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Cemiplimab-Rwlc for Head and Neck Squamous Cell Carcinoma

Phase 2
Waitlist Available
Led By Cesar Perez, MD
Research Sponsored by University of Miami
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 2 years
Awards & highlights

Study Summary

This study is evaluating whether a new immunotherapy drug may help improve outcomes for individuals with head and neck cancer.

Eligible Conditions
  • Head and Neck Squamous Cell Carcinoma
  • Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-Free Survival (PFS)
Secondary outcome measures
Incidence of Treatment-Related Toxicity and Adverse Events
Overall Survival (OS)
PFS Rate

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%
Immune-mediated hepatitis
1%
Autoimmune hepatitis
1%
Febrile neutropenia
1%
Pneumonia
1%
Pyelonephritis
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 After CRT in HNSCCExperimental Treatment1 Intervention
Participants will receive Cemiplimab for 6 consecutive months (a total of 8 cycles) 14-42 days after completion of standard of care CRT.
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?

University of MiamiLead Sponsor
898 Previous Clinical Trials
409,651 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
613 Previous Clinical Trials
379,758 Total Patients Enrolled
Cesar Perez, MDPrincipal InvestigatorUniversity of Miami

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Phase 2 Trial of Maintenance Cemiplimab for Head and Neck Squamous Cell Carcinoma (HNSCC)
Chukwuemeka Ikpeazu 2022. "Phase 2 Trial of Maintenance Cemiplimab for Head and Neck Squamous Cell Carcinoma (HNSCC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04831450.
~0 spots leftby Apr 2025
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