Abstract 285TiP
Background
High risk for relapse is observed in cHL patients (pts) with SER to initial chemotherapy and organ toxicities may be higher following dose intensification.
Trial design
The phase 2 KEYNOTE-667 (NCT03407144) study will enroll 440 pts aged 3-17 (children) or 18-25 years (young adults) with newly-diagnosed, confirmed stage IA, IB, or IIA cHL without bulky disease (Group 1 [low-risk]) or stage IIEB, IIIEA, IIIEB, IIIB, IVA, or IVB cHL (Group 2 [high-risk]); measurable disease; performance status per Lansky Play-Performance Scale ≥50 (age ≤16 years) or Karnofsky score ≥50 (age >16 years). Pts will receive induction with doxorubicin, bleomycin, vinblastine, dacarbazine (ABVD; Group 1) or vincristine, etoposide/etoposide phosphate, prednisone/prednisolone, doxorubicin (OEPA; Group 2) for 2 cycles, then early response assessment by PET/CT/MRI. Pts with rapid early response (Deauville score 1-3) will receive non-study consolidation chemotherapy. Pts with SER (Deauville score 4-5) will receive consolidation with pembro 2 mg/kg Q3W to 200 mg (children) or 200 mg Q3W (young adults) plus 2 cycles AVD (Group 1) or 4 cycles cyclophosphamide, vincristine, prednisone/prednisolone, dacarbazine (COPDAC-28; Group 2). PET/CT for late response assessment (LRA) will be performed after consolidation. After LRA, Group 1 SER pts and Group 2 pts (Deauville score 4-5) will receive radiotherapy (RT). All pts will receive maintenance pembro Q3W concomitantly with RT. Pembro will continue for 17 administrations, with option to stop after 8-administrations due to CR, or until progression, unacceptable toxicity, or withdrawal. Primary endpoint: ORR per Cheson 2007 IWG criteria by group in SER pts. Secondary endpoints: SERs with PET negativity after consolidation, 2-yr event-free survival (EFS), OS, RT frequency and details by group, RERs with PET negativity after ABVD induction, 3-yr EFS by investigator, OS by risk group, serum TARC levels at screening in SERs by risk group. ORR with 95% CI will be estimated by Clopper-Pearson method. EFS and OS will be estimated by Kaplan-Meier method. Safety will be assessed in all-treated pts.
Clinical trial identification
NCT03407144.
Legal entity responsible for the study
Merck & Co., Inc.
Funding
Merck & Co., Inc., Kenilworth, NJ, USA.
Disclosure
K. Kelly: Research grant / Funding (institution): Merck & Co., Inc. F. Keller: Research grant / Funding (institution): Merck & Co., Inc. A. Nahar: Shareholder / Stockholder / Stock options, Full / Part-time employment: Merck & Co., Inc. L. Giulino-Roth: Research grant / Funding (institution): Merck & Co., Inc. All other authors have declared no conflicts of interest.
Resources from the same session
YO20 - Can "Superman" have Chronic Myelomonocytic Leukemia?
Presenter: Alexander Luchinin
Session: Poster display session
Resources:
Abstract
YO21 - Sanctuary Site Central Nervous System Relapse-Refractory DLBCL Responding to Nivolumab and Lenalidomide.
Presenter: Irappa Madabhavi
Session: Poster display session
Resources:
Abstract
YO22 - External Auditory Canal Mass: A Case Series of Squamous Cell Carcinoma
Presenter: Mel Valerie Cruz-Ordinario
Session: Poster display session
Resources:
Abstract
YO23 - Soft tissue Giant cell tumor presented as Nasopharyngeal mass: A case report
Presenter: Emmelyn Buenacosa-Nepucpan
Session: Poster display session
Resources:
Abstract
YO25 - Hyperprogression after pembrolizumab in recurrent oropharyngeal cancer and the use of nab-paclitaxel as salvage treatment- A case report.
Presenter: Izzati Rosli
Session: Poster display session
Resources:
Abstract
YO26 - Exacerbation of radiation necrosis around the radiotherapy-pretreated brain metastases site after immune checkpoint inhibitors.
Presenter: Minako Nishio
Session: Poster display session
Resources:
Abstract
YO27 - Comparative Study Of 20Gray/5Fraction And 30Gray/10 Fraction Whole Brain Radiation In Brain Metastasis
Presenter: Pradip Bhandari
Session: Poster display session
Resources:
Abstract
YO28P - The response to anaplastic lymphoma kinase (ALK) inhibitor in metastatic anaplastic thyroid carcinoma (ATC)
Presenter: Nur Faizah Ab Muin
Session: Poster display session
Resources:
Abstract
YO29 - Acute kidney injury secondary to bilateral renal artery tumor thrombosis in a case of posterior mediastinal undifferentiated sarcoma: case report
Presenter: Ritsu Ibusuki
Session: Poster display session
Resources:
Abstract
YO30 - Follicular dendritic cell sarcoma of the tonsil- a multimodality approach
Presenter: Rich Ericson King
Session: Poster display session
Resources:
Abstract