25-APR-2024 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-18 228 103
  S2007 Breast, Brain Mets, Sacituzumab Govitecan 15-DEC-20 192 67
  S2206 Brst, Stg II-III, MP2, Neoadj Chemo +/- Durva 30-OCT-23 248 89
  S2212 Breast, TNBC, Neoadj Chemo + Pembro 21-JUL-23 267 110
  A011801 BRST, HER2+, T-DM1+Placebo v T-DM1+Tucatinib 06-JAN-21 405 199
  A012103 Breast,StgT1cN1-2/T2-4N0-2,obsvsPembrolizumab 03-MAY-23 293 141
  MA39 BREAST, Node-Pos, Reg RT vs No Reg RT 30-MAY-18 367 140
  NRGBR007 Breast, Stg I, De-Escalation of Breast RT 07-JUN-21 345 154
  NRGBR009 Breast, EarlyStg, Adjuvant Chemo 31-AUG-23 117 45
 
CCD S1703 Met Breast, STM-monitoring v Usual Care 16-JUL-18 220 90
  S1912CD CREDIT, Fin Counseling to reduce Fin Hardship 26-JUL-21 163 66
  S2108CD Genomic Tumor Board vs Usual Practice 22-AUG-22 24 29
  A191901 Brst, Text/Motivational Intervention ET Adher 10-DEC-20 182 88
  NHLBIMDS LEUK, National MDS Study 05-APR-16 185 86
 
ERLYTX S2012 Small Cell NEC, Stg IV, Combo Chemo +/- Atezo 02-DEC-21 179 71
  A071401 Prog Meningiomas,SMO/AKT/NF2 Inhib 28-AUG-15 246 90
  AGCT1531 Mult, Stg I-IV, Carbo vs Cisp, Ped &Adult 08-MAY-17 179 116
  EAY191 ComboMATCH 06-MAR-23 255 107
  EAY191-S3 ComboMATCH: Adv Solid Tumors, Pac+Ipatasertib 06-MAR-23 180 61
  EAY191A3 ComboMATCH-RAS-Mutant, All Stg, Palbo+Benim 15-NOV-23 77 27
  EAY191E4 ComboMATCH-Pr. Tax-Tx Tumors, Pac+Nilotinib 07-JUN-23 133 57
 
GI S1922 Small Bowel,Ram+Pac vs FOLFIRI, mets/unresect 16-DEC-19 145 53
  S2001 Rando II, Mets Pancreas , BRCA1/2, Comb Chemo 04-DEC-20 192 75
  S2104 Panc,Resect High-risk,Postop Adj Chemo vs Obs 14-OCT-21 160 60
  S2107 Colorectal, BRAF mut, Enc + CET +/-Nivo 06-JUN-22 160 66
  A021806 Pancreas, Perioperative vs Adjuvant Chemo 01-JUL-20 254 116
  A022001 PANC, METS, Lu 177 Dotatate PRRT vs CAPTEM 16-MAR-22 58 25
  A022004 Colon, Stg II-III, Encor+Cetux vs SOC 30-MAY-23 0 2
  A022102 Gastric, FOLFIRINOX +/-Nivo vs FOLFOX +/ Nivo 11-JAN-23 187 82
  A022104 Rectal, Loc Adv, Triplet vs Doublet Chemo 09-NOV-22 320 126
  EA2174 Esoph, Peri-Op Nivolumab +/- Ipilimumab 17-JAN-19 222 90
  EA2176 Anal, Met, Immune Check Pt Inhibition + Chemo 15-OCT-20 209 88
  EA2182 Anal, Erly, DECREASE 12-NOV-19 291 96
  EA2192 Panc, APOLLO 29-APR-21 145 84
  EA2197 Gal, Rando Perioperative TX 22-DEC-20 129 73
  NRGGI004 Colorectal, Stg IV, dMMR Immuno-Therapy 07-NOV-17 318 114
  NRGGI008 Colon, Stg III, Adj Chemo 10-MAR-22 408 171
 
