Clinical Trials

• Histologically or cytologically confirmed urothelial carcinoma with predominantly transitional-cell features
• Locally advanced or metastatic disease before starting ICI therapy
• Must be receiving current active treatment with SOC FDA approved PD-1/L1 ICI containing therapy
• Tumor decrease (either in target or non-target lesions) after 12-15 months on ICI.  Does not need to be formal PR/CR. Any decrease confirmed by repeat scan 4 weeks later is OK
• ECOG PS 0-2
• Adequately treated CNS disease is eligible
• No current immunosuppresive drugs

• T1c or T2, cN0 or cN1 early breast cancer with plans for surgical resection
• ER/PR <10%, HER2 negative
• ECOG PS 0-1
• ANC >1200, Hgb >10, Plt >100,000
• Tumor determined to have abnormal HER2-driven signaling activity based on the CELx HSF test (to be conducted during screening)
• No T3 or T4 tumors
• No definitive surgical treatment performed yet
• No evidence of metastatic disease
• No prior history of ipsilateral DCIS or breast cancer
• No prior therapy with anthracyclines, taxanes, or anti-HER2 therapy
• No other malignancies within 2 years prior
• No active cardiac disease
• No uncontrolled hypertension
• No known HIV/HBV/HCV
• No neuropathy grade >=2

• HER2 positive invasive breast cancer
• Stage at disease presentation: any cT2-4, any cN1-3, M0
  • Patients with cT1-3N0-1/M0 at presentation must have pathologic evidence of residual cancer in the axilla at time of surgery
  • Patients with T4 or N2-3 disease must have pathologic evidence of residual cancer in either the breast and/or the axilla
• Completion of at least 6 cycles and 16 weeks of pre-operative systemic chemotherapy including 9 weeks of a taxane and 9 weeks of trastuzumab
• Cannot have had a best response to neoadjuvant therapy of progressive disease
• < or = 12 weeks since primary surgery and randomization
• ECOG PS 0-1
• LVEF >or = 50%
• No prior T-DM1 or immune checkpoint inhibitors
• Documentation of PD-L1 status

• Must have confirmed HR+, HER2+ lymph node positive early invasive breast cancer 
• Must have undergone definitive surgery of the primary breast tumor
• Must have receievd a minimum of 4 cycles of chemotherapy either in neoadjuvant or adjuvant setting
• Must have completed 9 months to 1 year of followingadjuvant HER2-targeted therapy
  • For those treated with neoadjuvant chemo/HER2, must have received T-DM1 in adjuvant setting 
  • For those not-treated with neoadjuvant chemo/HER2, must have received adjuvant pertuzumab + trastuzumab
• Must have completed adjuvant HER2 therapy within 12 weeks of randomization
• High risk disease defined as follows:
  • Neoadjuvant patients must have positive axillary node at time of surgery
  • Non-neoadjuvant patients must either have
    • 4 or more positive lymph nodes at surgery
    • 1-3 positive lymph nodes with either
      • Grade 3 disease or
      • Tumor size 5 cm or greater
• No inflammatory breast cancer
• No prior invasive breast cancer including most DCIS/LCIS
• No history of VTE
• No prior CDK4/6 agents
• No prior neratinib, tucatinib, trastuzumab deruxtecan, or investigational HER2 therapy
• No history of tamoxifen or AI for primary prevention

• Postmenopausal or pre-menopausal but treated with LHRH agonist therapy for the duration of study treatment
• Locally advanced or metastatic adenocarcinoma of the breast not curable
• Documented ER-positive and HER2-negative
• No prior systemic anti-cancer therapy for metastatic disease
• Measurable disease
• ECOG PS 0-1
• No disease recurrence within 12 months of treatment with an AI or a CDK4/6 inhibitor in adjuvant/neoadjuvant setting
• No prior SERD
• No active CNS disease

• ER+, Her2 negative breast cancer
• Endocrine therapy recommended, cytotoxic chemotherapy not recommended
• Disease progression during or after first- or second-line hormonal therapy for locally advanced or metastatic disease (note: at least one line of therapy must have contained a CDK4/6i administered for a minimum of 8 weeks prior to disease progression.)
• Postmenopausal status 
• ECOG 0-1
• Available tumor specimen
• Prior fulvestrant therapy is allowed
• Measurable disease
• No prior cytotoxic chemotherapy for metastatic disease
• For patients receiving therapeutic anticoagulation: stable anticoagulant regimen

