Clinical trial of nivolumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck cancer after six months who finished platinum-based chemotherapy

Clinical trial of nivolumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck cancer after six months who finished platinum-based chemotherapy - Clinical trial of nivolumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck cancer after six months who finished platinum-based chemotherapy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000031324

Enrollment

Registered

2018-02-19

Start date

2018-02-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck squamous cell carcinoma

Interventions

Intravenous nivolumab is administered at a dose of 3 mg per kilogram of body weight every 2 weeks. Every 2 weeks of nivolumab as one course, patients receive nivolumab until disease progression, unac

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients in Recurrent or Metastatic after six months Squamous Cell Carcinoma of the Head and Neck who finished platinum-based chemotherapy 2) Histological proven squamous cell carcinoma of the head and neck 3) Primary site, maxillary sinus, oral cavity, epipharynx, oropharynx, hypopharynx or larynx 4) Age 20-75 years 5) Performance status (PS) 0-1 6) Adequate organ functions defined as indicated below before registration in 14 days (1)WBC >= 3,500 /mm3 , WBC <= 12,000 /mm3 (2)neutrophil >= 2,000 /mm3 (3)Plt >= 100,000 /mm3 (4) Hb>= 9.0 g/ dL (5) T.Bil <= 1.5 mg/dL (6) AST(GOT) , ALT(GPT) <= 100 IU/L (7) Cr < 1.2 mg/dL 7) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Patients with a past history of severe drug allergy of nivolumab and similar drug 2) Patients with a symptomatic brain metastasis and meningeal metastasis 3) Histological proven primary unknown squamous cell carcinoma, salivary gland cancer, non-squamous cell cancer. 4) Patients with a symptomatic autoimmune disease or history of Autoimmune disease. 5) Patients with infection 6) Patients with Gastrointestinal disease (Intestinal paralysis, Bowel obstruction) 7) Patients with Interstitial pneumonia or Pulmonary fibrosis 8) Uncontrolled diabetes 9) Uncontrolled heart disorder 10) Sever liver damage 11) Patients with diarrhea 12) Pregnant or lactating women or women of childbearing potential 13) Male expecting partner's pregnancy 14) Inadequate physical condition, as diagnosed by attending physician

Design outcomes

Primary

Measure	Time frame
Overall Survival	—

Secondary

Measure	Time frame
1) Progression Free Survival 2) Quality of Life score	—

Countries

Japan

Contacts

Public Contactisaku Okamoto

Tokyo Medical University Division of Otorhinolarygology, Head and neck Surgery

isaku@tokyo-med.ac.jp03-3342-6111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026