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Poster display session

1566 - KEYNOTE 029: Phase 1/2 randomized study of pembrolizumab (pembro) plus 2 dose regimens of ipilimumab (ipi) for advanced melanoma

Date

10 Sep 2017

Session

Poster display session

Presenters

Michael Atkins

Citation

Annals of Oncology (2017) 28 (suppl_5): v428-v448. 10.1093/annonc/mdx377

Authors

M.B. Atkins1, M.S. Carlino2, A.G. Hill3, C.M. McNeil4, A. Ribas5, V. Atkinson6, J.S. Cebon7, M.B. Jameson8, W. Hwu9, J.A. Thompson10, J. Anderson11, B. Homet Moreno12, N. Ibrahim12, G.V. Long13

Author affiliations

  • 1 Oncology, Lombardi Cancer Center Georgetown University, 20007 - Washington DC/US
  • 2 Medical Oncology, Westmead and Blacktown Hospitals, Melanoma Institute Australia, and the University of Sydney, Sydney/AU
  • 3 Medical Oncology, Tasman Oncology Research, Southport/AU
  • 4 Medical Oncology, Chris O’Brien Lifehouse, Royal Prince Alfred Hospital, Melanoma Institute Australia, and the University of Sydney, Sydney/AU
  • 5 Medicine-hematology/oncology, University of California, Los Angeles, Los Angeles/US
  • 6 Oncology, Gallipoli Medical Research Foundation, Greenslopes Private Hospital, Brisbane/AU
  • 7 Immunology, Therapeutics, Olivia Newton-John Cancer Wellness & Research Institute - Melbourne, 3084 - Heidelberg/AU
  • 8 Medical Oncology, Waikato Hospital, 3240 - Hamilton/NZ
  • 9 Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston/US
  • 10 Medicine, Seattle Cancer Care Alliance, 98109 - Seattle/US
  • 11 Bards, Late Development Statistics, Merck & Co., Inc., Kenilworth/US
  • 12 Oncology, Merck & Co., Inc., Kenilworth/US
  • 13 Melanoma Medical Oncology, Melanoma Institute Australia and Royal North Shore Hospital, The University of Sydney, Mater Hospital, Sydney/AU
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Resources

Abstract 1566

Background

Standard-dose pembro (2 mg/kg Q3W) + reduced-dose ipi (1 mg/kg Q3W × 4 doses) showed preliminary efficacy in patients (pts) with melanoma in part 1B of the phase 1/2 KEYNOTE-029 study (NCT02089685), but 42% of pts had treatment-related AEs (TRAEs). In part 1C, 2 more dosing regimens of this combination will be evaluated to further assess efficacy and aim to reduce the toxicity seen in part 1B.

Trial design

Pts aged ≥18 y with histologically confirmed unresectable stage III/IV melanoma not amenable to local therapy; no prior treatment ([neo]adjuvant treatment, excluding PD-1/PD-L1 or BRAF/MEK inhibitors, was allowed if pts did not discontinue for TRAEs, all TRAEs returned to baseline/stabilized, and relapse did not occur within 6 mo of discontinuation for anti–CTLA-4 therapy); measurable disease per RECIST v1.1; ECOG PS 0/1; tumor sample for determination of PD-L1 status; no active brain metastases (baseline brain MRI required) were eligible. ∼100 pts will be randomized 1:1 to pembro 200 mg Q3W + ipi 50 mg Q6W (arm 1) or 100 mg Q12W (arm 2). Combination therapy will continue for ≤24 wk in arm 1 and ≤48 wk in arm 2, followed by pembro monotherapy for ≤24 mo or until PD, intolerable toxicity, or patient/physician decision. Tumor imaging will occur every 6 wk until wk 24, and every 12 wk thereafter. Response will be assessed per RECIST v1.1 by independent central review (for efficacy) and modified RECIST v1.1 by investigator review (for treatment decisions). Survival follow-up will occur every 12 wk. AEs will be graded per CTCAE v4.0. Pts with investigator-determined, confirmed CR who received ≥24 wk pembro and ≥2 doses after initial CR may discontinue pembro; pts with investigator-determined, confirmed CR or very good PR (percentage change from baseline in tumor size >60%) who received ≥1 ipi dose may discontinue ipi. Pts with SD or better who subsequently have PD may be eligible for a second course of pembro + ipi or pembro monotherapy (maximum 17 doses pembro and 4 doses ipi). Eligible pts with PD may remain on treatment until a confirmatory scan ≥4 wk later. Primary end points are safety and ORR; secondary end points include PFS, OS, and DOR. Enrollment is ongoing in the US, Australia, and New Zealand.

Clinical trial identification

NCT02089685

Legal entity responsible for the study

Merck & Co., Inc., Kenilworth, New Jersey, USA

Funding

Merck & Co., Inc., Kenilworth, New Jersey, USA

Disclosure

M.B. Atkins: Advisory board member for Bristol-Myers Squibb, Merck, Roche, Novartis, Pfizer, Celldex, Allexion. M.S. Carlino: Advisory board member for Bristol-Myers Squibb, Merck, Amgen, Novartis. Honoraria from Merck, Bristol-Myers Squibb. C.M. McNeil: Advisory board member for Merck, Sharp & Dohme. Speakers bureau for Merck, Sharp & Dohme and Bristol-Myers Squibb. Research funding from Merck, Sharp & Dohme. Travel expenses, including accommodations from Merck, Sharp & Dohme. A. Ribas: Stock ownership in Kite Pharma. Honoraria from Amgen, Pfizer, Merck, Roche. V. Atkinson: Advisory board member: MSD, Bristol-Myers Squib, Novartis, Pierre Fabre. Speakers bureau: MSD, Bristol-Myers Squib, Novartis. Honararia: MSD, Bristol-Myers Squib, Novartis. Travel expenses, including accommodations: MSD, Bristol-Myers Squib, Novartis. M.B. Jameson: Travel expenses, including accommodations for Merck Sharp & Dohme W-J. Hwu: Advisory board member for Merck. Speakers bureau for Merck, Bristol-Myers Squibb, GlaxoSmithKline, MedImmune. J.A. Thompson: Advisory board: CellDex. Research funding to institution: Merck, Agensys, Seattle Genetics, Pfizer. Honoraria: CellDex. J. Anderson: Employment with Merck. B. Homet Moreno: Employee of Merck & Co, Inc. Stock ownership in Merck & Co., Inc. N. Ibrahim: Employment: Merck. Stock: Merck, GSK. G.V. Long: Advisory board member Amgen; Bristol-Myers Squibb; Array; Merck; Merck, Sharp & Dohme; Novartis, Roche, Pierre Fabre. Honararia from Bristol-Myers Squibb; Roche; Merch, Sharp & Dohme. All other authors have declared no conflicts of interest.

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