1 |
63 |
|
17 |
|
17 |
2 |
5 |
locally advanced |
6 |
or metastatic disease |
10 |
3 |
12 |
metastatic or |
6 |
disease |
9 |
4 |
11 |
locally advanced / |
5 |
or metastatic melanoma |
7 |
5 |
187 |
patients with |
5 |
or metastatic |
6 |
6 |
109 |
histologically or cytologically confirmed metastatic or |
4 |
sarcoma |
4 |
7 |
106 |
patients must have histologically or cytologically documented carcinoma primary to the intra or extra hepatic biliary system or gall bladder with clinical and / or radiologic evidence of |
3 |
tumors |
3 |
8 |
141 |
histologically confirmed |
3 |
or metastatic gastroesophageal adenocarcinoma . |
3 |
9 |
181 |
must have |
3 |
locally advanced or metastatic disease patients with ampmcLlary carcinoma are not eligible |
3 |
10 |
6 |
patients may have received up to one prior line of chemotherapy for metastatic or |
2 |
locally advanced breast cancer |
2 |
11 |
8 |
metastatic or locally advanced |
2 |
and for which additional radiation therapy or other locoregional therapies are not considered feasible . |
2 |
12 |
27 |
metastatic disease or locally advanced |
2 |
or metastatic disease . |
2 |
13 |
32 |
patients with metastatic lymph node or distant metastasis i . e . n or m1 or locally advanced |
2 |
locally advanced or metastatic melanoma |
2 |
14 |
103 |
histologically or cytologically confirmed adenocarcinoma of the breast with |
2 |
locally advanced recurrent nsclc that has been previously treated subjects who have failed adjuvant or locally advanced therapy within 6 months are also eligible to participate in the study |
2 |
15 |
110 |
histologically or cytologically confirmed diagnosis of metastatic or |
2 |
locally advanced or metastatic breast cancer |
2 |
16 |
120 |
has histologically or cytologically confirmed diagnosis of locally advanced |
2 |
gist . |
2 |
17 |
135 |
histologically confirmed breast adenocarcinoma that is |
2 |
or inoperable |
2 |
18 |
176 |
metastatic and / or |
2 |
melanoma |
2 |
19 |
180 |
have histologically confirmed |
2 |
tumor |
2 |
20 |
188 |
has received prior systemic treatment for |
2 |
disease documented on diagnostic imaging studies |
2 |
21 |
191 |
patients must be considered |
2 |
disease or subject refused surgery . |
2 |
22 |
197 |
tumor tissue from an |
2 |
breast cancer currently progressive after at least two prior lines of therapy in the advanced setting patients with her2 disease must have failed two or more different anti her2 agents |
1 |
23 |
202 |
patients must have metastatic or |
2 |
locally advanced or metastatic disease la / mbc |
1 |
24 |
204 |
diagnosed with advanced metastatic or |
2 |
breast cancer |
1 |
25 |
216 |
the cancer must be |
2 |
locally advanced breast cancer or metastatic breast cancer |
1 |
26 |
228 |
is |
2 |
pancreatic cancer by national comprehensive cancer network nccn criteria |
1 |
27 |
237 |
locally |
2 |
locally advanced within 6 months of completing definitive therapy for localized or locally advanced cancer can be considered as having received one line of therapy for advanced cancer |
1 |
28 |
253 |
patients must have |
2 |
breast cancer includes metastatic or locally advanced unresectable breast cancer which is diagnosed while on adjuvant letrozole or exemestane |
1 |
29 |
1 |
any breast cancer patient with metastatic or locally recurrent |
1 |
cancer cancer must be active i . e . demonstrable by physical examination blood tests or radiographical procedures |
1 |
30 |
2 |
pathologically confirmed diagnosis of breast cancer with radiographic evidence of incurable |
1 |
or metastatic breast cancer |
1 |
31 |
3 |
histologic proof of metastatic or locally advanced |
1 |
locally advanced / recurrent breast cancer |
1 |
32 |
4 |
have not previously received therapy for the treatment of |
1 |
or borderline resectable based on institutional standardized criteria of unresectability or medical inoperability patients with and without regional adenopathy are eligible |
1 |
33 |
7 |
patients whose esophageal or gej cancer has become metastatic or |
1 |
disease with no evidence of distant metastases or peritoneal disease the maximum dimension of the tumor must be = < 10 cm |
1 |
34 |
9 |
subjects must have metastatic or locally advanced |
