25-MAR-2025 6:11

OPEN STUDIES IRB REPORT

Disease
Site		 Study Study Name Open Date Number of
Active
Institutions		 Number of
Current
IRBs
 
BREAST S2007 Breast, Brain Mets, Sacituzumab Govitecan 15-DEC-20 190 59
  S2206 Brst, Stg II-III, MP2, Neoadj Chemo +/- Durva 30-OCT-23 356 126
  S2212 Breast, TNBC, Neoadj Chemo + Pembro 21-JUL-23 302 134
  A011801 BRST, HER2+, T-DM1+Placebo v T-DM1+Tucatinib 06-JAN-21 423 206
  A012103 Breast,StgT1cN1-2/T2-4N0-2,obsvsPembrolizumab 03-MAY-23 353 182
  A012301 Breast, Early Stg, Tamoxifen 05-FEB-25 146 25
  EA1211 Breast, HER2+, NeoAdj Therapy 10-MAY-23 128 58
  MA39 BREAST, Node-Pos, Reg RT vs No Reg RT 30-MAY-18 381 150
  NRGBR007 Breast, Stg I, De-Escalation of Breast RT 07-JUN-21 391 175
  NRGBR008 Breast, LowRisk HER2+, Radiotherapy 13-MAR-23 1 1
  NRGBR009 Breast, EarlyStg, Adjuvant Chemo 31-AUG-23 434 186
 
CCD S1703 Met Breast, STM-monitoring v Usual Care 16-JUL-18 202 90
  A191901 Brst, Text/Motivational Intervention ET Adher 10-DEC-20 174 86
  EAQ221CD Breast, Metastatic, Imp. Adherence 31-OCT-23 129 49
  EAQ222CD CostCOM, Cancer Patients, OOP Cost Com 29-FEB-24 26 12
 
ERLYTX S2012 Extrapulm NEC, Stg IV, Combo Chemo +/- Atezo 02-DEC-21 227 78
  A071401 Prog Meningiomas,SMO/AKT/NF2 Inhib 28-AUG-15 256 86
  AGCT1531 Mult, Stg I-IV, Carbo vs Cisp, Ped &Adult 08-MAY-17 192 117
  EAY191 ComboMATCH 06-MAR-23 284 119
  EAY191-S3 ComboMATCH: Adv Solid Tumors, Pac+Ipatasertib 06-MAR-23 170 66
  EAY191A3 ComboMATCH-RAS-Mutant, All Stg, Palbo+Benim 15-NOV-23 202 78
  EAY191A6 ComboMATCH: MAPK Tumors, Adv Stg, FOLFOX+Bin 11-AUG-23 188 75
 
GI S1922 Small Bowel,Ram+Pac vs FOLFIRI, mets/unresect 16-DEC-19 167 56
  S2001 Rando II, Mets Pancreas , BRCA1/2, Comb Chemo 04-DEC-20 169 73
  S2104 Panc,Resect High-risk,Postop Adj Chemo vs Obs 14-OCT-21 210 69
  S2303 Gas/Esoph/GEJ, Adv, Ram + Pac +/- Nivo 06-MAY-24 231 89
  A021806 Pancreas, Perioperative vs Adjuvant Chemo 01-JUL-20 263 115
  A022101 Colorectal, Metastatic, Ablative Tx 10-JAN-23 137 72
  A022102 Gastric, FOLFIRINOX +/-Nivo vs FOLFOX +/ Nivo 11-JAN-23 252 104
  A022104 Rectal, Loc Adv, Triplet vs Doublet Chemo 09-NOV-22 332 135
  CCTGCO32 Rectal, Early Stg, Neoadj/Exc/Obs vs ChemRad 29-FEB-24 107 38
  CCTGNE1 Midgut NET, Unresect, 177 Lut vs Ever 05-JUN-23 48 16
  EA2174 Esoph, Peri-Op Nivolumab +/- Ipilimumab 17-JAN-19 234 84
  EA2192 Panc, APOLLO 29-APR-21 136 80
  EA2197 Gal, Rando Perioperative TX 22-DEC-20 138 73
  EA2222 Colorectal, Stg II-III, Hep Art Infusion 19-OCT-23 53 33
  NRGGI004 Colorectal, Stg IV, dMMR Immuno-Therapy 07-NOV-17 318 111
  NRGGI006 Esophagus, Stg I-IVA, PBT vs IMRT 06-MAR-19 20 4
  NRGGI008 Colon, Stg III, Adj Chemo 10-MAR-22 431 186
 