• Breast cancer with history of HER2-low expression, defined as IHC2+/ISH negative or IHC1+ with a validated assay
• May be either hormone receptor positive or negative
• ECOG PS 0-1
• If hormone receptor positive disease
  • Part 1: Must have had at least 1 prior treatment line of endocrine therapy with or without a targeted therapy (CDK4/6, mTOR, or PI3K) and at least one prior line of chemotherapy, all for metastatic disease
  • Part 2: Only 1 prior treatment line of ET with or without a targeted therapy. No prior chemothearpy for MBC
• If hormone receptor negative disease
  • Part 1: At least 1 prior line of chemotherapy for MBC
  • Part 2: For Module 2, no prior lines of thearpy for MBC. For Modules 1 and 3, only 1 prior line fo chemotherapy for MBC
• No significant cardiovascular disease
• No history of pneumonitis requiring steroids
  • No clinically active CNS metastatses or spinal cord compression

• Triple negative metastatic breast cancer
• 2nd line
• ECOG PS 0-2
• No prior treatment with any study agents
• No history of autoimmune disease
• Presence of measurable disease
• No symptomatic or untreated CNS disease

• Must have measurable disease by RECIST 1.1
• Diagnosis of TNBC
• Must have received or been intolerant to not more than 2 lines of therapy for metastatic disease
• Prior therapy should have included anthracycline and/or taxane
• LDH must be <2x ULN at screening
• May be PD-L1 treatment refractory (number capped)
• ECOG PS 0-1
• No 2nd malignancy within 2 years
• No active CNS involvement
• No history of interstitial lung disease
• No active pneumonitis or history of non-infectious pneumonitis that required steroids
• No active autoimmune disease that required systemic tx in past 2 years (other than replacement therapy)
• No known HIV, HBV, HCV
• No need for steroids at dose of greater than 10mg prednisone or equivalent daily
• No recent history of substance abuse

• Metastatic, unresectable colorectal adenocarcinoma, PDL1+
• Has measurable disease per RECIST 1.1 
• Has been previously treated for the disease and radiographically progressed on or after or could not tolerate standard treatment.
• Submits an archival (≤ 5 years) or newly obtained tumor tissue sample or newly obtained tumor tissue sample that has not been previously irradiated.
• ECOG 0-1
• Life Expectancy >= 3 months
• Ability to swallow oral medications
• Has adequate organ function.
• MMR proficient
• Does not have active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease.
• Has not received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2), anti-lymphocyte activation gene 3 (LAG-3) antibody, with a tyrosine kinase inhibitor (TKI; eg, lenvatinib) other than rapidly accelerated fibrosarcoma (RAF) inhibitors (binimetinib is permitted if combined with a RAF inhibitor), or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4, OX-40, cluster of differentiation [CD] 137).
• Has not previously received regorafenib or TAS-102.
• Has not received prior radiotherapy within 2 weeks of start of study intervention.

• Female age 18 or greater
• Histologicall confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcoma, are allowed
• Disease in one of the following categories
  • Newly diagnosed Stage III disease (with measurable disease following surgery or biopsy)
  • Newly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy)
  • Recurrence of disease where the potential for cure by surgery alone or in combination is poor
• Naive to first line systemic anti-cancer treatment.  For patients with recurrent disease only, prior chemo is allowed only if administered in the adjuvant setting and there is at least 12 months from the date of the last dose of chemo to the date of subsequent relapse
• ECOG PS 0-1
• No CNS disease
• No prior treatment with PARP inhibitors or immunotherapy

