SAS Output

21-AUG-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-16 405 196
  S1706 Breast, Inflammatory, RT +/- Olaparib 12-SEP-18 0 84
  A011106 Breast, Neoadj, ALTERNATE study 15-FEB-14 199 95
  A011401 Breast, adj, Stage II/III HER2-, weight loss 29-AUG-16 378 214
  A011502 Brst, Adj, Nodal+&HER2-, Aspirin vs. Placebo 08-DEC-16 0 209
  A221405 Breast, ET interruption, Pregnancy Outcomes 15-OCT-15 0 53
  B51 Breast, Regional Nodal XRT 22-AUG-13 288 157
  EA1131 Brst, TNBC, Post-op Chemo vs Obs 20-AUG-14 268 126
  EA1151 Brst, Tomosynthesis Mammographic Screening 06-JUL-17 0 79
  NRGBR002 Brst, OMBC, II-III, SoC +/- SBRT and/or SA 24-DEC-14 0 115
  NRGBR003 Brst,Adj,TNBC,AC -> WP +/- Carbo 22-JAN-15 325 171
  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 76
  A191402C PROS, Testing Decision Aids for Minority Men 14-JUL-17 0 9
  ACCL16N1 Guideline Consistent Treatment AYA ALL 18-DEC-17 0 49
  EAQ162CD CCD, Financial Burden, Colon & Rectal Cancer 17-MAY-18 0 67
  NHLBIMDS LEUK, National MDS Study 05-APR-16 220 86
 
ERLYTX S1609 Rare Tumor, Comb Nivo/Ipi 13-JAN-17 332 159
  A071401 Prog Meningiomas,SMO/AKT/NF2 Inhib 06-AUG-15 232 91
  EAY131 MATCH 12-AUG-15 395 220
 
GI S1613 mCRC, Adv/Met, TP vs CETIRI 09-OCT-17 0 115
  S1815 Biliary, Met/LocAdv, GC+CPT±Nab-paclitaxel 03-DEC-18 0 88
  A021502 Colon, Stg III, Chemo +/- Atezol, ATOMIC 12-SEP-17 0 169
  A021602 PANC, Adv PNET Blinded Cabozantinib v Placebo 18-JUL-18 0 75
  EA2142 GI NEC, Adv G3, EP vs TMZ + CAP 06-NOV-15 192 81
  EA2161 PANC, Adv Rapalog Resistant PNETs, MLN0128 01-FEB-17 0 61
  EA2165 Anal, Stg II-III, Nivolumab after CMT 13-APR-18 0 115
  NRGGI004 Colorectal, Stg IV, dMMR Immuno-Therapy 07-NOV-17 0 121
 
GU S1500 pRCC,Adv, Sunitinib vs MET inhib 05-APR-16 214 88
  S1602 Blad, HG NMIBC, TICE/Tokyo/Prime+Tokyo BCG 07-FEB-17 188 89
  S1802 Pros, Stg IV, SST +/- Surg/RT to Primary Tum 17-SEP-18 0 114
  S1806 Blad, MIBC, ChemoRT +/- Atezolizumab 19-APR-19 0 89
  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 0 130
  A031701 Bladder, ddGC for MIBC with DDR Tumor Alt 01-AUG-18 0 43
  EA8143 RCC, HR, Surg +/- Nivolumab (PROSPER) 02-FEB-17 0 126
  EA8153 Pros, ADT + Abira +/- Cabazitaxel (CHAARTED2) 08-FEB-18 0 94
  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 0 118
  NRGGU005 PROS, intmd risk, IGRT& SBRT vs IGRT& HF-IMRT 16-NOV-17 0 105
  NRGGU006 PROS, post-RP PSA, SRT +/- ADT w/Apalutamide 27-APR-18 0 21
 
LEUK S1712 CML, Chronic Phase, TKI +/- Ruxolitinib 20-JUL-18 0 64
  A041501 B-Cell ALL, Frontline Tx +/- Intuzumab Ozo 01-JUN-17 0 59
  A041701 AML, Age 60+, Conv Chemo +/- Uproleselan 16-JAN-19 0 5
  A041702 CLL, Stg I-IV, IO with IM versus IVO 04-JAN-19 0 35
  E1910 BCR-ABL-neg, B ALL, Blinatumomab 23-DEC-13 181 80
  EA9161 CLL, untreated, IOV vs IO in younger pts 03-JAN-19 0 76
 
