Clinical Trials

• Histologic diagnosis of invasive breast cancer within the past 12 months
• Her-2 negative
• Stage II or III breast cancer
• ER and PR negative: T2-3N0 or T0-3N1-3
• ER and/or PR positive: T0-3N1-3 or T3N0
• No history of other malignancy within past 4 years
• No comorbid conditions that would cause life expectancy ≤ 5 years
• No diabetes mellitus currently treated
• BMI ≥ 27

• Stage I, II, or III patients who receive MammaPrint, with or without BluePrint testing (male or female)
• New primary lesion
• No metastatic disease
• No recurrent disease
• Life expectancy of ≥ 12 weeks
• No Stage 0 disease

• Clinically T1-3, N1 breast cancer at the time of diagnosis (before neoadjuvant therapy)
• Pathologic confirmation of axillary nodal involvement at presentation (before neoadjuvant therapy)
• At the time of definitive surgery, all removed axillary nodes must be histologically free from cancer.
• If negative for ER, assessment of PgR must also be performed.
• HER2-positive or HER2-negative are eligible.
• Complete a min of 8 wks of neoadjuvant therapy with an anthracycline and/or taxane-based regimen.
• Patients with HER2-positive tumors must have received neoadjuvant anti-HER2 therapy (with all or with a portion of the neoadjuvant chemotherapy regimen),
• Patients with pathologic staging of ypN0(i+) or ypN0(mol+) are eligible.
• Patients who have undergone a total mastectomy or lumpectomy are eligible

• Patients with histologically proven invasive breast cancer, who have started or are scheduled to start neo-adjuvant chemotherapy therapy or neo-adjuvant hormone therapy (endocrine therapy)

• Hepatocellular carcinoma of the liver
• ECOG PS score of ≤ 2 with a life expectancy of > 3 months
• > 4 weeks since prior RT or surgery
• > 1 month post other chemotherapy.
• Excludes contraindications to angiography and selective visceral catheterization
• Excludes extra-hepatic disease representing an imminent life-threatening outcome or active infection

• Locally advanced unresectable or metastatic GC or GEJ carcinoma and have histologically confirmed adenocarcinoma
• At least 1 measurable lesion as defined per RECIST v1.1
• No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer. NOTE: Patients may have received prior neoadjuvant or adjuvant therapy as long as it was completed and have no recurrence or disease progression for at least 6 months.
• Patients must be able to provide tumor tissues
• squamous cell or undifferentiated or other histological type GC not allowed

A Phase 2, Open-Label, Randomized Study to Assess the Antitumor Activity and Safety of Zolbetuximab (IMAB362) in Combination with Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects with Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma

Enrollment paused due to COVID-19 pandemic until further notice effective 27Mar2020

• Subject has histologically or cytologically confirmed adenocarcinoma of pancreas.
• Subjects must have metastatic pancreatic cancer that has not been previously treated with chemotherapy.
  • Prior treatment with fluorouracil (5-FU) or GEM administered as a radiation sensitizer during and up to 4 weeks after radiation therapy is allowed
  • o If a subject received therapy in the adjuvant setting, tumor recurrence or disease progression must have occurred at least 6 months after completing the last dose of adjuvant therapy.
• Subject has a measurable lesion(s) on at least 1 metastatic site based on RECIST 1.1 within 28 days prior to the first dose of study treatment. For subjects with only 1 measureable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy.
• Subject's tumor sample has CLDN18.2 expression in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central immunohistochemistry (IHC) testing
• Subject has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• 18 years of age or older
• Histologically confirmed pancreatic ductal adenocarcinoma
• Stage III or IV disease
• Received 1 line of systemic chemotherapy in advanced setting with or without targeted agents, immunotherapy or radiotherapy
• Archival or fresh tumor tissue
• Radiological evidence of disease progression following most recent prior treatment

• ECOG PS: 0 to 1
• Surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL (1.73 nM)
• Have a deleterious mutation in a BRCA1/2 or ATM gene
• Eligible for treatment with physician’s choice of comparator treatment
• PD after treatment with one prior next-generation AR-targeted therapy for castration-resistant disease

• Provision of written informed consent
• Age ≥18 years old
• Patients with histologically-confirmed diagnosis of UC and healthcare provider (HCP)-confirmed advanced UC prior to or during 1L therapy (primary histology UC; mixed histologies are allowed).
  Where the 1L therapy setting is defined as:
  • Patients with no prior systemic therapy given for advanced UC; 1L is the first systemic therapy given for advanced UC
  • Patients who received neoadjuvant or adjuvant platinum-based chemotherapy with recurrence more than 12 months from the last chemotherapy dose
• Patients with available tumor tissue sample (fresh or archival - up to 3 years old) that was collected as part of SoC any time prior to 1L treatment for advanced UC with a target of 18 slides available for biomarker testing (PD-L1 and tTMB).

