Clinical Trials for Squamous Cell Carcinoma Of The Skin

Pembrolizumab for Orbital and Periocular Cutaneous Squamous Cell Carcinoma (cSCC)

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.

HealthScout AI summary: Enrolls adults with locally advanced, diffuse, or recurrent orbital/periocular cutaneous SCC (measurable disease, ECOG 0–1) without prior checkpoint inhibitor therapy to receive pembrolizumab 200 mg IV q3w for up to 35 cycles. Pembrolizumab is an anti–PD-1 monoclonal antibody that restores T‑cell antitumor activity; study emphasizes response and globe-preservation outcomes.

ClinicalTrials.gov ID: NCT06580054

Open-label, Non-randomized, Multi-cohort, Phase 1b/2 Trial Investigating the Safety, Tolerability, and Antitumor Activity of STC-15 (a METTL3 Inhibitor) as a Part of Combination Therapy With Toripalimab in Participants With Selected Advanced Cancers

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 NSCLC, melanoma, endometrial cancer, or HNSCC who have progressed after standard therapies including prior anti-PD-1/L1 agents, and evaluates the combination of STC-15 (an oral METTL3 inhibitor targeting RNA methylation) plus toripalimab (anti-PD-1 antibody). Eligible patients must have measurable disease, ECOG 0–1, and no active CNS disease.

ClinicalTrials.gov ID: NCT06975293

A Phase 2 Study of Nivolumab and Ipilimumab in Combination With Sirolimus and Prednisone in Kidney Transplant Recipients With Selected Unresectable or Metastatic Cutaneous Cancers

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 functioning kidney transplants and unresectable or metastatic cutaneous melanoma (non-uveal), cSCC, BCC, or Merkel cell carcinoma receive nivolumab (PD‑1 inhibitor) plus ipilimumab (CTLA‑4 inhibitor) with concurrent sirolimus (mTOR inhibitor) and prednisone, followed by nivolumab maintenance. Designed to balance antitumor activity with graft preservation; prior PD-(L)1 exposure allowed, with re-induction permitted at progression.

ClinicalTrials.gov ID: NCT05896839

Phase 2 Study of Afatinib in Advanced Cutaneous Squamous Cell Carcinoma

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: Single-arm study of afatinib 40 mg PO daily in adults with unresectable locally advanced or metastatic cutaneous SCC, requiring prior anti–PD‑1/PD‑L1 therapy if eligible; includes immunosuppressed and transplant recipients, and allows treated/stable brain metastases. Afatinib is an irreversible ErbB (EGFR/HER2/HER4) inhibitor; treatment continues until progression/toxicity with imaging every 8 weeks.

ClinicalTrials.gov ID: NCT05070403

A Phase I/II Study of Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab in Advanced Solid Tumors (PNeoVCA)

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.

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 involves adults with unresectable or metastatic advanced solid tumors who have progressed on prior treatments or are candidates for pembrolizumab, combining pembrolizumab, which targets the PD-1 receptor to enhance immune response, with a personalized neoantigen peptide vaccine designed to stimulate an individualized immune attack against tumor-associated proteins.

ClinicalTrials.gov ID: NCT05269381

A Phase 1, First-in-Human, Open-Label, Multi-Center, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LB-LR1109 for the Treatment of Advanced or Metastatic Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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: The trial is for adult patients with advanced or metastatic non-small cell lung cancer, head and neck squamous cell carcinoma, renal cell carcinoma, urothelial carcinoma, or malignant melanoma who have no remaining standard treatment options, and it evaluates the safety, tolerability, and dosing of the investigational drug LB-LR1109, administered intravenously.

ClinicalTrials.gov ID: NCT06332755

A Seamless Phase 1/2 Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated Tmod™ CAR T, in Heterozygous HLA-A*02 Adults With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 recurrent unresectable, locally advanced, or metastatic solid tumors that express EGFR and have lost HLA-A*02 expression, including types such as CRC, NSCLC, HNSCC, TNBC, and RCC, and tests A2B395, a logic-gated Tmod™ CAR T-cell therapy designed to selectively target these tumor cells while sparing healthy cells. Participants receive a preconditioning lymphodepletion regimen followed by a single intravenous dose of A2B395.

ClinicalTrials.gov ID: NCT06682793

An Open-Label, Multicenter, First-in-Human, Dose-Escalation and Dose-Expansion, Phase 1/2 Study of BBI-355 and BBI-355 in Combination with Select Targeted Therapies in Subjects with Locally Advanced or Metastatic Solid Tumors with Oncogene Amplifications

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 locally advanced or metastatic solid tumors harboring oncogene amplifications who have progressed on or are ineligible for standard therapies may receive oral BBI-355, a selective CHK1 inhibitor, either as monotherapy or combined with erlotinib (EGFR inhibitor) or futibatinib (FGFR inhibitor) in cohorts defined by specific gene amplifications. Key exclusions include certain oncogenic mutations, prior targeted therapies, CNS involvement, and serious comorbidities.

ClinicalTrials.gov ID: NCT05827614

A Phase 1/2a, First-in-Human (FIH), Open-Label, Dose-Escalation and Dose Expansion Study of the Monoclonal Antibody IMT-009 in Patients with Advanced Solid Tumors or Lymphomas

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 or designated lymphomas (with confirmed CD161 expression) who have failed or are intolerant to standard therapies, to receive the investigational anti-CD161 monoclonal antibody IMT-009 (which blocks an inhibitory NK/T cell pathway) as monotherapy or in combination with fruquintinib.

ClinicalTrials.gov ID: NCT05565417

An Open-label, Phase 1 Dose Escalation and Phase 2 Dose Expansion Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SMP-3124LP in Adults With Advanced Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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, recurrent, or metastatic solid tumors (including platinum-resistant ovarian cancer, triple-negative breast cancer, squamous cell carcinoma of the anus or head and neck, non-small cell lung cancer, and uterine serous cancer) who have progressed on all standard therapies, to receive SMP-3124LP, a novel liposomal CHK1 inhibitor given by intravenous infusion. SMP-3124LP targets the DNA damage response pathway and is being assessed for safety, tolerability, and preliminary efficacy.

ClinicalTrials.gov ID: NCT06526819