1 |
or metastatic relapsed and / or refractory non hematological malignancy for which treatment with an approved agent that is considered standard of care in the indication either does not exist or has proven ineffective . |
1 |
35 |
13 |
participants must have metastatic or locally advanced incurable anal cancer that has been histologically confirmed patients with locally advanced anal cancer must have had cancer recurrence after chemoradiation and must be |
1 |
or metastatic gastroenteropancreatic neuroendocrine carcinoma that is either known or suspected to be of gastrointestinal gi origin primary tumors arising from the lung gynecologic organs or prostate are not permitted |
1 |
36 |
14 |
histologically or cytologically confirmed locally advanced adenocarcinoma of the pancreas that is considered |
1 |
disease stage ivb |
1 |
37 |
15 |
pathologically confirmed adenocarcinoma of the pancreas patients have resectable borderline resectable disease or |
1 |
gastrointestinal adenocarcinomas gastric cholangiocarcinoma pancreatic |
1 |
38 |
16 |
subject has a locally advanced |
1 |
or metastatic disease and have not received prior irinotecan patients must have received at least one prior line of standard treatment for locally advanced or metastatic disease |
1 |
39 |
18 |
re registration locally advanced / |
1 |
locally advanced or metastatic not amendable to curative therapy |
1 |
40 |
19 |
patients must have a locally advanced and |
1 |
or metastatic adenocarcinoma of gastric or gastroesophageal junction for the 1l cohort no prior systemic therapy for the locally advanced or metastatic disease for the 2l cohort disease progression during or following a first line platinum containing or fluoropyrimidine containing chemotherapy regimen |
1 |
41 |
20 |
patients must have either metastatic stage ivc or locally advanced |
1 |
or metastatic disease that has progressed since last treatment . |
1 |
42 |
21 |
in the dose escalation phase the trial will be open for patients with stage iv or locally advanced |
1 |
or metastatic disease which may be resected but with an associated level of morbidity deemed unacceptable by the treating clinician is considered eligible |
1 |
43 |
22 |
in the dose expansion phase arm a will be open for 25 patients with pancreatic adenocarcinoma patients must have histologic diagnosis and either locally advanced |
1 |
or metastatic stage 4 i . e . t4 or n3 or m1 penile squamous cell carcinoma pscc |
1 |
44 |
23 |
disease that is |
1 |
pscc |
1 |
45 |
24 |
histologically or cytologically confirmed locally advanced |
1 |
t4b tcc |
1 |
46 |
28 |
patients must have metastatic disease or locally advanced |
1 |
disease or disease that cannot be fmcLly resected obvious radiologic extracapsmcLar spread ecs |
1 |
47 |
29 |
disease must be locally advanced and |
1 |
resection is considered by the treating surgeon or patient to resmcLt in unacceptable functional or oncological resmcLts patient refuses surgery or surgery is not possible due to co morbidities r n human papillomavirus hpv or p16 locally / regionally advanced t3 4 or n2 3 oropharyngeal cancer r n hpv or p16 locally / regionally advanced t4 or n3 oropharyngeal cancer r n t3 or t4 laryngeal or hypopharyngeal cancer that is locally advanced |
1 |
48 |
31 |
the patient must have advanced disease defined as cancer that is either metastatic or locally advanced and |
1 |
or patient declines surgery r n stage iii / iv oral cavity or paranasal sinus cancers in patients who refuse surgery or are unfit for surgery r n locally / regionally advanced stage t3 4 and / or n3 nasopharyngeal cancer which is ebv epstein barr virus |
1 |
49 |
34 |
advanced stage iii iv n2c n3 or surgically |
1 |
disease involving the chest wall / nodal basins in which a curative surgical resection cannot be performed or those in whom de novo metastatic disease is suspected or confirmed |
1 |
50 |
35 |
and meet one of the following criteria r n primary tumor t4 with or without metastatic lymph nodes tumor or nodes are |
1 |
disease as defined by nccn criteria |
1 |
51 |
36 |
bmcLky > = 40 cc |
1 |
cancers for which no alternative therapies with proven survival advantage are available |
1 |
52 |
