Head and Neck Cancer Committee QuynhThu Le MD
- Slides: 9
Head and Neck Cancer Committee Quynh-Thu Le, MD, FACR, FASTRO Stanford University Erich M. Sturgis, MD, MPH Baylor College of Medicine Stuart J. Wong, MD Medical College of Wisconsin Neil Hayes, MD, MPH UT-West Institute for Cancer Research NRG Oncology Semiannual Meeting July 17, 2020
Committee Update • 7 active trials (HN 001, HN 004, HN 005, HN 006, RTOG 1008, RTOG 1216, RTOG 3507) • 2 protocols in development (HN 007, HN 008) • 5 concepts/LOIs approved by RSC (HN 1935, HN 1936, HN 1937, HN 2001, HN 2004) • 1 amendment (HN 005)
Active Studies Study Disease situation Accrual Comments 1 NRG-HN 001 Ph II/III Nasopharyngeal carcinoma based on EBV DNA Ph II: 115/126 Ph III: 383/632 (23/379 proton amendment) Proposed replacement concept (NRG-HN 2001) for the high-risk group (completion 12/2020) 2 NRG-HN 004 Ph II/III Locoregionally advanced H&N cancer w/ contraindication to cisplatin Lead-in: 10/10 Ph II: 88/234 Ph III: 0/444 Accruing ahead of target 3 NRG-HN 005 Ph II/III Early-stage, p 16+, non-associated oropharyngeal cancer Ph II: 64/399 Ph III: 0/474 • • Accruing ahead of target Amend 1 in progress
Active Studies Study Disease situation Accrual Comments 4 NRG-HN 006 Ph II/III SLN biopsy vs. END for earlystage oral cavity cancer Ph II: 0/228 Ph III: 0/618 Activated: July 8, 2020 5 RTOG 1008 Ph II/III High-risk malignant salivary gland tumors 235/252 Scheduled to complete 2/2021 RTOG 1216 Ph II/III High-risk HNSCC Ph II: 204/200 Ph III: 0/478 6 (9/82 proton amendment) Phase III activated: July 13, 2020
Active Studies 7 Study Disease situation Accrual RTOG 3507 Ph II SBRT for recurrent or new second primary HNSCC Lead-in: 7/8 Ph II: 1/102 Comments
Developing* Studies Study Disease situation Accrual Comments 1 NRG-HN 007 Ph III Recurrent or metastatic NPC 0/316 Received CIRB approval, pending CTEP final approval Absolute: 9/9/2020 2 NRG-HN 008 Ph I w/ expansion cohort Local-regionally advanced HNSCC 0/42 Avelumab removed per CTEP review comments; initial protocol resubmitted to CTEP Absolute: 10/19/2020 3 NRG-HN 1937 Ph III High vs. low dose cisplatin for LA HNSCC 0/990 Target CTEP submission: 7/21/2020 *Developing studies = Approved by NRG RSC but not activated
Developing* Studies Study Disease situation Accrual Comments 4 NRG-HN 2004 Ph II T-DM 1 +/- Atezo in metastatic HER 2 amplified salivary duct cancer 0/93 Target CTEP Submission: 9/22/2020 5 NRG-HN 2001 Ph II/III Placebo vs. adjuvant IO in LA NPC w/ persistently detectable EBV DNA 0/314 Submitted for Jan 2020 RSC; approved *Developing studies = Approved by NRG RSC but not activated
Developing* Studies Study Disease situation Accrual Comments 6 NRG-HN 1936 Ph II single arm Chemoimmunoselection for SS in recurrent/ persistent PD-L 1 enriched SCCHN 0/93 Submitted for Oct 2019 RSC; approved 7 NRG-HN 1935 Intermediate risk post-op HNSCC w/ post-op RT +/PD-1 inhibitor 0/360 Submitted for Oct 2019 RSC; approved *Developing studies = Approved by NRG RSC but not activated
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