SAS Output

16-OCT-2019 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-16 413 199
  S1706 Breast, Inflammatory, RT +/- Olaparib 12-SEP-18 0 85
  A011106 Breast, Neoadj, ALTERNATE study 15-FEB-14 199 95
  A011401 Breast, adj, Stage II/III HER2-, weight loss 29-AUG-16 383 217
  A011502 Brst, Adj, Nodal+&HER2-, Aspirin vs. Placebo 08-DEC-16 0 211
  A221405 Breast, ET interruption, Pregnancy Outcomes 15-OCT-15 0 49
  B51 Breast, Regional Nodal XRT 22-AUG-13 288 157
  EA1131 Brst, TNBC, Post-op Chemo vs Obs 20-AUG-14 269 127
  EA1151 Brst, Tomosynthesis Mammographic Screening 06-JUL-17 0 80
  NRGBR002 Brst, OMBC, II-III, SoC +/- SBRT and/or SA 24-DEC-14 0 115
  NRGBR003 Brst,Adj,TNBC,AC -> WP +/- Carbo 22-JAN-15 315 159
  NRGBR005 Br, Stg II&IIIA, Post NAdj Chemo Br Conserv 13-APR-17 0 81
 
CCD S1703 Met Breast, STM-monitoring v Usual Care 16-JUL-18 0 74
  S1916 Pain, Mets, Opioid Digital Medicine Pilot 15-OCT-19 0 4
  A191402C PROS, Testing Decision Aids for Minority Men 14-JUL-17 0 9
  ACCL16N1 Guideline Consistent Treatment AYA ALL 18-DEC-17 0 48
  EAQ162CD CCD, Financial Burden, Colon & Rectal Cancer 17-MAY-18 0 68
  NHLBIMDS LEUK, National MDS Study 05-APR-16 211 79
 
ERLYTX S1609 Rare Tumor, Comb Nivo/Ipi 13-JAN-17 328 153
  A071401 Prog Meningiomas,SMO/AKT/NF2 Inhib 06-AUG-15 233 91
  EAY131 MATCH 12-AUG-15 367 198
 
GI S1613 mCRC, Adv/Met, TP vs CETIRI 09-OCT-17 0 116
  S1815 Biliary, Met/LocAdv, GC+CPT±Nab-paclitaxel 03-DEC-18 0 96
  A021502 Colon, Stg III, Chemo +/- Atezol, ATOMIC 12-SEP-17 0 170
  A021602 PANC, Adv PNET Blinded Cabozantinib v Placebo 18-JUL-18 0 77
  EA2142 GI NEC, Adv G3, EP vs TMZ + CAP 06-NOV-15 193 84
  EA2161 PANC, Adv Rapalog Resistant PNETs, MLN0128 01-FEB-17 0 61
  EA2165 Anal, Stg II-III, Nivolumab after CMT 13-APR-18 0 119
  NRGGI004 Colorectal, Stg IV, dMMR Immuno-Therapy 07-NOV-17 0 123
 
GU S1500 pRCC,Adv, Sunitinib vs MET inhib 05-APR-16 176 80
  S1802 Pros, Stg IV, SST +/- Surg/RT to Primary Tum 17-SEP-18 0 116
  S1806 Blad, MIBC, ChemoRT +/- Atezolizumab 19-APR-19 0 98
  A031102 GCT, Recur, Std Chemo(TIP) vs HD Chemo(TI-CE) 01-JUL-15 60 37
  A031501 Bladder, MIBC/Loc Adv, Adjv Pembro vs Obs 21-SEP-17 0 131
  A031701 Bladder, ddGC for MIBC with DDR Tumor Alt 01-AUG-18 0 43
  A031702 GU, Mets, Cabozantinib+Nivo+Ipi (ICONIC) 12-APR-19 0 23
  A031704 RCC, Met, Ipi+Nivo followed by Nivo+/-Cabo 09-MAY-19 0 2
  EA8143 RCC, HR, Surg +/- Nivolumab (PROSPER) 02-FEB-17 0 127
  EA8153 Pros, ADT + Abira +/- Cabazitaxel (CHAARTED2) 08-FEB-18 0 95
  EA8171 PROS, newly diagnosed, mpMRI for pre-op stagi 09-JUL-18 0 34
  NRGGU002 Pros, RT + ADT After RP +/- Adj Docetaxel 30-DEC-16 0 93
  NRGGU005 PROS, intmd risk, IGRT& SBRT vs IGRT& HF-IMRT 16-NOV-17 0 108
  NRGGU006 PROS, post-RP PSA, SRT +/- ADT w/Apalutamide 27-APR-18 0 31
 
LEUK S1318 ALL, Age 65+, Ph±, Blinatumomab 12-JAN-15 132 52
  S1712 CML, Chronic Phase, TKI +/- Ruxolitinib 20-JUL-18 0 62
  A041501 B-Cell ALL, Frontline Tx +/- Intuzumab Ozo 01-JUN-17 0 59
  A041701 AML, Age 60+, Conv Chemo +/- Uproleselan 16-JAN-19 0 12
  A041702 CLL, Stg I-IV, IO with IM versus IVO 04-JAN-19 0 46
  E1910 BCR-ABL-neg, B ALL, Blinatumomab 23-DEC-13 189 81
  EA9161 CLL, untreated, IOV vs IO in younger pts 03-JAN-19 0 111
 
