02-OCT-2023 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-18 238 101
  S2007 Breast, Brain Mets, Sacituzumab Govitecan 15-DEC-20 186 67
  S2212 Breast, TNBC, Neoadj Chemo + Pembro 21-JUL-23 109 46
  A011801 BRST, HER2+, T-DM1+Placebo v T-DM1+Tucatinib 06-JAN-21 410 199
  A012103 Breast,StgT1cN1-2/T2-4N0-2,obsvsPembrolizumab 03-MAY-23 31 16
  EA1181 BRST, HER2-pCR, Preop THP and Postop HP 11-FEB-20 340 148
  EA1183 Brst, Met, FDG PET Assess Response, FEATURE 02-APR-20 123 58
  MA39 BREAST, Node-Pos, Reg RT vs No Reg RT 30-MAY-18 358 138
  NRGBR007 Breast, Stg I, De-Escalation of Breast RT 07-JUN-21 328 154
 
CCD S1703 Met Breast, STM-monitoring v Usual Care 16-JUL-18 225 87
  S1912CD CREDIT, Fin Counseling to reduce Fin Hardship 26-JUL-21 174 66
  S2108CD Genomic Tumor Board vs Usual Practice 22-AUG-22 25 31
  A191901 Brst, Text/Motivational Intervention ET Adher 10-DEC-20 224 97
  A231901C Breast, Shared Decision Engagement System 15-JAN-21 24 6
  NHLBIMDS LEUK, National MDS Study 05-APR-16 187 88
 
ERLYTX S2012 Small Cell NEC, Stg IV, Combo Chemo +/- Atezo 02-DEC-21 189 68
  A071401 Prog Meningiomas,SMO/AKT/NF2 Inhib 28-AUG-15 239 84
  AGCT1531 Mult, Stg I-IV, Carbo vs Cisp, Ped &Adult 08-MAY-17 210 113
 
GI S1922 Small Bowel,Ram+Pac vs FOLFIRI, mets/unresect 16-DEC-19 173 57
  S2001 Rando II, Mets Pancreas , BRCA1/2, Comb Chemo 04-DEC-20 203 75
  S2104 Panc,Resect High-risk,Postop Adj Chemo vs Obs 14-OCT-21 151 56
  S2107 Colorectal, BRAF mut, Enc + CET +/-Nivo 06-JUN-22 170 66
  A021602 PANC, Adv PNET Blinded Cabozantinib v Placebo 18-JUL-18 221 94
  A021806 Pancreas, Perioperative vs Adjuvant Chemo 01-JUL-20 281 124
  A022001 PANC, METS, Lu 177 Dotatate PRRT vs CAPTEM 16-MAR-22 0 2
  A022102 Gastric, FOLFIRINOX +/-Nivo vs FOLFOX +/ Nivo 11-JAN-23 29 17
  A022104 Rectal, Loc Adv, Triplet vs Doublet Chemo 09-NOV-22 68 45
  EA2174 Esoph, Peri-Op Nivolumab +/- Ipilimumab 17-JAN-19 217 96
  EA2176 Anal, Met, Immune Check Pt Inhibition + Chemo 15-OCT-20 194 86
  EA2182 Anal, Erly, DECREASE 12-NOV-19 270 93
  EA2186 PANC, mets, Gem+Abraxane vs 5-FU+LV+Nal-IRI 18-JUN-20 303 115
  EA2192 Panc, APOLLO 29-APR-21 136 72
  EA2197 Gal, Rando Perioperative TX 22-DEC-20 114 69
  NRGGI004 Colorectal, Stg IV, dMMR Immuno-Therapy 07-NOV-17 326 113
  NRGGI005 COLON,Stg IIA, ctDNA in Adjuvant Chemotherapy 16-DEC-19 429 163
  NRGGI008 Colon, Stg III, Adj Chemo 10-MAR-22 389 156
 
GU S1802 Pros, Stg IV, SST +/- Surg/RT to Primary Tum 17-SEP-18 340 140
  S1806 Blad, MIBC, ChemoRT +/- Atezolizumab 19-APR-19 335 126
  S1931 RENAL, Stg IV, IO + Nephrectomy. vs IO Only 16-NOV-20 181 75
  S2200 pRCC, Adv, Cabo +/- Atezo 19-SEP-22 137 56
  S2210 Pros, High Risk, BRCA, Neoadj Carbo 14-AUG-23 38 10
  A031701 Bladder, ddGC for MIBC with DDR Tumor Alt 01-AUG-18 139 51
  A031702 GU, Mets, Cabozantinib+Nivo+Ipi (ICONIC) 12-APR-19 252 95
  A031704 RCC, Met, Ipi+Nivo followed by Nivo+/-Cabo 09-MAY-19 273 129
  A031801 GU, mRCC, Cabozantinib +/- Radium-223 13-DEC-19 97 37
  A031803 Blad, NMIBC, Gemcitabine + MK-3475 06-JAN-20 134 56
  A031902 Pros, Adv, Enzalutamide + Rucaparib 19-FEB-21 198 86
  A032001 Blad, Met, Cabo +/- Avelumab after Chemo 10-MAR-22 75 31
  A032101 Pros, MHSPC ADT Interruption 15-JUL-22 7 4
  EA8134 Penile, Local Adv, ILND +/- Chemo or ChemoRT 08-SEP-17 29 14
  EA8171 PROS, newly diagnosed, mpMRI for pre-op stagi 09-JUL-18 92 49
  EA8185 Blad, Stg III, ChemoRT +/- Durv 25-AUG-20 139 55
  EA8191 Pros, Local vs Systemic Thrpy 08-OCT-20 181 70
  EA8192 Blad, High Grade UTUC, Durv + Chemo 06-MAY-21 147 55
  EA8212 Blad, NMIBC, BRIDGE 01-DEC-22 73 48
  NRGGU008 Pros,Node+, Abiraterone acetate + Apalutamide 05-MAR-20 213 81
  NRGGU009 Pros, PREDICT-RT 15-DEC-20 386 144
  NRGGU010 Pros, Parallel De-Intens & Intens Trials 03-NOV-21 368 144
  NRGGU011 Pros, Dbl Blinded RT +/- Androgen Dep Tx 08-DEC-21 178 63
 
