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PD-1 Inhibitor

cemiplimab for Basal 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 up to 40 months

Awards & highlights

Study Summary

This trial is testing a new cancer treatment for people with metastatic or locally advanced basal cell carcinoma.

Eligible Conditions

Basal Cell Carcinoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 40 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 40 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 40 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

Objective Response Rates (ORR) as Assessed by Independent Central Review (ICR)

Secondary outcome measures

Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

Change From Baseline of Patient-reported Outcomes in Skindex-16 Questionnaire

Duration of Response (DOR) Per ICR

+9 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

2Treatment groups

Experimental Treatment

Group I: Group 2 - unresectable locally advanced BCCExperimental Treatment1 Intervention

Administration of cemiplimab in accordance with protocol dosing regimen

Group II: Group 1- metastatic BCCExperimental Treatment1 Intervention

Administration of cemiplimab in accordance with protocol dosing regimen

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

619 Previous Clinical Trials

380,117 Total Patients Enrolled

SanofiIndustry Sponsor

2,164 Previous Clinical Trials

3,514,842 Total Patients Enrolled

Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals

261 Previous Clinical Trials

250,926 Total Patients Enrolled

Frequently Asked Questions

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

How many medical facilities are currently conducting this trial?

"Presently, there are 27 clinical trial sites administering this medical study. These include cities like Boston, Tampa and New york; among 24 other locations. It is wise to select a clinic in your vicinity to reduce the burden of travelling if you decide to participate."

Answered by AI

Is this experiment actively seeking participants?

"According to the records on clinicaltrials.gov, this research trial is not presently accepting participants. Initially posted on June 29th 2017 and last updated on June 30th 2022, no new volunteers are being sought for now; however there are 2532 other studies that currently require enrolment."

Answered by AI

How many recruits are being admitted to this experiment?

"This clinical trial is not seeking new participants as of this writing. First posted on June 29th 2017 and last updated on June 30th 2022, it is no longer accepting applications for enrolment. For those looking to participate in a similar medical study, there are 2476 active trials that involve carcinoma or basal cell research; likewise 56 studies making use of cemiplimab have open spots available."

Answered by AI

In what ways is cemiplimab typically employed?

"Cemiplimab is frequently administered as a treatment for alk gene mutations. Additionally, the medication can be used to combat metastatic cutaneous squamous cell carcinoma and other advanced neoplasms."

Answered by AI

Are there any analogous experiments conducted with cemiplimab?

"As of the current moment, there are 56 trails studying cemiplimab with 4 being in late-stage clinical trials. Although Barcelona and California are primary locations for these tests, a total of 1738 sites around the world have been identified to run them."

Answered by AI

Has cemiplimab attained the endorsement of federal regulatory agencies?

"Currently, cemiplimab has been allocated a safety rating of 2. This is because this Phase 2 trial supports the drug's safety but does not yet display any evidence for its efficacy."

Answered by AI

Recent research and studies

BMJ Case ReportsJournal

Rare Basal Cell Metastasis of a Basal-squamous Skin Collision Tumour to the Lung and Axillary Lymph Node

Li, Rui, Gina Lee, Min Huang, and Ahmed El-Sherief. 2019. “Rare Basal Cell Metastasis of a Basal-squamous Skin Collision Tumour to the Lung and Axillary Lymph Node”. BMJ Case Reports. BMJ. doi:10.1136/bcr-2019-231487.

The Lancet OncologyJournal

Cemiplimab in Locally Advanced Basal Cell Carcinoma After Hedgehog Inhibitor Therapy: An Open-label, Multi-centre, Single-arm, Phase 2 Trial

Stratigos, Alexander J, Aleksandar Sekulic, Ketty Peris, Oliver Bechter, Sorilla Prey, Martin Kaatz, Karl D Lewis, et al.. 2021. “Cemiplimab in Locally Advanced Basal Cell Carcinoma After Hedgehog Inhibitor Therapy: An Open-label, Multi-centre, Single-arm, Phase 2 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(21)00126-1.

clinicaltrials.govStudy

PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy

2017. "PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03132636.