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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 31.8 months (database cutoff date 29-jul-2020)

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

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor

2,286 Previous Clinical Trials

4,582,124 Total Patients Enrolled

Merck Sharp & Dohme LLCLead Sponsor

3,887 Previous Clinical Trials

5,054,815 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,063,705 Total Patients Enrolled

Frequently Asked Questions

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

Is enrollment for this medical experiment still open to participants?

"Unfortunately, the recruitment period of this clinical trial has already concluded and it was last modified on June 30th 2022. Currently, there are 2592 studies for squamous cell carcinoma and 961 Pembrolizumab trials actively seeking participants if you are searching for other opportunities to get involved in medical research."

Answered by AI

What therapeutic applications does Pembrolizumab have?

"Pembrolizumab has been approved for use in treating malignant tumours, unresectable melanoma, and microsatellite instability high."

Answered by AI

Has the federal regulatory agency given its blessing to Pembrolizumab?

"The safety of Pembrolizumab is appraised at 2, as it has been evaluated in Phase 2 trials with demonstrated security but no efficacy."

Answered by AI

What is the breadth of this study's geographical management?

"Currently, 19 clinics are participating in this trial. Locations include La Jolla, New Haven and Tulsa as well as 16 other destinations. To reduce unnecessary travel costs, it is best to check the nearest clinic for participation opportunities."

Answered by AI

To how many test subjects has the clinical trial been extended?

"Unfortunately, this experiment is no longer actively recruiting volunteers. It was initially launched on October 26th 2017 and had its last update on June 30th 2022. If you're searching for an alternate study, there are presently 2592 trials exploring squamous cell carcinoma and 961 studies involving Pembrolizumab that are currently taking participants."

Answered by AI

Could you please provide insights into the past research involving Pembrolizumab?

"The initial research into pembrolizumab began at City of Hope in 2010, and since then 251 studies have been concluded. At present, 961 clinical trials are ongoing; many conducted out La Jolla, California."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Pembrolizumab Monotherapy for Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma: A Single-arm Phase II Trial (KEYNOTE-629)

Grob, Jean-Jacques, Rene Gonzalez, Nicole Basset-Seguin, Olga Vornicova, Jacob Schachter, Abhishek Joshi, Nicolas Meyer, et al.. 2020. “Pembrolizumab Monotherapy for Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma: A Single-arm Phase II Trial (KEYNOTE-629)”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.19.03054.

Dermatology and TherapyJournal

Hughes, Brett G. M., Rene Gonzalez Mendoza, Nicole Basset-Seguin, Olga Vornicova, Jacob Schachter, Abhishek Joshi, Nicolas Meyer, et al.. 2021. “Health-related Quality of Life of Patients with Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma Treated with Pembrolizumab in KEYNOTE-629”. Dermatology and Therapy. Springer Science and Business Media LLC. doi:10.1007/s13555-021-00598-6.

Dermatology and TherapyJournal

clinicaltrials.govStudy

Study of Pembrolizumab (MK-3475) in Adults With Recurrent/Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) or Locally Advanced Unresectable cSCC (MK-3475-629/KEYNOTE-629)

2017. "Study of Pembrolizumab (MK-3475) in Adults With Recurrent/Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) or Locally Advanced Unresectable cSCC (MK-3475-629/KEYNOTE-629)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03284424.