# JAVELIN Head and Neck 100

Source: https://onco.cc/trials/javelin-hn-100/  
OnCo record `javelin-hn-100` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Adding a PD-L1 blocker to curative chemoradiation did not help, the first of several such failures in head and neck cancer.

## Summary

JAVELIN Head and Neck 100, trial NCT02952586 sponsored by Merck KGaA and Pfizer and reported in 2020, found that adding the PD-L1 antibody avelumab to curative chemoradiation for locally advanced head and neck cancer did not help, the first of several such failures. It randomised 697 patients to avelumab with chemoradiation followed by avelumab maintenance, or chemoradiation with placebo, and was stopped for futility with no improvement in progression-free survival. OnCo links it to head and neck cancer, modern external beam radiotherapy, immune checkpoint inhibitors, PD-L1 as a target and the pairing that places immunotherapy before surgery rather than with chemoradiation. Radiation-induced lymphopenia and steroid use are suspected to blunt the effect, which is why KEYNOTE-689 placed immunotherapy before surgery.

## Fields

- Kind: Trial
- Status: negative
- Last checked: 2026-09-07
- Tags: failure; lesson:concurrent-io-with-chemoradiation
- Registry id: NCT02952586
- Phase: 3
- Setting: Locally advanced HNSCC: avelumab + chemoradiation then avelumab maintenance vs chemoradiation
- Sponsor: Merck KGaA / Pfizer
- Enrolled: 697
- Result: PFS HR 1.21; futility.
- Outcomes: Progression-free survival: Avelumab + chemoradiotherapy, then avelumab maintenance vs Placebo + chemoradiotherapy, HR 1.21
- Replication: Consistent with KEYNOTE-412 (pembrolizumab + CRT, EFS HR 0.83, not significant) and IMvoke010: concurrent PD-(L)1 blockade with definitive chemoradiotherapy has failed in three phase 3 trials.

## Sources

- ClinicalTrials.gov NCT02952586: https://clinicaltrials.gov/study/NCT02952586
- Lancet Oncology 2021: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(20)30737-3/fulltext

## Connected records

- cancers: [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/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/), [IMRT / IGRT (modern external beam)](https://onco.cc/technologies/imrt-igrt/)
- targets: [PD-L1](https://onco.cc/targets/pdl1/)
- companies: [Merck KGaA (EMD Serono)](https://onco.cc/companies/merck-kgaa/), [Pfizer (incl. Seagen)](https://onco.cc/companies/pfizer/)
- pairings: [Immunotherapy before surgery rather than with chemoradiation (HNSCC)](https://onco.cc/pairings/io-before-surgery-hnscc/)
- terms: [Data monitoring committee (DSMB, IDMC)](https://onco.cc/terms/data-monitoring-committee/), [Futility analysis (stopped for futility)](https://onco.cc/terms/futility/), [Group sequential design, stopping rules and alpha spending](https://onco.cc/terms/group-sequential-design/)
- roadmaps: [Radiotherapy roadmap: X-rays → shaped beams → fewer fractions, particles and FLASH](https://onco.cc/roadmaps/radiation-roadmap/)

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