Clinical trialPhase 3Cervical cancer

Pembrolizumab Plus Chemotherapy for Cervical Cancer: An Exploratory Analysis of the KEYNOTE-826 Randomized Clinical Trial

JAMA Oncol · 2026617 patients

Hasegawa K, Colombo N, Tewari KS, Dubot C, Cáceres MV, Lorusso D, et al. JAMA Oncol. 2026

Study type: Clinical trial
Study name: KEYNOTE
Phase: Phase 3
Design: Exploratory ad hoc analysis of the 5-year follow-up of a randomised, double-blind phase 3 trial at 151 centres in 19 countries
Sample size: 617 patients
Source: JAMA Oncol · 2026
Trial registration: NCT03635567

In plain words

After about 5 years of follow-up, adding pembrolizumab to chemotherapy still helps patients with advanced or recurrent cervical cancer live longer; in patients with PD-L1-positive tumours, median survival rose from about 16.5 months to 28.6 months, and no new side effects were seen.

Key results

28.6 vs 16.5 months

Median overall survival (PD-L1 CPS ≥1)

HR 0.62 (0.50–0.76)

26.4 vs 16.8 months

Median overall survival (all patients)

HR 0.64 (0.53–0.78)

10.5 vs 8.2 months

Median progression-free survival (CPS ≥1)

HR 0.58 (0.48–0.71)

10.4 vs 8.2 months

Median progression-free survival (all patients)

HR 0.61 (0.51–0.74)

Drugs in this study:Bevacizumab (Avastin)Carboplatin (Paraplatin)Cisplatin (Platinol)Paclitaxel (Taxol)Pembrolizumab (Keytruda)

Dose and schedule cards

Pembrolizumab + paclitaxel and platinum ± bevacizumab (KEYNOTE-826)

First-line persistent, recurrent or metastatic disease with PD-L1 CPS ≥1 (by an approved test)Cycle length: Every 21 daysOn the page “Cervical cancer” · Metastatic, persistent or recurrent disease: first line

First-line persistent, recurrent or metastatic disease with PD-L1 CPS ≥1 (by an approved test)

Drug	Dose	Route	Schedule
Pembrolizumab	200 mg (or 400 mg every 6 weeks per the label)	IV	Day 1 every 3 weeks, before chemotherapy
Paclitaxel	175 mg/m²	IV	Day 1
Cisplatin or carboplatin	Cisplatin 50 mg/m² or carboplatin AUC 5	IV	Day 1
Bevacizumab (at the physician’s discretion)	15 mg/kg	IV	Day 1

Cycle length: Every 21 days
Duration: Chemotherapy up to 6 cycles; pembrolizumab up to 35 cycles (about 2 years); all until progression or unacceptable toxicity

The most common grade 3–5 adverse events were anaemia (30.3% vs 26.9%) and neutropenia (12.4% vs 9.7%). Source for dosing: protocol NCT03635567.

On the page “Cervical cancer” · Metastatic, persistent or recurrent disease: first line

KEYNOTE-826

Recurrent or metastatic cervical cancer, first lineCycle length: Every 21 daysOn the page “Pembrolizumab in cervical cancer: with chemoradiotherapy and in metastatic disease”

Recurrent or metastatic cervical cancer, first line

Drug	Dose	Route	Schedule
Pembrolizumab	200 mg	IV	Day 1
Paclitaxel	175 mg/m²	IV	Day 1
Cisplatin 50 mg/m² or carboplatin AUC 5		IV	Day 1
Bevacizumab (optional)	15 mg/kg	IV	Day 1

Cycle length: Every 21 days
Duration: Chemotherapy 6 cycles; pembrolizumab up to 35 cycles

As in KEYNOTE-826.

Dose source:.

On the page “Pembrolizumab in cervical cancer: with chemoradiotherapy and in metastatic disease”

Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.

Treatment arms and regimens

1Pembrolizumab + chemotherapy

Pembrolizumab 200 mg IV on day 1 of each 21-day cycle for up to 35 cycles (about 2 years), plus investigator's choice of chemotherapy for up to 6 cycles: paclitaxel 175 mg/m² + cisplatin 50 mg/m², or paclitaxel 175 mg/m² + carboplatin AUC 5 (all IV, day 1); each with or without bevacizumab 15 mg/kg IV (at the investigator's discretion). All treatments continued until disease progression or toxicity.

2Placebo + chemotherapy

Placebo (normal saline or dextrose) IV on day 1 of each 21-day cycle for up to 35 cycles (about 2 years), plus investigator's choice of chemotherapy for up to 6 cycles: paclitaxel 175 mg/m² + cisplatin 50 mg/m², or paclitaxel 175 mg/m² + carboplatin AUC 5 (all IV, day 1); each with or without bevacizumab 15 mg/kg IV (at the investigator's discretion). All treatments continued until disease progression or toxicity.

Source of the regimen details: Abstract of the paper (pembrolizumab 200 mg every 3 weeks for up to 35 cycles) and ClinicalTrials.gov NCT03635567 (chemotherapy and bevacizumab doses)

Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.

Study population

Patients with persistent, recurrent or metastatic cervical cancer who had not previously received systemic therapy.

According to the FDA label for pembrolizumab: patients had not received previous chemotherapy except chemotherapy given concurrently with radiotherapy (as a radiosensitiser) and were enrolled regardless of PD-L1 expression; patients with autoimmune disease requiring systemic treatment in the past 2 years or conditions requiring immunosuppression were excluded.

Endpoints

Progression-free survival and overall survival at 5-year follow-up.

Safety and side effects

No new safety signal was observed, and no new deaths from treatment-related adverse events had occurred since the final analysis.

Clinical significance and place in guidelines

Confirms the durability of the overall survival benefit at 5-year follow-up and strengthens the position of pembrolizumab with platinum-based chemotherapy (with or without bevacizumab) as the standard first-line treatment for PD-L1-positive tumours.

Limitations

Exploratory ad hoc analysis without formal hypothesis testing.

Original article (DOI)PubMed ClinicalTrials.gov

This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.