SAS Output

10-APR-2021 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-16 415 209
  S1706 Breast, Inflammatory, RT +/- Olaparib 12-SEP-18 201 100
  S2007 Breast, Brain Mets, Sacituzumab Govitecan 15-DEC-20 48 25
  A011202 Breast, Nodal XRT +/- ALND 07-FEB-14 310 170
  A011401 Breast, adj, Stage II/III HER2-, weight loss 29-AUG-16 0 225
  A011801 BRST, HER2+, T-DM1+Placebo v T-DM1+Tucatinib 06-JAN-21 14 11
  EA1131 Brst, TNBC, Post-op Chemo vs Obs 20-AUG-14 276 129
  EA1181 BRST, HER2-pCR, Preop THP and Postop HP 11-FEB-20 192 110
  EA1183 Brst, Met, FDG PET Assess Response, FEATURE 02-APR-20 7 6
  MA39 BREAST, Node-Pos, Reg RT vs No Reg RT 30-MAY-18 253 112
  NRGBR003 Brst,Adj,TNBC,AC -> WP +/- Carbo 22-JAN-15 310 153
  NRGBR004 BREAST, Met HER2+, Pac+Tras+Pert +/- Atezo 12-MAR-19 362 160
 
CCD S1703 Met Breast, STM-monitoring v Usual Care 16-JUL-18 206 82
  A231601C CCD, OPTI-Surg in older cancer patients 01-APR-19 102 34
  EA1151 CCD, Tomosynthesis Mammographic Screening 06-JUL-17 183 88
  EAQ171CD Smoke Free Support Study 2.0 11-APR-19 5 31
  NHLBIMDS LEUK, National MDS Study 05-APR-16 209 97
  NRGCC007 CCD, Increased Dose of SCP in Pros Survivors 27-MAR-19 9 5
 
ERLYTX S1609 Rare Tumor, Comb Nivo/Ipi 13-JAN-17 348 155
  EAY131 MATCH 12-AUG-15 368 198
 
GI S1613 mCRC, Adv/Met, TP vs CETIRI 09-OCT-17 292 115
  S1922 Small Bowel,Ram+Pac vs FOLFIRI, mets/unresect 16-DEC-19 148 54
  S2001 Rando II, Mets Pancreas , BRCA1/2, Comb Chemo 04-DEC-20 72 36
  A021502 Colon, Stg III, Chemo +/- Atezol, ATOMIC 12-SEP-17 354 179
  A021602 PANC, Adv PNET Blinded Cabozantinib v Placebo 18-JUL-18 241 96
  A021703 COLON, Adv/Met, Chemo + Std v High dose V-D3 30-SEP-19 268 144
  A021806 Pancreas, Perioperative vs Adjuvant Chemo 01-JUL-20 206 104
  EA2142 GI NEC, Adv G3, EP vs TMZ + CAP 06-NOV-15 169 89
  EA2165 Anal, Stg II-III, Nivolumab after CMT 13-APR-18 274 138
  EA2186 PANC, mets, Gem+Abraxane vs 5-FU+LV+Nal-IRI 18-JUN-20 19 18
  EA2187 ICC, Carboplatin+Paclitaxel +/- Pevonedistat 31-JAN-20 25 9
 
GU S1802 Pros, Stg IV, SST +/- Surg/RT to Primary Tum 17-SEP-18 286 132
  S1806 Blad, MIBC, ChemoRT +/- Atezolizumab 19-APR-19 283 130
  S1931 RENAL, Stg IV, IO + Nephrectomy. vs IO Only 16-NOV-20 59 34
  S1937 Blad, Mets, Eribulin +/- Gem vs SOC 16-FEB-21 15 13
  A031102 GCT, Recur, Std Chemo(TIP) vs HD Chemo(TI-CE) 01-JUL-15 62 46
  A031501 Bladder, MIBC/Loc Adv, Adjv Pembro vs Obs 21-SEP-17 274 151
  A031701 Bladder, ddGC for MIBC with DDR Tumor Alt 01-AUG-18 141 59
  A031702 GU, Mets, Cabozantinib+Nivo+Ipi (ICONIC) 12-APR-19 205 96
  A031704 RCC, Met, Ipi+Nivo followed by Nivo+/-Cabo 09-MAY-19 229 116
  A031801 GU, mRCC, Cabozantinib +/- Radium-223 13-DEC-19 8 4
  EA8143 RCC, HR, Surg +/- Nivolumab (PROSPER) 02-FEB-17 290 164
  EA8153 Pros, ADT + Abira +/- Cabazitaxel (CHAARTED2) 08-FEB-18 209 94
  EA8171 PROS, newly diagnosed, mpMRI for pre-op stagi 09-JUL-18 93 43
  NRGGU002 Pros, RT + ADT After RP +/- Adj Docetaxel 30-DEC-16 185 96
  NRGGU005 PROS, intmd risk, IGRT& SBRT vs IGRT& HF-IMRT 16-NOV-17 278 125
  NRGGU008 Pros,Node+, Abiraterone acetate + Apalutamide 05-MAR-20 158 70
 
