A study in patients with advanced head and neck cancer comparing tablet based chemotherapy plus low dose immunotherapy with standard IV chemotherapy to evaluate effectiveness and side effects.

Triple Oral Metronomic Chemotherapy with Paclitaxel and Carboplatin plus Low Dose Nivolumab: First-line Immunotherapy and Repurposed- drug combination A Phase III Randomized Controlled Trial in Platinum- Sensitive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/02/105089

Enrollment

436

Registered

2026-02-27

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: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

Intervention1: Paclitaxel, Carboplatin, Methotrexate, Celecoxib, Erlotinib, Nivolumab: Paclitaxel 80 mg/m IV weekly + Carboplatin AUC 2 IV weekly + Methotrexate 9 mg/m orally once weekly + Celecoxib

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age greater than equal to 18 years 2.Histologically or cytologically confirmed squamous cell carcinoma of the head and neck oral cavity, oropharynx, larynx, hypopharynx, carcinoma of unknown primary in cervical lymph nodes 3.Locally advanced or recurrent or metastatic disease not amenable to curative therapy 4.Platinum sensitive recurrence greater than equal to 3 months from last platinum dose 5.ECOG performance status 0 to 2 6.Adequate organ function 7.Signed informed consent

Exclusion criteria

Exclusion criteria: 1.Nasopharyngeal carcinoma 2.Salivary gland tumours 3.Active autoimmune disease requiring systemic treatment 4.Prior treatment with anti PD 1, PD L1, or CTLA4 inhibitors 5.Uncontrolled infections or comorbidities 6.Pregnant or breastfeeding women

Design outcomes

Primary

Measure	Time frame
Overall Survival (OS)Timepoint: Time from date of randomization to death from any cause. Patients lost to follow-up or alive at the time of analysis will be censored on the date of last contact.	—

Secondary

Measure	Time frame
Progression-Free Survival (PFS)Timepoint: every 8 12 weeks (as per institutional practice) Until progression;Objective Response Rate (ORR)Timepoint: First radiological assessment at approximately 8 12 weeks;Disease Control Rate (DCR)Timepoint: Proportion of patients achieving CR, PR, or stable disease (SD) for greater than equal to 6 weeks.At first response evaluation (~8 12 weeks);Time to Treatment Failure (TTF)Timepoint: During treatment every weekly or 3 weekly as per protocol;Adverse Events (Toxicity)Timepoint: During treatment every weekly or 3 weekly as per protocol;Quality of Life (QoL)Timepoint: Baseline, weekly or 3 weekly and after completion of treatment and at follow up;Treatment ComplianceTimepoint: During treatment every 3 weekly	—

Measure

Time frame

Progression-Free Survival (PFS)Timepoint: every 8 12 weeks (as per institutional practice) Until progression;Objective Response Rate (ORR)Timepoint: First radiological assessment at approximately 8 12 weeks;Disease Control Rate (DCR)Timepoint: Proportion of patients achieving CR, PR, or stable disease (SD) for greater than equal to 6 weeks.At first response evaluation (~8 12 weeks);Time to Treatment Failure (TTF)Timepoint: During treatment every weekly or 3 weekly as per protocol;Adverse Events (Toxicity)Timepoint: During treatment every weekly or 3 weekly as per protocol;Quality of Life (QoL)Timepoint: Baseline, weekly or 3 weekly and after completion of treatment and at follow up;Treatment ComplianceTimepoint: During treatment every 3 weekly

—

Countries

India

Contacts

Public ContactKavita Nawale

Tata Memorial Hospital

vanita.noronha@gmail.com9769328047

Outcome results

None listed

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