Study: NCT03107182

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: nab-paclitaxel
Description: All enrolled patients will receive three 21-day cycles of nab-paclitaxel (100 mg/m2 on days 1, 8, 15; 9 doses total)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Carboplatin
Description: All enrolled patients will receive three 21-day cycles of carboplatin (AUC 6 on day 1; 3 doses total).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nivolumab
Description: All enrolled patients will receive three 21-day cycles of nivolumab (360 mg on days 1; 3 doses total).~Adjuvant nivolumab will be offered to all patients for 6-months post completion of locoregional therapy for a total of 7 doses.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nivolumab
Description: All enrolled patients will receive three 21-day cycles of nivolumab (360 mg on days 1; 3 doses total).~Adjuvant nivolumab will be offered to all patients for 6-months post completion of locoregional therapy for a total of 7 doses.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nivolumab
Description: All enrolled patients will receive three 21-day cycles of nivolumab (360 mg on days 1; 3 doses total).~Adjuvant nivolumab will be offered to all patients for 6-months post completion of locoregional therapy for a total of 7 doses.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nivolumab
Description: All enrolled patients will receive three 21-day cycles of nivolumab (360 mg on days 1; 3 doses total).~Adjuvant nivolumab will be offered to all patients for 6-months post completion of locoregional therapy for a total of 7 doses.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cisplatin
Description: Cisplatin will be given on an every 3 weeks basis at a dose of 100 mg/m2 IV over 3-4 hrs day 1 (or 2) and 22 (or 23). Only for patients on the Intermediate Dose Arm and additionally on day 43 (or 44) for patients on the Regular Dose Arm.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cisplatin
Description: Cisplatin will be given on an every 3 weeks basis at a dose of 100 mg/m2 IV over 3-4 hrs day 1 (or 2) and 22 (or 23). Only for patients on the Intermediate Dose Arm and additionally on day 43 (or 44) for patients on the Regular Dose Arm.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Hydroxyurea
Description: Patients on the Intermediate or Regular Dose Arms will receive chemoradiation for 3-5 cycles (6-10 weeks). On day 0 patients will start hydroxyurea at 500 mg PO q 12 hours x 6 days (11 doses). The first daily dose of hydroxyurea on days 1 - 5 is given 2 hours prior to the first fraction of daily radiotherapy.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Hydroxyurea
Description: Patients on the Intermediate or Regular Dose Arms will receive chemoradiation for 3-5 cycles (6-10 weeks). On day 0 patients will start hydroxyurea at 500 mg PO q 12 hours x 6 days (11 doses). The first daily dose of hydroxyurea on days 1 - 5 is given 2 hours prior to the first fraction of daily radiotherapy.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 5-FU
Description: Patients on the Intermediate or Regular Dose Arms will receive chemoradiation for 3-5 cycles (6-10 weeks). On day 0 at 1800 patients will start continuous infusion of 5-FU at 600 mg/m2/day x 5 days (120 hours).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 5-FU
Description: Patients on the Intermediate or Regular Dose Arms will receive chemoradiation for 3-5 cycles (6-10 weeks). On day 0 at 1800 patients will start continuous infusion of 5-FU at 600 mg/m2/day x 5 days (120 hours).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: Patients on the Intermediate or Regular Dose Arms will receive chemoradiation for 3-5 cycles (6-10 weeks). On days 1-5 patients will receive dexamethasone 20 mg PO (IV) in am Day 1, 1 hr prior to paclitaxel

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: Patients on the Intermediate or Regular Dose Arms will receive chemoradiation for 3-5 cycles (6-10 weeks). On days 1-5 patients will receive dexamethasone 20 mg PO (IV) in am Day 1, 1 hr prior to paclitaxel

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Famotidine
Description: Patients on the Intermediate or Regular Dose Arms will receive chemoradiation for 3-5 cycles (6-10 weeks). On days 1-5 patients will receive famotidine 20 mg PO (IV) in am Day 1, 1 hr prior to paclitaxel.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Famotidine
Description: Patients on the Intermediate or Regular Dose Arms will receive chemoradiation for 3-5 cycles (6-10 weeks). On days 1-5 patients will receive famotidine 20 mg PO (IV) in am Day 1, 1 hr prior to paclitaxel.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Diphenhydramine
Description: Patients on the Intermediate or Regular Dose Arms will receive chemoradiation for 3-5 cycles (6-10 weeks). On days 1-5 patients will receive diphenhydramine 50 mg PO (IV) in am Day 1, 30 mins prior to paclitaxel.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Diphenhydramine
Description: Patients on the Intermediate or Regular Dose Arms will receive chemoradiation for 3-5 cycles (6-10 weeks). On days 1-5 patients will receive diphenhydramine 50 mg PO (IV) in am Day 1, 30 mins prior to paclitaxel.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Paclitaxel
Description: Patients on the Intermediate or Regular Dose Arms will receive chemoradiation for 3-5 cycles (6-10 weeks). On days 1-5 patients will start paclitaxel 100 mg/m2 after first RT fraction on day 1 of each cycle. Paclitaxel should be administered in 250 ml 0.9% NaCl over 60 minutes.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Paclitaxel
Description: Patients on the Intermediate or Regular Dose Arms will receive chemoradiation for 3-5 cycles (6-10 weeks). On days 1-5 patients will start paclitaxel 100 mg/m2 after first RT fraction on day 1 of each cycle. Paclitaxel should be administered in 250 ml 0.9% NaCl over 60 minutes.