Pembrolizumab as First Line Treatment in Subjects with Recurrent/Metastatic HNSCC.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 750

Inclusion Criteria

1. Have histologically or cytologically-confirmed R/M HNSCC that is
considered incurable by local therapies.
2. Be willing and able to provide documented informed consent for the trial. The subject may also provide consent for FBR. However, the subject may participate in the main trial without participating in FBR.
3. Be ? 18 years of age on day of signing informed consent.
4. Have measurable disease based on RECIST 1.1 as determined by the site. Tumor lesions situated in a previously irradiated area are
considered measurable if progression has been demonstrated in such lesions.
5. Have a performance status of 0 or 1 on the ECOG Performance Scale.
6. Demonstrate adequate organ function
7. Have results from testing of HPV status for oropharyngeal cancer
defined as p16 IHC testing using CINtec® p16 Histology assay and a
70% cutoff point (please see Section 7.1.2.7 for details). If HPV status was previously tested using this method, no additional testing is required.
8. Have provided tissue for PD-L1 biomarker analysis from a core or
excisional biopsy (FNA is not adequate).
9. Female subjects of childbearing potential should have a negative
blood pregnancy test within 72 hours prior to receiving the first dose of study medication. A urine test can be considered if a blood test is not appropriate.
10. 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 180 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.
11. Male subjects should agree to use an adequate method of
contraception starting with the first dose of study therapy through 180 days after the last dose of study therapy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

1. Has disease that is suitable for local therapy administered with
curative intent.
2. Has PD within 6 months of completion of curatively intended
systemic treatment for locoregionally advanced HNSCC.
3. Has had radiation therapy (or other nonsystemic therapy) within 2 weeks prior to randomization or subject has not fully recovered (i.e., = Grade 1 or at baseline) from AEs due to a previously administered treatment.
4. Is currently participating and receiving study therapy, or has
participated in a study of an investigational agent and received study therapy, or used an investigational device, any of which occurred within 4 weeks of the first dose of treatment.
5. Has a life expectancy of less than 3 months and/or has rapidly
progressing disease (e.g. tumor bleeding, uncontrolled tumor pain) in the opinion of the treating investigator.
6. 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. Corticosteroid use as premedication for allergic reactions (e.g. IV contrast), or as a
prophylactic management of AEs related to the chemotherapies specified in the protocol is allowed. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor.
7. Has a diagnosed and/or treated additional malignancy within 5 years prior to randomization 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. Other exceptions may be considered with Sponsor consultation.
8. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
9. Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). 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.
10. Has had an allogeneic tissue/solid organ transplant.
11. Has a history of (noninfectious) pneumonitis that required steroids or current pneumonitis.
12. Has an active infection requiring systemic therapy.
13. Has a history or current evidence of any condition, therapy, or
laboratory abnormality that might confound the results of the trial,
interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
14. Has known psychiatric or substance abuse disorders that would
interfere with cooperation with the requirements of the trial.
15. Is pregnant or breastfeeding, or expecting to conceive or father
children within the projected duration of the trial, starting with the
screening visit through 180 days after the last dose of trial treatment.
16. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-
PD-L2 agent or if the patient has previously participated in Merck MK-3475 clinical trials.
17. Has a known history of HIV (HIV 1/2 antibodies).
18. Has known active Hepatitis B or Hepatitis C .
19. Has received a live vaccine within 30 days of planned start of study therapy.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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