GU S1802 Pros, Stg IV, SST ± Surg/RT to Primary Tum 17-SEP-18 319 138
  S1931 RENAL, Stg IV, IO + Nephrectomy. vs IO Only 16-NOV-20 252 96
  S1937 Blad, Mets, Eribulin + Gem vs SOC 16-FEB-21 230 74
  S2200 pRCC, Adv, Cabo ± Atezo 19-SEP-22 191 82
  S2210 Pros, High Risk, BRCA, Neoadj Carbo 14-AUG-23 149 45
  S2312 Pros, MCRPC, Cab +/- Carb 03-SEP-24 189 74
  A021804 Adren, Advanced Stg, Temo w/wo Ola 02-NOV-20 51 30
  A031701 Bladder, ddGC for MIBC with DDR Tumor Alt 01-AUG-18 159 55
  A031702 GU, Mets, Cabozantinib+Nivo+Ipi (ICONIC) 12-APR-19 230 88
  A031801 GU, mRCC, Cabozantinib ± Radium-223 13-DEC-19 83 38
  A031803 Blad, NMIBC, Gemcitabine + MK-3475 06-JAN-20 135 58
  A032103 Urothelial, All Stg, MRD-Based Adj Tx 09-JAN-24 322 133
  EA8134 Penile, Local Adv, ILND +/- Chemo or ChemoRT 08-SEP-17 38 16
  EA8191 Pros, Local vs Systemic Thrpy 08-OCT-20 197 62
  EA8192 Blad, High Grade UTUC, Durv + Chemo 06-MAY-21 155 53
  EA8212 Blad, NMIBC, BRIDGE 01-DEC-22 166 79
  NRGGU008 Pros,Node+, Abiraterone acetate + Apalutamide 05-MAR-20 251 91
  NRGGU009 Pros, PREDICT-RT 15-DEC-20 441 168
  NRGGU010 Pros, Parallel De-Intens & Intens Trials 03-NOV-21 450 169
  NRGGU011 Pros, Dbl Blinded RT +/- Androgen Dep Tx 08-DEC-21 247 84
  NRGGU012 Renal, Stg IV, Stereo Abl Rad Therapy 30-JUN-22 223 79
  NRGGU013 Prostate, High-Risk, Five Fraction Radiation 13-NOV-23 231 88
 
LEUK S1905 T-ALL/T-LBL, Rel/Ref, OBI-3424 17-AUG-20 70 26
  S1925 CLL/SLL, Newly Dx HR, Early vs Delayed V+O 14-DEC-20 253 99
  A041501 B-Cell ALL, Frontline Tx +/- Intuzumab Ozo 01-JUN-17 239 85
  A041703 ALL, Newly Dx, Inotuzumab Ozogamicin + Blinat 16-NOV-18 134 56
  A042001 B-Cell ALL, Inotuzunab+chemo v Standard chemo 27-FEB-23 134 44
  EA9181 ALL, BCR-ABL+, Steroids+TKI+CT/Blinatumomab 14-OCT-20 155 55
  EA9213 T-ALL, dara-hyal for chemo refractory MRD 16-JUN-22 78 17
  MM1OAEA02 MyeloMATCH: AML, New Dx, Ven+HMA 06-JUN-24 218 66
  MM1YA-S01 AML, High Risk, Age <60, 7+3 vs experimental 16-MAY-24 207 76
  MM1YACTG01 AML, New/Young/Intermediate, Ven+Chemo 18-JUL-24 187 62
  MYELOMATCH MSRP for the NCI myeloMATCH Clinical Trials 16-MAY-24 285 109
 
LUNG S1827 SCLC, MRI Surveillance +/- PCI 10-JAN-20 335 128
  S1900G EGFR-Mut, MET-Amp: Capmat + Osimert +/- Ramu 03-APR-23 267 102
  S1900J MET Amplification: Amivantamab-SC 27-SEP-24 167 68
  S1900K MET Exon 14: Tepotinib +/- Ramucirumab 18-DEC-23 248 86
  S1933 NSCLC, Stg II-III, RT + Atezo 15-JUN-20 105 40
  S2414 NSCLC, Stg II-IIIB, Durva vs Surveillance 14-MAR-25 6 1
  A081801 ALCHEMIST4, ALK and EGFR negative, Chemo-IO 03-JUN-20 413 173
  A082002 Lung, Adv, Systemic Tx +/- SBRT 21-DEC-21 218 67
  EA5162 NSCLC,StgIV/IIB,EGFR exon20 insertion,AZD9291 05-APR-18 67 32
  EA5182 NSCLC, Met EGFR mut, AZD9291+Beva vs AZD9291 22-OCT-20 180 82
  EA5221 Lung, Advanced NSCLC, ChemoImmuno/Immuno 15-FEB-24 174 71
  LUNGMAP NSCLC, Adv, Master 28-JAN-19 426 183
  NRGLU008 Lung NSCL, StgII-III, StereoBodyRad/MedChemo 10-MAY-23 281 111
 
LYMPH S1918 DLBCL, Adv, Age 75+, CC-486 +/- R-miniCHOP 19-MAR-21 164 65
  S2114 NHL, Rel/Ref, CD19 CAR-T +/- Consolidation 23-FEB-23 100 42
  S2207 LBCL, Transplant Inelig, Targeted Tx + Tafa 30-JUN-23 119 38
  S2308 FL, LTB, Mosunetuzumab vs Rituximab 01-AUG-24 204 69
  A051902 PTCL,CHO(E)PvCC-486-CHO(E)PvDuvelisib-CHO(E)P 30-JUL-21 167 76
  A052101 Lymph, Stg I-IV, Cont v Intermittent Zanub 08-SEP-23 196 77
  AHOD2131 cHL,StgI-II,StdTherapyvImmuno-oncologyTherapy 28-APR-23 259 125
  ANHL1931 PMBCL, Chemo-Immunotherapy +/- Nivo 07-JUN-21 219 107
 
