Study of Nivolumab Alone or in Combination With Ipilimumab as Immunotherapy vs Standard Follow-up in Surgical Resectable HNSCC After Adjuvant Therapy

Sponsor
Universitätsklinikum Hamburg-Eppendorf
Study ID
NCT03700905
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Surgical resection of primary tumor — PROCEDURE
    Surgical resection of primary tumor including neck dissection according to standard of care
  • Adjuvant radio(-chemo)therapy — RADIATION
    Risk-adapted adjuvant radio(-chemo)therapy 56-66 Gy (chemotherapy Cisplatin 100 mg/m2 on days 1, 22, 43, or Cisplatin once weekly (40mg/m2) for high risk patients only)
  • Neoadjuvant Nivolumab — DRUG
    Neoadjuvant dose with Nivolumab 3mg/kg after randomization within 2 weeks before surgery
  • Adjuvant Nivolumab — DRUG
    Administration of Nivolumab 3mg/kg i.v. d1 every 2 weeks within 6 weeks after end of radiotherapy until progression or up to 6 months
  • Adjuvant Nivolumab and Ipilimumab — DRUG
    Administration of Nivolumab 3mg/kg i.v. d1 every 2 weeks and Ipilimumab 1mg/kg i.v. d1 every 6 weeks within 6 weeks after end of radiotherapy until progression or up to 6 months

Study Details

Multicenter randomized controlled phase III study of nivolumab alone or in combination with ipilimumab as immunotherapy vs standard follow-up in surgical resectable HNSCC after adjuvant therapy

Key Dates

Start date
Aug 21, 2018
Status verified
May 2023
Primary completion
May 31, 2024
Completion
May 31, 2024

Study Design

Enrollment
276 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant/adjuvant Nivolumab and Ipilimumab
    * Neoadjuvant dose with Nivolumab 3mg/kg after randomization within 2 weeks before surgery * Surgical resection of primary tumor including neck dissection according to standard of care * 6-7 weeks risk-adapted adjuvant radio(-chemo)therapy 56-66 Gy (chemotherapy Cisplatin 100 mg/m2 on days 1, 22, 43, or Cisplatin once weekly (40mg/m2) for high risk patients only), start within 6 weeks post-surgery Arm Ia: • Adjuvant administration of Nivolumab 3mg/kg i.v. d1 every 2 weeks within 6 weeks after end of radiotherapy until progression or up to 6 months Arm Ib: • Adjuvant administration of Nivolumab 3mg/kg i.v. d1 every 2 weeks and Ipilimumab 1mg/kg i.v. d1 every 6 weeks within 6 weeks after end of radiotherapy until progression or up to 6 months
  • Active Comparator: Surgical resection + adjuvant radio(-chemo)therapy
    * Surgical resection of primary tumor including neck dissection according to standard of care * 6-7 weeks risk-adapted adjuvant radio(-chemo)therapy 56-66 Gy (chemotherapy Cisplatin 100 mg/m2 on days 1, 22, 43 or Cisplatin once weekly (40mg/m2) in high risk patients), start within 6 weeks post-surgery * Standard follow-up

Primary Outcome Measure

Disease Free Survival [ Time Frame: approximately 71 months ]

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