LEUK S1712 CML, Chronic Phase, TKI +/- Ruxolitinib 20-JUL-18 156 68
  S1905 T-ALL/T-LBL, Rel/Ref, OBI-3424 17-AUG-20 41 22
  S1925 CLL/SLL, Newly Dx HR, Early vs Delayed V+O 14-DEC-20 154 54
  A041501 B-Cell ALL, Frontline Tx +/- Intuzumab Ozo 01-JUN-17 189 84
  A041701 AML, Age 60+, Conv Chemo +/- Uproleselan 16-JAN-19 132 63
  A041702 CLL, Stg I-IV, IO with IM versus IVO 04-JAN-19 268 121
  A041703 ALL, Dx, Inotuzumab Ozogamicin + Blinatumomab 16-NOV-18 86 48
  EA9161 CLL, untreated, IOV vs IO in younger pts 03-JAN-19 260 129
  EA9171 CML, Anti-PD-1 Pembrolizumab + TKIs 03-OCT-18 85 38
  EA9181 ALL, BCR-ABL+, Steroids+TKI+CT/Blinatumomab 14-OCT-20 8 7
 
LUNG S1701 Thymic Adv, Carbo/Pac/Ram vs. Carbo/Pac 09-AUG-18 109 41
  S1827 SCLC, MRI Surveillance +/- PCI 10-JAN-20 250 107
  S1900B RET Fusion: Selpercatinib (LOXO-292) 10-FEB-20 257 122
  S1900E KRAS G12C: AMG 510 02-APR-21 59 27
  S1914 NSCLC, High Risk Early Stg, SBRT +/- Atezo 25-MAR-20 236 89
  S1929 ESCLC, SLFN11+, Atezolizumab Talazoparib 15-JUN-20 160 74
  S1933 NSCLC, Stg II-III, RT + Atezo 15-JUN-20 97 47
  A081801 ALCHEMIST4, ALK and EGFR negative, Chemo-IO 03-JUN-20 334 169
  A151216 ALCHEMIST0 - screening 06-FEB-14 391 241
  E4512 ALCHEMIST2, ALK mut, Crizotinib 18-AUG-14 378 214
  EA5163 NSCLC, Immunotherapy +/- 2nd line therapy 28-FEB-19 302 131
  EA5181 NSCLC, Unresect Stg 3, Chemo/RT+/-MED4736 09-APR-20 232 91
  EA5191 NSCLC, Cabozantinib +/- Nivolumab vs Chemo 22-MAY-20 162 64
  LUNGMAP NSCLC, Adv, Master 28-JAN-19 356 182
  NRGCC003 SCLC, PCI or HA-PCI 07-DEC-15 214 118
  NRGLU002 LUNG, Limited Met NSCLC, MST vs LCT + MST 07-APR-17 261 126
  NRGLU005 LUNG, LS-SCLC, ChemoRT v ChemoRT+Atezo 28-MAY-19 338 147
 
LYMPH S1608 FL, TGR-1202/Lenalidomide/CHOP or Benda +Ob 10-AUG-17 205 83
  S1826 HD, Adv, Age 12+, N+AVD vs BV+AVD 19-JUL-19 291 142
  S1918 DLBCL, Adv, Age 75+, CC-486 +/- R-miniCHOP 19-MAR-21 4 1
  A051301 ABC DLBCL, Auto HCT and Ibrutinib/Placebo 06-JUL-16 156 66
  E4412 HD, RR, Ipilimumab +Nivo +Brentuximab Vedotin 24-JAN-14 143 66
  EA4151 Lymph, AHCT +/-Ritux, MRD Neg 29-AUG-17 148 74
  EA4181 MCL, Randomization BR/CR v BR/CR-A v BR-A 03-OCT-19 170 72
 
