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

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, 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

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.

HealthScout 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.

HealthScout 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.

HealthScout 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.

HealthScout 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.

HealthScout AI summary: This trial enrolls adults with advanced, metastatic, or unresectable melanoma, small cell or non-small cell lung cancer, or squamous cell head and neck cancer that is refractory to prior anti-PD-(L)1 therapy, and treats them with standard carboplatin/paclitaxel plus infusions of autologous rapamycin-resistant Th1/Tc1-polarized T cells (RAPA-201, designed to resist immunosuppression and checkpoint inhibition), with anti-PD1 maintenance (pembrolizumab) in selected cohorts. Eligible patients must have good performance status and adequate organ function for apheresis.

ClinicalTrials.gov ID: NCT05144698

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

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 solid tumors or pancreatic ductal adenocarcinoma harboring a KRAS G12D mutation who have received prior standard therapies, testing ARV-806, an investigational IV protein degrader specifically targeting mutant KRAS G12D. Patients with prior KRAS G12D/pan-KRAS inhibitor exposure or uncontrolled comorbidities are excluded.

ClinicalTrials.gov ID: NCT07023731

AN OPEN-LABEL PHASE 1 STUDY TO EVALUATE PF-08046037 AS MONOTHERAPY AND PART OF COMBINATION THERAPY IN PARTICIPANTS 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.

HealthScout AI summary: This trial enrolls patients with advanced or metastatic NSCLC, HNSCC, melanoma, or PDAC to receive PF-08046037, an immune-stimulating antibody-drug conjugate targeting PD-L1 and delivering a TLR7 agonist, either as monotherapy or in combination with sasanlimab (anti-PD-1). Participants must have measurable disease and available tumor tissue, with other eligibility based on prior therapies and comorbidities.

ClinicalTrials.gov ID: NCT06974734

An Open-Label Phase 1 Study to Evaluate PF-08046032 as Monotherapy and Part of Combination Therapy in Participants 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.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic malignancies—including relapsed/refractory Hodgkin lymphoma, certain non-Hodgkin lymphomas, and selected solid tumors—who meet specific prior treatment criteria, to receive PF-08046032, an investigational CD25-targeting antibody-drug conjugate designed to deplete tumor-infiltrating Tregs, as monotherapy or in combination with the anti-PD-1 antibody sasanlimab. Key exclusions are active autoimmune disease, significant prior immune toxicity, or ongoing neuropathy.

ClinicalTrials.gov ID: NCT06870487

A Phase I Study of In Situ Immunomodulation With CDX-301, Radiotherapy, CDX-1140, and Poly-ICLC in Patients With Unresectable and Metastatic Solid Tumors With Injectable Palpable Disease

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: Adult patients with unresectable and metastatic melanoma, cutaneous SCC, BCC, Merkel cell carcinoma, high-grade sarcomas, or HER2-negative breast cancer with palpable, injectable lesions are eligible for this trial evaluating intratumoral CDX-301 (Flt3 ligand), radiotherapy, CDX-1140 (agonistic anti-CD40 antibody), and Poly-ICLC, with additional arms including pembrolizumab (PD-1 inhibitor) and tocilizumab (IL-6 receptor antagonist). The study focuses on safety and immunologic activity of this multi-agent in situ immunomodulation approach.

ClinicalTrials.gov ID: NCT04616248