38 |
patients must have had disease progression on or following their most recent treatment regimen or on presentation for the first time with locally advanced |
1 |
locally advanced or metastatic urothelial carcinoma also known as aka transitional cell carcinoma previously not treated with systemic chemotherapy for current stage of disease r n low dose chemotherapy e . g . low dose cisplatin cisplatin plus fluorouracil 5 fu mitomycin plus 5 fu |
1 |
53 |
39 |
patients with inflammatory breast cancer widespread locally advanced |
1 |
locally advanced urothelial cancer comcLd have been previously radiated but must have response evaluation criteria in solid tumors recist 1 . 1 measurable |
1 |
54 |
41 |
stage iv or locally advanced |
1 |
disease as determined by site attending urologic oncologist or metastatic disease |
1 |
55 |
42 |
patients with recurrent |
1 |
. patients with locally advanced cutaneous squamous cell carcinoma that are technically resectable but in whom surgery is expected to lead to substantial function impairment or disfigurement are eligible |
1 |
56 |
43 |
or cisplatin plus paclitaxel given concurrently with radiation to the primary tumor site is not considered systemic chemotherapy in that clinical setting chemotherapy is given with the purpose of sensitizing the tumor to local radiation it is not administered at doses with any systemic efficacy r n surgery is not considered first line therapy following diagnosis of advanced / metastatic disease r n if |
1 |
locally advanced pancreatic carcinoma |
1 |
57 |
44 |
stage iv disease or locally advanced / |
1 |
adenocarcinoma without distant metastatic disease or resectable t3 4 nxmo disease or m1 with controlled distant disease |
1 |
58 |
46 |
must have histologically or cytologically documented rare tumor as defined per protocol that is metastatic or locally advanced and |
1 |
recurrent locally advanced or metastatic neuroendocrine tumor including r n cohort a unresectable |
1 |
59 |
47 |
stage iii |
1 |
locally advanced or metastatic tumors who have failed or are refractory to available therapy other neuroendocrine cancer varieties as characterized by expression of neuroendocrine markers on tumor tissue including cd56 |
1 |
60 |
48 |
pathologically confirmed adenocarcinoma of the pancreas patients with either initially diagnosed or recurrent locally advanced disease the maximum dimension of the treatment target must be = < 10 cm locally advanced disease defined as t 1 2n mo or t3 4 nxmo or borderline resectable and |
1 |
or metastatic disease with no standard curative therapy available |
1 |
61 |
49 |
subjects must have |
1 |
locally advanced |
1 |
62 |
50 |
recurrent locally advanced or metastatic pheochromocytoma paraganglioma pc pg who have failed or are refractory to available therapies sample size n = 12 r n cohort b will include only patients with |
1 |
locally advanced pancreatic cancer ajcc stage iii . excluded resectable and borderline resectable patients are ineligible per nccn criteria |
1 |
63 |
51 |
primitive neuroectodermal tumor pnet desmoplastic small round cell tumor round cell sarcoma and |
1 |
or metastatic disease within 28 days prior to the first dose of study treatment . |
1 |
64 |
54 |
have an |
1 |
i . e . invading the pelvic or abdominal wall stage t4b or presenting with bmcLky nodal disease n2 3 . |
1 |
65 |
55 |
subject has radiologically confirmed locally advanced |
1 |
or borderline resectable pancreatic cancer based on computed tomography ct imaging as determined by the principal investigator pi |
1 |
66 |
56 |
locally advanced t4b any n or any t n 2 3 or metastatic disease any t any n and m1 . locally advanced bladder cancer must be |
1 |
as determined by local surgeon or metastatic disease |
1 |
67 |
57 |
locally advanced including |
1 |
or metastatic small bowel adenocarcinoma |
1 |
68 |
59 |
have locally advanced |
1 |
locally advanced disease including inflammatory breast cancer patients without pathologic or cytologic confirmation of metastatic disease or unresectable locally advanced disease shomcLd have unequivocal evidence of metastasis or unresectable locally advanced disease by physical examination or radiologic study |