LEUK S1905 T-ALL/T-LBL, Rel/Ref, OBI-3424 02-OCT-23 53 23
  S1925 CLL/SLL, Newly Dx HR, Early vs Delayed V+O 14-DEC-20 248 97
  A041501 B-Cell ALL, Frontline Tx +/- Intuzumab Ozo 01-JUN-17 222 85
  A041701 AML, Age 60+, Conv Chemo +/- Uproleselan 16-JAN-19 170 58
  A041703 ALL, Newly Dx, Inotuzumab Ozogamicin + Blinat 16-NOV-18 128 54
  EA9152 ALL, T/B-Cell, Venetoclax + Vincristine 26-APR-18 53 23
  EA9171 CML, Anti-PD-1 Pembrolizumab + TKIs 03-OCT-18 91 40
  EA9181 ALL, BCR-ABL+, Steroids+TKI+CT/Blinatumomab 14-OCT-20 162 57
  EA9213 T-ALL, dara-hyal for chemo refractory MRD 16-JUN-22 1 1
 
LUNG S1827 SCLC, MRI Surveillance +/- PCI 10-JAN-20 331 131
  S1900E KRAS G12C: Sotorasib (AMG 510) 02-APR-21 315 127
  S1900G EGFR-Mut, MET-Amp: Capmat + Osimert +/- Ramu 03-APR-23 250 93
  S1914 NSCLC, High Risk Early Stg, SBRT +/- Atezo 25-MAR-20 321 127
  S1933 NSCLC, Stg II-III, RT + Atezo 15-JUN-20 144 50
  S2302 NSCLC, Stg IV or Recur, Ramu + Pembro vs SoC 06-MAR-23 376 144
  A081801 ALCHEMIST4, ALK and EGFR negative, Chemo-IO 03-JUN-20 415 177
  A082002 Lung, Adv, Systemic Tx +/- SBRT 21-DEC-21 174 66
  A151216 ALCHEMIST0 - screening 18-AUG-14 506 245
  E4512 ALCHEMIST2, ALK mut, Crizotinib 18-AUG-14 471 213
  EA5163 NSCLC, Immunotherapy +/- 2nd line therapy 28-FEB-19 379 133
  EA5181 NSCLC, Unresect Stg 3, Chemo/RT+/-MED4736 09-APR-20 296 113
  EA5182 NSCLC, Met EGFR mut, AZD9291+Beva vs AZD9291 22-OCT-20 187 81
  EA5191 NSCLC, Cabozantinib +/- Nivolumab vs Chemo 22-MAY-20 196 80
  LUNGMAP NSCLC, Adv, Master 28-JAN-19 423 182
  NRGLU002 LUNG, Limited Met NSCLC, MST vs LCT + MST 07-APR-17 250 101
  NRGLU005 LUNG, LS-SCLC, ChemoRT v ChemoRT+Atezo 28-MAY-19 385 134
  NRGLU006 Meso, Stg I-IIIA, Pleurectomy +/- Adj RT 29-JAN-20 77 24
  R1308 Lung, Stg II/III, Photon vs Proton Chemo RT 03-FEB-14 42 30
 
LYMPH S1608 FL, TGR-1202/Lenalidomide/CHOP or Benda +Ob 10-AUG-17 207 76
  S1918 DLBCL, Adv, Age 75+, CC-486 +/- R-miniCHOP 19-MAR-21 183 73
  S2114 NHL, Rel/Ref, CD19 CAR-T +/- Consolidation 23-FEB-23 106 28
  S2207 LBCL, Transplant Inelig, Targeted Tx + Tafa 30-JUN-23 20 8
  ANHL1931 PMBCL, Chemo-Immunotherapy +/- Nivo 07-JUN-21 203 106
  E4412 HD, RR, Ipilimumab +Nivo +Brentuximab Vedotin 24-JAN-14 95 60
  EA4151 Lymph, AHCT +/-Ritux, MRD Neg 29-AUG-17 217 83
 
