Melanoma

A Phase 2, Multicenter, Open-label Study of Lifileucel (Tumor-infiltrating Lymphocytes [TIL]) in Participants With Previously Treated Advanced 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.

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 unresectable stage IIIC/IIID or stage IV cutaneous melanoma (ECOG 0–1) with RECIST-measurable disease and at least one resectable lesion for TIL manufacturing, whose disease progressed on prior anti–PD-(L)1 therapy (including relapse during/within 12 weeks after adjuvant anti–PD-(L)1); BRAF V600–mutant patients may also have had (or refused) prior BRAF±MEK inhibitors. Participants receive lifileucel (LN-145), an autologous tumor-infiltrating lymphocyte cell therapy expanded ex vivo and reinfused to provide tumor-reactive T cells.

ClinicalTrials.gov ID: NCT07288203

A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN 144/LN-145/LN-145-S1) in Patients With Solid Tumors

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.

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 patients with unresectable or metastatic melanoma (including those previously treated with PD-1 inhibitors or BRAF-targeted therapies), advanced head and neck squamous cell carcinoma, or locally advanced/metastatic non-small cell lung cancer, providing treatment with autologous tumor-infiltrating lymphocyte (TIL) products—lifileucel (LN-144/LN-145) or next-generation PD-1-selected LN-145-S1—either as monotherapy or in combination with immune checkpoint inhibitors (ICIs). Eligibility requires at least one resectable lesion and ECOG 0-1, and excludes active autoimmune disease or untreated symptomatic brain metastases.

ClinicalTrials.gov ID: NCT03645928

Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Patients With Select Solid Tumors

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.

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: Enrolling adults with advanced solid tumors requiring an injectable lesion: first-line PD-1–eligible HNSCC (PD-L1 CPS ≥1%, no prior PD-(L)1), cutaneous melanoma with primary resistance or progression on prior PD-(L)1 (BRAF+ should have received/declined targeted therapy), and a closed-to-enrollment non–MSI-H CRC cohort; ECOG 0–1 required. Treatment is intratumoral VV1 (VSV engineered to express IFN-β and NIS; oncolytic/immune-stimulatory) combined with IV cemiplimab every 3 weeks until progression/toxicity.

ClinicalTrials.gov ID: NCT04291105

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 and measurable brain metastases after immune checkpoint inhibitors, including BRAF V600E/K–mutant and non‑BRAF cohorts; requires at least one untreated 0.5–4 cm parenchymal lesion, ECOG 0–1, and known RAS/BRAF/NF1 status. Treatment is avutometinib (dual RAF/MEK “clamp”) plus defactinib (FAK/Pyk2 inhibitor), with an added encorafenib (BRAF inhibitor) dose‑finding and expansion for BRAF V600E/K disease.

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: This trial evaluates MDNA11, an IL-2 Superkine targeting the IL-2 beta receptor to enhance anti-tumor immunity, administered alone or with pembrolizumab, in adult patients with locally advanced or metastatic solid tumors. Eligible patients must have an ECOG performance status of 0 or 1 and adequate organ function.

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: This trial involves adult patients with advanced solid tumors, including those with platinum-resistant ovarian cancer or cutaneous squamous cell carcinoma, assessing the safety and efficacy of OR502, a monoclonal antibody targeting LILRB2 on tumor-associated macrophages, alone and with cemiplimab, an anti-PD-1 antibody.

ClinicalTrials.gov ID: NCT06090266

An Open-Label Phase 1/2A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Advanced and/or Refractory Solid Tumor 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: This trial enrolls adults with advanced or refractory solid tumors—including specific cohorts for endometrial, head and neck squamous, melanoma, non-small cell lung, and pMMR/MSS colorectal cancers—who have failed standard therapies and have good performance status. Patients receive GV20-0251, a first-in-class anti-IGSF8 monoclonal antibody targeting a novel immune checkpoint, as monotherapy or combined with pembrolizumab.

ClinicalTrials.gov ID: NCT05669430

A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1311 in Subjects With Advanced/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.

TrialFetch AI summary: This trial enrolls adults with advanced or metastatic solid tumors—including SCLC, NSCLC, ESCC, CRPC, melanoma, HCC, cervical cancer, HNSCC, and select rare cancers—who have progressed after or are intolerant to standard therapies. Patients receive DB-1311, an anti-B7-H3 antibody-drug conjugate linked to a topoisomerase I inhibitor, administered intravenously every 3 weeks.

ClinicalTrials.gov ID: NCT05914116

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: This trial enrolls adults with advanced or metastatic melanoma (post anti-PD-1/PD-L1 and ≤2 prior systemic therapies) or relapsed/refractory metastatic non-small cell lung cancer, treating them with OBX-115, an autologous tumor-infiltrating lymphocyte (TIL) therapy engineered to express membrane-bound IL-15, aiming to enhance efficacy while reducing cytokine-related toxicities compared to standard TIL regimens.

ClinicalTrials.gov ID: NCT06060613

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