A Study to See if Low-Dose Nivolumab Helps Prevent Recurrence After Surgery in High-Risk Head and Neck Cancer Patients

A Phase II Randomized Trial of Adjuvant Low-Dose Nivolumab in Resected High-Risk Head and Neck Squamous Cell Carcinoma - NIL

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/05/110101

Enrollment

120

Registered

2026-05-06

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx

Interventions

Intervention1: Low-dose Nivolumab, Radiotherapy (RT), Cisplatin: 40 mg IV every 4 weekly x 6 cycle, 60-64 Gy/ 30-32 # IMRT, 40 mg/m IV Control Intervention1: Radiotherapy (RT), Cisplatin: 60-64 Gy

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age greater than or equal to 18 years 2. ECOG performance status 0 to 2 3. Completely resected head and neck squamous cell carcinoma (HNSCC) 4. High-risk pathological features, defined as at least one of: 4.1 Positive surgical margins or Extra-nodal extension (ENE) or four or more pathologically positive lymph nodes or more than two intermediate risk factors 4.1.1 Presence of Lymphovascular Invasion (LVI) 4.1.2 Multiple nodes more than one lymph node 4.1.3 Presence of Perineural Invasion (PNI) 4.1.4 Close margin less than 5 mm 4.1.5 Worst Pattern of Invasion (WPOI) equals 5 4.1.6 Poorly differentiated squamous cell carcinoma (PDSCC) or Sarcomatoid features 4.1.7 Depth of Invasion (DOI) more than 1 cm 4.1.8 Pathological T4 5. Adequate organ function 6. Ability to start adjuvant therapy within 4 to 6 weeks after surgery 7. Patients who have received neoadjuvant chemotherapy (NACT), including regimens containing immunotherapy, are eligible for inclusion in the study

Exclusion criteria

Exclusion criteria: 1. Recurrent / Metastatic disease orsecond primary head and neck cancer. 2. Active autoimmune disease requiring systemic steroids or immunosuppressive therapy 3. Uncontrolled infection, including active TB, uncontrolled HIV, or untreated hepatitis B/C 4. Significant uncontrolled comorbidity 5. Primary tumor arising from the nasopharynx orsinonasal region will be excluded from the study

Design outcomes

Primary

Measure	Time frame
Disease-free survival (DFS)Timepoint: 2 years	—

Secondary

Measure	Time frame
1.Overall survival (OS) at 2 years 2.Loco-regional control (LRC) at 2 years 3. Safety and tolerability, assessed using CTCAE version 5 4. Health-related quality of life (HRQoL)Timepoint: 1. 2 years 2. 2 years 3. From start of treatment up to 2 years 4. At baseline and during follow-up up to 2 years	—

Countries

India

Contacts

Public ContactDr Aditya Dhanawat

The Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)

adi.dhanawat@gmail.com9040040900

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026