SAS Output

13-JUL-2020 6:11

OPEN STUDIES IRB REPORT

The REPORT Procedure

Detailed and/or summarized report

Table 1

Disease
Site
Study Study Name Open Date Number of
Active
Institutions
Number of
Current
IRBs
 
BREAST S1418 Breast, Adj, TNBC, MK-3475 (Pembrolizumab) 15-NOV-16 412 204
  S1706 Breast, Inflammatory, RT +/- Olaparib 12-SEP-18 0 92
  A011401 Breast, adj, Stage II/III HER2-, weight loss 29-AUG-16 382 218
  A011502 Brst, Adj, Nodal+&HER2-, Aspirin vs. Placebo 08-DEC-16 0 213
  B51 Breast, Regional Nodal XRT 22-AUG-13 289 160
  EA1131 Brst, TNBC, Post-op Chemo vs Obs 20-AUG-14 289 127
  EA1181 BRST, HER2-pCR, Preop THP and Postop HP 11-FEB-20 0 59
  MA39 BREAST, Node-Pos, Reg RT vs No Reg RT 30-MAY-18 0 109
  NRGBR003 Brst,Adj,TNBC,AC -> WP +/- Carbo 22-JAN-15 319 158
  NRGBR004 BREAST, Met HER2+, Pac+Tras+Pert +/- Atezo 12-MAR-19 0 27
 
CCD S1703 Met Breast, STM-monitoring v Usual Care 16-JUL-18 0 80
  S1916 Pain, Mets, Opioid Digital Medicine Pilot 15-OCT-19 0 8
  ACCL16N1 Guideline Consistent Treatment AYA ALL 18-DEC-17 0 50
  EA1151 CCD, Tomosynthesis Mammographic Screening 06-JUL-17 0 93
  EAQ162CD CCD, Financial Burden, Colon & Rectal Cancer 17-MAY-18 0 69
  EAQ171CD Smoke Free Support Study 2.0 11-APR-19 0 40
  NHLBIMDS LEUK, National MDS Study 05-APR-16 219 84
 
ERLYTX S1609 Rare Tumor, Comb Nivo/Ipi 13-JAN-17 341 159
  EAY131 MATCH 12-AUG-15 378 207
 
GI S1613 mCRC, Adv/Met, TP vs CETIRI 09-OCT-17 0 121
  S1815 Biliary, Met/LocAdv, GC+CPT±Nab-paclitaxel 03-DEC-18 0 117
  S1922 Small Bowel,Ram+Pac vs FOLFIRI, mets/unresect 16-DEC-19 0 47
  A021502 Colon, Stg III, Chemo +/- Atezol, ATOMIC 12-SEP-17 0 171
  A021602 PANC, Adv PNET Blinded Cabozantinib v Placebo 18-JUL-18 0 93
  A021703 COLON, Adv/Met, Chemo + Std v High dose V-D3 30-SEP-19 0 24
  EA2142 GI NEC, Adv G3, EP vs TMZ + CAP 06-NOV-15 191 83
  EA2165 Anal, Stg II-III, Nivolumab after CMT 13-APR-18 0 136
  NRGGI004 Colorectal, Stg IV, dMMR Immuno-Therapy 07-NOV-17 0 130
  NRGGI005 COLON,Stg IIA, ctDNA in Adjuvant Chemotherapy 16-DEC-19 0 2
 
