# Low-dose nivolumab plus metronomic chemotherapy (Tata Memorial)

Source: https://onco.cc/trials/low-dose-nivolumab-tmh/  
OnCo record `low-dose-nivolumab-tmh` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A Mumbai trial that added about one-twentieth of the usual dose of the immunotherapy nivolumab to cheap oral chemotherapy and nearly tripled the share of patients alive at one year.

## Summary

151 patients were randomised to triple metronomic chemotherapy (methotrexate, celecoxib and erlotinib) alone or with nivolumab at a flat 20 mg every 3 weeks, a small fraction of the standard 240 mg dose. One-year overall survival rose from 16.3% (95% CI 8.0-27.4) to 43.4% (30.8-55.3) and median overall survival from 6.7 to 10.1 months (hazard ratio 0.545; 95% CI 0.362-0.820; P=0.0036), with no increase in grade 3 or worse adverse events (50% versus 46.1%). The authors proposed the combination as an alternative standard for patients who cannot access full-dose checkpoint inhibitors, which is most of the world. It is the leading example of dose-optimisation trials that make immunotherapy affordable.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-10
- Phase: 3
- Setting: Recurrent or newly diagnosed advanced head and neck squamous cell carcinoma, palliative intent: triple oral metronomic chemotherapy with or without nivolumab 20 mg every 3 weeks
- Sponsor: Tata Memorial Centre
- Enrolled: 151
- Result: 1-year OS 43.4% vs 16.3%; median OS 10.1 vs 6.7 months; HR 0.545.
- Outcomes: Overall survival at 1 year: Metronomic chemotherapy + low-dose nivolumab 43.4% vs Metronomic chemotherapy 16.3%, HR 0.545; Median overall survival: Metronomic chemotherapy + low-dose nivolumab 10.1 months vs Metronomic chemotherapy 6.7 months

## Sources

- Patil et al., JCO 2023: https://doi.org/10.1200/JCO.22.01015

## Connected records

- cancers: [Buccal mucosa and gingivobuccal cancer (oral cancer in India)](https://onco.cc/cancers/buccal-mucosa-cancer/), [Head and neck squamous cell carcinoma](https://onco.cc/cancers/head-and-neck/), [HPV-negative head and neck squamous cell carcinoma (including HPV-negative oropharyngeal cancer)](https://onco.cc/cancers/hpv-negative-head-and-neck-cancer/), [Recurrent or metastatic head and neck squamous cell carcinoma](https://onco.cc/cancers/recurrent-metastatic-hnscc/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- targets: [PD-1](https://onco.cc/targets/pd1/)
- drugs: [Methotrexate](https://onco.cc/drugs/methotrexate/), [Nivolumab](https://onco.cc/drugs/nivolumab/)
- institutions: [Tata Memorial Centre](https://onco.cc/institutions/tata-memorial/)
- terms: [Dose-escalation designs (3+3, BOIN, dose-expansion)](https://onco.cc/terms/dose-escalation-design/), [Ethics review (IRB, research ethics committee)](https://onco.cc/terms/ethics-review/), [Overall survival (OS)](https://onco.cc/terms/os/), [Project Optimus](https://onco.cc/terms/project-optimus/)
- people: [Kumar Prabhash](https://onco.cc/people/prabhash-kumar/), [Vanita Noronha](https://onco.cc/people/noronha-vanita/), [Vijay Patil](https://onco.cc/people/patil-vijay/)
- bottlenecks: [Most of the world has almost no cancer care](https://onco.cc/bottlenecks/b-global-access/), [Prices and value](https://onco.cc/bottlenecks/b-drug-pricing/), [Wrong doses](https://onco.cc/bottlenecks/b-dose-optimisation/)
- key papers: [Low-dose immunotherapy in head and neck cancer: a randomised study (Tata Memorial)](https://onco.cc/key-papers/paper-patil-low-dose-nivolumab-jco-2023/)
- roadmaps: [Chemotherapy roadmap: mustard gas → curative combinations → the warhead inside smarter drugs](https://onco.cc/roadmaps/chemotherapy-roadmap/), [Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation](https://onco.cc/roadmaps/global-access-roadmap/)

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