• Histologic confirmed diagnosis of GBM per WHO classification criteria
• Age >or= 22
• Recovered from maximal debulking surgery, if applicable (gross total resection, partial resection, and biopsy-only patients are all acceptable)
• Planned treatment with RT-TMZ followed by TTFields and maintenance TMZ
• KPS >or= 70%
• Must have stable or decreasing steroid use
• Concomitant RT with TMZ planned to start no later than 8 weeks post surgery
• Able to undergo MRI with contrast of brain
• No infratentorial or leptomeningeal disease
• No plts <100, ANC <1.5, AST/ALT > 3xULN, Tbili >1.5x ULN, creatinine >1.7
• No institutionalized patients
• No active implanted medical devices, bullet fragments, or other skull defects

• Squamous cell carcinoma of the oropharynx
• Measurable disease either in primary or lymph node
• P16 posotive locally
• T1-2N1M0 or T3N0-1M0
• No more than 10 pack years of smoking history
• ECOG PS 0-1
• No T4 or N2
• No recurrent disease
• No supraclavicular nodes
• No prior malignancy unless disease free for at least 3 years
• No allergy to cisplatin

• Must have one of the following
  • Disease progression after platinum based chemotherapy (with or without PD-1 therapy) for recurrent or metastatic disease
  • Refractory disease defined as progression or recurrence within six months after the last dose of platinum based chemoradiation for locally advanced disease
• No more than two prior lines of treatment
• ECOG PS 0-1
• Able to swallow and retain oral medications
• No prior taxane
• No symptomatic CNS disease
• No known HIV
• No symptomatic CHF or LVEF <50%
• No active psychiatric illness

• SCCHN
• Must have received prior PD-1 or PD-L1 inhibitor
• ECOG PS 0-1
• No known autoimmune disease
• No need for steroids or other immunsuppressive medicine
• No interstitual lung disease or pulmonary fibrosis

• Advanced SCCHN
  • eligible to receive single agent pembrolizumab as standard-of-care OR
  • eligible to receive single-agent docetaxel as standard of care 
• Measurable disease
• ECOG PS 0-1
• No history of severe autoimmune disease
• Not receiving high-dose systemic steorid therapy or any other form of immunosuppressive therapy

• Histologically or cytologicall confirmed Stage IV (M1a or M1b) non-squamous NSCLC
  • Mixed histologies allowed if predominant type non-squamous
  • No small cell allowed (even if non-predominant part of mixed histology)
  • May be untreated or could have received 1 prior regimen
  • EGFR or ALK positive should have had prior treatment with TKI
• No prior radiation therapy to the lung >30Gy within past 6 months
• Must have measurable disease by RECIST 1.1
• ECOG PS 0-1
• No 2nd malignancy within 2 years
• No active CNS involvement
• No history of interstitial lung disease
• No active pneumonitis or history of non-infectious pneumonitis that required steroids
• No active autoimmune disease that required systemic tx in past 2 years (other than replacement therapy)
• No known HIV, HBV, HCV
• No need for steroids at dose of greater than 10mg prednisone or equivalent daily
• No recent history of substance abuse

• New diagnosis of brain mets from a histologically or cytological confirmed primary or metastatic NSCLC tumor. If original histologic proof of malignancy is >5 years, new pathologic confirmation is needed
• KPS >70
• 1 inoperable brain mets or 2-10 brain lesions per screening MRI, confirmed by contrast enhanced MRI amenable to SRS according to following criteria
  • Largest tumor volume < 10cc
  • Longest tumor diameter < 3cm
  • Cumulative volume of all tumors < 15cc
• At least one measurable lesion per RANO-BM
• May continue on systemic therapy during trial. Should be receiving optimal systemic therapy.
• Patient must be able to operate NovoTTF-100M device independently or with caregiver
• No ALK/ROS-1 alterations. No BRAF, EGFR mutations
• No significant edema with risk of brain herniation
• No midline shift > 10mm
• No intractable seizures
• No infratentorial or leptomeningeal mets
• No recurrent brain mets or brain mets previously treated with surgery/XRT/radiosurgery
• No implantable electronic medical devices in the brain
• No other concurrent brain directed therapy

• Histologically confirmed diagnosis of metastatic or unresectable NSCLC (squamous or nonsquamous) not a candidate for definitive therapy
• KRAS G12C mutation
• Known PD-L1 status (can enroll regardless of level)
• 1st line- no prior treatment for metastatic NSCLC
  • OK to have had radiosensitizing chemo >1 year prior
• ECOG PS 0-1
• Measurable disease
• No active CNS mets
• No XRT to the lungs within 6 months prior to first dose of study treatment
• No known autimmune disease

