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PD-1 Inhibitor

Pembrolizumab for Squamous Cell Carcinoma

Phase 2
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
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 approximately 31.8 months (database cutoff date 29-jul-2020)
Awards & highlights

Study Summary

This trial will test if pembrolizumab is an effective treatment for people with advanced skin cancer that can't be removed by surgery or other treatments.

Eligible Conditions
  • Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 31.8 months (database cutoff date 29-jul-2020)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 31.8 months (database cutoff date 29-jul-2020) 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 Rate (ORR)
Secondary outcome measures
Disease Control Rate (DCR)
Duration of Response (DOR)
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
+3 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

2Treatment groups
Experimental Treatment
Group I: R/M cSCC cohortExperimental Treatment1 Intervention
Participants with R/M cSCC receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to approximately 2 years.
Group II: LA cSCC cohortExperimental Treatment1 Intervention
Participants with LA cSCC receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to approximately 2 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,853 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,908 Previous Clinical Trials
5,066,528 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,790 Previous Clinical Trials
8,067,490 Total Patients Enrolled
~21 spots leftby Jun 2025
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