S1609 FAQ 1 UPCOMING DART COHORT CLOSURES AS OF 24-SEP-2021 6:10 AM Up-coming Closure Closure # COHORT Name Date Type 40 Peritoneal mesothelioma 10/06/2021 Temporary CLOSED DART COHORTS AS OF 24-SEP-2021 6:10 AM 2 REGS. REGS. REGS. REGS. REGS. LAST LAST LAST LAST LAST # of # of TOTAL 12 6 3 30 7 ACT. CURR Closure Type # COHORT NAME REGS. Month Month Month DAYS DAYS INSTs IRBs Permanent 1 Epithelial tumors of nasal cavity, sinuses, nasopharynx 7 0 0 0 0 0 337 150 Close Permanent 2 Epithelial tumors of major salivary glands 30 0 0 0 0 0 Close Permanent 3 Salivary gland type tumors of head and neck, lip, esophagus, stomach, trachea and lung, breast and other location 6 0 0 0 0 0 Close Permanent 4 Undifferentiated carcinoma of gastrointestinal (GI) tract 6 1 0 0 0 0 Close Permanent 5 Adenocarcinoma with variants of small intestine 26 0 0 0 0 0 Close Permanent 6 Squamous cell carcinoma with variants of GI tract (stomach small intestine, colon, rectum, pancreas) 6 0 0 0 0 0 Close Permanent 7 Fibromixoma and low grade mucinous adenocarcinoma (pseudomixoma peritonei) of the appendix and ovary 10 0 0 0 0 0 Close Permanent 8 Rare Pancreatic tumors including acinar cell carcinoma, mucinous cystadenocarcinoma or serous 11 0 0 0 0 0 Close cystadenocarcinoma Permanent 9 Intrahepatic cholangiocarcinoma 9 0 0 0 0 0 Close Permanent 10 Extrahepatic cholangiocarcinoma and bile duct tumors 10 0 0 0 0 0 Close Permanent 13 Non-epithelial tumors of the ovary 25 0 0 0 0 0 Close Permanent 14 Trophoblastic tumor 3 0 0 0 0 0 Close Permanent 15 Transitional cell carcinoma other than that of the renal, pelvis, ureter, or bladder 1 0 0 0 0 0 Close Permanent 16 Cell tumor of the testes and extragonadal germ tumors 17 0 0 0 0 0 Close Permanent 17 Epithelial tumors of penis - squamous adenocarcinoma cell carcinoma with variants of penis 23 0 0 0 0 0 Close Temporary 18 Squamous cell carcinoma variants of the genitourinary (GU) system 7 3 1 1 0 0 Close Permanent 20 Adenocarcinoma with variants of GU system (excluding prostate cancer) 9 0 0 0 0 0 Close Permanent 21 Odontogenic malignant tumors 4 0 0 0 0 0 Close Permanent 22 Pancreatic neuroendocrine tumor (PNET) 22 0 0 0 0 0 Close Permanent 23 Neuroendocrine carcinoma including carcinoid of the lung 35 0 0 0 0 0 Close Permanent 24 Pheochromocytoma, malignant 7 0 0 0 0 0 Close CLOSED DART COHORTS AS OF 24-SEP-2021 6:10 AM 3 REGS. REGS. REGS. REGS. REGS. LAST LAST LAST LAST LAST # of # of TOTAL 12 6 3 30 7 ACT. CURR Closure Type # COHORT NAME REGS. Month Month Month DAYS DAYS INSTs IRBs Permanent 25 Paraganglioma 6 0 0 0 0 0 Close Permanent 26 Carcinomas of pituitary gland, thyroid gland parathyroid gland and adrenal cortex 21 0 0 0 0 0 Close Permanent 27 Desmoid tumors 17 0 0 0 0 0 Close Permanent 28 Peripheral nerve sheath tumors and NF1-related tumors 9 0 0 0 0 0 Close Temporary 29 Malignant giant cell tumors 6 1 0 0 0 0 Close Permanent 30 Chordoma 11 0 0 0 0 0 Close Permanent 31 Adrenal cortical tumors 23 