GU S1602 Blad, HG NMIBC, TICE/Tokyo/Prime+Tokyo BCG 07-FEB-17 184 91
  S1802 Pros, Stg IV, SST +/- Surg/RT to Primary Tum 17-SEP-18 0 128
  S1806 Blad, MIBC, ChemoRT +/- Atezolizumab 19-APR-19 0 126
  A031102 GCT, Recur, Std Chemo(TIP) vs HD Chemo(TI-CE) 01-JUL-15 53 37
  A031501 Bladder, MIBC/Loc Adv, Adjv Pembro vs Obs 21-SEP-17 0 139
  A031701 Bladder, ddGC for MIBC with DDR Tumor Alt 01-AUG-18 0 56
  A031702 GU, Mets, Cabozantinib+Nivo+Ipi (ICONIC) 12-APR-19 0 85
  A031704 RCC, Met, Ipi+Nivo followed by Nivo+/-Cabo 09-MAY-19 0 106
  A031803 Blad, NMIBC, Gemcitabine + MK-3475 06-JAN-20 0 15
  EA8143 RCC, HR, Surg +/- Nivolumab (PROSPER) 02-FEB-17 0 146
  EA8153 Pros, ADT + Abira +/- Cabazitaxel (CHAARTED2) 08-FEB-18 0 91
  EA8171 PROS, newly diagnosed, mpMRI for pre-op stagi 09-JUL-18 0 38
  NRGGU002 Pros, RT + ADT After RP +/- Adj Docetaxel 30-DEC-16 0 102
  NRGGU005 PROS, intmd risk, IGRT& SBRT vs IGRT& HF-IMRT 16-NOV-17 0 117
  NRGGU006 PROS, post-RP PSA, SRT +/- ADT w/Apalutamide 27-APR-18 0 129
 
LEUK S1318 ALL, Age 65+, Ph±, Blinatumomab 12-JAN-15 118 45
  S1712 CML, Chronic Phase, TKI +/- Ruxolitinib 20-JUL-18 0 68
  A041501 B-Cell ALL, Frontline Tx +/- Intuzumab Ozo 01-JUN-17 0 77
  A041701 AML, Age 60+, Conv Chemo +/- Uproleselan 16-JAN-19 0 58
  A041702 CLL, Stg I-IV, IO with IM versus IVO 04-JAN-19 0 120
  EA9161 CLL, untreated, IOV vs IO in younger pts 03-JAN-19 0 124
  EA9171 CML, Anti-PD-1 Pembrolizumab + TKIs 03-OCT-18 0 2
 
LUNG S1701 Thymic Adv, Carbo/Pac/Ram vs. Carbo/Pac 09-AUG-18 0 38
  S1800A Non-Match: Ramu + Pembro vs SoC 17-MAY-19 0 161
  S1827 SCLC, MRI Surveillance +/- PCI 10-JAN-20 0 83
  S1900A LOH and/or BRCA: Rucaparib 28-JAN-19 0 165
  S1900B RET Fusion: Selpercatinib (LOXO-292) 10-FEB-20 0 110
  S1900C STK11: Talazoparib + Avelumab 16-JAN-20 0 126
  S1914 NSCLC, High Risk Early Stg, SBRT +/- Atezo 25-MAR-20 0 47
  S1929 ESCLC, SLFN11+, Atezolizumab ± Talazoparib 15-JUN-20 0 8
  S1933 NSCLC, Stg II-III, RT + Atezo 15-JUN-20 0 9
  A081105 ALCHEMIST1, EGFR mut, Erlotinib 02-JAN-14 0 211
  A151216 ALCHEMIST0 - screening 06-FEB-14 388 220
  E4512 ALCHEMIST2, ALK mut, Crizotinib 18-AUG-14 393 216
  EA5163 NSCLC, Immunotherapy +/- 2nd line therapy 28-FEB-19 0 125
  LUNGMAP NSCLC, Adv, Master 28-JAN-19 0 188
  NRGCC003 SCLC, PCI or HA-PCI 07-DEC-15 236 129
  NRGLU002 LUNG, Limited Met NSCLC, MST vs LCT + MST 07-APR-17 0 137
  NRGLU005 LUNG, LS-SCLC, ChemoRT v ChemoRT+Atezo 28-MAY-19 0 135
 
LYMPH S1608 FL, TGR-1202/Lenalidomide/CHOP or Benda +Ob 10-AUG-17 0 98
  S1826 HD, Adv, Age 12+, N+AVD vs BV+AVD 19-JUL-19 0 131
  A051301 ABC DLBCL, Auto HCT and Ibrutinib/Placebo 15-JUL-16 177 70
  A051701 LYMPH, MYC/BC2 DHL&DEL, R-chemo+/-Venetoclax 07-AUG-19 0 90
  E4412 HD, RR, Ipilimumab +Nivo +Brentuximab Vedotin 24-JAN-14 0 56
  EA4151 Lymph, AHCT +/-Ritux, MRD Neg 29-AUG-17 0 75
  EA4181 MCL, Randomization BR/CR v BR/CR-A v BR-A 03-OCT-19 0 33
 