GU S1802 Pros, Stg IV, SST +/- Surg/RT to Primary Tum 17-SEP-18 334 139
  S1931 RENAL, Stg IV, IO + Nephrectomy. vs IO Only 16-NOV-20 211 76
  S1937 Blad, Mets, Eribulin + Gem vs SOC 16-FEB-21 187 68
  S2200 pRCC, Adv, Cabo +/- Atezo 19-SEP-22 141 62
  S2210 Pros, High Risk, BRCA, Neoadj Carbo 14-AUG-23 119 37
  A031701 Bladder, ddGC for MIBC with DDR Tumor Alt 01-AUG-18 137 50
  A031702 GU, Mets, Cabozantinib+Nivo+Ipi (ICONIC) 12-APR-19 227 92
  A031704 RCC, Met, Ipi+Nivo followed by Nivo+/-Cabo 09-MAY-19 273 130
  A031801 GU, mRCC, Cabozantinib +/- Radium-223 13-DEC-19 99 39
  A031803 Blad, NMIBC, Gemcitabine + MK-3475 06-JAN-20 131 56
  A032103 Urothelial, All Stg, MRD-Based Adj Tx 09-JAN-24 12 13
  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 48
  EA8191 Pros, Local vs Systemic Thrpy 08-OCT-20 185 62
  EA8192 Blad, High Grade UTUC, Durv + Chemo 06-MAY-21 146 54
  EA8212 Blad, NMIBC, BRIDGE 01-DEC-22 126 68
  NRGGU008 Pros,Node+, Abiraterone acetate + Apalutamide 05-MAR-20 226 82
  NRGGU009 Pros, PREDICT-RT 15-DEC-20 420 156
  NRGGU010 Pros, Parallel De-Intens & Intens Trials 03-NOV-21 421 157
  NRGGU011 Pros, Dbl Blinded RT +/- Androgen Dep Tx 08-DEC-21 199 72
  NRGGU012 Renal, Stg IV, Stereo Abl Rad Therapy 30-JUN-22 171 56
 
LEUK S1905 T-ALL/T-LBL, Rel/Ref, OBI-3424 17-AUG-20 61 25
  S1925 CLL/SLL, Newly Dx HR, Early vs Delayed V+O 14-DEC-20 242 97
  A041501 B-Cell ALL, Frontline Tx +/- Intuzumab Ozo 01-JUN-17 224 84
  A041701 AML, Age 60+, Conv Chemo +/- Uproleselan 16-JAN-19 169 58
  A041703 ALL, Newly Dx, Inotuzumab Ozogamicin + Blinat 16-NOV-18 127 55
  A042001 B-Cell ALL, Inotuzunab+chemo v Standard chemo 27-FEB-23 117 44
  EA9152 ALL, T/B-Cell, Venetoclax + Vincristine 26-APR-18 53 24
  EA9171 CML, Anti-PD-1 Pembrolizumab + TKIs 03-OCT-18 78 38
  EA9181 ALL, BCR-ABL+, Steroids+TKI+CT/Blinatumomab 14-OCT-20 164 59
  EA9213 T-ALL, dara-hyal for chemo refractory MRD 16-JUN-22 40 15
 