MELAN S2000 MELAN, M1d/ BRAF, Enco+Bini+Nivo vs Ipil+Nivo 23-SEP-20 123 47
  S2015 MELAN, Stg I-II, 1cm v 2cm excision margins 08-APR-22 178 69
  A091903 Melan, Resected Mucosal, Adj Nivo +/- Cabo 01-JUN-22 96 48
  EA6141 Melan, Adv, Nivolumab+Ipi ± Sargmostim 10-SEP-15 240 91
  EA6174 Merkel, Adjuvant Pembrolizumab vs Observation 23-JUL-18 302 108
  EA6192 Melan, Adv, Erly Discont of Antibdy Thrpy 27-AUG-20 133 50
 
MMYEL S1803 MM, Maintenance, Len vs Len/Dara 27-JUN-19 310 114
  S2209 MM, Newly Dx, VRd-R->R v DRd-R->R v DRD-DR->D 30-MAY-23 111 36
  EAA173 MYEL, SMM, Rd +/- Daratumumab 30-APR-19 237 98
  EAA181 Myel, Newly Dx, DRd=>DRd+/-Btz=>DR (EQUATE) 27-OCT-20 173 74
 
MULT S2101 Melan or HNSCC, Adv, Cabo + Nivo 14-OCT-22 160 63
  EAY191-S3 ComboMATCH: Adv Solid Tumors, Pac+Ipatasertib 06-MAR-23 108 46
 
OTHER A071701 BRAIN, Met, Geno-guided trial 15-AUG-19 231 83
  A071702 BRAIN, Blockade Tx in Recurrent Glioblastoma 30-OCT-20 127 66
  A091802 cSCC, Advanced Avelumab +/- Cetuximab 17-MAY-19 168 51
  A151804 irAEs, National Biorepository to Adv Studies 31-JAN-20 151 72
  EA3132 HN SCC, Stg III-IV , Adj RT +/- Cisp 29-MAR-16 235 74
  EA3161 HNC, HPV+ OPCA, (cisplatin+RT) +/- Nivo 20-JUN-19 245 90
  EA3163 Nasal, T3 vs T4a, Surgery+RT +/- NeoAdj CT 28-MAR-18 102 34
  EA3191 HN, High Risk HNSCC, Adj +/- Pembro 08-JAN-21 178 74
  EAF151 Brain, GBM, Bev, Blood Volume 14-APR-17 86 24
  EAY191E4 ComboMATCH 07-JUN-23 7 5
  N0577 BRN, Glio,Tem vs Tem+RT vsRT+PVC 22-SEP-09 288 95
  NRGBN003 Mening, Grd II, Observation vs Irradiation 14-JUN-17 245 87
  NRGBN011 Brain, Lomustine + Temo vs Temo 29-NOV-21 250 84
  NRGBN012 Brain, Pre- vs Post-Op Stereotactic Radiosurg 31-AUG-22 155 71
  NRGHN001 Nasopharyngeal , Indiviual Tx EBV 21-APR-14 143 68
  NRGHN005 HN, early stg P16-pos, randomize de-intensifi 10-JUL-19 386 130
  NRGHN006 HN, Erly Stg, Biopsy vs Dissection 08-JUL-20 230 74
  NRGHN009 HN, RT + HD Cisp vs RT + LD Cisp for SCCHN 27-OCT-21 237 93
  NRGHN010 HER2+ SGC, T-DM1 vs TH 30-SEP-22 141 42
  R1216 HN, Adv,Cis vs Dtx vs Dtx+Cetux 18-MAR-13 349 111
 
PREV S1823 GCT, Obs. Cohort, miRNA371 01-JUN-20 121 54
  S1904 Breast, Decision making for chemoprevention 01-SEP-20 19 47
  A212102 Blind Ref Set for Multicancer Early Detection 01-AUG-22 193 83
  EA1151 Prev, Tomosynthesis Mammographic Screening 06-JUL-17 239 92
  EA2185 Panc, Impact of Panc Cyst Surveillance 16-JAN-20 118 70
  EA8184 Pros, Dbl Blind GTC vs Placebo 20-MAY-21 72 38
  NRGCC008 Ovar, BRCA1, non-inferiority of BLS vs BSO 23-JUN-20 281 130
 
SURV S1501 Surv, Breast Stg IV, Card Tox w/ Carvedilol 15-SEP-17 227 92
 
SXQOL S1600 Bladder,Radical Cystectomy Outcomes Nutrition 21-FEB-19 150 39
  S2010 ASPEN: Brst, Stg I-III, ASM vs Pt Ed 17-JAN-23 216 94
  S2013 I-CHECKIT: ICI toxicity risk prediction study 16-AUG-21 200 103
  S2205 ICE COMPRESS: Reduction of CIPN from Taxanes 16-MAR-23 11 26
  A221805 Colorectal, Duloxetine for Oxaliplatin CIPN 01-MAY-20 245 110
  A222004 Mult, Olanza vs Megestrol for Anorexia 15-OCT-21 0 49
  EAQ202 Improving AYA PROs in EA Trials 28-OCT-21 62 28
  NRGCC010 Endo, Stg I, LN Map for LE Limb Dysfunction 19-SEP-22 74 25