{"entity":{"id":"low-dose-nivolumab-tmh","kind":"trial","name":"Low-dose nivolumab plus metronomic chemotherapy (Tata Memorial)","aka":[],"tldr":"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.","status":"positive","asOf":"2026-09-10","links":[{"label":"Patil et al., JCO 2023","url":"https://doi.org/10.1200/JCO.22.01015"}],"tags":[],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc","buccal-mucosa-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":["pd1"],"drugs":["nivolumab","methotrexate"],"companies":[],"institutions":["tata-memorial"],"pathways":[],"terms":["os"],"trials":[],"people":["patil-vijay","prabhash-kumar","noronha-vanita"],"bottlenecks":["b-dose-optimisation","b-drug-pricing","b-global-access"],"keyPapers":["paper-patil-low-dose-nivolumab-jco-2023"],"journals":[],"dependsOn":[],"notes":[],"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","result":"1-year OS 43.4% vs 16.3%; median OS 10.1 vs 6.7 months; HR 0.545.","yearReported":2023,"enrolled":151,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival at 1 year","primary":true,"unit":"%","arms":[{"name":"Metronomic chemotherapy + low-dose nivolumab","n":76,"value":43.4},{"name":"Metronomic chemotherapy","n":75,"value":16.3}],"hr":0.545,"ci":[0.362,0.82],"p":"0.0036","source":"https://doi.org/10.1200/JCO.22.01015"},{"endpoint":"Median overall survival","unit":"months","arms":[{"name":"Metronomic chemotherapy + low-dose nivolumab","value":10.1},{"name":"Metronomic chemotherapy","value":6.7}],"source":"https://doi.org/10.1200/JCO.22.01015"}]},"route":"/trials/low-dose-nivolumab-tmh/","neighbours":{"cancer":[{"id":"buccal-mucosa-cancer","kind":"cancer","name":"Buccal mucosa and gingivobuccal cancer (oral cancer in India)","route":"/cancers/buccal-mucosa-cancer/"},{"id":"head-and-neck","kind":"cancer","name":"Head and neck squamous cell carcinoma","route":"/cancers/head-and-neck/"},{"id":"hpv-negative-head-and-neck-cancer","kind":"cancer","name":"HPV-negative head and neck squamous cell carcinoma (including HPV-negative oropharyngeal cancer)","route":"/cancers/hpv-negative-head-and-neck-cancer/"},{"id":"recurrent-metastatic-hnscc","kind":"cancer","name":"Recurrent or metastatic head and neck squamous cell carcinoma","route":"/cancers/recurrent-metastatic-hnscc/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"target":[{"id":"pd1","kind":"target","name":"PD-1","route":"/targets/pd1/"}],"drug":[{"id":"methotrexate","kind":"drug","name":"Methotrexate","route":"/drugs/methotrexate/"},{"id":"nivolumab","kind":"drug","name":"Nivolumab","route":"/drugs/nivolumab/"}],"institution":[{"id":"tata-memorial","kind":"institution","name":"Tata Memorial Centre","route":"/institutions/tata-memorial/"}],"term":[{"id":"dose-escalation-design","kind":"term","name":"Dose-escalation designs (3+3, BOIN, dose-expansion)","route":"/terms/dose-escalation-design/"},{"id":"ethics-review","kind":"term","name":"Ethics review (IRB, research ethics committee)","route":"/terms/ethics-review/"},{"id":"os","kind":"term","name":"Overall survival (OS)","route":"/terms/os/"},{"id":"project-optimus","kind":"term","name":"Project Optimus","route":"/terms/project-optimus/"}],"person":[{"id":"prabhash-kumar","kind":"person","name":"Kumar Prabhash","route":"/people/prabhash-kumar/"},{"id":"noronha-vanita","kind":"person","name":"Vanita Noronha","route":"/people/noronha-vanita/"},{"id":"patil-vijay","kind":"person","name":"Vijay Patil","route":"/people/patil-vijay/"}],"bottleneck":[{"id":"b-global-access","kind":"bottleneck","name":"Most of the world has almost no cancer care","route":"/bottlenecks/b-global-access/"},{"id":"b-drug-pricing","kind":"bottleneck","name":"Prices and value","route":"/bottlenecks/b-drug-pricing/"},{"id":"b-dose-optimisation","kind":"bottleneck","name":"Wrong doses","route":"/bottlenecks/b-dose-optimisation/"}],"paper":[{"id":"paper-patil-low-dose-nivolumab-jco-2023","kind":"paper","name":"Low-dose immunotherapy in head and neck cancer: a randomised study (Tata Memorial)","route":"/key-papers/paper-patil-low-dose-nivolumab-jco-2023/"}],"roadmap":[{"id":"chemotherapy-roadmap","kind":"roadmap","name":"Chemotherapy roadmap: mustard gas → curative combinations → the warhead inside smarter drugs","route":"/roadmaps/chemotherapy-roadmap/"},{"id":"global-access-roadmap","kind":"roadmap","name":"Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation","route":"/roadmaps/global-access-roadmap/"}]}}