Clinical Trials

• 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

• Histologically confirmed invasive carcinoma of the breast of any of the following histologies (ductal, lobular, mammary, medullary, or tubular). Metaplastic breast cancer are not eligible.
• For patients not receiving neoadjuvant chemotherapy, pathologic staging must be T0N1-2a, T1N1-2a, T2N1-2a, T3N0-2a, and all M0 status.
  • For patients receiving neoadjuvant chemotherapy, clinical pre-chemo staging and post mastectomy pathological staging is required for all patients.
  • Patients who have received neoadjuvant chemotherapy and are pathologically cT0-2 and N0 are only eligible if biopsy-proven clinically N1 or N2 disease is documented prior to the start of neoadjuvant chemotherapy. cT3N0 patients or ypT3N0 patients who receive neoadjuvant chemotherapy may be eligible based on clinical or pathological T stage, and do not require pathologically positive lymph nodes.
  • Note: Higher of the clinical or pathological T and N stage are used for final staging, if receiving neoadjuvant chemotherapy.
  • All patients with clinical, radiographic or pathological T4, N3 or involved internal mammary disease (N1b, N1c, and N2b) are not eligible.
• No prior therapeutic radiation therapy to the chest, neck or axilla. Prior radioactive oral iodine is permitted.
• No prior history of ipsilateral breast cancer (invasive disease or DCIS). LCIS and benign breast disease is allowed.
• No other malignancy within 5 years of registration
• ECOG (Zubrod) Performance Status 0-1

• 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

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

• 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

• Unresectable, locally advanced stage disease according to the following criteria:
• Head/uncinate process:
  • Solid tumor contact with SMA>180°
  • Solid tumor contact with the CA>180°
  • Solid tumor contact with the first jejunal SMA branch
  • Unreconstructible SMV/PV due to tumor involvement or occlusion (can be d/t tumor or bland thrombus)
  • Contact with most proximal draining jejunal branch into SMV
• Body and tail:
  • Solid tumor contact of >180° with the SMA or CA
  • Solid tumor contact with the CA and aortic involvement
  • Unreconstructible SMV/PV due to tumor involvement or occlusion (can be d/t tumor or bland thrombus)
• No distant metastasis, including non-regional lymph node metastasis

• 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).

• 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.

• Histologically documented la/mUC, including squamous differentiation or mixed cell types.
• An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2
• Participants with ECOG performance status of 2 must meet the following additional criteria: hemoglobin ≥10 g/dL, GFR ≥50 mL/min, may not have NYHA Class III heart failure.
• Eligible for pembrolizumab (Dose-escalation cohorts, Cohorts A, B, G and K Combination Arm).
• Dose-escalation cohorts: Ineligible for first-line cisplatin-based chemotherapy and no prior treatment for la/mUC, or have disease progression following at least 1 platinum-containing treatment.

• 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.

• 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

• Histologically or cytologically proven Limited stage SCLC
• Must have received one pre-reg cycle of platinum/etoposide chemo prior to study entry
• PET/CT scan for staging and CT chest/abdomen with IV contrast (can be obtained as part of PET/CT if diagnostic quality)
• ECOG 0-2 within 30 days prior to registration
• No prior atezolizumab or other immunotherapy agent
• No prior radiotherapy to the lungs or mediastinum that would result in clinically significant overlap of radiation therapy fields
• Patients with cytologically positive pleural or pericardial fluid are not eligible
• No active, known or suspected autoimmune disease
• No Active or prior documented inflammatory bowel disease
• No Hx of primary immunodeficiency
• No clinically significant ILD

• Primary tumor in the lung must be biopsy confirmed non-small cell lung cancer
• Tumor ≤ 4 cm maximum diameter, including clinical stage IA and selected IB by PET/CT scan
• Tumor verified by a thoracic surgeon to be in a location that will permit sublobar resection
• Tumor located peripherally within the lung
• No evidence of distant metastases
• Availability of pulmonary function tests
• No prior intra-thoracic radiation therapy for previously identified intra-thoracic primary tumor
• Previous chemotherapy, radiotherapy, or surgical resection specifically for the lung cancer being treated on this protocol is NOT permitted
• No prior lung resection on the ipsilateral side

• Patient has unresectable Stage III NSCLC that has not progressed following concurrent platinum-based chemotherapy and radiation therapy and is eligible to receive durvalumab according to the US FDA approved package insert.
• Patient will initiate durvalumab treatment within 2 weeks of Baseline and receive at least 1 dose of durvalumab.
• Patient is able and willing to use the mobile application and connected devices on a daily basis for up to 12 months.
• Patient is able to complete QoL assessments once every 2 weeks for the first 3 months of the study and monthly thereafter.

• 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

• 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

• 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.