05-JUL-2022 6:11

OPEN STUDIES IRB REPORT

Disease
Site		 Study Study Name Open Date Number of
Active
Institutions		 Number of
Current
IRBs
 
BREAST S1706 Breast, Inflammatory, RT +/- Olaparib 12-SEP-18 180 93
  S2007 Breast, Brain Mets, Sacituzumab Govitecan 15-DEC-20 210 74
  A011202 Breast, Nodal XRT +/- ALND 07-FEB-14 384 169
  A011801 BRST, HER2+, T-DM1+Placebo v T-DM1+Tucatinib 06-JAN-21 417 186
  EA1181 BRST, HER2-pCR, Preop THP and Postop HP 11-FEB-20 322 138
  EA1183 Brst, Met, FDG PET Assess Response, FEATURE 02-APR-20 151 66
  MA39 BREAST, Node-Pos, Reg RT vs No Reg RT 30-MAY-18 348 134
  NRGBR003 Brst,Adj,TNBC,AC -> WP +/- Carbo 22-JAN-15 376 164
  NRGBR004 BREAST, Met HER2+, Pac+Tras+Pert +/- Atezo 12-MAR-19 405 159
  NRGBR007 Breast, Stg I, De-Escalation of Breast RT 07-JUN-21 11 9
 
CCD S1703 Met Breast, STM-monitoring v Usual Care 16-JUL-18 232 89
  S1912CD CREDIT, Fin Counseling to reduce Fin Hardship 26-JUL-21 195 66
  A191901 Brst, Text/Motivational Intervention ET Adher 10-DEC-20 205 94
  A231601C CCD, OPTI-Surg in older cancer patients 01-APR-19 97 30
  A231701C Brst, Srg Decision Engagement 01-MAR-19 0 11
  A231901C Breast, Shared Decision Engagement System 15-JAN-21 35 11
  EAQ171CD Smoke Free Support Study 2.0 11-APR-19 5 32
  NHLBIMDS LEUK, National MDS Study 05-APR-16 213 95
  NRGCC007 CCD, Increased Dose of SCP in Pros Survivors 27-MAR-19 60 27
 
ERLYTX S1609 Rare Tumor, Comb Nivo/Ipi 13-JAN-17 400 155
  S2012 Small Cell NEC, Stg IV, Combo Chemo +/- Atezo 02-DEC-21 123 43
  AGCT1531 Mult, Stg I-IV, Carbo vs Cisp, Ped &Adult 08-MAY-17 231 110
  EAY131 MATCH 12-AUG-15 427 193
 
GI S1922 Small Bowel,Ram+Pac vs FOLFIRI, mets/unresect 16-DEC-19 155 57
  S2001 Rando II, Mets Pancreas , BRCA1/2, Comb Chemo 04-DEC-20 195 77
  S2104 Panc,Resect High-risk,Postop Adj Chemo vs Obs 14-OCT-21 112 36
  S2107 Colorectal, BRAF mut, Enc + CET +/-Nivo 06-JUN-22 23 8
  A021502 Colon, Stg III, Chemo +/- Atezol, ATOMIC 12-SEP-17 400 177
  A021602 PANC, Adv PNET Blinded Cabozantinib v Placebo 18-JUL-18 237 92
  A021703 COLON, Adv/Met, Chemo + Std v High dose V-D3 30-SEP-19 336 155
  A021806 Pancreas, Perioperative vs Adjuvant Chemo 01-JUL-20 257 119
  EA2174 Esoph, Peri-Op Nivolumab +/- Ipilimumab 17-JAN-19 225 84
  EA2176 Anal, Met, Immune Check Pt Inhibition + Chemo 15-OCT-20 185 82
  EA2186 PANC, mets, Gem+Abraxane vs 5-FU+LV+Nal-IRI 18-JUN-20 278 108
  EA2187 ICC, Carboplatin+Paclitaxel +/- Pevonedistat 31-JAN-20 193 69
  EA2197 Gal, Rando Perioperative TX 22-DEC-20 122 66
  NRGGI004 Colorectal, Stg IV, dMMR Immuno-Therapy 07-NOV-17 291 120
  NRGGI005 COLON,Stg IIA, ctDNA in Adjuvant Chemotherapy 16-DEC-19 410 163
 