MELAN S1512 Melan, Adv, Desmoplastic, MK-3475 (pembro) 20-OCT-16 92 40
  S1801 Melan, Adv, Adj vs Neoadj Pembrolizumab 06-DEC-18 287 128
  S2000 MELAN, M1d/ BRAF, Enco+Bini+Nivo vs Ipil+Nivo 23-SEP-20 88 42
  EA6134 Adv, BRAF mut, D+T/Ipi+Niv vs Ipi+Niv/D+T 15-DEC-15 275 119
  EA6141 Melan, Avd, Nivolumab+Ipi Sargmostim 01-MAR-16 173 77
  EA6174 Merkel, Adjuvant Pembrolizumab vs Observation 23-JUL-18 192 93
 
MMYEL S1803 MM, Maintenance, Len vs Len/Dara 27-JUN-19 260 99
  EAA173 MYEL, SMM, Rd +/- Daratumumab 30-APR-19 208 82
 
OTHER A091802 cSCC, Advanced Avelumab +/- Cetuximab 17-MAY-19 123 60
  A091902 Sarcoma, Paclit +/- Nivo and Nivo + Caboz 04-SEP-20 23 12
  A151804 irAEs, National Biorepository to Adv Studies 31-JAN-20 150 71
  ARST1431 Sarcoma, IR RMS, Randomized VAC/VI +/- TORI 23-MAY-16 116 84
  EA3132 HN SCC, Stg III-IV , Adj RT +/- Cisp 29-MAR-16 192 70
  EA3161 HNC, HPV+ OPCA, (cisplatin+RT) +/- Nivo 20-JUN-19 200 85
  EA3163 Nasal, T3 vs T4a, Surgery+RT +/- NeoAdj CT 28-MAR-18 81 40
  EAF151 Brain, GBM, Bev, Blood Volume 14-APR-17 70 26
  G0263 Cerv, Stg I/IIA, adjv RT vs chemoRT 12-APR-10 151 62
  N0577 BRN, Glio,Tem vs Tem+RT vsRT+PVC 22-SEP-09 212 82
  NCICOVID NCI COVID-19 in Cancer Patients Study 21-MAY-20 316 170
  NRGBN001 HN, novel vs. std chemoradiation + chemo 28-AUG-15 145 71
  NRGBN003 Mening, Grd II, Observation vs Irradiation 14-JUN-17 234 96
  NRGGY005 OVAR, Cedir vs Olaparib vs C+O vs Std of Care 06-FEB-16 303 131
  NRGHN001 Nasopharyngeal , Indiviual Tx EBV 21-APR-14 157 76
  NRGHN004 HN, Adv, RT+Durvalumab vs RT+Cetuximab 12-DEC-17 282 122
  NRGHN005 HN, early stg P16-pos, randomize de-intensifi 10-JUL-19 286 117
  R0724 Cervical, Chem+RT +/- Adj. Chemo 15-JAN-14 0 78
  R1216 HN, Adv,Cis vs Dtx vs Dtx+Cetux 18-MAR-13 246 99
 
PEOLC S1820 Rectal, Diet modification to manage GI sx 09-DEC-19 198 73
 
PREV S1823 GCT, Obs. Cohort, miRNA371 01-JUN-20 102 53
  S1904 Breast, Decision making for chemoprevention 01-SEP-20 17 39
  A211601 Breast, Stg II-III, Aspirin 01-AUG-18 134 61
  EA2185 Impact of Panc Cyst Surveillance 16-JAN-20 4 3
 
SURV S1501 Surv, Breast Stg IV, Card Tox w/ Carvedilol 15-SEP-17 234 98
  E1Q11 EROS: Reproductive Health in Cancer Survivors 30-SEP-15 0 44
 
SXQOL S1600 Bladder,Radical Cystectomy Outcomes Nutrition 21-FEB-19 132 39
  S1714 CIPN Risk Prediction Cohort Study, Taxanes 01-MAR-19 145 63
  A221505 Brst, Hypofractionated Post Mast Rad 01-FEB-18 234 109
  A221602 CINV in HEC patients, Olanza +/- Fosapre 15-OCT-18 116 74
  A221702 BREAST, SLN/ALND +/- ARM 31-MAY-19 207 75
  A221805 Colorectal, Duloxetine for Oxaliplatin CIPN 01-MAY-20 10 13
  EAZ171 Breast, Stg I-III, TIPN Docetaxel/Paclitaxel 27-JUN-19 108 59