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July 12, 2014

NRG Oncology Research Strategy Committee Update Mitchell Machtay , M.D. Deputy Group Chair for Research Strategy. July 12, 2014. NRG Structure RSC and CPAC Report to Group Chairs. NRG Research Strategy Committee (RSC).

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July 12, 2014

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  1. NRG Oncology Research Strategy Committee Update Mitchell Machtay, M.D.Deputy Group Chair for Research Strategy July 12, 2014

  2. NRG StructureRSC and CPAC Report to Group Chairs

  3. NRG Research StrategyCommittee (RSC) • NRG Internal Peer review of Protocol concepts submitted by NRG committees – ~50 members. • Meets face-to-face at semi-annual meetings. • Periodic teleconferences between meetings. • Voting and scoring performed by the RSC members via survey-monkey post-meeting. • Protocol concepts with a ‘positive’ vote are sent to NRG CPAC for prioritization

  4. Voting/Prioritizing

  5. RSC Concepts ApprovedBy NRG Thus Far • Legacy protocols already well under development by NSABP, RTOG, GOG. • Series of ‘Nivo’ protocol concepts in response to high priority NCI mass solicitation. • Brain, H&N, Lung, Cervix, Ovary • Nine protocol concepts formally reviewed and presented at February 2014 NRG meeting: • 2 brain; 4 GYN; 2 Lung; 1 Sarcoma

  6. OEWG Developing Studies (Concepts NCI Approved) Developing Concepts (Concepts NRG RSC Approved But not yet NCI approved) • Brain/CNS: 2 • Breast: 2 • Gastrointestinal: 1 • Genitourinary: 2 • Gyn (incl. Dev. Ther.): 3 • Head & Neck: 1 • Lung/Thoracic: 1 • CPC: 1 • Brain/CNS: 3 • Breast: 1 • Gastrointestinal: 0 • Genitourinary: 0 • Gyn (incl. Dev. Ther.): 9 • Head & Neck: 0 • Lung/Thoracic: 1 • CPC: 1

  7. OEWG Developing Studies(i.e. NCI approved concepts) • Breast: N=2 • BR-001: Multifocal SBRT for oligometastatic disease (Ph. I) • BR-002: Unifocal SBRT for oligometastatic disease (Ph. II/III) • Gynecologic: N=3 • GY-001: XL-184 for recurrent ovarian CA (Ph. II) • GY-00x: Nivolumab for recurrent cervix CA (Ph. II) • GY-00x: Nivolumab/Ipilimumab for adv. ovarian CA (Ph. II) • Cancer Control/Prevention: N=1 • CC-001: Memantine/hippocampal sparing brain RT for metastases (Ph. III)

  8. OEWG Developing Studies(i.e. NCI approved concepts) • Brain/CNS: N=2 • BN-001: High dose IMRT/protons for GBM (Ph. III) • BN-002: RT/Temodar/Nivolumab for GBM (Ph. I) • Head and Neck: N=2 • HN-001: EBV-based chemo-RT for Nasoph CA (Ph II/III). • HN-002: RT/chemo dose for HPV+ Oroph. (Ph II) • Gastrointestinal: N=1 • GI-001: Chemo +/- RT for CholangioCA (Ph. III) • Lung: N=1 • LU-001: Chemo-RT +/- Metformin for Lung CA (Ph. II) • Genitourinary: N=1 • GU-001: Postop IMRT for Loc. Adv. bladder CA (Ph. II/III)

  9. NRG Developing Concepts(i.e. RSC approved but not NCI approved) • Brain: N=3 • RT + Veliparib (ABT-888) for GBM (Ph. IIR) • RT/Temodar + Valcyte for GBM (Ph. IIR) • Postop RT for Atypical Meningioma (Ph. IIR) • Breast: N=1 • Advanced Imaging/biopsies after NeoadjuvantTx. (Ph. II) • Lung: N=2 • Local RT/SBRT for oligometastatic Stage IV NSCLC (Ph. IIR) • Pazopanib after SBRT for oligometastatic sarcoma (Ph. IIR) • Cancer Control/Prevention: N=1 • Hippocampal sparing prophylactic cranial irradiation for small cell lung CA.

  10. NRG Developing Concepts(i.e. RSC approved but not NCI approved) • GYN (incl. Dev. Ther.): N= 9 • Paclitaxel +/- Nintedanib (BIBF1120) for Adv. Endometrium. • Chemo-RT +/- Triapine for Loc. Adv. Cervix CA. • Chemo vs. Trametinib for L.G. Serous Ovary CA • Trametinib + GSK214179 (akt-i) for L.G. Serous Ovary CA • IMGN 853 + carbo vs. chemo for Ovarian CA • Carbo/Paclitaxel +/- OMF-54F28 for Uterine sarcoma • Cediranib/Olaparib vs. chemo for rec. Ovary (Pt sensitive). • Cediranib vs. Olaparib vs. both for rec. Ovary (Pt resistant) • Lymphadenectomy vs. no Lymphadenecotomy Endometrial CA

  11. Summary • NRG ‘Pipeline’ includes: • 13 studies ‘approved’ by NCI, on OEWG timeline. • 15 studies ‘approved’ by NRG-RSC, being submitted or resubmitted to NCI. • Heavily weighted toward GYN cancer (including Dev. Therapeutics). • Heavily weighted toward early phase trials. • Consistent with NCI goals for the new NCTN to have fewer trials, less accrual than previously.

  12. The King (of Protocols)is Back!

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