1 |
69 |
60 |
pstat3 screening participants must have histologically or cytologically confirmed invasive breast cancer testing of either the primary tumor or in the metastatic setting with either metastatic disease or |
1 |
locally advanced disease patients without pathologic or cytologic confirmation of metastatic disease or unresectable locally advanced disease shomcLd have unequivocal evidence of metastasis or unresectable locally advanced disease by physical examination or radiologic study |
1 |
70 |
61 |
participants must have histologically or cytologically confirmed invasive breast cancer with either metastatic disease or |
1 |
or metastatic msi high crc . |
1 |
71 |
62 |
subjects with histological confirmation of locally advanced |
1 |
locally advanced recurrent bc or metastatic bc |
1 |
72 |
64 |
subjects with recurrent locally advanced |
1 |
or metastatic adenocarcinoma of the pancreas who have progressed after primary therapy with folfirinox or folfirinox like regimen or were intolerant of it . |
1 |
73 |
65 |
prior treatment for bc in the adjuvant |
1 |
locally advanced or metastatic settings which must include both a taxane and trastuzumab alone or in combination with another agent |
1 |
74 |
66 |
prior systemic therapy and chemoradiotherapy for treatment of resectable borderline resectable or locally advanced |
1 |
disease is allowed and does not count toward prior therapy for metastatic disease |
1 |
75 |
67 |
patients who received systemic therapy with gemcitabine / nab paclitaxel for resectable or borderline / locally advanced |
1 |
disease and progressed with metastatic disease within 3 months of the past dose of systemic therapy are eligible |
1 |
76 |
68 |
receipt of prior systemic anti cancer therapy for |
1 |
disease . |
1 |
77 |
70 |
inclusion criteria cohort expansion phase n n histologically proven |
1 |
locally advanced or metastatic melanoma or nsclc n n melanoma advanced or metastatic melanoma patients may be systemic therapy naïve n or may have received systemic treatment for unresectable locally advanced or n metastatic disease . a patient who previously received systemic therapy must have n had progression on a checkpoint inhibitor e . g . anti pd l1 |
1 |
78 |
71 |
anti pd 1 n anti ctla 4 as the most recent prior therapy . n n nsclc nsclc that has progressed during or following 1 or more prior systemic n therapies for |
1 |
locally advanced or metastatic disease . patients who n are intolerant of or have refused treatment with standard first line cancer n therapy will be allowed to enroll . patients must not have had more than 5 prior n systemic regimens excluding experimental therapies for unresectable locally n advanced or metastatic disease . n n b7 h3 expression is not required for eligibility in this study however |
1 |
79 |
72 |
radiographic and pathologic staging consistent with pancreatic cancer locally advanced |
1 |
per nccn criteria |
1 |
80 |
73 |
histologic or cytologic evidence of a malignant solid tumor or lymphoma any histology and must have advanced disease defined as cancer that is either metastatic or locally advanced and |
1 |
locally advanced or metastatic disease or melanoma patients who are intolerable of or have refused standard cancer therapy . pre and on study biopsy required . |
1 |
81 |
74 |
melanoma that has progressed during or following at least 1 and up to 5 prior systemic treatments for |
1 |
or metastatic gist and have progressed on imatinib |
1 |
82 |
75 |
in the phase i dose escalation study must have locally advanced |
1 |
locally advanced or metastatic mpm after locally confirmed progression on 1st line treatment with platinum in combination with pemetrexed . |
1 |
83 |
77 |
measurable metastatic disease or locally advanced and |
1 |
or metastatic gastric or gej siewert types i iii adenocarcinoma . |
1 |
84 |
78 |
locally advanced clearly |
1 |
disease by computed tomography ct scan or clinical evidence |
1 |
85 |
79 |
the participant received > = 1 line of prior therapy for the treatment of locally advanced and |
1 |
colorectal cancer with histological confirmation of adenocarcinoma |
1 |
86 |
80 |
confirmed metastatic or locally advanced |
1 |
