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
15P - Comparing the outcomes of the mastectomy using the tumescent technique by between the special and non-special surgeons
Presenter: Naoya Takeda
Session: Poster display session
Resources:
Abstract
16P - Risk factors and prognostic value of non-alcoholic fatty liver disease (NAFLD) in hormone positive, non-metastatic breast cancer receiving adjuvant hormonal therapy
Presenter: Kartika Taroeno Hariadi
Session: Poster display session
Resources:
Abstract
17P - Distance related outcome in indigenous and non-indigenous breast cancer women of Western Australia
Presenter: Azim Khan
Session: Poster display session
Resources:
Abstract
18P - Usefulness of neutrophil to lymphocyte ratio in early stage breast cancer as predictor of disease-free survival in a Babylon Oncology Center
Presenter: Yaala Raof Al-Bairmany
Session: Poster display session
Resources:
Abstract
19P - Silymarin functionalized quantum cores as selective inhibitor of polo-like kinase 1, and preclinical antitumor activity in human breast cancer xenografts
Presenter: Manickam Paulpandi
Session: Poster display session
Resources:
Abstract
20P - Diagnostic value of serum HER-2 level in compression with tissue HER-2 in breast cancer: A systematic review and meta-analysis
Presenter: Amir Shamshirian
Session: Poster display session
Resources:
Abstract
21P - Clinical outcome of treatment without trastuzumab in HER2 positive breast cancer patients
Presenter: Than Than Aye
Session: Poster display session
Resources:
Abstract
22P - Clinical outcomes after skin-sparing or nipple areolar complex-sparing mastectomy with sentinel lymph node biopsy in early breast cancer patients
Presenter: Hye Yoon Lee
Session: Poster display session
Resources:
Abstract
23P - The correlations between knowledge and attitudes of productive age women toward “SADARI” (breast self-assessment) as early detection of breast cancer in Pejeng Kaja Village, Ubud, Bali
Presenter: Yorky Brahmantya
Session: Poster display session
Resources:
Abstract
24TiP - KEYNOTE-756: A randomized, double-blind, phase III study of pembrolizumab or placebo with neoadjuvant chemotherapy and adjuvant endocrine therapy for high-risk, early-stage, ER+/HER2−breast cancer
Presenter: Fatima Cardoso
Session: Poster display session
Resources:
Abstract