Head and Neck CancerPhase 2NCT02609503
Pembrolizumab + Radiation for Locally Adv SCC of the Head and Neck (SCCHN) Not Eligible Cisplatin
A Phase 2 study testing Pembrolizumab and Intensity Modulated Radiation Therapy in people with Head and Neck Cancer, run by UNC Lineberger Comprehensive Cancer Center at 3 sites in United States.
Trial summary
This study is being done to evaluate the efficacy of Pembrolizumab, concomitant with and following standard of care definitive radiation, for locally advanced squamous cell carcinoma of the head and neck patients who are not good candidates for Cisplatin. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Pembrolizumab and Intensity Modulated Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 May 2016to 20 Nov 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be willing and able to provide written informed consent/assent for the trial
- Be greater than or equal to 18 years of age
- Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 1
- Histologically or cytologically confirmed stage III-IV (non-metastatic) squamous cell carcinoma of the head and neck as defined by American Joint Committee on Cancer. Nasopharyngeal cancer patients will be excluded.
- Ineligible for high dose cisplatin therapy; the reason for ineligibility must be defined.
- Demonstrate adequate organ function. All screening labs should be performed within 14 days of treatment initiation.
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- No prior curative attempts for this cancer (i.e., surgery, radiation and/or other).
- Female patients of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. Serum pregnancy test may be required.
- Female patients of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication.
- Male patients should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
- As determined by the enrolling physician or protocol designee, ability of the patient to understand and comply with study procedures for the entire length of the study.
- Consent for the use of any residual material from biopsy (archival tissue) and serial blood draws will be required for enrollment.
Who cannot join
- If currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
- Has a 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.
- Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered from adverse events due to agents administered more than 4 weeks earlier
- Had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered from adverse events due to a previously administered agent.
- Has a known additional malignancy that is metastatic, progressing or requires active treatment.
- Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease even if resolved; patients with vitiligo or resolved childhood asthma/atopy would be an exception to this rule.
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- Has clinical or radiologic evidence of interstitial lung disease or active, non-infectious pneumonitis
- Has an active infection requiring systemic therapy.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Has inadequate home environment or social support to safely complete the trial procedures.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
- Has received prior therapy with an anti-programmed cell death (PD-1), anti-PD-L1, anti-PD-L1, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody.
- Has a known history of Human Immunodeficiency Virus (HIV) HIV 1/2 antibodies) Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C )e.g., HCV RNA [qualitative] is detected).
- Has received a live vaccine within 30 days prior to the first dose of trial treatment.
- Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
Trial locations and contacts
3 sites in 1 country.
United States3 sites
John Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: Pembrolizumab and Radiation for Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) Not Eligible for Cisplatin Therapy
This study is being done to evaluate the efficacy of Pembrolizumab, concomitant with and following standard of care definitive radiation, for locally advanced squamous cell carcinoma of the head and neck patients who are not good candidates for Cisplatin.
Read the detailed description
This open label, phase II trial will enroll 29 subjects in order to evaluate the efficacy of Pembrolizumab, concomitant with and following standard of care definitive radiation for locally advanced squamous cell carcinoma head and neck patients who are not good candidates for Cisplatin. Objectives include estimating progression free survival and overall survival, response rates, safety and toxicity, and quality of life in these patients. Correlative studies, based on serial blood collections and tumor samples, may be done under a separate protocol based on availability of archival diagnostic tissue.
- Conditions
- Head and Neck Cancer
- Being tested
- Pembrolizumab, Intensity Modulated Radiation Therapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called Keytruda
Pembrolizumab, 200 mg IV during cycle visits every 3-weeks for up to 6 cycles, or until toxicities are no longer tolerable
Intensity Modulated Radiation TherapyRadiation
Also called IMRT
Eligible participants will receive Intensity Modulated Radiation Therapy daily x 7 weeks
| Study group | Role | What they receive |
|---|---|---|
| Open label | Experimental | Pembrolizumab Receives: Drug: Pembrolizumab |
| Radiation | Other | Intensity Modulated Radiation Therapy (IMRT) Receives: Radiation: Intensity Modulated Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
20 Week Progression Free Survival Rate
the proportion of patients who are alive and free of progression from disease at 20 weeks from the start of treatment
Measured: 20 weeks after D1 of treatment
One Year Progression Free Survival Rate
the proportion of patients who are alive and free of progression from disease atoneyears from the start of treatment
Measured: 1 years after D1 of treatment
Two Year Progression Free Survival Rate
the proportion of patients who are alive and free of progression from disease at two years from the start of treatment
Measured: 2 years after D1 of treatment
Median Progression Free Survival
Progression-free survival is defined as the time from D1 of treatment to progression or death from any cause. The median was not reached, thus Kaplan Meier's estimated rate at 5 years is reported.
