NCT02609503

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for phase_2 head-and-neck-cancer

Timeline
Completed

Started May 2016

Longer than P75 for phase_2 head-and-neck-cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

May 16, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2019

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

March 19, 2021

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2023

Completed
Last Updated

November 5, 2024

Status Verified

October 1, 2024

Enrollment Period

3.6 years

First QC Date

November 12, 2015

Results QC Date

January 5, 2021

Last Update Submit

October 10, 2024

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (4)

  • 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

    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

    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

    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.

    up to 5 years after D1 of treatment

Secondary Outcomes (9)

  • One Year Overall Survival Rate

    1 year after Day 1 of treatment

  • Two Year Overall Survival Rate

    2 years after Day 1 of treatment

  • Proportion of Participants Who Received <95% of Intended Dose of Radiation

    7 weeks

  • Number of Participants With Clinically Relevant Adverse Events

    Monitored continuously from D1 of treatment through 40 weeks.

  • Overall Response Rate

    2 years after start of treatment

  • +4 more secondary outcomes

Study Arms (2)

Open label

EXPERIMENTAL

Pembrolizumab

Drug: Pembrolizumab

Radiation

OTHER

Intensity Modulated Radiation Therapy (IMRT)

Radiation: Intensity Modulated Radiation Therapy

Interventions

PembrolizumabDRUG

Pembrolizumab, 200 mg IV during cycle visits every 3-weeks for up to 6 cycles, or until toxicities are no longer tolerable

Also known as: Keytruda
Open label
Intensity Modulated Radiation TherapyRADIATION

Eligible participants will receive Intensity Modulated Radiation Therapy daily x 7 weeks

Also known as: IMRT
Radiation

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.
  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

John Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21231, United States

Location

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Related Publications (1)

  • 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.

    PMID: 32371539DERIVED

Related Links

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

pembrolizumabRadiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Results Point of Contact

Title
Robin V. Johnson
Organization
University of North Carolina Lineberger Comprehensive Cancer Center
Robin_V_Johnson@med.unc.edu
919-966-1125

Study Officials

  • Jared Weiss, MD

    UNC Lineberger Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2015

First Posted

November 20, 2015

Study Start

May 16, 2016

Primary Completion

December 23, 2019

Study Completion

November 20, 2023

Last Updated

November 5, 2024

Results First Posted

March 19, 2021

Record last verified: 2024-10

Locations

US(3)