GU S1802 Pros, Stg IV, SST +/- Surg/RT to Primary Tum 17-SEP-18 336 135
  S1806 Blad, MIBC, ChemoRT +/- Atezolizumab 19-APR-19 359 136
  S1931 RENAL, Stg IV, IO + Nephrectomy. vs IO Only 16-NOV-20 146 71
  S1937 Blad, Mets, Eribulin +/- Gem vs SOC 16-FEB-21 130 49
  S2011 Blad, MIBC,Gem+Carbo+Avelumab+Srg vs Srg Only 06-OCT-21 83 27
  A031102 GCT, Recur, Std Chemo(TIP) vs HD Chemo(TI-CE) 01-JUL-15 74 47
  A031701 Bladder, ddGC for MIBC with DDR Tumor Alt 01-AUG-18 144 51
  A031702 GU, Mets, Cabozantinib+Nivo+Ipi (ICONIC) 12-APR-19 224 95
  A031704 RCC, Met, Ipi+Nivo followed by Nivo+/-Cabo 09-MAY-19 250 121
  A031801 GU, mRCC, Cabozantinib +/- Radium-223 13-DEC-19 97 37
  A031803 Blad, NMIBC, Gemcitabine + MK-3475 06-JAN-20 115 56
  A031902 Pros, Adv, Enzalutamide + Rucaparib 19-FEB-21 177 75
  EA8134 Penile, Local Adv, ILND +/- Chemo or ChemoRT 08-SEP-17 3 6
  EA8171 PROS, newly diagnosed, mpMRI for pre-op stagi 09-JUL-18 91 43
  EA8183 Pros, Dbl Blind Andro Dep + Daro vs Placebo 09-DEC-20 145 59
  EA8191 Pros, Local vs Systemic Thrpy 08-OCT-20 158 60
  EA8192 Blad, High Grade UTUC, Durv + Chemo 06-MAY-21 1 2
  NRGGU002 Pros, RT + ADT After RP +/- Adj Docetaxel 30-DEC-16 197 80
  NRGGU005 PROS, intmd risk, IGRT& SBRT vs IGRT& HF-IMRT 16-NOV-17 297 123
  NRGGU009 Pros, PREDICT-RT 15-DEC-20 302 112
  NRGGU010 Pros, Parallel De-Intens & Intens Trials 03-NOV-21 175 70
 
LEUK S1712 CML, Chronic Phase, TKI +/- Ruxolitinib 20-JUL-18 159 64
  S1905 T-ALL/T-LBL, Rel/Ref, OBI-3424 17-AUG-20 67 27
  S1925 CLL/SLL, Newly Dx HR, Early vs Delayed V+O 14-DEC-20 220 83
  A041501 B-Cell ALL, Frontline Tx +/- Intuzumab Ozo 01-JUN-17 196 86
  A041701 AML, Age 60+, Conv Chemo +/- Uproleselan 16-JAN-19 148 58
  A041702 CLL, Stg I-IV, IO with IM versus IVO 04-JAN-19 285 128
  A041703 ALL, Newly Dx, Inotuzumab Ozogamicin + Blinat 16-NOV-18 116 57
  EA9171 CML, Anti-PD-1 Pembrolizumab + TKIs 03-OCT-18 90 35
  EA9181 ALL, BCR-ABL+, Steroids+TKI+CT/Blinatumomab 14-OCT-20 82 43
 
