# RUBY / ENGOT-EN6 / GOG-3031

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

## TL;DR

Adding immunotherapy to first chemotherapy for advanced endometrial cancer extended life by more than a year on average, most dramatically in tumours with a broken DNA spell-checker.

## Summary

In dMMR/MSI-H tumours, 24-month PFS was 61.4% vs 15.7% (HR 0.28); in the overall population PFS HR 0.64 (NEJM 2023). Overall survival in the overall population was 44.6 vs 28.2 months (HR 0.69; Annals of Oncology 2024), with dMMR OS HR 0.32. FDA approval July 2023 (dMMR) and August 2024 (all comers).

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT03981796
- Phase: 3
- Setting: Primary advanced (stage III-IV) or first recurrent endometrial cancer: dostarlimab + carboplatin-paclitaxel, then dostarlimab up to 3 years, vs chemotherapy
- Sponsor: GSK
- Enrolled: 494
- Result: OS 44.6 vs 28.2 months overall (HR 0.69); dMMR PFS HR 0.28.
- Outcomes: Progression-free survival at 24 months (dMMR/MSI-H): Dostarlimab + chemo 61.4% vs Placebo + chemo 15.7%, HR 0.28; Overall survival (overall population): Dostarlimab + chemo 44.6 months vs Placebo + chemo 28.2 months, HR 0.69
- Replication: NRG-GY018/KEYNOTE-868 (pembrolizumab) and DUO-E (durvalumab) reproduced the dMMR effect; RUBY is the only one with a reported all-comers OS benefit so far.

## Sources

- ClinicalTrials.gov NCT03981796: https://clinicaltrials.gov/study/NCT03981796
- NEJM 2023: https://www.nejm.org/doi/full/10.1056/NEJMoa2216334
- OS, Annals of Oncology 2024: https://www.annalsofoncology.org/article/S0923-7534(24)00721-X/fulltext

## Connected records

- cancers: [Advanced or recurrent endometrial cancer](https://onco.cc/cancers/advanced-recurrent-endometrial-cancer/), [Endometrial cancer](https://onco.cc/cancers/endometrial/), [Endometrial cancer with no specific molecular profile](https://onco.cc/cancers/endometrial-nsmp/), [Mismatch-repair-deficient endometrial cancer](https://onco.cc/cancers/endometrial-mmr-deficient/), [p53-abnormal endometrial cancer, including uterine serous carcinoma](https://onco.cc/cancers/endometrial-p53-abnormal/), [Uterine carcinosarcoma](https://onco.cc/cancers/uterine-carcinosarcoma/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- targets: [PD-1](https://onco.cc/targets/pd1/)
- drugs: [Carboplatin](https://onco.cc/drugs/carboplatin/), [Dostarlimab](https://onco.cc/drugs/dostarlimab/), [Paclitaxel / nab-paclitaxel](https://onco.cc/drugs/paclitaxel/)
- companies: [GOG Foundation](https://onco.cc/companies/gog-foundation/)
- terms: [Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR)](https://onco.cc/terms/msi/)
- people: [Mansoor Raza Mirza](https://onco.cc/people/mansoor-raza-mirza/)
- pairings: [Chemotherapy + PD-1/PD-L1 blockade, first-line advanced endometrial cancer](https://onco.cc/pairings/chemo-io-first-line-endometrial/)
- institutions: [Society of Gynecologic Oncology](https://onco.cc/institutions/sgo/)

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