MELAN S2015 MELAN, Stg I-II, 1cm v 2cm excision margins 08-APR-22 179 76
  A091903 Melan, Resected Mucosal, Adj Nivo +/- Cabo 01-JUN-22 129 58
  EA6141 Melan, Adv, Nivolumab+Ipi ± Sargmostim 10-SEP-15 291 98
  EA6192 Melan, Adv, Erly Discont of Antibdy Thrpy 27-AUG-20 155 62
 
MMYEL S1803 MM, Maintenance, Len vs Len/Dara 27-JUN-19 330 128
  S2005 WM, Prev. Untreated, I/R +/- Venetoclax 24-JUN-21 79 23
  S2209 MM, Newly Dx, VRd-R->R v DRd-R->R v DRD-DR->D 30-MAY-23 219 84
  S2213 AL Amyloidosis, Newly Dx, Dara-VCD v ASCT 01-DEC-23 133 42
  EAA173 MYEL, SMM, Rd +/- Daratumumab 30-APR-19 235 101
  EAA181 Myel, Newly Dx, DRd=>DRd+/-Btz=>DR (EQUATE) 27-OCT-20 204 81
 
MMYL A062102 MMYL, All Stg, Iberdomide Tx 04-APR-24 68 25
 
MULT S2101 Melan or HNSCC, Adv, Cabo + Nivo 14-OCT-22 142 60
 
OTHER A071701 BRAIN, Met, Geno-guided trial 15-AUG-19 150 62
  A071702 BRAIN, Blockade Tx in Recurrent Glioblastoma 30-OCT-20 131 61
  A151804 irAEs, National Biorepository to Adv Studies 31-JAN-20 150 78
  CCTGHN11 HN, All Stg, Guided Elec Contra Neck Tx 29-SEP-22 78 21
  CE7 Brain, 5+ Metastases, Radiosurg/Radiotherapy 25-MAY-18 106 39
  EA3132 HN SCC, Stg III-IV , Adj RT +/- Cisp 29-MAR-16 238 72
  EA3191 HN, High Risk HNSCC, Adj +/- Pembro 08-JAN-21 198 69
  EA7222 Sarcoma, Poorly Diff, Dox+Pembro vs Dox 13-JUN-24 3 7
  NRGBN003 Mening, Grd II, Observation vs Irradiation 14-JUN-17 267 84
  NRGBN011 Brain, Lomustine + Temo vs Temo 29-NOV-21 288 110
  NRGBN012 Brain, Pre- vs Post-Op Stereotactic Radiosurg 31-AUG-22 234 96
  NRGBN013 Brain, Intact Metas, SRS vs FSRS 28-AUG-24 52 23
  NRGGY019 Ovar, Stg II-IV, Pac/Carb/Let vs. Let Mono 26-AUG-19 393 151
  NRGGY022 Mult Site/Stg, Carboplat Clearance Predict 18-NOV-19 79 39
  NRGGY026 Endomet, Stage I-IV, Pac/Car w/ HER HYL/PHE 12-AUG-22 306 129
  NRGHN006 HN, Erly Stg, Biopsy vs Dissection 08-JUL-20 216 73
  NRGHN009 HN, RT + HD Cisp vs RT + LD Cisp for SCCHN 27-OCT-21 257 106
  NRGHN010 HER2+ SGC, T-DM1 vs TH 30-SEP-22 160 47
  R1216 HN, Adv,Cis vs Dtx vs Dtx+Cetux 18-MAR-13 338 112
 
PEOLC S1501 Surv, Breast Stg IV, Card Tox w/ Carvedilol 15-SEP-17 229 84
 
PREV A212102 Blind Ref Set for Multicancer Early Detection 01-AUG-22 174 90
  EA2185 Panc, Impact of Panc Cyst Surveillance 16-JAN-20 129 73
  EA8184 Pros, Dbl Blind GTC vs Placebo 20-MAY-21 87 43
  NRGCC005 Colon,Non-AdvancedAdenomas,Colonoscopy5v10yrs 06-OCT-21 184 77
  NRGCC008 Ovar, BRCA1, non-inferiority of BLS vs BSO 23-JUN-20 336 144
 
SXQOL S2013 I-CHECKIT: ICI toxicity risk prediction study 16-AUG-21 205 117
  S2205 ICE COMPRESS: Reduction of CIPN from Taxanes 16-MAR-23 14 29
  A211901 Cancer survivors who smoke, txt cessation 01-DEC-21 121 51
  A222004 Mult, Olanza vs Megestrol for Anorexia 15-OCT-21 0 53
  ACCL1931 Leuk, All Stg, Levocarnitine Prophylaxis 14-AUG-23 150 69
  EAQ202 Improving AYA PROs in EA Trials 28-OCT-21 39 21
  NRGCC010 Endo, Stg I, LN Map for LE Limb Dysfunction 19-SEP-22 68 25
  NRGCC011 Breast, Survivors, Cog Training 02-FEB-24 236 90