• Histologically confirmed advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) renal cell carcinoma with a clear-cell component
• Intermediate- or poor-risk RCC as defined by International Metastatic RCC Database Consortium (IMDC) criteria
• Measurable disease per RECIST 1.1 as determined by the investigator
• Karnofsky Performance Status (KPS) ≥ 70%
• Adequate organ and marrow function

• Subjects with advanced or metastatic solid tumors who have completed treatment with 1st line therapy:
  1. Epithelial ovarian, fallopian tube, or peritoneal cancer.
  2. Hepatocellular carcinoma (HCC)
  3. Non-small cell lung cancer (NSCLC)
  4. Urothelial cancer (BlCa)
  5. Microsatellite instability high (MSI-H) solid tumors, other than the above indicators
• Radiologic and/or biochemical evidence of disease progression
• Completion of pre-treatment tumor biopsy
• Subjects with HCC, NSCLC, BlCa, or MSI-H subjects other than those with gastric or colorectal cancer must have evidence of surviving expression in their pre-treatment biopsy sample
• Must have measurable disease by RECIST v1.1
• Life expectancy ≥ 6 months
• Meet protocol specific laboratory requirements

• Histological/cytological evidence of metastatic or surgically unresectable transitional carcinoma (TCC) of the urothelium involving the renal pelvis, ureter, bladder or urethra
• Measurable disease by CT or MRI
• Prior systemic chemo for metastatic or surgically unresectable UC is not allowed
• Cisplatin-ineligible patients will receive gemcitabine-carboplatin treatment
• Fresh tumor biopsy from the primary or metastatic site. If not available, tissue block from most recent resection acceptable if within 2 years of enrollment.
• Re-enrollment of participant that has discontinued study as pre-treatment failure is permitted.

• Squamous cell carcinoma of the head and neck
• Treatment plan to receive IMRT delivered as single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose of 60-72 Gy
• Treatment plan to receive standard cisplatin monotherapy
• Age 18 years or older
• ECOG status ≤ 2
• Adequate hematologic, renal and liver function
• Negative serum pregnancy test
• Use of effective contraception

• Histologically confirmed cSCC as the primary site of malignancy
• Must have undergone complete macroscopic resection of all known cSCC disease with or without microscopic positive margins
• Must have histologically confirmed LA cSCC with high-risk feature(s)
• Must have completed adjuvant RT for LA cSCC with last dose of RT ≥ 4 weeks and ≤ 16 weeks from randomization
• Must have completed at least 45 Gy of adjuvant RT for LA cSCC prior to study entry
• Provide tumor tissue sample adequate for PD-L1 testing

• ECOG PS: 0 or 1
• No neoadjuvant (chemo or radio-therapy) for this lung cancer
• No prior treatment with agents targeting EGFR mutation or ALK rearrangement
• Pre-surgical: Suspected clinical stage of IIIA, II or large IB (defined as size ≥4cm)
• Post-surgical: Pathologic stage IIIA, II or IB (defined as size ≥4 cm)
• No recurrence of lung cancer after prior resection

• ECOG PS: 0 or 1
• Registered to A151216 with result of EGFR exon 19 deletion or L858R mutation
• Completely resected stage IB (≥ 4cm), II, or IIIA non-squamous NSCLC with negative margins
• Patients with known resistant mutations in the EGFR TK domain (T790M) are not eligible.
• Patients that are both EGFR mutant and ALK rearrangements will be registered to A081105

• ECOG PS: 0 or 1
• Pre-registered to A151216
• Completely resected stage IB (≥4 cm), II or IIIA non-squamous NSCLC with negative margins
• Positive for translocation or inversion events involving the ALK gene locus
• No prior treatment with crizotinib or another ALK inhibitor
• No known interstitial fibrosis or interstitial lung disease.

• 18 years of age or older
• Diagnosis of NSCLC
• EGFR mutation status wildtype or unknown
• If prior treatment for local disease, then documented disease progression and treatment completed prior to VeriStrat

• Participants must have histologically documented NSCLC who present with Stage III locally advanced, unresectable disease (International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology
• Participants with tumor harboring an Epidermal growth factor receptor (EGFR) sensitizing (activating) mutation, Anaplastic lymphoma kinase (ALK) translocation, ROS-1 rearrangement are eligible.
• Participants must have adequate pulmonary function defined as a forced expiratory volume in 1 second (FEV1) greater than equals to (>=) 1.2 liters or >= 50% of predicted normal volume measured within 3 weeks prior to randomization.
• Adequate hematological, hepatic and renal function as defined in the protocol.
• Contraceptive use by males or females will be consistent with local regulations on contraception methods for those participating in clinical studies.

