# NCI9673: nivolumab for previously treated unresectable metastatic anal cancer

Source: https://onco.cc/key-papers/paper-nci9673-nivolumab-metastatic-anal-cancer-morris-lancet-oncol-2017/  
OnCo record `paper-nci9673-nivolumab-metastatic-anal-cancer-morris-lancet-oncol-2017` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

In the first completed immunotherapy trial for anal cancer, the PD-1 antibody nivolumab shrank tumours in a quarter of heavily pretreated patients with few side effects.

## Summary

Multicentre single-arm phase 2 trial: 37 patients with previously treated metastatic squamous cell carcinoma of the anal canal received nivolumab 3 mg/kg every two weeks.

Nine patients (24 percent, 95% CI 15 to 33) responded, two completely and seven partially. Grade 3 adverse events were anaemia (2), fatigue, rash and hypothyroidism (1 each); there were no serious adverse events.

## Fields

- Kind: Key paper
- Last checked: 2026-09-22
- Journal: The Lancet Oncology
- Year: 2017
- DOI: 10.1016/S1470-2045(17)30104-3
- Authors: Morris VK, Salem ME, Nimeiri H, et al.
- Findings: Objective response 24 percent (95% CI 15 to 33): 2 complete and 7 partial responses in 37 patients.; Grade 3 adverse events in 5 patients; no serious adverse events.
- What it means: PD-1 blockade is an option for metastatic anal cancer after chemotherapy, and the basis for later immunotherapy combinations in the disease.
- Caveats: Single-arm design with 37 patients.

## Sources

- Lancet Oncol 2017: https://doi.org/10.1016/S1470-2045(17)30104-3
- PubMed: https://pubmed.ncbi.nlm.nih.gov/28223062/

## Connected records

- cancers: [Anal cancer (squamous cell carcinoma)](https://onco.cc/cancers/anal/), [Metastatic and recurrent anal squamous cell carcinoma](https://onco.cc/cancers/metastatic-anal-cancer/)
- drugs: [Nivolumab](https://onco.cc/drugs/nivolumab/)
- trials: [NCI9673](https://onco.cc/trials/nci9673/)
- journals: [The Lancet Oncology](https://onco.cc/journals/lancet-oncology/)

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