LUNG S1827 SCLC, MRI Surveillance +/- PCI 10-JAN-20 326 128
  S1900E KRAS G12C: Sotorasib (AMG 510) 02-APR-21 304 125
  S1900G EGFR-Mut, MET-Amp: Capmat + Osimert +/- Ramu 03-APR-23 253 104
  S1900K MET Exon 14: Tepotinib +/- Ramucirumab 18-DEC-23 184 68
  S1914 NSCLC, High Risk Early Stg, SBRT +/- Atezo 25-MAR-20 355 123
  S1933 NSCLC, Stg II-III, RT + Atezo 15-JUN-20 104 42
  S2302 NSCLC, Stg IV or Recur, Ramu + Pembro vs SoC 06-MAR-23 440 180
  A081801 ALCHEMIST4, ALK and EGFR negative, Chemo-IO 03-JUN-20 405 172
  A082002 Lung, Adv, Systemic Tx +/- SBRT 21-DEC-21 172 61
  A151216 ALCHEMIST0 - screening 18-AUG-14 495 236
  E4512 ALCHEMIST2, ALK mut, Crizotinib 18-AUG-14 461 209
  EA5162 NSCLS,StgIV/IIB,EGFR exon20 insertion,AZD9291 05-APR-18 74 38
  EA5182 NSCLC, Met EGFR mut, AZD9291+Beva vs AZD9291 22-OCT-20 168 78
  LUNGMAP NSCLC, Adv, Master 28-JAN-19 405 176
  NRGLU008 Lung NSCL, StgII-III, StereoBodyRad/MedChemo 10-MAY-23 27 6
 
LYMPH S1608 FL, TGR-1202/Lenalidomide/CHOP or Benda +Ob 10-AUG-17 192 71
  S1918 DLBCL, Adv, Age 75+, CC-486 +/- R-miniCHOP 19-MAR-21 172 70
  S2114 NHL, Rel/Ref, CD19 CAR-T +/- Consolidation 23-FEB-23 123 39
  S2207 LBCL, Transplant Inelig, Targeted Tx + Tafa 30-JUN-23 95 33
  A051902 PTCL,CHO(E)PvCC-486-CHO(E)PvDuvelisib-CHO(E)P 30-JUL-21 159 70
  A052101 Lymph, Stg I-IV, Cont v Intermittent Zanub 08-SEP-23 74 25
  AHOD2131 cHL,StgI-II,StdTherapyvImmuno-oncologyTherapy 28-APR-23 169 105
  ANHL1931 PMBCL, Chemo-Immunotherapy +/- Nivo 07-JUN-21 214 104
  E4412 HD, RR, Ipilimumab +Nivo +Brentuximab Vedotin 24-JAN-14 93 59
  EA4151 Lymph, AHCT +/-Ritux, MRD Neg 29-AUG-17 226 81
 
MELAN S2000 MELAN, M1d/ BRAF, Enco+Bini+Nivo vs Ipil+Nivo 23-SEP-20 115 45
  S2015 MELAN, Stg I-II, 1cm v 2cm excision margins 08-APR-22 160 65
  A091903 Melan, Resected Mucosal, Adj Nivo +/- Cabo 01-JUN-22 97 52
  EA6141 Melan, Adv, Nivolumab+Ipi ± Sargmostim 10-SEP-15 238 93
  EA6174 Merkel, Adjuvant Pembrolizumab vs Observation 23-JUL-18 303 104
  EA6192 Melan, Adv, Erly Discont of Antibdy Thrpy 27-AUG-20 114 49
  EA6194 Melan, Stage IIIB-D, Pembro +/- CMP-001 19-MAR-21 0 2
 
MMYEL S1803 MM, Maintenance, Len vs Len/Dara 27-JUN-19 311 118
  S2209 MM, Newly Dx, VRd-R->R v DRd-R->R v DRD-DR->D 30-MAY-23 173 61
  S2213 AL Amyloidosis, Newly Dx, Dara-VCD v ASCT 01-DEC-23 57 19
  EAA173 MYEL, SMM, Rd +/- Daratumumab 30-APR-19 226 97
  EAA181 Myel, Newly Dx, DRd=>DRd+/-Btz=>DR (EQUATE) 27-OCT-20 185 82
 
