Trial Title:
Neoadjuvant Pembrolizumab and IO102-103 for Squamous Cell Carcinoma of the Head and Neck (SCCHN).
NCT ID:
NCT05977907
Condition:
Head and Neck Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Pembrolizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
All participants receive same dose of drug. One Cohort
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Pembrolizumab is an investigational drug in this study
Arm group label:
Single Cohort
Other name:
Keytruda
Intervention type:
Drug
Intervention name:
IO102-103
Description:
IO102-103 is an investigational drug in this study.
Arm group label:
Single Cohort
Summary:
This research is being done to see if it is safe to give investigational combination of
study drugs (Pembrolizumab and IO102-103) before surgery to people with surgically
resectable (removable) newly diagnosed or recurrent metastatic SCCHN. This will be done
by watching participants closely for possible side effects from Pembrolizumab and
IO102-103. In addition, participants will be monitored for any delays to their surgery
due to the study drugs.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Be willing and able to provide written informed consent/assent for the trial.
- Be 18 years of age on day of signing informed consent.
- Patients with non-bulky/non-bulky squamous cell carcinomas of the head and neck,
with an indication for surgical therapy.
1. Surgically resectable disease - generally that is T1N1-N2B, T2-4N0-N2b stage
are generally eligible (AJCC 7th), however exceptions can be made after
approval by the PI for surgically appropriate cases.
2. If determined per tumor board that a low-volume/non-bulky tumor of another
stage is appropriate for resection (e.g. small volume T4 with a small amount of
bone invasion) such tumors may also be considered for this study if
recommendation in tumor board is such.
- Be appropriate candidates for resection and curative intent therapy in general.
- Have a performance status of 0 or 1 on the ECOG Performance Scale.
- Consent to undergo biopsy from a newly obtained core or excisional biopsy of a tumor
lesion before study drug administration, and during treatment. Biopsy in case of
progressive disease is optional.
- Demonstrate adequate organ function
- Female subject of childbearing potential should have a negative urine or serum
pregnancy within 72 hours prior to receiving the first dose of study medication. If
the urine test is positive or cannot be confirmed as negative, a serum pregnancy
test will be required.
- Female subjects 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.
Subjects of childbearing potential are those who have not been surgically sterilized
or have not been free from menses for > 1 year.
- Male subjects 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.
1. Abstinence is considered an adequate contraception method.
Exclusion Criteria:
- A Women of child bearing potential (WOCBP) who has a positive urine pregnancy test
within 72 hours prior to treatment allocation/registration . If the urine test is
positive or cannot be confirmed as negative, a serum pregnancy test will be
required.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or
with an agent directed to another stimulatory or co-inhibitory T-cell receptor
- Has received prior systemic anti-cancer therapy for HNSCC including investigational
agents within 4 weeks of first dose of study treatment.
- Has received prior radiotherapy within 2 weeks of start of study intervention.
Participants must have recovered from all radiation-related toxicities, not require
corticosteroids, and not have had radiation pneumonitis. A 1-week washout is
permitted for palliative radiation (≤2 weeks of radiotherapy) to non- Central
nervous system (CNS) disease.
- Has received a live vaccine or live-attenuated vaccine within 30 days prior to the
first dose of study drug (including live COVID-19 vaccines). Administration of
killed vaccines is allowed. Administration of messenger RNA (mRNA) or peptide
vaccines (e.g., for COVID-19) is allowed.
- Is currently participating in or has participated in a study of an investigational
agent or has used an investigational device within 4 weeks prior to the first dose
of study intervention.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
(in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of
immunosuppressive therapy within 7 days prior to the first dose of study drug.
- Has a known additional malignancy that is progressing or has required active
treatment within the past 2 years. Participants with basal cell carcinoma of the
skin, squamous cell carcinoma of the skin, low grade cancers that are not expected
to impact life expectancy within the next 3 years and not impact interpretation of
this study are allowed
- Has known active CNS metastases and/or carcinomatous meningitis. Participants with
previously treated brain metastases may participate provided they are radiologically
stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its
excipients.
- Has active autoimmune disease that has required systemic treatment in the past 2
years (i.e., with use of disease modifying agents, corticosteroids or
immunosuppressive drugs), unless it is systemic steroid therapy equal or less than
outlined in exclusion criteria 7.
Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement
.
therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of
systemic treatment and is allowed.
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that
required steroids or has current pneumonitis/interstitial lung disease.
- Has an active infection requiring systemic therapy.
- Has a known history of Human Immunodeficiency Virus (HIV) infection.
- Has a known history of Hepatitis B or Hepatitis C virus
- Has a history or current evidence of any condition, therapy, or laboratory
abnormality that might confound the results of the study, interfere with the
participant's participation for the full duration of the study, or is not in the
best interest of the participant 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 as per assessment of the treating
physician. Chronic managed disorders that are not clinically active are acceptable.
- Is pregnant or breastfeeding or expecting to conceive or father children within the
projected duration of the study, starting with the screening visit through 120 days
after the last dose of trial treatment.
- Has had an allogenic tissue/solid organ transplant.
- Congestive heart failure , unstable angina, serious uncontrolled cardiac arrhythmia,
a myocardial infarction within 6 months prior to study entry or a history of
myocarditis
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sibley Memorial Hospital
Address:
City:
Washington
Zip:
20016
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Karim Boudadi, MD
Facility:
Name:
Northwestern Memorial Hospital
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Jochen Lorch, MD
Facility:
Name:
Johns Hopkins University
Address:
City:
Baltimore
Zip:
21287
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tanguy Seiwert, M.D
Phone:
443-287-8312
Email:
tseiwert@jhmi.edu
Contact backup:
Last name:
Zubair Khan, M.D.
Phone:
410-955-3157
Email:
zkhan@jhmi.edu
Facility:
Name:
Providence Cancer Institute
Address:
City:
Portland
Zip:
97213
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Rom Leidner, MD
Facility:
Name:
Thomas Jefferson University Hospital
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Adam Luginbuhl, MD
Start date:
December 14, 2023
Completion date:
October 16, 2028
Lead sponsor:
Agency:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Agency class:
Other
Collaborator:
Agency:
IO Biotech
Agency class:
Industry
Collaborator:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05977907