MELAN S1512 Melan, Adv, Desmoplastic, MK-3475 (pembro) 20-OCT-16 91 40
  S1607 MELAN, Adv, T-VEC, MK-3475 02-OCT-17 0 23
  S1616 MELAN, Adv, Ipilimumab ± Nivolumab 17-JUL-17 0 100
  S1801 Melan, Adv, Adj vs Neoadj Pembrolizumab 06-DEC-18 0 130
  EA6134 Adv, BRAF mut, D+T/Ipi+Niv vs Ipi+Niv/D+T 15-DEC-15 297 129
  EA6141 Melan, Avd, Nivolumab+Ipi ± Sargmostim 01-MAR-16 203 80
  EA6174 Merkel, Adjuvant Pembrolizumab vs Observation 23-JUL-18 0 93
 
MMYEL S1803 MM, Maintenance, Len vs Len/Dara 27-JUN-19 0 95
  EAA173 MYEL, SMM, Rd +/- Daratumumab 30-APR-19 0 76
 
OTHER A091802 cSCC, Advanced Avelumab +/- Cetuximab 17-MAY-19 0 8
  A151804 irAEs, National Biorepository to Adv Studies 31-JAN-20 0 7
  AGCT1532 Inter/Poor Met GCTs, Accel v Std BEP Chemo 30-JUL-18 0 67
  EA3132 HN SCC, Stg III-IV , Adj RT +/- Cisp 29-MAR-16 0 66
  EA3161 HNC, HPV+ OPCA, (cisplatin+RT) +/- Nivo 20-JUN-19 0 74
  EAF151 Brain, GBM, Bev, Blood Volume 14-APR-17 0 32
  G0263 Cerv, Stg I/IIA, adjv RT vs chemoRT 12-APR-10 0 56
  N0577 BRN, Glio,Tem vs Tem+RT vsRT+PVC 22-SEP-09 213 86
  NCICOVID NCI COVID-19 in Cancer Patients Study 21-MAY-20 0 27
  NRGBN001 HN, novel vs. std chemoradiation + chemo 28-AUG-15 0 71
  NRGBN003 Mening, Grd II, Observation vs Irradiation 14-JUN-17 0 100
  NRGGY005 OVAR, Cedir vs Olaparib vs C+O vs Std of Care 06-FEB-16 294 123
  NRGHN001 Nasopharyngeal , Indiviual Tx EBV 21-APR-14 172 74
  NRGHN004 HN, Adv, RT+Durvalumab vs RT+Cetuximab 12-DEC-17 0 134
  NRGHN005 HN, early stg P16-pos, randomize de-intensifi 10-JUL-19 0 103
  R0724 Cervical, Chem+RT +/- Adj. Chemo 15-JAN-14 177 69
 
PEOLC S1820 Rectal, Diet modification to manage GI sx 09-DEC-19 0 56
 
PREV S1823 GCT, Obs. Cohort, miRNA371 01-JUN-20 0 14
  A211601 Breast, Stg II-III, Aspirin 01-AUG-18 0 65
 
SURV S1501 Surv, Breast Stg IV, Card Tox w/ Carvedilol 15-SEP-17 0 99
  E1Q11 EROS: Reproductive Health in Cancer Survivors 30-SEP-15 0 46
  EA9131 Leuk, Strategy to decrease early APL deaths 16-AUG-17 0 24
 
SXQOL S1614 HBV in Ca Pts, TAF vs SOC 21-FEB-19 0 26
  S1714 CIPN Risk Prediction Cohort Study, Taxanes 01-MAR-19 0 58
  A171601 Breast, ER+ HER2- Met, Palboc + Letroz/Fulves 15-AUG-18 0 2
  A221504 NSCL, Advanced, placebo vs naloxegol 13-OCT-17 0 83
  A221505 Brst, Hypofractionated Post Mast Rad 01-FEB-18 0 116
  A221602 CINV in HEC patients, Olanza +/- Fosapre 15-OCT-18 0 66
  A221702 BREAST, SLN/ALND +/- ARM 31-MAY-19 0 70