• Histologically or cytologically confirmed melanoma
• Clinically detectable and resectable Stage IIIB, IIIC, or IIID melanoma
• Has been untreated for the melanoma with the exception that primary lesion may have been resected or irradiated
• No known CNS mets
• No ocular or mucosal melanoma
• No known HIV/HBV/HCV
• No active autoimmune disease requiring therapy in past 2 years
• Must not have received prior oncolytic viruses

• Has unresectable Stage III or Stage IV melanoma, not amenable to local therapy
• Has been untreated for advanced disease
• No ocular or mucosal melanoma
• No known additional malignancy that is progressing or requires active treatment within the past two years
• No known CNS metastatses
• No active autoimmune disease requiring systemic treatment in the past two years
• No known HIV/HBV/HCV
• Adequate organ function

• Has unresectable Stage III or Stage IV melanoma not amenable to curative therapy
• Has progressed on treatment with an anti-PD1/L1 monoclonal antibody administered either as monotherapy or in combination with other therapies
• Hsa not received more than 3 lines of therapy
• No known additional malignancy with past 2 years
• No known CNS metastases
• No active autoimmune disease requiring systemic treatment in the last 2 years
• No known HIV/HBV/HCV

• Stage IIIB-IV melanoma, following progression on PD-1 containing regimen
• ECOG PS 0-1
• At least one injectable tumor (visceral or deep nodal lesions may be injectable)
• Measruable disease by RECIST 1.1
• No prior oncolytic virus therapy (no prior T-VEC)
• No active CNS disease
• No history of major autoimmune disease
• No known HBV, HCV, or HIV
• No need for steroids >20mg prednisone daily or equivalent
• No need for chronic use of anti-virals (e.g. acyclovir)
• No prior malignancy in past 3 years except locally curable cancers such as non-melanoma skin cancer, or carcinoma in situ.

• Histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies (laparoscopic or percutaneous)
• Histologic documentation of the original primary tumor is required
• FIGO Stage III-IV
• Following histologic subtypes eligible: high grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma NOS.
• ECOG PS 0-2
• No need for treatment with immunosuppressive medication
• No patients receiving treatment for active autoimmune disease
• No known CNS involvement
• No prior abdominal radiation or chemotherapy for abdominal or pelvic tumor

• Recurrent high-grade serous, endometrioid, or clear-cell ovarian, fallopian tube, or primary peritoneal cancer
• Must be considered resistant to the last administered platinum therapy
• Must be 2nd, 3rd, or 4th line
• Must have been previously treated with platinu-based regimen, taxane, and bevacizumab
• Measurable disease
• ECOG PS 0-1
• Did not have disease progression within 3 months of starting first-line platinum therapy
• No known BRCA mutation
• No prior therapy with PD-1 or PD-L1 agent
• No known immunodeficiency or on steroids >10mg/day prednisone or equivalent
• No uncontrolled CNS disease
• No other cancers within 2 years
• No known HIV, HBV, HCV

• Histologic confirmation of adenocarcinoma of the prostate without small cell features
• Current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue lesions on CT/MRI
• ECOG PS 0-1
• Ongoing androgen deprivation therapy (ADT) with a GnRH analogue or bilateral orchiectomy
• Documented disease progression per PCWG3 criteria within 6 months prior to screening
• Only one prior 2nd generation hormonal therapy in the metastatic setting
  • Patients may have received two prior 2nd gen HT (abi + enza or apalutamide or darolutamide) if and only if the first drug had been used in the non-metastatic setting
• Chemotherapy naive for metastatic CRPC
• Must have progressed during or after 2nd gen hormonal therapy or have documented intolerance to 2nd gen HT
• No active brain mets
• No known or suspected autoimmune disease
• No condition requiring systemic corticosteroids (>10 mg prednisone or equivalent)
• No prior treatment with PD-1 or PD-L1 antibodies
•  

