← Back to Search

PD-1 Inhibitor

cemiplimab for Squamous Cell Carcinoma

Phase 2

Waitlist Available

Research Sponsored by Regeneron Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 months

Awards & highlights

Study Summary

This trial is testing cemiplimab, a new treatment for skin cancer, to see if it is effective and safe.

Eligible Conditions

Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Response Rate (ORR)

Secondary outcome measures

Anti-cemiplimab antibodies

Cemiplimab PK: Absolute bioavailability after SC administration

Cemiplimab PK: Area under the plasma concentration-time curve after the first SC or IV dose

+15 more

Side effects data

From 2023 Phase 2 trial • 138 Patients • NCT03132636

43%

Fatigue

37%

Diarrhoea

22%

Constipation

20%

Hypertension

17%

Arthralgia

15%

Pruritus

15%

Weight increased

13%

Pyrexia

13%

Vomiting

11%

Headache

11%

Nausea

11%

Pain in extremity

11%

Anaemia

11%

Oedema peripheral

11%

Decreased appetite

11%

Hyperglycaemia

Dizziness

Weight decreased

Back pain

Asthenia

Dry skin

Eczema

Rash maculo-papular

Hyperthyroidism

Rash

Abdominal pain

Urinary tract infection

Dyspnoea

Neck pain

Hypothyroidism

Hypokalaemia

Blood creatinine increased

Blood creatine phosphokinase increased

Cough

Fall

Haematuria

Pain

Alanine aminotransferase increased

Muscle spasms

Myalgia

Upper respiratory tract infection

Actinic keratosis

Anxiety

Basal cell carcinoma

Dry mouth

Infusion related reaction

Influenza like illness

Colitis

Pancytopenia

Autoimmune myocarditis

Infection

Clostridium difficile infection

Autoimmune hepatitis

Respiratory failure

Urinary retention

Pneumonia

Pneumonitis

Haemoptysis

Clostridium difficile colitis

Skin infection

Somnolence

Lymphoproliferative disorder

Pneumonia staphylococcal

Immune-mediated myocarditis

Atypical pneumonia

Autoimmune pericarditis

Arthritis bacterial

Hypoalbuminaemia

Lymphadenopathy mediastinal

Atrial fibrillation

Facial paralysis

Acute coronary syndrome

Tibia fracture

General physical health deterioration

Procedural pain

Pleural effusion

Multiple fractures

Wound haemorrhage

Seborrhoeic keratosis

Tumour haemorrhage

Leukocytosis

100%

80%

60%

40%

20%

Study treatment Arm

Group 1: Metastatic BCC (mBCC)

Group 2: Unresectable Locally Advanced BCC (laBCC)

Trial Design

5Treatment groups

Experimental Treatment

Group I: Group 6Experimental Treatment1 Intervention

Patients with advanced CSCC (metastatic [nodal or distant] or locally advanced) who received cemiplimab IV Q3W for at least 27 weeks without experiencing disease progression, will have the option to receive cemiplimab by subcutaneous (SC) injection Q3W (first 12 patients) or Q6W (next ≥ 6 patients) basis.

Group II: Group 4Experimental Treatment1 Intervention

Patients with advanced CSCC [metastatic (nodal or distal) or unresectable locally advanced] Cemplimab administered IV Q4 weeks.

Group III: Group 3Experimental Treatment1 Intervention

Patients with metastatic CSCC to distant sites or lymph nodes. Cemiplimab administered IV Q3 weeks.

Group IV: Group 2Experimental Treatment1 Intervention

Patients with unresectable locally advanced CSCC. Cemiplimab administered IV Q2 weeks.

Group V: Group 1Experimental Treatment1 Intervention

Patients with metastatic CSCC: to distant sites or lymph nodes. Cemiplimab administered intravenously (IV) every 2 weeks (Q2W).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

cemiplimab

2016

Completed Phase 2

~570

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor

615 Previous Clinical Trials

379,402 Total Patients Enrolled

Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals

259 Previous Clinical Trials

250,612 Total Patients Enrolled

Media Library

Cemiplimab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02760498 — Phase 2

Squamous Cell Carcinoma Research Study Groups: Group 1, Group 2, Group 3, Group 4, Group 6

Squamous Cell Carcinoma Clinical Trial 2023: Cemiplimab Highlights & Side Effects. Trial Name: NCT02760498 — Phase 2

Cemiplimab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02760498 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what ailments is cemiplimab commonly prescribed?

"Cemiplimab is typically prescribed to those with the ALK gene mutation but can also assist in managing metastatic cutaneous squamous cell carcinoma and other varieties of malignant neoplasms."

Answered by AI

To what extent could cemiplimab be hazardous for individuals?

"Cemiplimab is assessed to be a 2 on our safety scale, as this Phase 2 trial only has limited data supporting its efficacy and some evidence of safety."

Answered by AI

Can you provide a synopsis of previous research involving cemiplimab?

"Currently, 56 trials of cemiplimab are in progress. Four of those investigations lie within Phase 3 and can be found across 1738 locations, with the bulk located around Barcelona and California."

Answered by AI

Is enrollment still an option for individuals seeking to join this clinical trial?

"Clinicaltrials.gov attests that this trial, which has been public since April 7 2016 and was last updated on December 23 2021, is currently not enrolling new patients. However, there are still 2644 other trials actively recruiting volunteers for their studies."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

Cemiplimab in Locally Advanced Cutaneous Squamous Cell Carcinoma: Results from an Open-label, Phase 2, Single-arm Trial

Migden, Michael R, Nikhil I Khushalani, Anne Lynn S Chang, Karl D Lewis, Chrysalyne D Schmults, Leonel Hernandez-Aya, Friedegund Meier, et al.. 2020. “Cemiplimab in Locally Advanced Cutaneous Squamous Cell Carcinoma: Results from an Open-label, Phase 2, Single-arm Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(19)30728-4.

Advances in TherapyJournal

Fixed Dose of Cemiplimab in Patients with Advanced Malignancies Based on Population Pharmacokinetic Analysis

Paccaly, Anne J., Michael R. Migden, Kyriakos P. Papadopoulos, Feng Yang, John D. Davis, Ronda K. Rippley, Israel Lowy, Matthew G. Fury, Elizabeth Stankevich, and Danny Rischin. 2021. “Fixed Dose of Cemiplimab in Patients with Advanced Malignancies Based on Population Pharmacokinetic Analysis”. Advances in Therapy. Springer Science and Business Media LLC. doi:10.1007/s12325-021-01638-5.

Journal for ImmunoTherapy of CancerJournal

Phase 2 Study of Cemiplimab in Patients with Metastatic Cutaneous Squamous Cell Carcinoma: Primary Analysis of Fixed-dosing, Long-term Outcome of Weight-based Dosing

Rischin, Danny, Michael R Migden, Annette M Lim, Chrysalyne D Schmults, Nikhil I Khushalani, Brett G M Hughes, Dirk Schadendorf, et al.. 2020. “Phase 2 Study of Cemiplimab in Patients with Metastatic Cutaneous Squamous Cell Carcinoma: Primary Analysis of Fixed-dosing, Long-term Outcome of Weight-based Dosing”. Journal for Immunotherapy of Cancer. BMJ. doi:10.1136/jitc-2020-000775.

Journal for ImmunoTherapy of CancerJournal