locally advanced or metastatic adenocarcinoma |
1 |
87 |
82 |
patients must have an |
1 |
stage iii |
1 |
88 |
83 |
documented evidence of nsclc locally advanced |
1 |
disease it will be up to the investigator to determine what constitutes a regimen in each case cohort 2 patients must have had a minimum of 1 and maximum of any number of prior chemotherapy regimens for recurrent / metastatic disease or locally advanced / unresectable disease cohort 3 patients may have had any number of prior therapies for recurrent / metastatic or locally advanced / unresectable disease there are no restrictions all cohorts the last dose of systemic therapy much have been given at least 28 days prior to initiation of therapy patients receiving carmustine bcnu or mitomycin c must have received their last dose at least 6 weeks prior to initiation of therapy |
1 |
89 |
84 |
cohort 1 patients must have had a minimum of 1 and a maximum of 4 prior chemotherapy regimens for recurrent / metastatic disease or locally advanced / |
1 |
locally advanced or metastatic melanoma . |
1 |
90 |
85 |
naïve untreated patients or patients who have progressed on or after any number of prior lines of immunotherapy for |
1 |
locally advanced or metastatic hereditary or sporadic mtc objective disease progression within the previous 14 months prior to enrolment and / or |
1 |
91 |
86 |
previous systemic chemotherapy for |
1 |
or metastatic pancreatic adenocarcinoma proven by histology or cytology and previously untreated with chemotherapy or systemic therapy other than |
1 |
92 |
87 |
written consent from female or male patients aged 18 years and over . previously confirmed histological diagnosis of |
1 |
or advanced metastatic disease patients with adenocarcinoma of the distal pancreatic body or tail are ineligible patients with endocrine tumors lymphoma of the pancreas or ampmcLlary cancer are also ineligible |
1 |
93 |
88 |
subjects > = > = 18 years of age with locally advanced |
1 |
or advanced metastatic disease patients with adenocarcinoma of the pancreatic body or tail are ineligible |
1 |
94 |
89 |
patient has borderline resectable locally advanced |
1 |
locally advanced malignant solid tumor . |
1 |
95 |
90 |
patient has localized resectable locally advanced |
1 |
locally advanced or metastatic hcc |
1 |
96 |
91 |
subjects must have metastatic or |
1 |
locally advanced disease or metastatic disease |
1 |
97 |
92 |
inoperable metastatic or locally advanced |
1 |
pdac |
1 |
98 |
93 |
subject with more than 2 prior cytotoxic therapies not including treatment administered for locally curable disease for |
1 |
or metastatic melanoma who meet all of the following criteria r n subjects have received any number of prior lines of therapy or may be treatment naive r n if the subject has been treated with a prior line of therapy they must have had disease progression or be refractory to treatment or r n subjects with histologically or cytologically confirmed locally advanced / unresectable or metastatic urothelial carcinoma including mixed histologies of urothelial carcinoma with elements of other subtypes of the renal pelvis ureter bladder or urethra referred to broadly in this protocol as bladder cancer who meet the following criteria r n subjects must have disease progression or refractory disease after their prior line of therapy subjects must have had at least 1 platinum based chemotherapy regimen for the treatment of metastatic or locally advanced unresectable disease subjects may have received any number of prior lines of therapy or r n subjects with disease recurrence within 1 year of a platinum based neoadjuvant or adjuvant therapy for bladder cancer or r n the subject actively refuses chemotherapy for the treatment of metastatic or locally advanced disease considered as standard treatment for this disease stage i . e . a patient who has relapsed > = 1 year after treatment with neoadjuvant or adjuvant chemotherapy |
1 |
99 |
95 |
have borderline resectable or |
1 |
locally advanced or metastatic disease diagnosed within 6 weeks prior to screening |
1 |
100 |
96 |
intraoperative evidence of metastatic or locally |
1 |
or resectable but suitable for an organ sparing approach |
1 |