Phase II Trial of Pembrolizumab in Recurrent or Metastatic HNSCC

Phase 2

Active, not recruiting

• Conditions: Metastatic Head and Neck Squamous Cell Carcinoma; Recurrent Head and Neck Squamous Cell Carcinoma
• Interventions: Drug: Pembrolizumab

• Registration Number: NCT03813836
• Lead Sponsor: University College, London

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-15
• Study First Submitted QC: 2019-01-22
• Study First Posted: 2019-01-23
• Study Start: 2019-07-05
• Primary Completion: 2024-01-10
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-08
• Last Update Posted: 2024-11-12
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 63

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pembrolizumab + best supportive care	Pembrolizumab	Best supportive care and pembrolizumab 200mg every 3 weeks for a maximum duration of 24 months

Primary Outcome Measures

Name	Time	Method
Disease control rate at 24 weeks assessed using iRECIST	24 weeks after registration	Disease control rate (proportion of patients with CR, PR or SD) assessed using iRECIST

Secondary Outcome Measures

Name	Time	Method
Disease control rate assessed using iRECIST	12 months after registration	Disease control rate (proportion of patients with CR, PR or SD) assessed using iRECIST
Best Response Rate- measured using the change from baseline tumour size. Assessed using iRECIST.	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
Clinical Benefit Rate -defined as patient's best response rate lasting at least 18 weeks	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
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	Duration of Response, defined as the time from first documented evidence of CR or PR until disease progression or death
Time to Progression -defined as time from registration to the first documented disease progression	From registration to 30 months post start of treatment	Time to Progression, defined as time from registration to the first documented disease progression
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	Progression Free Survival, defined as the time from registration to the first documented disease progression or death due to any cause, whichever occurs first.
Overall Survival- defined as the time from registration to death due to any cause.	From registration to 30 months post start of treatment	Overall Survival, defined as the time from registration to death due to any cause.
Frequency and severity of adverse events- throughout the patient's treatment and until 6 months after completion of trial treatment.	From date of registration until 6 months after completion of trial treatment	Frequency and severity of adverse events

Trial Locations

Locations (12)

Aberdeen Royal Infirmary (NHS Grampian); 🇬🇧 Aberdeen, United Kingdom

Bristol Haematology and Oncology Centre (University Hospital Bristol NHS Foundation Trust); 🇬🇧 Bristol, United Kingdom

Western General Hospital (NHS Lothian); 🇬🇧 Edinburgh, United Kingdom

East Suffolk and North Essex NHS Foundation Trust; 🇬🇧 Ipswich, United Kingdom

Guy's and St Thomas' NHS Foundation Trust; 🇬🇧 London, United Kingdom

University College London Hospital; 🇬🇧 London, United Kingdom

The Christie NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom

East and North Hertfordshire NHS Trust; 🇬🇧 Northwood, United Kingdom

Queens Hospital (Barking, Havering and Redbridge University Hospitals NHS Trust); 🇬🇧 Romford, United Kingdom

Musgrove Park Hospital (Somerset NHS Foundation Trust); 🇬🇧 Taunton, United Kingdom

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