LUNG S1701 Thymic Adv, Carbo/Pac/Ram vs. Carbo/Pac 09-AUG-18 123 40
  S1800D Non-Match: N-803 + Pembro vs SoC 15-FEB-22 317 119
  S1827 SCLC, MRI Surveillance +/- PCI 10-JAN-20 323 122
  S1900E KRAS G12C: Sotorasib (AMG 510) 02-APR-21 329 121
  S1914 NSCLC, High Risk Early Stg, SBRT +/- Atezo 25-MAR-20 298 113
  S1929 ESCLC, SLFN11+, Atezolizumab ± Talazoparib 15-JUN-20 222 81
  S1933 NSCLC, Stg II-III, RT + Atezo 15-JUN-20 107 39
  S1934 Superior Sulcus NSCLC, Trimodality +/- Atezo 09-SEP-21 56 28
  A081801 ALCHEMIST4, ALK and EGFR negative, Chemo-IO 03-JUN-20 404 183
  A151216 ALCHEMIST0 - screening 06-FEB-14 475 246
  E4512 ALCHEMIST2, ALK mut, Crizotinib 18-AUG-14 473 231
  EA5163 NSCLC, Immunotherapy +/- 2nd line therapy 28-FEB-19 384 137
  EA5181 NSCLC, Unresect Stg 3, Chemo/RT+/-MED4736 09-APR-20 300 103
  EA5182 NSCLC, Met EGFR mut, AZD9291+Beva vs AZD9291 22-OCT-20 156 75
  EA5191 NSCLC, Cabozantinib +/- Nivolumab vs Chemo 22-MAY-20 203 82
  LUNGMAP NSCLC, Adv, Master 28-JAN-19 430 185
  NRGCC003 SCLC, PCI or HA-PCI 07-DEC-15 222 115
  NRGLU002 LUNG, Limited Met NSCLC, MST vs LCT + MST 07-APR-17 302 125
  NRGLU005 LUNG, LS-SCLC, ChemoRT v ChemoRT+Atezo 28-MAY-19 385 151
  R1308 Lung, Stg II/III, Photon vs Proton Chemo RT 03-FEB-14 32 27
 
LYMPH S1826 HD, Adv, Age 12+, N+AVD vs BV+AVD 19-JUL-19 344 159
  S1918 DLBCL, Adv, Age 75+, CC-486 +/- R-miniCHOP 19-MAR-21 173 61
  A051301 ABC DLBCL, Auto HCT and Ibrutinib/Placebo 06-JUL-16 160 57
  ANHL1931 PMBCL, Chemo-Immunotherapy +/- Nivo 07-JUN-21 62 13
  E4412 HD, RR, Ipilimumab +Nivo +Brentuximab Vedotin 24-JAN-14 104 64
  EA4151 Lymph, AHCT +/-Ritux, MRD Neg 29-AUG-17 185 81
  EA4181 MCL, Randomization BR/CR v BR/CR-A v BR-A 03-OCT-19 201 80
 
MELAN S2000 MELAN, M1d/ BRAF, Enco+Bini+Nivo vs Ipil+Nivo 23-SEP-20 108 50
  EA6141 Melan, Adv, Nivolumab+Ipi ± Sargmostim 01-MAR-16 187 82
  EA6174 Merkel, Adjuvant Pembrolizumab vs Observation 23-JUL-18 279 109
  EA6192 Melan, Adv, Erly Discont of Antibdy Thrpy 27-AUG-20 136 45
 
MMYEL S1803 MM, Maintenance, Len vs Len/Dara 27-JUN-19 289 106
  S2005 WM, Prev. Untreated, I/R +/- Venetoclax 24-JUN-21 104 31
  EAA173 MYEL, SMM, Rd +/- Daratumumab 30-APR-19 252 89
  EAA181 Myel, Newly Dx, DRd=>DRd+/-Btz=>DR (EQUATE) 27-OCT-20 179 64
 
