Phase II Trial of Pembrolizumab in Recurrent or Metastatic HNSCC (POPPY)

November 8, 2024 updated by: University College, London

A Phase II Trial to Assess the Efficacy and Safety Profile of Pembrolizumab in Patients With Performance Status 2 With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

A single-arm phase II trial to assess the efficacy and safety profile of pembrolizumab in patients with performance status of 2 with recurrent or metastatic squamous cell carcinoma of the head and neck. Patients will receive best supportive care + pembrolizumab 200mg every 3 weeks for a maximum duration of 24 months

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
      • Aberdeen, United Kingdom
        • Aberdeen Royal Infirmary (NHS Grampian)
      • Bristol, United Kingdom
        • Bristol Haematology and Oncology Centre (University Hospital Bristol NHS Foundation Trust)
      • Edinburgh, United Kingdom
        • Western General Hospital (NHS Lothian)
      • Ipswich, United Kingdom
        • East Suffolk and North Essex NHS Foundation Trust
      • London, United Kingdom
        • University College London Hospital
      • London, United Kingdom
        • Guy's and St Thomas' NHS Foundation Trust
      • Manchester, United Kingdom
        • The Christie NHS Foundation Trust
      • Northwood, United Kingdom
        • East and North Hertfordshire NHS Trust
      • Romford, United Kingdom
        • Queens Hospital (Barking, Havering and Redbridge University Hospitals NHS Trust)
      • Taunton, United Kingdom
        • Musgrove Park Hospital (Somerset NHS Foundation Trust)
      • Truro, United Kingdom
        • Royal Cornwall Hospital Trust
      • Wirral, United Kingdom
        • The Clatterbridge Cancer Centre NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Histologically confirmed locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck that is considered incurable by local therapies
  2. Measurable disease evaluated by RECIST criteria version 1.1
  3. WHO performance status of 2
  4. Life expectancy >12 weeks
  5. Aged ≥18 years of age
  6. Adequate bone marrow function
  7. Adequate renal function
  8. Adequate liver function
  9. Willing to use highly effective contraception for the duration of trial treatment and for 120 days after completion of treatment
  10. Able to give informed consent, indicating that the patient has been informed of and understands the experimental nature of the study, possible risks and benefits, trial procedures, and alternative options
  11. Willing and able to comply with the protocol for the duration of the study, including the treatment plan, investigations required and follow up visits

Exclusion Criteria:

  1. Patients with undifferentiated nasopharyngeal or sino-nasal cancers
  2. Disease suitable for treatment with curative intent
  3. Prior therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent
  4. Any investigational agents within 4 weeks prior to registration
  5. Anti-cancer monoclonal antibody therapy within 4 weeks prior to registration
  6. Chemotherapy, targeted small molecule therapy, or radiotherapy within 2 weeks prior to registration
  7. Patients with concurrent or previous malignancy that could compromise assessment of the primary or secondary endpoints of the trial
  8. Women who are pregnant or breast feeding
  9. Grade 3 or 4 peripheral neuropathy
  10. Any serious and/or unstable pre-existing medical, psychiatric or other condition that, in the treating clinician's judgment, could interfere with patient safety or obtaining informed consent
  11. Active central nervous system (CNS) metastases and/or carcinomatous meningitis
  12. Active hepatitis B or C infection
  13. Immunocompromised patients (e.g. known HIV positive status)
  14. Prior organ transplantation including allogenic stem-cell transplantation
  15. History of (non-infectious) pneumonitis/interstitial lung disease that required steroids, or current pneumonitis/interstitial lung disease
  16. Active infection requiring systemic therapy
  17. Received a live vaccine within 30 days prior to registration
  18. Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
  19. Active autoimmune disease that might deteriorate when receiving an immune-stimulatory agent.
  20. Current use of immunosuppressive medication (exceptions apply) Refer to section 7.2 for full list of eligibility criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: pembrolizumab + best supportive care
Best supportive care and pembrolizumab 200mg every 3 weeks for a maximum duration of 24 months
Drug: Pembrolizumab
Patients will receive best supportive care + pembrolizumab 200mg every 3 weeks for a maximum duration of 24 months
Other Names:
  • Keytruda

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Disease control rate at 24 weeks assessed using iRECIST
Time Frame: 24 weeks after registration
Disease control rate (proportion of patients with CR, PR or SD) assessed using iRECIST
24 weeks after registration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Disease control rate assessed using iRECIST
Time Frame: 12 months after registration
Disease control rate (proportion of patients with CR, PR or SD) assessed using iRECIST
12 months after registration
Best Response Rate- measured using the change from baseline tumour size. Assessed using iRECIST.
Time Frame: 6 months after registration
Best Response Rate, defined as proportion of patients who have a CR or PR as their best response, measured using the change from baseline tumour size, assessed using iRECIST
6 months after registration
Clinical Benefit Rate -defined as patient's best response rate lasting at least 18 weeks
Time Frame: From start of treatment to 30 months post start of treatment
Clinical Benefit Rate, defined as proportion patients who have achieved CR, PR or SD as their best response lasting at least 18 weeks
From start of treatment to 30 months post start of treatment
Duration of Response- defined as the time from first documented evidence of CR or PR until disease progression or death.
Time Frame: From start of treatment to 30 months post start of treatment
Duration of Response, defined as the time from first documented evidence of CR or PR until disease progression or death
From start of treatment to 30 months post start of treatment
Time to Progression -defined as time from registration to the first documented disease progression
Time Frame: From registration to 30 months post start of treatment
Time to Progression, defined as time from registration to the first documented disease progression
From registration to 30 months post start of treatment
Progression Free Survival defined as the time from registration to the first documented disease progression or death due to any cause, whichever occurs first.
Time Frame: From registration to 30 months post start of treatment
Progression Free Survival, defined as the time from registration to the first documented disease progression or death due to any cause, whichever occurs first.
From registration to 30 months post start of treatment
Overall Survival- defined as the time from registration to death due to any cause.
Time Frame: From registration to 30 months post start of treatment
Overall Survival, defined as the time from registration to death due to any cause.
From registration to 30 months post start of treatment
Frequency and severity of adverse events- throughout the patient's treatment and until 6 months after completion of trial treatment.
Time Frame: From date of registration until 6 months after completion of trial treatment
Frequency and severity of adverse events
From date of registration until 6 months after completion of trial treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University College, London

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Merck Sharp & Dohme LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Martin Forster, FRCP PhD, University College, London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 5, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 10, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 15, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UCL/17/0396

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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