Clinical Trials for Squamous Cell Carcinoma Of The Skin

A Randomized Phase II Study of Amivantamab (JNJ-61186372) and Hyaluronidase (rHuPH20) Versus Cetuximab in Immunocompromised Participants With Recurrent Inoperable or Metastatic 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.

TrialFetch AI summary: Adults with locally recurrent inoperable/locoregionally incurable or metastatic cutaneous squamous cell carcinoma who are actively immunocompromised (e.g., solid organ transplant recipients, hematologic malignancy, or autoimmune disease on immunosuppressants; ECOG 0–2; no recent EGFR inhibitor) are treated with subcutaneous amivantamab plus rHuPH20, a bispecific anti-EGFR/MET antibody (hyaluronidase to enable SC delivery), with an initial safety cohort and a randomized cohort comparing progression-free survival versus IV cetuximab (anti-EGFR).

ClinicalTrials.gov ID: NCT07042295

Knight Cancer Institute Study of Histology-Agnostic Immunotherapy With Focus on Timing: - Knight SHIFT - A Prospective, Multi-Histology Pragmatic Study

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 measurable advanced/metastatic solid tumors eligible for standard FDA-approved immune checkpoint inhibitor therapy (anti–PD-1/PD-L1 and/or anti–CTLA-4), including NSCLC, HNSCC, RCC, biliary, HCC, and melanoma, who are ICI-naive. Patients are randomized to receive their planned standard-of-care immunotherapy in the morning versus afternoon for the first 4 doses to evaluate whether administration timing affects outcomes.

ClinicalTrials.gov ID: NCT07405086

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 aged 18–80 with unresectable stage III/IV melanoma, basal cell carcinoma, squamous cell carcinoma, or other solid tumors that have progressed on anti-PD-1/PD-L1 therapy receive oral R-5780 alongside ongoing PD-1 pathway inhibition. R-5780 is an investigational engineered Lactococcus lactis probiotic that generates muramyl dipeptide to activate NOD2.

ClinicalTrials.gov ID: NCT06398418

A Phase IV Master Protocol of Cosibelimab in Special Populations With Advanced Cutaneous Squamous Cell Carcinoma (CosiMaster)

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 cutaneous squamous cell carcinoma who are either kidney transplant recipients or have a coexisting hematologic malignancy receive cosibelimab, an anti-PD-L1 antibody. Transplant recipients also receive prednisone plus sirolimus or everolimus to maintain immunosuppression; the study assesses tumor response and safety, including renal allograft rejection.

ClinicalTrials.gov ID: NCT07426484

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: Adults with advanced or metastatic NSCLC, head and neck squamous cell carcinoma, renal cell carcinoma, urothelial carcinoma, or melanoma who lack a suitable standard treatment option receive escalating doses of LB-LR1109 monotherapy. This investigational antibody blocks the inhibitory immune receptor LILRB1 to enhance antitumor immune activity.

ClinicalTrials.gov ID: NCT06332755