Induction TPN Followed by Nivolumab With Radiation in Locoregionally Advanced Laryngeal and Hypopharyngeal Cancer

Conditions

• Head and Neck Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nivolumab — DRUG
  Nivolumab is a type of immunotherapy.
• Cisplatin — DRUG
  Cisplatin is a chemotherapy drug.
• Docetaxel — DRUG
  Docetaxel is a chemotherapy drug.
• Intensity-modulated radiotherapy — RADIATION
  IMRT is definitive treatment for head and neck cancer.

Study Details

This research is being performed to treat patient for head and neck cancer patients who have not received prior chemotherapy.

Key Dates

Start date

Jun 11, 2019

Status verified

Dec 2023

Primary completion

Oct 31, 2022

Completion

Dec 16, 2022

Study Design

Enrollment

6 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Induction Docetaxel (T)+Cisplatin (P)+Nivolumab (N) then Radioimmunotherapy (IMRT+N) then adjuvant N
  Participants received 3 cycles of induction with docetaxel, cisplatin and nivolumab (TPN) every 3 weeks (or 21 days): docetaxel 75 mg/m2 IV day 1, cisplatin 100 mg/m2 IV day 1, and nivolumab 240 mg IV flat dose day 1. Induction was followed by clinical and radiologic assessment of response. Participants without partial response or better based on RECIST 1.1 were offered salvage laryngectomy and/or pharyngectomy. Participants with partial or complete response per RECIST 1.1 proceeded with immunoradiotherapy concurrently with nivolumab. Intensity-modulated radiotherapy (IMRT) was preferred and proton beam radiotherapy not permitted. Nivolumab 240 mg IV flat dose day 1 was repeated every 2 weeks concurrently with IMRT (for a total of 3-4 doses). Participants then received adjuvant nivolumab (480 mg IV flat dose day 1) every 4 weeks within 3-8 weeks from the last day of IMRT for up to 6 cycles or until disease progression or recurrence.

Primary Outcome Measure

Median Laryngectomy-free Survival (LFS) [ Time Frame: Disease was assessed following the completion of 2-3 cycles of induction TPN, 10-12 weeks after the completion of immunoradiotherapy or surgery and every 3 months until disease progression (PD). Participants were followed up to 18.9 months. ]

Locations (4)

Find similar trials in Atlanta, GA

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