0 0 0 0 0 Close Permanent 32 Tumor of unknown primary (Cancer of Unknown Primary; CuP) 25 0 0 0 0 0 Close Permanent 33 Not Otherwise Categorized (NOC) Rare Tumors, after discussion with Study Chairs 59 0 0 0 0 0 Close Permanent 34 Adenoid cystic carcinoma 29 0 0 0 0 0 Close Permanent 35 Vulvar cancer 19 0 0 0 0 0 Close Permanent 36 MetaPLASTIC carcinoma (of the breast) 19 0 0 0 0 0 Close Permanent 37 Gastrointestinal stromal tumor (GIST) 12 0 0 0 0 0 Close Permanent 39 Apocrine tumors/Extramammary Paget’s Disease 9 0 0 0 0 0 Close Permanent 41 Basal cell carcinoma 18 0 0 0 0 0 Close Permanent 42 Clear cell cervical cancer 5 0 0 0 0 0 Close Permanent 43 Esthenioneuroblastoma 7 0 0 0 0 0 Close Permanent 44 Endometrial carcinosarcoma (malignant mixed Mullerian tumors) 22 0 0 0 0 0 Close Permanent 45 Clear cell endometrial cancer 9 0 0 0 0 0 Close Temporary 46 Clear cell ovarian cancer 25 0 0 0 0 0 Close Permanent 48 Gallbladder cancer 22 0 0 0 0 0 Close CLOSED DART COHORTS AS OF 24-SEP-2021 6:10 AM 4 REGS. REGS. REGS. REGS. REGS. LAST LAST LAST LAST LAST # of # of TOTAL 12 6 3 30 7 ACT. CURR Closure Type # COHORT NAME REGS. Month Month Month DAYS DAYS INSTs IRBs Permanent 51 Angiosarcoma 18 0 0 0 0 0 Close Permanent 52 High-grade neuroendocrine carcinoma 21 0 0 0 0 0 Close Temporary 53 Treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC) 19 6 2 2 0 0 Close DART ACCRUAL REPORT 5 REGS. REGS. REGS. REGS. REGS. LAST LAST LAST LAST LAST # of # of TOTAL 12 6 3 30 7 ACT. CURR Status # COHORT NAME REGS. Month Month Month DAYS DAYS INSTs IRBs Permanent Close 1 Epithelial tumors of nasal cavity, sinuses, nasopharynx 7 0 0 0 0 0 337 150 Permanent Close 2 Epithelial tumors of major salivary glands 30 0 0 0 0 0 Permanent Close 3 Salivary gland type tumors of head and neck, lip, esophagus, stomach, trachea and lung, breast and other 6 0 0 0 0 0 location Permanent Close 4 Undifferentiated carcinoma of gastrointestinal (GI) tract 6 1 0 0 0 0 Permanent Close 5 Adenocarcinoma with variants of small intestine 26 0 0 0 0 0 Permanent Close 6 Squamous cell carcinoma with variants of GI tract (stomach small intestine, colon, rectum, pancreas) 6 0 0 0 0 0 Permanent Close 7 Fibromixoma and low grade mucinous adenocarcinoma (pseudomixoma peritonei) of the appendix and ovary 10 0 0 0 0 0 Permanent Close 8 Rare Pancreatic tumors including acinar cell carcinoma, mucinous cystadenocarcinoma or serous 11 0 0 0 0 0 cystadenocarcinoma Permanent Close 9 Intrahepatic cholangiocarcinoma 9 0 0 0 0 0 Permanent Close 10 Extrahepatic cholangiocarcinoma and bile duct tumors 10 0 0 0 0 0 Open 11 Sarcomatoid carcinoma of lung 13 2 1 1 1 1 Open 12 Bronchoalveolar carcinoma lung (a.k.a. adenocarcinoma in situ, minimally invasive adenocarcinoma, lepidic 8 0 0 0 0 0 predominant adenocarcinoma, or invasive mucinous adenocarcinoma) Permanent Close 13 Non-epithelial tumors of the ovary 25 0 0 0 0 0 Permanent Close 14 Trophoblastic tumor 3 0 0 0 0 0 Permanent Close 15 