MULT S2101 Melan or HNSCC, Adv, Cabo + Nivo 14-OCT-22 165 63
 
OTHER A071701 BRAIN, Met, Geno-guided trial 15-AUG-19 214 73
  A071702 BRAIN, Blockade Tx in Recurrent Glioblastoma 30-OCT-20 148 68
  A092104 Uter,Adv, Olaparib+Temozolomide vs Inv Choice 09-DEC-22 26 9
  A092107 DDLPS. Palbocicli v Palbociclib+Cemiplimab 24-MAR-23 25 10
  A151804 irAEs, National Biorepository to Adv Studies 31-JAN-20 140 74
  ARST2031 RMS, Stg IV, VINO-AC+VINO-CPO vs VAC+VINO-CPO 13-SEP-21 182 94
  CCTGHN11 HN, All Stg, Guided Elec Contra Neck Tx 29-SEP-22 0 2
  EA3132 HN SCC, Stg III-IV , Adj RT +/- Cisp 29-MAR-16 212 69
  EA3161 HNC, HPV+ OPCA, (cisplatin+RT) +/- Nivo 20-JUN-19 240 94
  EA3191 HN, High Risk HNSCC, Adj +/- Pembro 08-JAN-21 185 68
  N0577 BRN, Glio,Tem vs Tem+RT vsRT+PVC 22-SEP-09 275 91
  NRGBN003 Mening, Grd II, Observation vs Irradiation 14-JUN-17 251 89
  NRGBN011 Brain, Lomustine + Temo vs Temo 29-NOV-21 253 96
  NRGBN012 Brain, Pre- vs Post-Op Stereotactic Radiosurg 31-AUG-22 187 81
  NRGGY019 Ovar, Stg II-IV, Pac/Carb/Let vs. Let Mono 26-AUG-19 29 4
  NRGHN005 HN, early stg P16-pos, randomize de-intensifi 10-JUL-19 377 124
  NRGHN006 HN, Erly Stg, Biopsy vs Dissection 08-JUL-20 205 71
  NRGHN009 HN, RT + HD Cisp vs RT + LD Cisp for SCCHN 27-OCT-21 256 102
  NRGHN010 HER2+ SGC, T-DM1 vs TH 30-SEP-22 142 45
  R1216 HN, Adv,Cis vs Dtx vs Dtx+Cetux 18-MAR-13 339 111
 
PREV S1823 GCT, Obs. Cohort, miRNA371 01-JUN-20 128 59
  S1904 Breast, Decision making for chemoprevention 01-SEP-20 19 39
  A212102 Blind Ref Set for Multicancer Early Detection 01-AUG-22 184 88
  EA1151 Prev, Tomosynthesis Mammographic Screening 06-JUL-17 235 94
  EA2185 Panc, Impact of Panc Cyst Surveillance 16-JAN-20 137 73
  EA8184 Pros, Dbl Blind GTC vs Placebo 20-MAY-21 73 42
  NRGCC005 Colon,Non-AdvancedAdenomas,Colonoscopy5v10yrs 06-OCT-21 19 14
  NRGCC008 Ovar, BRCA1, non-inferiority of BLS vs BSO 23-JUN-20 314 138
 
SURV A211901 Cancer survivors who smoke, txt cessation 01-DEC-21 117 47
 
SXQOL S2010 ASPEN: Brst, Stg I-III, ASM vs Pt Ed 17-JAN-23 216 108
  S2013 I-CHECKIT: ICI toxicity risk prediction study 16-AUG-21 191 114
  S2205 ICE COMPRESS: Reduction of CIPN from Taxanes 16-MAR-23 15 29
  A221805 Colorectal, Duloxetine for Oxaliplatin CIPN 01-MAY-20 249 105
  A222004 Mult, Olanza vs Megestrol for Anorexia 15-OCT-21 0 55
  ACCL1931 Leuk, All Stg, Levocarnitine Prophylaxis 14-AUG-23 22 3
  EAQ202 Improving AYA PROs in EA Trials 28-OCT-21 52 28
  NRGCC010 Endo, Stg I, LN Map for LE Limb Dysfunction 19-SEP-22 75 25
  NRGCC011 Breast, Survivors, Cog Training 02-FEB-24 42 12