Clinical Trials for Squamous Cell Carcinoma Of The Skin

Phase III Randomized Trial of Immunotherapy With or Without Consolidative Radiotherapy for Oligometastatic Head and Neck 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.

TrialFetch AI summary: Adults with oligometastatic HNSCC (≤4 metastatic sites) who have not progressed after 3 cycles of pembrolizumab plus platinum/fluorouracil- or paclitaxel-based chemotherapy are randomized to maintenance pembrolizumab (PD-1 inhibitor) with consolidative radiotherapy to all disease sites versus pembrolizumab alone. Requires measurable disease, ECOG 0–1 at induction (0–2 at randomization), no prior head/neck RT, and no active autoimmune disease needing systemic therapy.

ClinicalTrials.gov ID: NCT05721755

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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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

A Prospective International Multicenter, Pivotal, Single Arm, Open Label Clinical Study to Assess the Efficacy and Safety of Intratumoral Alpha DaRT224 for the Treatment of Patients With Recurrent 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.

TrialFetch AI summary: Adults with histologically confirmed, nonmetastatic recurrent cutaneous SCC, ECOG 0–2, with a single measurable lesion ≤7 cm not amenable to surgery or standard radiation and after failure of at least first-line therapy, receive intratumoral Alpha DaRT-224 seeds (Ra-224 alpha-emitter brachytherapy) placed for ~2–3 weeks to deliver short-range, high–linear energy transfer radiation for local tumor control. Excludes nodal/distant metastases, T4/perineural spread, mucosal/anogenital SCC, and lesions inaccessible for seed placement.

ClinicalTrials.gov ID: NCT05323253

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.

TrialFetch 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 Single and Repeat Dosing and Expansion Study of the Safety, Drug Exposure and Clinical Activity of R-5780 in Combination With a PD-1 (Checkpoint Protein on Immune Cells Called T Cells) Pathway Checkpoint Inhibitor in Patients With Solid Tumors

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

TrialFetch AI summary: Adults with unresectable stage III/IV solid tumors (e.g., melanoma, BCC, SCC) refractory to prior anti–PD‑1/PD‑L1 therapy receive an oral, precision‑engineered live biotherapeutic (R‑5780) added to their ongoing PD‑1 pathway inhibitor. R‑5780 is designed to modulate gut–immune pathways to enhance anti‑tumor T‑cell responses and potentiate checkpoint inhibition; key exclusions include recent broad‑spectrum antibiotics, active infections, significant autoimmune disease, untreated brain mets, and >4 prior systemic therapies.

ClinicalTrials.gov ID: NCT06398418

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

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 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.

TrialFetch 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.

TrialFetch 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