• Age ≥ 18years
• Histologically or cytologically documented NSCLC with resectable (Stage IIA to select [ie, N2] Stage IIIB) disease
• WHO/ECOG PS of 0 or 1 at enrollment
• At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline
• No prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-DP-L2 antibodies, excluding therapeutic anticancer vaccines
• Adequate organ and marrow function
• Confirmation of a patient’s tumor PD-L1 status
• Documented EGFR and ALK status

• Have a histologically or cytologically confirmed diagnosis nonsquamous NSCLC.
• Have stage IV nonsquamous NSCLC.
• Have confirmation that epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or Proto-oncogene tyrosine-protein kinase (ROS1)-directed therapy is not indicated.
• Have measurable disease based on RECIST 1.1.
• Have provided archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated.
• Have a life expectancy of at least 3 months.
• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status assessed within 7 days prior to the administration of study intervention.
• Have not received prior systemic treatment for their advanced/metastatic NSCLC.
• Have adequate organ function.
• Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for 180 days afterwards.
• Male participants must refrain from donating sperm during the treatment period and for 180 days afterwards.

• Have a histologically or cytologically confirmed diagnosis squamous NSCLC.
• Have stage IV squamous NSCLC.
• Have measurable disease based on RECIST 1.1.
• Have not received prior systemic treatment for their advanced/metastatic NSCLC.
• Have provided archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated.
• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status assessed within 7 days prior to the administration of study intervention.
• Have a life expectancy of at least 3 months.
• Have adequate organ function.
• Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for 180 days afterwards.
• Male participants must refrain from donating sperm during the treatment period and for 180 days afterwards.

• Age ≥ 22 years
• Histologic/pathologic confirmation of lung cancer
• Any stage of disease
• Any treatment time point
• Individuals with a history of malignant disease other than lung cancer that was resected greater than 5 yeaars ago and are currently in remission are eligible

• 70 years or older at time of cancer diagnosis
• Understand and adhere to study related assessments/procedures
• No prior cancer treatment
• Scheduled to start cytotoxic chemotherapy and/or radiation therapy
• No restriction on tumor stage

• Personal history or family history of cancer suggestive of presence of an inherited predisposition
• In a group known or suspected to have increased risk of carrying genetic alteration or of sustaining exposure that would place them at risk of cancer
• Willing historian to provide information or access
• Young age cancer diagnosis
• Multiple primary neoplasms in affected member
• Presence of rare tumor types in family
• Congential malformations
• Any other family clustering of cancer
• Any other cancer-predisposing genetic disease/conditions

• Histologically proven intracranial glioblastoma or gliosarcoma at initial surgery
• Karnofsky performance status >= 70
• Progression of disease assessed by Revised Assessment in Neuro-Oncology (RANO) criteria
• Patient must not have been treated previously with immunotherapies (vaccines, checkpoint inhibitors, T-cells)
• Intratumoral hemorrhage as seen MRI may preclude inclusion
• Progressive enhancement on MRI
• Patients must be able to tolerate brain MRI scans with dynamic intravenous gadolinium-based contrast agent injections
• Patient must be scheduled to receive treatment with a standard dose regimen of bevacizumab

• ECOG PS: 0, 1 or 2
• Newly diagnosed and ≤ 3 months from surgical diagnosis
• Histological confirmation of anaplastic glioma or low grade glioma
• Surgery (partial or gross total resection or biopsy) performed ≥ 2 weeks prior to registration with recovering from effects of surgery.
• Tumor must show 1p/19q codeletion

• Newly diagnosed unifocal intracranial meningioma, gross totally resection and histologically confirmed Grade II
• GTR must be confirmed on post-operative imaging following the most recent surgery
• Post-operative Zubrod performance status 0-1

• Adults scheduled to undergo brain surgery to remove tumor tissue

• Patients scheduled to have surgery for removal of brain tumor.
• Age: 18 years and older.

• Adults 18 years and older diagnosed and treated with neoplastic meningitis.

• High-grade neuroendocrine carcinoma or combined SCLC and NSCLC is permitted.
• Prior to chemotherapy +/- thoracic radiotherapy, patients must be defined as limited-stage or extensive-stage SCLC after clinical staging evaluation.
• Radiographic partial or complete response to chemotherapy in at least one disease site
• Patients must have a baseline raw score greater than 2 on the HVLT-R Delayed Recall, as determined by central assessment
• No Radiographic evidence of CNS metastases
• Concurrent atezolizumab permitted with PCI

• Histologically confirmed metastatic disease to the brain from any solid tumor.
• New or progressive brain metastases defined as any one of the following:
  • Untreated measurable lesions in patients who have received surgery and/or SRS to one or more other lesions.
  • Residual or progressive lesions after surgery if asymptomatic.
  • Patients who have had prior WBRT and.or SRS and then whose lesions have progressed by BM-RANO criteria or there are new lesions.
  • Patients who have not previously been treated with cranial radiation must be asymptomatic or neurologically stable from their CNS metastases.
• Ability to obtain MRIs
• Tissue available for sequencing (any brain metastasis tissue and extracranial site from any prior resection or biopsy).

• Grade II and III gliomas IDH mutant.
• Age 18 and over.
• Trial is open to both genders.
• Trial is open to English and French speaking subjects.