Measured: up to 5 years after D1 of treatment
Secondary outcomes (9)
One Year Overall Survival Rate
the proportion of patients who are alive at one year after Day 1 of treatment
Measured: 1 year after Day 1 of treatment
Two Year Overall Survival Rate
the proportion of patients who are alive at two years after Day 1 of treatment
Measured: 2 years after Day 1 of treatment
Proportion of Participants Who Received <95% of Intended Dose of Radiation
Evaluate the safety of the proposed regimen by Estimating the proportion of patients who receive <95% of the intended dose of radiation (i.e., <67 Gray)
Measured: 7 weeks
Number of Participants With Clinically Relevant Adverse Events
Safety was assessed by documenting clinically relevant adverse events, defined as events reported by both the clinician and participant related to concurrent radiation plus pembrolizumab. Clinicians classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0). The grading (severity) scale for each AE term: Grade (G) 1 Mild; asymptomatic/mild symptoms; clinical/diagnostic observations only; G 2 Moderate; G 3 Severe or medically significant but not immediately life-threatening; hospitalization/prolongation of hospitalization indicated; disabling; G 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. Patient assessed toxicity were classified based on the Patient-Reported Outcome version of the CTCAE (PRO-CTCAE) which measures the severity, interference, and frequency of events on a 5 point likert scale (0-4) with a higher score indicating worse or more bothersome event
Measured: Monitored continuously from D1 of treatment through 40 weeks.
Overall Response Rate
Overall response rate will be determined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) which defines Complete Response (CR) as Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Overall Response Rate (ORR) = CR + PR/total number of subjects.
Measured: 2 years after start of treatment
Complete Response Rate
complete response rate will be determined using RECIST 1.1 and is defined as the percentage of participants who achieve a Complete response (CR)-Disappearance of all target lesions. Any pathological lymph node (LN) (whether target or non-target) must have decreased in short axis to <10mm.
Measured: 2 years after start of treatment
Five Years Locoregional Recurrence Rate
Time to locoregional recurrence is defined from Day 1 of treatment until the first locoregional progression
Measured: 5 years from start of treatment
Five Years Distant Metastasis Rate
Time to distant metastasis is defined as the time from day 1 of treatment to progression of disease at a distant site; deaths or other progressions will be censored
Measured: 5 years from start of treatment
Quality of Life Measured by Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN)
The FACT-HN is the FACT-General (FACT-G) and a head and neck cancer specific (HNC) subscale given at baseline, at end of treatment, and at first follow-up visit. The FACT-G is a measure of general QOL with Items rated by patients on a Likert scale from 0 to 4, assessing function in 4 domains: physical well-being (PWB) (7 items, score range 0-28), social-family well-being (SFWB) (7 items, score range 0-28), emotional well-being (EWB) (6 items, score range 0-24) and functional well-being (FWB) (7 items, score range 0-28). The HNC subscale has 12 items and a score range from 0 to 48. Higher scores represent better QOL.
Measured: At baseline, 10 and 20 weeks after initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study start16 May 2016
- Primary completion23 Dec 2019
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Jared Weiss, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609503
- Sponsor's protocol ID
- LCCC1509
- Status last verified
- Oct 2024
- First submitted
- 12 Nov 2015
- Last updated
- 5 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Weiss J, Sheth S, Deal AM, Grilley Olson JE, Patel S, Hackman TG, Blumberg JM, Galloway TJ, Patel S, Zanation AM, Shen CJ, Hayes DN, Hilliard C, Mehra R, McKinnon KP, Wang HH, Weissler MC, Bauman JR, Chera BS, Vincent BG. Concurrent Definitive Immunoradiotherapy for Patients with Stage III-IV Head and Neck Cancer and Cisplatin Contraindication. Clin Cancer Res. 2020 Aug 15;26(16):4260-4267. doi: 10.1158/1078-0432.CCR-20-0230. Epub 2020 May 5.
PubMed 32371539
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pembrolizumab and Radiation for Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) Not Eligible for Cisplatin Therapy
- ClinicalTrials.gov ID
- NCT02609503
- Acronym / sponsor ID
- LCCC1509
- Conditions
- Head and Neck Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 16 May 2016 (actual)
- Primary completion
- 23 Dec 2019 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Posted 19 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to evaluate the efficacy of Pembrolizumab, concomitant with and following standard of care definitive radiation, for locally advanced squamous cell carcinoma of the head and neck patients who are not good candidates for Cisplatin.
