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

NCT03700905 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2023-05-23

No results posted yet for this study

Summary

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

Conditions

Interventions

PROCEDURE

Surgical resection of primary tumor

Surgical resection of primary tumor including neck dissection according to standard of care

RADIATION

Adjuvant radio(-chemo)therapy

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)

DRUG

Neoadjuvant Nivolumab

Neoadjuvant dose with Nivolumab 3mg/kg after randomization within 2 weeks before surgery

DRUG

Adjuvant Nivolumab

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

DRUG

Adjuvant Nivolumab and Ipilimumab

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

Sponsors & Collaborators

  • University Hospital, Essen

    collaborator OTHER

  • Westpfalz-Clinical Center GmbH

    collaborator UNKNOWN

  • Charite University, Berlin, Germany

    collaborator OTHER

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • PD Dr. med. Chia-Jung Busch · Universitätsklinikum Hamburg-Eppendorf

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-21
Primary Completion
2024-05-31
Completion
2024-05-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03700905 on ClinicalTrials.gov