A Phase 2/3, Randomized, Open-label Study to Compare Bempegaldesleukin Combined with Pembrolizumab Versus Pembrolizumab Alone in First-Line Treatment of Patients with Metastatic or Recurrent Head and Neck Squamous-Cell Carcinoma with PD-L1 Expressing Tumors (PROPEL-36)
- Conditions
- plaveiselcelcarcinoom van hoofd en halsHead and Neck tumorsMetastatic or Recurrent Head and Neck Squamous-Cell Carcinoma with PD-L1 Expressing Tumors10027656
- Registration Number
- NL-OMON49921
- Lead Sponsor
- ektar Therapeutics
- Brief Summary
Trial never started
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 6
* Provide written, informed consent to participate in the study and follow the
study procedures.
* Male or female patients, age 18 years or older on the day of signing the
informed consent form.
* Have histologically or cytologically-confirmed recurrent or metastatic HNSCC
that is considered incurable by local therapies.
o No prior systemic therapy for recurrent or metastatic disease. Systemic
therapy given as part of multimodal treatment for locally advanced disease is
allowed if completed more than 6 months prior to signing consent.
o The eligible primary tumor locations are oropharynx, oral cavity,
hypopharynx, and larynx.
o Patients may not have a primary tumor site of nasopharynx (any histology)
and/or unknown primary.
* Have measurable disease based on RECIST 1.1 as determined by the local site
Investigator. Tumor lesions situated in a previously irradiated area are
considered measurable if progression has been shown in such lesions since
irradiation.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Tumor tissue from a core, incisional, or excisional biopsy (fine needle
aspirates are not acceptable) to the central laboratory for determination of PD
L1 status (if not determined at local laboratory) and exploratory biomarker
analyses. A newly obtained biopsy is strongly preferred, but archival tumor
biopsy may be used and provided.
* The tumor must have positive PD-L1 expression (ie, CPS * 1) as determined
with the PD-L1 IHC 22C3 PharmDx diagnostic kit at either a local or central
laboratory.
* Patients with oropharyngeal cancer: must have results from testing of HPV
status defined as p16 IHC testing using CINtec® p16 Histology assay (Ventana
Medical Systems Inc., Tucson AZ). If HPV status was previously tested using
this method, no additional testing is required. Note:
o If local p16 testing results are not available, or cannot be assessed by the
specified method, a tumor tissue sample may be submitted to the central
laboratory for p16 testing.
Patients with oral cavity, hypopharynx, or larynx cancers: HPV testing by p16
IHC is not required as by convention these tumor locations are assumed to be
HPV negative.
* Has disease that is suitable for local therapy administered with curative
intent.
* Has progressive disease within 6 months of completion of curatively intended
systemic treatment for locoregionally advanced HNSCC.
* Has had radiation therapy (or other non-systemic therapy) within 2 weeks
prior to initiation of study drug, or patient has not fully recovered (ie, *
Grade 1 or at baseline) from AEs due to a previously administered treatment. A
1 week washout is permitted for palliative radiation (* 2 weeks of
radiotherapy) to non-central nervous system (CNS) disease. Note:
o Patients with * Grade 2 neuropathy or * Grade 2 alopecia are an exception to
this criterion and qualify for the study.
o If patient received major surgery, they must have recovered adequately from
the toxicity and/or complications from the intervention prior to starting
therapy.
* Has a life expectancy of less than 3 months and/or has rapidly progressing
disease (eg, tumor bleeding, uncontrolled tumor pain) as determined by
Investigator.
* Has a known additional malignancy that is progressing or has required active
treatment within 5 years prior to the first dose of study drug with the
exception of: curatively treated basal cell carcinoma of the skin, squamous
cell carcinoma of the skin, curatively resected in situ cervical cancer, and
curatively resected in situ breast cancer.
* Has an active autoimmune disease that has required systemic treatment in the
past 2 years (ie, with use of disease modifying agents, corticosteroids or
immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or
physiologic corticosteroid replacement therapy for adrenal or pituitary
insufficiency) is not considered a form of systemic treatment and is allowed.
* 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 study drug. Corticosteroid use as pre-medication for allergic reactions
(eg, intravenous [IV] contrast) is allowed. The use of physiologic doses of
corticosteroids may be approved after consultation with the Sponsor.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method