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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 below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 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
Secondary outcome measures
Overall Survival
Progression Free Survival

Side effects data

From 2023 Phase 3 trial • 608 Patients • NCT03257267
25%
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.
~1 spots leftby Mar 2025