• Diagnosis of locally advanced or metastatic non-melanoma skin cancer not considered treatable by surgery. Could include;
  • Basal cell carcinoma,
  • Cutaneous squamous cell carcinoma,
  • Merkel cell carcinoma
  • Angiosarcoma of the skin
  • Eccrine carcinoma
  • high grade dermatofibroma protuberans
  • CTCL is NOT allowed
• Must have exhausted or refused currently available therapy
• ECOG PS 0-1
• At least one injectable tumor (visceral or deep nodal lesions may be injectable)
• Measurable disease by RECIST 1.1
• No prior oncolytic virus therapy (no prior T-VEC)
• No active CNS disease
• No history of major autoimmune disease
• No known HBV, HCV, or HIV
• No need for steroids >20mg prednisone daily or equivalent
• No need for chronic use of anti-virals (e.g. acyclovir)
• No prior malignancy in past 3 years except locally curable cancers such as non-melanoma skin cancer, or carcinoma in situ.

• Patient planned to receive one of the following agents for Cancer with or without chemotherapy that has a risk of diarrhea in 50% of patients
  • CDK4/6 inhibitors (abemaciclib), 
  • PI3 kinase blockers (alpelisib),
  • anti-EGFR TKIs (afatinib, dacomitinib, erlotinib, gefitinib) 
  • anti VEGF-TKIs (axitinib, cabozantinib, lenvatinib, pazopanib, sorafenib, sunitinib, vendatinib)
  • anti ALK TKIs (ceritinib, crizotinib)
  • MEK inhibitor (cobimetinib) 
  • Anti HER2 TKIs (lapatinib, tucatinib)
• ECOG PS 0-2
• Not receiving immunotherapy (PD-1, CTLA-4, IL-2)
• No diarrhea before enrolling on the study (or starting TKI)
• No ongoing IBS or colitis
• Not planning on receiving an agent where anti-diarrheal prophylaxis is mandatory (e.g. neratinib, irinotecan, etc.)
• No laxative use within 7 days prior to randomization

• Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
• Positive biomarker results from a CLIA certified lab, either tissue or blood sample
• ROS1 gene fusion positivity
• No non-small lung cancer (NSCLC)
• ECOG PS 0-2
• No symptomatic CNS metastases
• No known HIV/HBV/HCV
• No other malignancy within 3 years of study
• No prior treatment with crizotinib

• Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
• Positive biomarker results from a CLIA certified lab, either tissue or blood sample
• Not Non-small cell lung cancer (NO NSCLC)
• ALK gene fusion positivety defined as a 3' AALK fusion with a protein coding 5' gene fusion partner, predicted to be in frame with an intact kinase domain
• ECOG PS 0-2
• No symptomatic CNS metastases
• No known HIV/HBV/HCV
• No other malignancy within 3 years of study
• No prior treatment with crizotinib

• Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
• Positive biomarker results from a CLIA certified lab, either tissue or blood sample
• Microsatellite instability high (MSI-h) or deficient mismatch repair dMMR
• No prior treatment with anti-PD1 or anti-PD-L1 agents
• ECOG PS 0-2
• No symptomatic CNS metastases
• No known HIV/HBV/HCV
• No other malignancy within 3 years of study
• No prior treatment with crizotinib
• No active autoimmune disease

• Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
• Positive biomarker results from a CLIA certified lab, either tissue or blood sample
• No breast cancer (breast cancer is excluded)
• Either ERBB2 (HER2) amplification defined as a copy number of 6 or higher via FISH, CISH or DNA NGS assay OR
• Any of the following ERBB2 mutations:
  • 222C; R226S; E265K; D277H; G292R; G309A/E; S310F/Y; C311R/S; E321G; C334S; S418T; A440T; P551L; R552S; S653C; V659E; G660D; R678Q; T733I; L755P/S_T759del; I767M; L768S; D769H/N/Y; Y772_A775dup; A775_G776ins(SVMA/VVMA/YAMA/YVMA/YVMD); G776delins(VC/VV/LC); V777L; G778_P780dup; V779A/L; T798M; L841V; V842I; N857S; T862A; L869R; H878Y; R896C​​G
• ​TMB must be <10 mutations/megabase
• ECOG PS 0-2
• No symptomatic CNS metastases
• No known HIV/HBV/HCV
• No other malignancy within 3 years of study
• No prior treatment with crizotinib
• No active autoimmune disease

• Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
• Positive biomarker results from a CLIA certified lab, either tissue or blood sample
• No breast cancer (breast cancer is excluded)
• Either ERBB2 (HER2) amplification defined as a copy number of 6 or higher via FISH, CISH or DNA NGS assay OR
• Any of the following ERBB2 mutations:
  • 222C; R226S; E265K; D277H; G292R; G309A/E; S310F/Y; C311R/S; E321G; C334S; S418T; A440T; P551L; R552S; S653C; V659E; G660D; R678Q; T733I; L755P/S_T759del; I767M; L768S; D769H/N/Y; Y772_A775dup; A775_G776ins(SVMA/VVMA/YAMA/YVMA/YVMD); G776delins(VC/VV/LC); V777L; G778_P780dup; V779A/L; T798M; L841V; V842I; N857S; T862A; L869R; H878Y; R896C​​G
• Must ALSO have one of the following alterations
  • ​TMB > or =10 mutations/megabase
  • MSI-h
  • dMMR (negative IHC for MLH1, MSH2, MSH6, or PMS2_
• ECOG PS 0-2
• No symptomatic CNS metastases
• No known HIV/HBV/HCV
• No other malignancy within 3 years of study
• No prior treatment with crizotinib
• No active autoimmune disease

• One of the following malignancies:
  • Cervical cancer
  • HR+/HER2- Breast cancer with prior CDK4/6 inhibitor
  • HR+/HER2 - Breast cancer without prior CDK4/6 inhibitor
  • TNBC
  • Salivary Gland tumor
  • NSCLC with EGFR exon-18 mutation
• Documented HER2 (ERBB2) mutation (or EGFR exon 18 mutation in NSCLC).
• At least one measurable or evaluable lesion
• LVEF >/=50%
• ECOG PS 0-2
• No prior treatment with ERBB2 (HER2) directed TKIs (eg lapatinib, afatinib, neratinib)
• No symptomatic or unstable brain mets (stable are allowed)
• No cumulative prior anthracycline dose >450mg/m2 doxorubicin or equivalent
• No uncontrolled cardiac disease
• No chronic diarrheal disorder

• Histologically or cytologically confirmed, locally advanced or metastatic solid malignancy and has exhausted all available standard therapy or not a candidate for standard therapy
• ECOG PS 0-1
• Prior therapy with immune therapy are eligible (except in ovarian cohort)
• In Expansion cohorts patients must either have
  • Advanced epithelial cancer of the ovary, fallopian tube, or peritoneum
  • Advanced MSS endometrial cancer
  • A different malignancy that has high expression of PVRL2
• No active autoimmune disease
• No interstitial lung disease
• No active CNS metastases
• In ovaran cohort, no prior immunotherapy
• No prior therapy with PVRIG inhibitor or anti-TIGIT antibody

Part 1:

• Locally advanced or metastatic NSCLC, or SCCHN
  • NSCLC and SCCHN must have received prior platinum-based therapy
  • Patients with targetable mutations (e.g. ALK, ROS, EGFR, etc.) must have had prior treatment with approved targeted therapy
• 1st line- no prior therapy for metastatic disease
• ECOG PS 0-1
• LVEF 50% or higher
• No known CNS mets
• No history of pneumonitis
• No prior cancer within 3 years (except locally curable cancers)
• No history of life-threatening toxicity to immunotherapy
• No known HBV/HCV/HIV

• Histologically or cytologically confirmed patients with advanced or metastatic solid tumors
• Measurable disease
• Must have been treated with all estrablished standard-of-care therapy or determined by the physician that such established therapy is not sufficiently efficacious, or patients have declined to receive standard of care therapy
• ECOG PS 0-1
• Must have Globo-H overexpression as measured by central lab
• No known active autoimmune or inflammatory disease
• Not receiving systemic steroids of >10mg prednisone per day or equivalent

