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PD-1 Inhibitor
Cemiplimab-rwlc treatment for Squamous Cell Carcinoma
Phase 2
Waitlist Available
Led By Christine H Chung, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Note: In lieu of individual consults performed during screening, it will suffice to document the contraindication of surgery and radiation therapy via a clinic note from the investigator indicating that an individualized benefit:risk assessment was performed by a multidisciplinary team (consisting of, at minimum, a radiation oncologist AND EITHER a medical oncologist with expertise in cutaneous malignancies OR a dermato-oncologist, OR a head and neck surgeon) within 60 days prior to enrollment in the proposed study, and the radiation therapy was deemed to be contraindicated. This is not required for patients with distant metastatic disease.
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Study Summary
This trial will test how well a new immunotherapy drug works in people with skin cancer that has spread and can't be removed by surgery.
Eligible Conditions
- Squamous Cell Carcinoma
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
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
Secondary outcome measures
Overall Survival
Progression Free Survival
Side effects data
From 2023 Phase 3 trial • 608 Patients • NCT0325726725%
Anaemia
20%
Nausea
17%
Fatigue
16%
Vomiting
15%
Decreased appetite
15%
Constipation
11%
Asthenia
11%
Back pain
11%
Pyrexia
11%
Diarrhoea
10%
Arthralgia
9%
Urinary tract infection
9%
Dyspnoea
9%
Abdominal pain
7%
Cough
7%
Oedema peripheral
7%
Hypoalbuminaemia
7%
Headache
6%
Pain in extremity
6%
Rash
6%
Blood creatinine increased
6%
Insomnia
6%
Hypokalaemia
6%
Hypothyroidism
5%
Pruritus
5%
Vaginal haemorrhage
4%
Alanine aminotransferase increased
4%
Aspartate aminotransferase increased
4%
Pelvic pain
4%
Stomatitis
3%
Neutropenia
2%
Acute kidney injury
1%
Febrile neutropenia
1%
Pneumonia
1%
Pyelonephritis
1%
Autoimmune hepatitis
1%
Immune-mediated hepatitis
1%
Thrombocytopenia
1%
Neutrophil count decreased
1%
Pyelonephritis acute
1%
White blood cell count decreased
1%
Sepsis
1%
Duodenal ulcer
1%
Haematuria
1%
Hydronephrosis
1%
Hyperpyrexia
1%
Kidney infection
1%
Pneumonitis
1%
Hyperglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cemiplimab
Investigator Choice (IC) Chemotherapy
Trial Design
1Treatment groups
Experimental Treatment
Group I: Cemiplimab-rwlc treatmentExperimental Treatment1 Intervention
Immunocompromised patients will be given Cemiplimab-rwlc every 3 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab-Rwlc
2019
Completed Phase 2
~40
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
537 Previous Clinical Trials
134,988 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
613 Previous Clinical Trials
379,456 Total Patients Enrolled
Christine H Chung, MDPrincipal InvestigatorMoffitt Cancer Center
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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