Transitional cell carcinoma other than that of the renal, pelvis, ureter, or bladder 1 0 0 0 0 0 Permanent Close 16 Cell tumor of the testes and extragonadal germ tumors 17 0 0 0 0 0 Permanent Close 17 Epithelial tumors of penis - squamous adenocarcinoma cell carcinoma with variants of penis 23 0 0 0 0 0 Temporary Close 18 Squamous cell carcinoma variants of the genitourinary (GU) system 7 3 1 1 0 0 Open 19 Spindle cell carcinoma of kidney, pelvis, ureter 7 1 0 0 0 0 Permanent Close 20 Adenocarcinoma with variants of GU system (excluding prostate cancer) 9 0 0 0 0 0 Permanent Close 21 Odontogenic malignant tumors 4 0 0 0 0 0 Permanent Close 22 Pancreatic neuroendocrine tumor (PNET) 22 0 0 0 0 0 Permanent Close 23 Neuroendocrine carcinoma including carcinoid of the lung 35 0 0 0 0 0 Permanent Close 24 Pheochromocytoma, malignant 7 0 0 0 0 0 Permanent Close 25 Paraganglioma 6 0 0 0 0 0 Permanent Close 26 Carcinomas of pituitary gland, thyroid gland parathyroid gland and adrenal cortex 21 0 0 0 0 0 Permanent Close 27 Desmoid tumors 17 0 0 0 0 0 Permanent Close 28 Peripheral nerve sheath tumors and NF1-related tumors 9 0 0 0 0 0 Temporary Close 29 Malignant giant cell tumors 6 1 0 0 0 0 Permanent Close 30 Chordoma 11 0 0 0 0 0 Permanent Close 31 Adrenal cortical tumors 23 0 0 0 0 0 Permanent Close 32 Tumor of unknown primary (Cancer of Unknown Primary; CuP) 25 0 0 0 0 0 Permanent Close 33 Not Otherwise Categorized (NOC) Rare Tumors, after discussion with Study Chairs 59 0 0 0 0 0 Permanent Close 34 Adenoid cystic carcinoma 29 0 0 0 0 0 Permanent Close 35 Vulvar cancer 19 0 0 0 0 0 Permanent Close 36 MetaPLASTIC carcinoma (of the breast) 19 0 0 0 0 0 Permanent Close 37 Gastrointestinal stromal tumor (GIST) 12 0 0 0 0 0 DART ACCRUAL REPORT 6 REGS. REGS. REGS. REGS. REGS. LAST LAST LAST LAST LAST # of # of TOTAL 12 6 3 30 7 ACT. CURR Status # COHORT NAME REGS. Month Month Month DAYS DAYS INSTs IRBs Open 38 Perivascular epithelioid cell tumor (PEComa) 16 9 6 2 2 1 Permanent Close 39 Apocrine tumors/Extramammary Paget’s Disease 9 0 0 0 0 0 Open 40 Peritoneal mesothelioma 16 8 5 4 2 0 Permanent Close 41 Basal cell carcinoma 18 0 0 0 0 0 Permanent Close 42 Clear cell cervical cancer 5 0 0 0 0 0 Permanent Close 43 Esthenioneuroblastoma 7 0 0 0 0 0 Permanent Close 44 Endometrial carcinosarcoma (malignant mixed Mullerian tumors) 22 0 0 0 0 0 Permanent Close 45 Clear cell endometrial cancer 9 0 0 0 0 0 Temporary Close 46 Clear cell ovarian cancer 25 0 0 0 0 0 Open 47 Gestational trophoblastic disease (GTD) 3 2 1 0 0 0 Permanent Close 48 Gallbladder cancer 22 0 0 0 0 0 Open 49 Small cell carcinoma of the ovary, hypercalcemic type 4 0 0 0 0 0 Open 50 PD-L1 amplified tumors (single-agent Nivolumab therapy) 10 2 1 1 1 1 Permanent Close 51 Angiosarcoma 18 0 0 0 0 0 Permanent Close 52 High-grade neuroendocrine carcinoma 21 0 0 0 0 0 Temporary Close 53 Treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC) 19 6 2 2 0 0 TOTAL 782 35 17 11 6 3.