• Histologically confirmed metastatic cancer that is approved to be treated with nivolumab or pembrolizumab
• Must not be eligible for curative resection
• Must be positive for at least 1 of the following human leukocyte antigens:
  • HLA-A*02:01
  • HLA-A*02:06
  • HLA-A*24:02
  • HLA-A*03:01
  • HLA-B*15:01
• ECOG PS 0-1
• No known CNS mets
• No known HIV/HBV/HCV

• One of the following malignancies
  • Small cell lung cancer: locally recurrent or metastatic SCLC whose disease has progressed after at least 1 prior line of chemo
  • Gastric or GEJ adenoCA: Disease that has progressed after at least 1 prior line of chemo
  • SCC of genitalia (anus, cervix, vulva, or penis): disease that has progressed after at least 1 prior line (adjuvant counts as prior line)
  • Pancreatic CA: Disease that has progressed after at least 1 line of prior therapy (adjuvant tx counts as a line if recurrence is within 6 months)
  • Endometrial CA: Disease that has progressed after at least 1 line of prior therapy (adjuvant tx counts as a line if recurrence is within 6 months)
• ECOG PS 0-1
• Measurable disease
• No prior topoisomerase I inhibitor
• No symptomatic CNS involvement
• No known HIV/HBV/HCV

• Advanced solid tumor or relapsed/refractory lymphoma OR
  • eligible to receive single agent pembrolizumab as standard-of-care OR
  • eligible to receive single-agent docetaxel as standard of care OR
    ​advanced pancreatic adenocarcinoma and eligible to receive gemcitabine plus nab-paclitaxel as standard of care
• Measurable disease
• ECOG PS 0-1
• No history of severe autoimmune disease
• Not receiving high-dose systemic steorid therapy or any other form of immunosuppressive therapy

• Advanced Solid Malignancy
• Fresh and/or archival tumor tissue
• Evidence of measurable disease (except for prostate)
• Life expectancy >12 weeks
• ECOG PS 0-1
• No therapeutic anticoagulation
• no history of autoimmune disease
• No uncontrolled intercurrent illness
• No HTN >150/90 despite optimal management
• No active CNS mets
• No other malignancies within 3 years
• No autoimmune toxicity >Grade 3 from prior immunotherapy

• Renal cell, NSCLC, or SCCHN
• Must have received prior PD-1 or PD-L1 inhibitor
• ECOG PS 0-1
• No known autoimmune disease
• No need for steroids or other immunsuppressive medicine
• No interstitual lung disease or pulmonary fibrosis

• Histologically or cytologically confirmed, metastatic solid malignancy
• Has exhausted all available standard therapy or not a candidate for standard therapy
• ECOG PS 0-1
• Prior PD-1/PD-L1 allowed
• No other malignancy within 2 years prior
• No active autoimmune disease requiring systemic therapy within last 2 years
• No chronic steroids or immunosuppressants.

• Patients must have pathologic confirmation of axillary nodal involvement at presentation (before neoadjuvant therapy) based on a positive FNA (demonstrating malignant cells) or positive core needle biopsy (demonstrating invasive adenocarcinoma).  Patients may not have had documentation of axillary nodal positivity by sentinel node biopsy (before neoadjuvant therapy).

• Patient must have clinically T1-3, N1 breast cancer at the time of diagnosis (before neoadjuvant chemotherapy)

• Hormone receptor status must be performed on the primary breast tumor before neoadjuvant chemotherapy.

• HER2 status must be performed on the primary breast tumor before neoadjuvant chemotherapy. Patients who have a primary tumor that is either HER2-positive or HER2-negative are eligible)

• Patients must have completed a minimum of 8 weeks of standard neoadjuvant chemoterahyp consisting of an anthracycline and/or taxane-based regimen

• For patients who receive adjuvant chemotherapy after surgery a maximum of 12 weeks of intended chemotherapy may be administered but must be completed before randomization

• Patients with HER2-positive tumors must have received neoadjuvant anti-HER2 therapy (with all or with a portion of the neoadjuvant chemotherapy regimen), unless medically contraindicated.

• At the time of definitive surgery, all removed axillary nodes must be histologically free of cancer

• ECOG PS 0-1