LUNG S1619 Meso,Stg I-III, Nadj chemo/Atezmb->Atezmb+SOC 03-NOV-17 0 33
  S1701 Thymic Adv, Carbo/Pac/Ram vs. Carbo/Pac 09-AUG-18 0 31
  S1800A Non-Match: Ramu + Pembro vs SoC 17-MAY-19 0 123
  S1900A LOH and/or BRCA: Rucaparib 28-JAN-19 0 136
  A081105 ALCHEMIST1, EGFR mut, Erlotinib 02-JAN-14 0 221
  A151216 ALCHEMIST0 - screening 06-FEB-14 394 226
  C30610 SCLC, Thoracic RT 21-MAR-08 157 86
  E4512 ALCHEMIST2, ALK mut, Crizotinib 18-AUG-14 390 220
  EA5142 ALCHEMIST3, Non-match, Nivolumab 16-MAY-16 390 216
  EA5163 NSCLC, Immunotherapy +/- 2nd line therapy 28-FEB-19 0 26
  LUNGMAP NSCLC, Adv, Master 28-JAN-19 0 170
  NRGCC003 SCLC, PCI or HA-PCI 07-DEC-15 244 130
  NRGLU005 LUNG, LS-SCLC, ChemoRT v ChemoRT+Atezo 28-MAY-19 0 6
 
LYMPH S1608 FL, TGR-1202/Lenalidomide/CHOP or Benda +Ob 10-AUG-17 0 97
  S1826 HD, Adv, Age 12+, N+AVD vs BV+AVD 19-JUL-19 0 12
  E4412 HD, RR, Ipilimumab +Nivo +Brentuximab Vedotin 24-JAN-14 0 1
  EA4151 Lymph, AHCT +/-Ritux, MRD Neg 29-AUG-17 0 67
 
MELAN S1512 Melan, Adv, Desmoplastic, MK-3475 (pembro) 20-OCT-16 103 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 0 114
  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-16 220 93
  EA6174 Merkel, Adjuvant Pembrolizumab vs Observation 23-JUL-18 0 32
 
MMYEL S1702 AL Amyloidosis, Relapsed, Isatuximab 08-MAR-18 0 58
  S1803 MM, Maintenance, Len vs Len/Dara 27-JUN-19 0 19
 
OTHER A091401 Sarc, 18-JUN-15 182 71
  EA3132 HN SCC, Stg III-IV , Adj RT +/- Cisp 29-MAR-16 0 68
  EAF151 Brain, GBM, Bev, Blood Volume 14-APR-17 0 34
  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-09 183 81
  NRGBN001 HN, novel vs. std chemoradiation + chemo 28-AUG-15 0 74
  NRGGY005 OVAR, Cedir vs Olaparib vs C+O vs Std of Care 06-FEB-16 268 124
  NRGGY009 Ovar, PLD/Atexo vs PLD/Atezo/Bev vs PLD/Bev 12-MAY-17 0 132
  NRGGY012 End, Recurrent/Met, Ola vs Cedir vs Ola+Cedir 04-SEP-18 0 12
  NRGHN001 Nasopharyngeal , Indiviual Tx EBV 21-APR-14 147 65
  NRGHN004 HN, Adv, RT+Durvalumab vs RT+Cetuximab 12-DEC-17 0 13
  R0724 Cervical, Chem+RT +/- Adj. Chemo 15-JAN-14 177 70
  R1216 HN, Adv,Cis vs Dtx vs Dtx+Cetux 18-MAR-13 215 89
 
PREV A211401 Lung, Varenic v Placebo, Surg Complications 29-SEP-17 0 4
  A211601 Breast, Stg II-III, Aspirin 01-AUG-18 0 15
 
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 S1600 Bladder,Radical Cystectomy Outcomes Nutrition 21-FEB-19 0 25
  S1614 HBV in Ca Pts, TAF vs SOC 21-FEB-19 0 20
  S1714 CIPN Risk Prediction Cohort Study, Taxanes 01-MAR-19 0 34
  A221504 NSCL, Advanced, placebo vs naloxegol 13-OCT-17 0 72
  A221505 Brst, Hypofractionated Post Mast Rad 01-FEB-18 0 107