# NRG-GY018 / KEYNOTE-868

Source: https://onco.cc/trials/nrg-gy018-keynote-868/  
OnCo record `nrg-gy018-keynote-868` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

NRG-GY018 is the pembrolizumab twin of RUBY: immunotherapy plus chemotherapy cut the risk of progression by 70% in dMMR tumours and 46% in the rest.

## Summary

NRG-GY018, also KEYNOTE-868, trial NCT03914612 run by NRG Oncology with Merck support and published in the New England Journal of Medicine in 2023, is the pembrolizumab twin of RUBY: adding immunotherapy to carboplatin and paclitaxel, followed by pembrolizumab maintenance, cut the risk of progression by seventy percent in mismatch-repair-deficient advanced or recurrent endometrial cancer and by nearly half in the rest. It randomised 816 patients analysed by mismatch repair status, met its primary progression-free survival endpoint in both cohorts, and led to FDA approval in June 2024 regardless of mismatch repair status. OnCo links it to endometrial cancer, PD-1 as a target, pembrolizumab, NRG Oncology, the dMMR term, Ramez N. Eskander and the pairing of chemotherapy with PD-1 blockade. Whether mismatch-repair-proficient patients gain a survival benefit is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT03914612
- Phase: 3
- Setting: Advanced or recurrent endometrial cancer: pembrolizumab + carboplatin-paclitaxel then pembrolizumab maintenance vs chemotherapy, analysed by MMR status
- Sponsor: NRG Oncology / Merck
- Enrolled: 816
- Result: PFS HR 0.30 (dMMR), 0.54 (pMMR).
- Outcomes: Progression-free survival (dMMR): Pembrolizumab + chemo vs Placebo + chemo, HR 0.3; Progression-free survival (pMMR): Pembrolizumab + chemo vs Placebo + chemo, HR 0.54

## Sources

- ClinicalTrials.gov NCT03914612: https://clinicaltrials.gov/study/NCT03914612
- NEJM 2023: https://www.nejm.org/doi/full/10.1056/NEJMoa2302312

## 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/)
- 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/), [Paclitaxel / nab-paclitaxel](https://onco.cc/drugs/paclitaxel/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- companies: [GOG Foundation](https://onco.cc/companies/gog-foundation/), [NRG Oncology](https://onco.cc/companies/nrg-oncology/)
- terms: [Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR)](https://onco.cc/terms/msi/)
- people: [Ramez N. Eskander](https://onco.cc/people/ramez-eskander/)
- 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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