PD-1 Inhibitor

Pembrolizumab 200 mg for Head and Neck Cancers

Beacon Cancer Care ( Site 2052), Post Falls, ID

Pembrolizumab 200 mg +4 morePhase 3RecruitingResearch 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

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upup to ~92 months

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Pivotal Trial

Study Summary

This trial is testing whether adding pembrolizumab to radiotherapy (with or without cisplatin) before and after surgery improves outcomes in people with newly diagnosed, resectable head and neck squamous cell carcinoma.

Eligible Conditions

Head and Neck Cancers

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~92 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to ~92 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~92 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

Event-free Survival (EFS)

Secondary outcome measures

Change From Baseline in Global Health Status/Physical Functioning Scales

Change From Baseline in Global Health Status/Quality of Life Scale (GHS/QoL)

Change from Baseline in Swallowing, Speech, and Pain Symptoms

+5 more

Side effects data

From 2023 Phase 3 trial • 616 Patients • NCT02578680

55%

Nausea

44%

Anaemia

40%

Fatigue

34%

Constipation

28%

Decreased appetite

28%

Diarrhoea

26%

Neutropenia

23%

Vomiting

21%

Cough

20%

Rash

20%

Dyspnoea

19%

Asthenia

19%

Oedema peripheral

18%

Pyrexia

17%

Lacrimation increased

16%

Thrombocytopenia

13%

Back pain

12%

Alanine aminotransferase increased

12%

Headache

11%

Hypokalaemia

11%

Blood creatinine increased

11%

Pruritus

11%

Dizziness

11%

Dysgeusia

Stomatitis

Mucosal inflammation

Upper respiratory tract infection

Aspartate aminotransferase increased

Weight decreased

Hypomagnesaemia

Arthralgia

Chest pain

Conjunctivitis

Nasopharyngitis

Pain in extremity

Urinary tract infection

Hyperglycaemia

Abdominal pain

Epistaxis

White blood cell count decreased

Febrile neutropenia

Pneumonia

Leukopenia

Hypothyroidism

Musculoskeletal pain

Abdominal pain upper

Dyspepsia

Insomnia

Hypophosphataemia

Erythema

Paraesthesia

Oropharyngeal pain

Productive cough

Rhinorrhoea

Alopecia

Dry skin

Pneumonitis

Haemoptysis

Acute kidney injury

Sepsis

Myocardial infarction

Pancytopenia

Death

General physical health deterioration

Bronchitis

Cellulitis

Lung infection

Dehydration

Cancer pain

Pleural effusion

Pulmonary embolism

Cardiac failure

Chronic obstructive pulmonary disease

Gastroenteritis

Colitis

Cerebrovascular accident

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab

Control

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pembro Neoadjuvant+Pembro SOC AdjuvantExperimental Treatment5 Interventions

Participants receive 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles as a neoadjuvant prior to surgery. Following surgical resection, high risk participants receive 200 mg pembrolizumab by IV infusion administered on Day 1 every 3 weeks (Q3W) for fifteen 21-day cycles plus standard of care radiotherapy plus cisplatin 100 mg/m^2 by IV infusion on Day 1 Q3W for three 21-day cycles as adjuvant therapy. Following surgical resection, low risk participants receive 200 mg pembrolizumab by IV infusion administered on Day 1 Q3W for fifteen 21-day cycles plus standard of care radiotherapy as adjuvant therapy.

Group II: No Neoadjuvant+SOC AdjuvantActive Control4 Interventions

Participants receive no neoadjuvant prior to surgery. Following surgical resection, high risk participants receive standard of care radiotherapy plus cisplatin 100 mg/m^2 by IV infusion on Day 1 Q3W for three 21-day cycles as adjuvant therapy. Following surgical resection, low risk participants receive standard of care radiotherapy as adjuvant therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

FDA approved

Do I qualify?Apply below to find out

Find a site

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor

2,286 Previous Clinical Trials

4,577,369 Total Patients Enrolled

Merck Sharp & Dohme LLCLead Sponsor

3,795 Previous Clinical Trials

5,001,604 Total Patients Enrolled

Medical DirectorStudy Director

Merck Sharp & Dohme LLC

2,710 Previous Clinical Trials

7,991,727 Total Patients Enrolled

Media Library

Pembrolizumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03765918 — Phase 3

Head and Neck Cancers Research Study Groups: Pembro Neoadjuvant+Pembro SOC Adjuvant, No Neoadjuvant+SOC Adjuvant

Head and Neck Cancers Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03765918 — Phase 3

Pembrolizumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03765918 — Phase 3

Frequently Asked Questions

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

What is the history of Pembrolizumab 200 mg in medical research?

"The first study involving pembrolizumab 200 mg was conducted at City of Hope Comprehensive Cancer Center in 1997. As of now, there have been 1158 completed studies and 1619 ongoing trials. A large number these clinical trials are based in Pittsburgh, Pennsylvania."

Answered by AI

The FDA has greenlit Pembrolizumab 200 mg, correct?

"Pembrolizumab 200 mg is considered safe because it has passed Phase 3 clinical trials. This means that not only does the medication show some efficacy, but also that there are multiple rounds of data supporting its safety."

Answered by AI

In how many distinct locations is this clinical trial running?

"Presently, 44 medical facilities are recruiting patients for this study with locations such as Pittsburgh, Sioux Falls and Bethlehem. It would be advantageous to choose the clinical trial site nearest you to limit travel time if enrolled."

Answered by AI

Are patients still being recruited for this research project?

"Yes, this information can be found on the website clinicaltrials.gov. The trial was created on December 17th, 2018 and has been updated as recently as November 7th, 2020."

Answered by AI

How many test subjects are participating in this experiment?

"Yes, this is an ongoing study that is recruiting patients from 44 different sites. According to the listing on clinicaltrials.gov, 704 people are needed for the trial. The dates you provided are accurate - it was posted on 12/17/2018 and last updated on 11/7/2022."

Answered by AI

What goals does this research hope to achieve?

"According to the sponsor of this clinical trial, Merck Sharp & Dohme Corp., the primary outcome being measured over a period of up to 5 years is Major Pathological Response (mPR). In addition to measuring the primary outcome, this trial will also be measuring secondary outcomes including Percentage of Participants Experiencing An Adverse Event (AEs), which is defined as the percentage of participants experiencing any sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study therapy. Anothersecondary outcome being measured is Pathological Complete Response (pCR), which is defined"

Answered by AI

What are the standard conditions that Pembrolizumab 200 mg is used to address?

"Pembrolizumab 200 mg is the standard care medication for treating malignant neoplasms. However, this immunotherapy can also be useful in other cases such as unresectable melanoma, microsatellite instability high, and instances where there is a high risk of recurrence."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)

2018. "Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03765918.

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