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8110 Gatehouse Road, Falls Church, VA 22042

Phase I Trial with Expansion Cohort of DNA-PK Inhibition and IMRT in Cisplatin-Ineligible Patients with Stage 3-4 Local-Regionally Advanced Head And Neck Squamous Cell Carcinoma (HNSCC) (NRG-HN008)

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General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT04533750

Background Information

This study is being done to discover if it is safe and tolerable to give M3814 (peposertib) in combination with radiation in patients with advanced head and neck cancer who cannot receive cisplatin. The study will also attempt to determine what is the safe dose of M3814 (peposertib), if any, that can be given in combination with radiation.

The combination of the experimental drug M3814 (peposertib) and radiation therapy (IMRT) is not approved by the Food and Drug Administration (FDA).

The usual approach for patients who are not in a study is treatment with radiation therapy and the chemotherapy drug, cisplatin; or radiation therapy and cetuximab for patients who are unable to receive cisplatin. For patients who get the usual approach for this cancer and cannot receive cisplatin, about 50 out of 100 are free of cancer after 5 years.

This study has public funding from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) in the United States Department of Health and Human Services.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Dr.
Fairfax, VA 22031

A department of Inova Fairfax Hospital

Eligibility Information

  • Pathologically (histologically) proven diagnosis of HNSCC of the oral cavity, oropharynx, larynx, or hypopharynx
    • Participants with oropharynx cancer need p16 determination by immunohistochemistry (where positive is defined as greater than 70% strong nuclear or nuclear and cytoplasmic staining of tumor cells)
    • Oral cavity, larynx, hypopharynx, or p16-negative oropharynx cancer must be stages T1-2N2 -3 or T3N1-3 or T4N0-3
    • p16-positive oropharynx cancer patients, stages T4N0-3 or T1-3N2-3 (AJCC version 8)
  • A histological or pathological specimen from cervical lymph nodes with well-defined primary site documented clinically or radiologically is acceptable.
  • Age ≥ 18 years
  • Participants must have a contraindication to cisplatin
  • Additional eligibility in protocol

Ineligibility Information

  • Definitive clinical or radiologic evidence of distant (beyond cervical lymph node and neck tissue) metastatic disease.
  • Carcinoma of the neck of unknown primary site origin
  • Prior invasive malignancy (except non-melanomatous skin cancer carcinoma, in situ of the breast, oral cavity, or cervix, low or very low-risk prostate cancer) unless disease free for a minimum of 3 years
  • Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable if not within < 3 years
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Severe, active co-morbidity defined as follows:
    • History of bone marrow transplant and organ transplant, including allogenic stem cell transplantation
    • Unstable angina requiring hospitalization in the last 6 months
    • New York Heart Association Functional Classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)
    • Myocardial infarction within the last 6 months
    • Persistent Grade 3-4 (CTCAE version 5.0) electrolyte abnormalities that cannot be reversed despite as indicated by repeat testing
    • Ongoing active infection that is associated with symptoms and/or requires antibiotic therapy at the time of registration (excluding asymptomatic bacteriuria, genital herpes, oral herpes, thrush, bacterial vaginosis, vaginal candidiasis, topical antifungals)
  • Pregnancy and nursing females
  • Concomitant use of proton pump inhibitors (or unable to stop 5 days prior to treatment)
  • Patients unable to discontinue medications or substances that are strong inhibitors, inducers or sensitive substrates of CYP3A4/5 or CYP2C19 prior to study treatment. See section 5.3.1 for more details
  • QTcF > 450 ms for males and > 470 ms for females
  • Additional ineligibility in protocol

Additional information can be found at: https://clinicaltrials.gov/ct2/show/NCT04533750