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2022-RA-1276-ESGO Pembrolizumab monotherapy for advanced clear cell gynaecological cancer: phase II PEACOCC trial
  1. Rowan E Miller1,
  2. Andrew Clamp2,
  3. Charlie Gourley3,
  4. Rene Roux4,
  5. Marcia Hall5,
  6. Michael-John Devlin6,
  7. Rachel Nirsimloo7,
  8. Valentinos Kounnis4,
  9. Laura Hughes8,
  10. Nicholas Counsell9,
  11. Laura Farrelly10 and
  12. Rebecca S Kristeleit11
  1. 1Medical Oncology, University College London Hospital, London, UK
  2. 2The Christie NHS Foundation Trust, Manchester, UK
  3. 3Cancer Research UK Scotland Centre, University of Edinburgh, Edinburgh, UK
  4. 4Medical Oncology, Churchill Hospital, Oxford, UK
  5. 5Mount Vernon Cancer Centre, Northwood, UK
  6. 6Bart’s Cancer Institute, London, UK
  7. 7Edinburgh Cancer Centre, Western General Hospital, Edinburgh, UK
  8. 8CRUK and UCL Cancer Trials Centre, Univeristy College London, London, UK
  9. 9CRUK and UCL Cancer Trials Centr, University College London, London, UK
  10. 10CRUK and UCL Cancer Trials Centre, University College London, London, UK
  11. 11Guy’s and St Thomas’ NHS Foundation Trust, London, UK


Introduction/Background Advanced clear cell gynaecological cancers (CCGC) have poor prognosis with objective response rates (ORR) to second-line chemotherapy between 0–8%. Preliminary clinical activity with PD-1 inhibitors have been described in CCGC. We investigated pembrolizumab monotherapy for advanced CCGC.

Methodology PEACOCC is a Phase II, multicentre, single-arm trial in patients with advanced CCGC who had ≥1 prior line of chemotherapy with progression (PD) at study entry. Pembrolizumab 200 mg iv q21 days was given until PD (RECIST v1.1), unacceptable adverse event (AE), 2 years (y) pembrolizumab completed, patient or clinician decision. Primary endpoint was progression-free survival (PFS) rate at 12 weeks (w) (H0≤15%; H1≥33%; 5% 1-sided α; 90% power). Secondary endpoints included ORR, duration of response (DOR), PFS, overall survival (OS) and safety.

Results 49 patients were enrolled with 48 evaluable. Median age 58.5 y (32–77 y), ECOG 0/1 54.2%/45.8%, 85.4% ovarian CCGC. Median number of prior systemic therapy 2 (1–6); 19 patients (39.6%) had received anti-angiogenic therapy. 42 patients completed median of 4 cycles pembrolizumab (1–25), 6 patients (12.5%) continue pembrolizumab. 16.7% patients had Grade(G)3 treatment-related AE (TRAE) of hyperthyroidism, acute kidney injury, raised alanine aminotransferase, raised alkaline phosphatase, anaemia, encephalitis and diabetic ketoacidosis. There were no G4 or G5 TRAE. 3 patients (6.3%) discontinued pembrolizumab due to TRAEs. The PFS rate at 12w was 43.8% (90%CI:31.5–56.6) exceeding the pre-stated lower bound of 15%. Best ORR was 25.0% (90%CI:15.1–37.3) [1 complete, 11 partial], with 1 y DOR rate 47.7% (95%CI:14.1–75.6). After a median follow-up of 2.1 y, median PFS was 12.2w (95%CI:5.9–32.9) and median OS 71.0w (95%CI:29.1–137.6).

Conclusion The PEACOCC trial suggests that pembrolizumab is effective in heavily pre-treated patients with advanced CCGC: 43.8% patients were alive and progression-free at 12w. Clinical outcomes were durable with limited toxicity. These promising results justify consideration of pembrolizumab monotherapy as a new standard-of-care for advanced CCGC.

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