Detailed description
This open label, phase II trial will enroll 29 subjects in order to evaluate the efficacy of Pembrolizumab, concomitant with and following standard of care definitive radiation for locally advanced squamous cell carcinoma head and neck patients who are not good candidates for Cisplatin. Objectives include estimating progression free survival and overall survival, response rates, safety and toxicity, and quality of life in these patients. Correlative studies, based on serial blood collections and tumor samples, may be done under a separate protocol based on availability of archival diagnostic tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open label | Experimental | Drug: PembrolizumabPembrolizumab |
| Radiation | Other | Radiation: Intensity Modulated Radiation TherapyIntensity Modulated Radiation Therapy (IMRT) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Be willing and able to provide written informed consent/assent for the trial
- Be greater than or equal to 18 years of age
- Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 1
- Histologically or cytologically confirmed stage III-IV (non-metastatic) squamous cell carcinoma of the head and neck as defined by American Joint Committee on Cancer. Nasopharyngeal cancer patients will be excluded.
- Ineligible for high dose cisplatin therapy; the reason for ineligibility must be defined.
Key exclusion criteria (16 listed)
- If currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
- Has a 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.
- Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered from adverse events due to agents administered more than 4 weeks earlier
- Had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered from adverse events due to a previously administered agent.
- Has a known additional malignancy that is metastatic, progressing or requires active treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabAlso: KeytrudaPembrolizumab, 200 mg IV during cycle visits every 3-weeks for up to 6 cycles, or until toxicities are no longer tolerable | Drug | Open label |
| Intensity Modulated Radiation TherapyAlso: IMRTEligible participants will receive Intensity Modulated Radiation Therapy daily x 7 weeks | Radiation | Radiation |
Primary outcome
20 Week Progression Free Survival Rate
Time frame: 20 weeks after D1 of treatment
the proportion of patients who are alive and free of progression from disease at 20 weeks from the start of treatment
One Year Progression Free Survival Rate
Time frame: 1 years after D1 of treatment
the proportion of patients who are alive and free of progression from disease atoneyears from the start of treatment
Two Year Progression Free Survival Rate
Time frame: 2 years after D1 of treatment
the proportion of patients who are alive and free of progression from disease at two years from the start of treatment
Median Progression Free Survival
Time frame: up to 5 years after D1 of treatment
Progression-free survival is defined as the time from D1 of treatment to progression or death from any cause. The median was not reached, thus Kaplan Meier's estimated rate at 5 years is reported.
9 secondary outcomes
One Year Overall Survival Rate
Time frame: 1 year after Day 1 of treatment
Two Year Overall Survival Rate
Time frame: 2 years after Day 1 of treatment
Proportion of Participants Who Received <95% of Intended Dose of Radiation
Time frame: 7 weeks
Number of Participants With Clinically Relevant Adverse Events
Time frame: Monitored continuously from D1 of treatment through 40 weeks.
Overall Response Rate
Time frame: 2 years after start of treatment
Complete Response Rate
Time frame: 2 years after start of treatment
Five Years Locoregional Recurrence Rate
Time frame: 5 years from start of treatment
Five Years Distant Metastasis Rate
Time frame: 5 years from start of treatment
Quality of Life Measured by Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN)
Time frame: At baseline, 10 and 20 weeks after initiation of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32371539Weiss J, Sheth S, Deal AM, Grilley Olson JE, Patel S, Hackman TG, Blumberg JM, Galloway TJ, Patel S, Zanation AM, Shen CJ, Hayes DN, Hilliard C, Mehra R, McKinnon KP, Wang HH, Weissler MC, Bauman JR, Chera BS, Vincent BG. Concurrent Definitive Immunoradiotherapy for Patients with Stage III-IV Head and Neck Cancer and Cisplatin Contraindication. Clin Cancer Res. 2020 Aug 15;26(16):4260-4267. doi: 10.1158/1078-0432.CCR-20-0230. Epub 2020 May 5.
- UNC Lineberger Comprehensive Cancer CenterLink provided by the sponsor.
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Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jared Weiss, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab and Intensity Modulated Radiation Therapy in people with Head and Neck Cancer, run by UNC Lineberger Comprehensive Cancer Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
20 Week Progression Free Survival Rate (time frame: 20 weeks after D1 of treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02609503, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.