Clinical Trial Information

Protocol – NRG – HN007

SCHEMA NRG HN007

Please Note: Below is a brief description of the eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

Eligibility:

1. Pathologically (histologically or cytologically) proven diagnosis of NPC that has recurred at locoregional and/or distant sites. For locoregional recurrence, the disease must not be amenable to potentially curative surgery or re-irradiation. The following histological types are accepted: (a) Keratinizing – squamous cell carcinoma; (b) Non-keratinizing – undifferentiated or poorly differentiated.
2. Measurable disease by the RECIST 1.1 criteria. Lesion(s) that have been irradiated previously can be counted as measurable as long as radiological progression has been demonstrated prior to enrollment.
3. Age ≥ 18.
4. History/Physical examination by Medical Oncologist or Clinical Oncologist within 14 days prior to registration.
5. Zubrod/ECOG Performance Status of 0-1 within 14 days prior to registration.
6. Contrast enhanced MRI or CT of the nasopharynx and neck within 30 days prior to registration.
7. Contrast enhanced CT scan of the chest, abdomen and pelvis within 30 days prior to registration.

Ineligibility:

1. Diagnosed with another invasive malignancy (except non-melanomatous skin cancer) unless disease free for more than 3 years. Note: Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) who have undergone potentially curative therapy are not excluded).
2. Any prior systemic anti-cancer agents (including chemotherapy and investigational agents) for the purpose of treating locoregional and/or distant recurrence of NPC.
3. Patients who have received neoadjuvant (induction) and/or adjuvant chemotherapy for primary NPC with chemotherapy (any drug regimens including those containing platinum and/or gemcitabine) at or within 6 months prior to registration are excluded (counting from the last day of the chemotherapy for the primary NPC, prior to enrolling into the current study). The following subgroups of patients are NOT excluded:
   1. Patients who have received neoadjuvant (induction) and/or adjuvant chemotherapy for primary (non-metastatic/non-recurrent) NPC more than 6 months prior to registration, counting from the last day of the chemoradiotherapy for the primary NPC, prior to enrolling into the current study.
   2. For prior RT with radical intent: Patients who have prior radiotherapy (RT) to the primary and locoregional disease (i.e. non-recurrent disease) with or without concurrent cisplatin or carboplatin monotherapy are not excluded as long as they have not received any neoadjuvant/adjuvant chemotherapy within 6 months prior to registration (counting from the last day of the chemotherapy), and that the last RT fraction (with radical intent) has been given more than 3 months prior to registration.
   3. For RT with palliative intent: Prior radiotherapy (RT) at or within 30 days prior to registration, this includes RT given with palliative intent (with or without concurrent cisplatin or carboplatin alone) to recurrent/ metastatic sites in patients with recurrent/metastatic NPC. The re-irradiated sites must not be the only sites of measurable recurrent disease.
   4. Prior chemotherapy for cancers other than NPC is allowed as long as the last course of chemotherapy was administered more than 3 years prior to registration and the patient has remained disease-free for more than 3 years.
4. Prior therapy for any indication, 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 (e.g. CTLA-4, OX-40, CD137).

Clinical Trial Information

Protocol – RTOG – 1008

SCHEMA RTOG 1008

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

ELIGIBILITY:

1. Pathologically proven diagnosis of a malignant major salivary gland tumor or malignant minor salivary gland tumor of the head and neck of the following histologic subtypes:
   1.  intermediate-grade adenocarcinoma or intermediate-grade mucoepidermoid
      carcinoma;
       high-grade adenocarcinoma or high-grade mucoepidermoid carcinoma or salivary
      duct carcinoma;
       high-grade acinic cell carcinoma or high-grade (>30% solid component) adenoid
      cystic carcinoma.
   2. Pathologic interpretation of salivary gland malignancies can be very difficult. Patients with diagnoses such as “undifferentiated or poorly differentiated carcinoma”, “carcinoma-ex pleomorphic adenoma”, “carcinoma NOS” and others should be considered for this trial.
2. Surgical resection with curative intent within 8 weeks prior to registration.
3. Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (≤1mm) or microscopically positive surgical margin. Patients must be free of
   distant metastases based upon the following minimum diagnostic workup:
   1.  History/physical examination within 8 weeks prior to registration;
       Radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to registration; at a minimum, contrast CT imaging of the chest is required; PET/CT is acceptable.
4. Zubrod Performance Status 0-1.
5. Age ≥ 18.
6.  No residual macroscopic disease after surgery.
7.  No prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
8.  No prior systemic chemotherapy or radiation therapy for salivary gland malignancy; note that prior chemotherapy for a different cancer is allowable.
9.  No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.

Clinical Trial Information

PROTOCOL: ECOG-EA3132

SCHEMA EA3132

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

ELIGIBILITY:

1. Age ≥ 18 years.
2. Pathologically proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell
   carcinoma, carcinoma NOS) of the head/neck (oral cavity, oropharynx, hypopharynx or larynx); pathologic stage III or IVA (AJCC
   8): T3-T4a, N0-3, M0 or T1-T2, N1-3, M0.
3. Patient has undergone total resection of the primary tumor with curative intent.
   1. NOTE: Patient is to be pre-registered to screening (Step 0) and tissue submitted to Foundation Medicine as soon as possible after surgery in order to meet the 8 week deadline to register the patient to Step 1 after surgery. Full assay minimum turn-around time is 17-24 days.
4. For oropharynx primary tumors, the patient must have negative HPV status of the tumor as determined by p16 protein expression using immunohistochemistry (IHC).
5. Patients with, per the operative and/or pathology report, positive margin(s) [tumor present at the cut or inked edge of the tumor] which is not superceded by an additional margin of tumor-negative tissue, nodal extracapsular extension, and/or gross residual disease after surgery are not eligible.
6. Patients with a history of a curatively treated malignancy must be disease-free for at least two years except for carcinoma in situ of
   cervix and/or non-melanomatous skin cancer. Patients must not have received chemotherapy or investigational therapy within two years of surgical resection of the primary tumor.
7. Patient must not have had previous irradiation to the head and neck that would result in overlap in radiation fields for the current disease.
8. Patients with recurrent disease or multiple primaries are ineligible.