OTHER A071701 BRAIN, Met, Geno-guided trial 15-AUG-19 227 80
  A071801 Brain, Mets, Post-Srg Single SRS vs Fract SRS 11-OCT-19 260 91
  A091802 cSCC, Advanced Avelumab +/- Cetuximab 17-MAY-19 180 62
  A091902 Sarcoma, Paclit +/- Nivo and Nivo + Caboz 04-SEP-20 157 52
  A151804 irAEs, National Biorepository to Adv Studies 31-JAN-20 160 68
  ARST1431 Sarcoma, IR RMS, Randomized VAC/VI +/- TORI 23-MAY-16 136 89
  EA3132 HN SCC, Stg III-IV , Adj RT +/- Cisp 29-MAR-16 249 72
  EA3161 HNC, HPV+ OPCA, (cisplatin+RT) +/- Nivo 20-JUN-19 222 82
  EA3163 Nasal, T3 vs T4a, Surgery+RT +/- NeoAdj CT 28-MAR-18 125 41
  EA3191 HN, High Risk HNSCC, Adj +/- Pembro 08-JAN-21 22 8
  EAF151 Brain, GBM, Bev, Blood Volume 14-APR-17 86 30
  G0263 Cerv, Stg I/IIA, adjv RT vs chemoRT 12-APR-10 166 62
  N0577 BRN, Glio,Tem vs Tem+RT vsRT+PVC 22-SEP-09 247 91
  NCICOVID NCI COVID-19 in Cancer Patients Study 21-MAY-20 13 3
  NRGBN001 HN, novel vs. std chemoradiation + chemo 28-AUG-15 184 79
  NRGBN003 Mening, Grd II, Observation vs Irradiation 14-JUN-17 246 90
  NRGBN007 Brain, New Dx, Ipi + Nivo vs Temozomide 06-AUG-20 292 118
  NRGGY005 OVAR, Cedir vs Olaparib vs C+O vs Std of Care 06-FEB-16 246 112
  NRGGY018 Endo, Stg III-IVB/Recur, Pac/Carbo +/- Pembro 16-JUL-19 392 151
  NRGGY020 Endo, Erly Stg, Rando RT +/- Pembro 07-FEB-20 233 97
  NRGGY023 Ovar, Rando Durv Triplet TX vs Chemo 28-APR-21 194 70
  NRGHN001 Nasopharyngeal , Indiviual Tx EBV 21-APR-14 141 72
  NRGHN004 HN, Adv, RT+Durvalumab vs RT+Cetuximab 12-DEC-17 269 118
  NRGHN005 HN, early stg P16-pos, randomize de-intensifi 10-JUL-19 383 128
  NRGHN006 HN, Erly Stg, Biopsy vs Dissection 08-JUL-20 211 72
  NRGHN009 HN, RT + HD Cisp vs RT + LD Cisp for SCCHN 27-OCT-21 39 17
  R0724 Cervical, Chem+RT +/- Adj. Chemo 15-JAN-14 0 78
  R1216 HN, Adv,Cis vs Dtx vs Dtx+Cetux 18-MAR-13 315 105
 
PREV S1823 GCT, Obs. Cohort, miRNA371 01-JUN-20 125 53
  S1904 Breast, Decision making for chemoprevention 01-SEP-20 19 45
  S0820 PACES: ColrecStg0-3 Blind DFMO/Sulindac 01-MAR-13 75 30
  A211102 Breast, Atypia via RPFNA, Metformin v Placebo 01-FEB-15 0 1
  EA1151 Prev, Tomosynthesis Mammographic Screening 06-JUL-17 224 87
  EA2185 Panc, Impact of Panc Cyst Surveillance 16-JAN-20 110 63
  NRGCC008 Ovar, BRCA1, non-inferiority of BLS vs BSO 23-JUN-20 214 107
 
SURV S1501 Surv, Breast Stg IV, Card Tox w/ Carvedilol 15-SEP-17 242 99
 
SXQOL S1600 Bladder,Radical Cystectomy Outcomes Nutrition 21-FEB-19 150 39
  S1614 HBV in Ca Pts, anti-HBV therapy vs SOC 21-FEB-19 42 21
  S2013 I-CHECKIT: ICI toxicity risk prediction study 16-AUG-21 164 73
  A221702 BREAST, SLN/ALND +/- ARM 31-MAY-19 208 74
  A221805 Colorectal, Duloxetine for Oxaliplatin CIPN 01-MAY-20 216 103
  A222004 Mult, Olanza vs Megestrol for Anorexia 15-OCT-21 0 48
  EAQ202 Improving AYA PROs in EA Trials 28-OCT-21 41 14
  EAZ171 Breast, Stg I-III, TIPN Docetaxel/Paclitaxel 27-JUN-19 115 58