LUNG S1619 Meso,Stg I-III, Nadj chemo/Atezmb->Atezmb+SOC 03-NOV-17 0 32
  S1701 Thymic Adv, Carbo/Pac/Ram vs. Carbo/Pac 09-AUG-18 0 30
  S1800A Non-Match: Ramu + Pembro vs SoC 17-MAY-19 0 143
  S1900A LOH and/or BRCA: Rucaparib 28-JAN-19 0 142
  A081105 ALCHEMIST1, EGFR mut, Erlotinib 02-JAN-14 0 221
  A151216 ALCHEMIST0 - screening 06-FEB-14 394 226
  C30610 SCLC, Thoracic RT 21-MAR-08 158 75
  E4512 ALCHEMIST2, ALK mut, Crizotinib 18-AUG-14 391 221
  EA5142 ALCHEMIST3, Non-match, Nivolumab 16-MAY-16 390 216
  EA5163 NSCLC, Immunotherapy +/- 2nd line therapy 28-FEB-19 0 40
  LUNGMAP NSCLC, Adv, Master 28-JAN-19 0 172
  NRGCC003 SCLC, PCI or HA-PCI 07-DEC-15 242 124
  NRGLU005 LUNG, LS-SCLC, ChemoRT v ChemoRT+Atezo 28-MAY-19 0 28
 
LYMPH S1826 HD, Adv, Age 12+, N+AVD vs BV+AVD 19-JUL-19 0 60
  E4412 HD, RR, Ipilimumab +Nivo +Brentuximab Vedotin 24-JAN-14 0 53
  EA4151 Lymph, AHCT +/-Ritux, MRD Neg 29-AUG-17 0 72
 
MELAN S1512 Melan, Adv, Desmoplastic, MK-3475 (pembro) 20-OCT-16 104 44
  S1607 MELAN, Adv, T-VEC, MK-3475 02-OCT-17 0 27
  S1616 MELAN, Adv, Ipilimumab ± Nivolumab 17-JUL-17 0 95
  S1801 Melan, Adv, Adj vs Neoadj Pembrolizumab 06-DEC-18 0 126
  EA6134 Adv, BRAF mut, D+T/Ipi+Niv vs Ipi+Niv/D+T 15-DEC-15 288 122
  EA6141 Melan, Avd, Nivolumab+Ipi ± Sargmostim 01-MAR-16 209 82
  EA6174 Merkel, Adjuvant Pembrolizumab vs Observation 23-JUL-18 0 64
 
MMYEL S1702 AL Amyloidosis, Relapsed, Isatuximab 08-MAR-18 0 58
  S1803 MM, Maintenance, Len vs Len/Dara 27-JUN-19 0 55
 
OTHER A091401 Sarc, 18-JUN-15 2 2
  EA3132 HN SCC, Stg III-IV , Adj RT +/- Cisp 29-MAR-16 0 65
  EAF151 Brain, GBM, Bev, Blood Volume 14-APR-17 0 36
  G0263 Cerv, Stg I/IIA, adjv RT vs chemoRT 12-APR-10 0 53
  N0577 BRN, Glio,Tem vs Tem+RT vsRT+PVC 22-SEP-09 176 74
  NRGBN001 HN, novel vs. std chemoradiation + chemo 28-AUG-15 0 74
  NRGBN003 Mening, Grd II, Observation vs Irradiation 14-JUN-17 0 10
  NRGGY005 OVAR, Cedir vs Olaparib vs C+O vs Std of Care 06-FEB-16 269 123
  NRGGY009 Ovar, PLD/Atexo vs PLD/Atezo/Bev vs PLD/Bev 12-MAY-17 0 134
  NRGGY012 End, Recurrent/Met, Ola vs Cedir vs Ola+Cedir 04-SEP-18 0 18
  NRGHN001 Nasopharyngeal , Indiviual Tx EBV 21-APR-14 161 66
  NRGHN004 HN, Adv, RT+Durvalumab vs RT+Cetuximab 12-DEC-17 0 131
  R0724 Cervical, Chem+RT +/- Adj. Chemo 15-JAN-14 177 70
  R1216 HN, Adv,Cis vs Dtx vs Dtx+Cetux 18-MAR-13 216 92
 
PREV A211401 Lung, Varenic v Placebo, Surg Complications 29-SEP-17 0 56
  A211601 Breast, Stg II-III, Aspirin 01-AUG-18 0 25
 
SURV S1501 Surv, Breast Stg IV, Card Tox w/ Carvedilol 15-SEP-17 0 103
  E1Q11 EROS: Reproductive Health in Cancer Survivors 30-SEP-15 0 43
  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 23
  S1714 CIPN Risk Prediction Cohort Study, Taxanes 01-MAR-19 0 38
  A221504 NSCL, Advanced, placebo vs naloxegol 13-OCT-17 0 72
  A221505 Brst, Hypofractionated Post Mast Rad 01-FEB-18 0 108