The HCA Midwest Health clinical research program supports overall patient care by offering another therapeutic option through clinical trials. These clinical studies are available through the Kansas City Clinical Oncology Program (KCCOP), Sarah Cannon Research Institute, and various pharmaceutical and CRO partners.

CLL 38: Ublituximab and TGR-1202 provided - B-cell CLL that warrants treatment consistent with accepted IWCLL criteria, ECOG performance status ≤ 2, Treatment naïve and previously treated patients enrolled; Excludes patients with prior exposure to PI3K inhibitors. obinutuzumab and/or chlorambucil, Baseline bone marrow aspirate/biopsy. Marrow Aspirate and biopsy should be performed at least two months after the last treatment to be compared to baseline. PI: Suman Kambhampati, MD
Facility: Menorah Medical Center, Research Medical Center

CLL 39: Cross over study for CLL 38. PI: Suman Kambhampati, MD
Facility: Menorah Medical Center, Research Medical Center

LYM 119: Denintuzumab mafodotin provided - treatment-naive patients with histologically confirmed systemic de novo or transformed DLBCL (from follicular or marginal zone lymphoma), or FL Grade 3b; must have high-intermediate or high-risk disease based on standard IPI (score ≥3 for > 60 years of age) or aaIPI (score 2 or 3 for ≤60 years of age), and state IAX (bulk defined as a single lymph node mass >10 cm in diameter) - IV disease, tumor tissue available from most recent biopsy, fluorodeoxyglucose (FDG) - avid disease by PET based on the Lugano classification criteria. PI: Suman Kambhampati, MD
Facility: Menorah Medical Center, Research Medical Center

LYM 120: Diffuse Large B-Cell Lymphoma - Relapsed or refractory to prior standard therapy AND who are non-candidates for high-dose therapy or autologous stem cell transplant. Histologically confirmed diagnosis of Diffuse Large B-Cell Lymphoma; central pathology to confirm DL BCL subtype is required. E COG performance status ≥ 2. No known Central Nervous System (CNS) lymphoma; patients with symptoms of CNS disease must have a negative CT scan and negative diagnostic lumbar puncture. No known histological transformation from indolent lympl1oma (e.g. follicular lymphoma) or chronic lymphocytic leukemia (i.e. Ricllter's transformation) to large cell lymphoma. PI: Suman Kambhampati, MD
Facility: Menorah Medical Center, Research Medical Center

MM 74: Observational study of presentation, treatment patterns, and outcomes in multiple myeloma patients. Either newly diagnosed within 3 months from initiation of treatment or relapsed/refractory who have received 1 to 3 prior lines of therapy regardless if stem cell transplant was part, consolodation/maintenance was part or treated on a clinical trial. Patient must be willing to follow up for five years. PI: Suman Kambhampati, MD
Facility: Menorah Medical Center, Research Medical Center

MM 75: Elotuzumab and Nivolumab provided - Must have received >/= 2 prior lines of therapy which must have included at least 2 consecutive cycles of each immune modulatory drug (IMiD) and a proteasome inhibitor alone or in combination, Refractory (progressed on or within 60 days of treatment) to their last treatment, ECOG >/= 2. Subjects with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma ( SMM), amyloidosis, Waldenstrom's macroglobulinemia, or POEMS syndrome (plasma cell dyscrasia with poly neuropathry organomegaly, endocrinopathy., monoclonal protein, and skin changes) are not eligible. PI: Suman Kambhampati, MD
Facility: Menorah Medical Center, Research Medical Center

PREAMBLE: A Prospective Research Assessment in Multiple Myeloma: An Observational Evaluation. PI: Jaswinder Singh, MD
Facility: Centerpoint Medical Center, Menorah Medical Center, Research Medical Center

BRE 231: CDX-011 provided - GPNMB over-expressing, have failed taxane therapy and have received anthracycline therapy or for whom anthracycline therapy is not clinically indicated. Received no more than two prior chemo regimens for locally advanced/ recurrent or metastatic dz. PS 0-1, males or females. PI: Stephanie Graff, MD
Facility: Menorah Medical Center, Research Medical Center

BRE 258: MPDL3280A (Atezolizumab) and nab-paclitaxel provided Patients with incurable locally advanced or metastatic TNBC (per ASCO/CAP). No prior chemo or targeted systemic therapy for MBC (Adj/neoadj chemo allowed if >12 months prior to randomization) FFPE tumor tissue must be submitted for determining PD-L 1 status prior to enrolmet, measurable disease per RECIST v1.1, Treated asymptomatic brain mets (supratentorial and cerebellar mets) permitted. Ongoing corticosteroids not pennitted. PI: Stephanie Graff, MD
Facility: Menorah Medical Center, Research Medical Center

BRE 263: Pertuzumab and T-DM1 provided - Both men and women are eligible, minimum tumor size 2 cm determined, bilateral breast cancers allowed as long as both are HER2-positive. Breast imaging should include ipsilateral axilla. For subjects with a clinically negative axilla, a sentinel lymph node biopsy will be performed either before or after preoperative therapy at the discretion of the subject's physicians. For subjects with a clinically positive axilla, a needle aspiration, core biopsy or SLN procedure will be performed to determine the presence of metastatic disease in the lymph nodes. PI: Stephanie Graff, MD
Facility: Menorah Medical Center

BRE 273: FRα peptide and GM-CSF provided - Tumor must be ER/PR- (<10% nuclear staining in tumor cells) and HER-, Residual disease after neoadjuvant chemotherapy in the breast and/or LN, Adjuvant pts: pN1-3 (excluding pN1m, Completed surgery and radio/chemotherapy in the (neo) adjuvant setting (between 60-360 days from last chemo or RT prior I 1to vaccination), Good option for high risk adjuvant TNBC patients. PI: Stephanie Graff, MD
Facility: Menorah Medical Center, Research Medical Center

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G! 214: MM-141, Nab-Paclitaxel and Gemcitabine provided - ECOG 0 or 1, Islet cell neoplasms are not eligible. High free IGF‐1 (assessed by central lab) required for enrollment into interventional group. (Those will low free IGF‐1 will be included in the observational group in addition to those with high free IGF-1 who are not eligible for treatment. Prior systemic treatment in the adjuvant setting (either alone and/or as a radiosensitizer) is only allowed if administered ≥ 6 months prior to enrollment. Prior radiotherapy to metastatic lesions will be considered on a case by case basis after discussion with the sponsor. PI: Jaswinder Singh, MD
Facility:

GI 195: Carfilzomib - well-to-moderately differentiated (or low-grade) neuroendocrine carcinoma, including typical carcinoid, pancreatic islet cell and other well-to-moderately differentiated neuroendocrine carcinomas.- No limit on prior therapies, Patients currently receiving or previously treated with single agent somatostatin analogues (e.g. sandostatin LAR® or lanreotide) are eligible. However. this is not a mandatory criterion to be included in the study - unresectable or metastatic, previously treated with single agent somatostatin eligible, must be well-to-moderately differentiated, untreated brain mets excluded. PI: Jaswinder Singh, MD
Facility: Menorah Medical Center, Research Medical Center

GI 201: nab-paclitaxel provided - Esophageal, GE junction or gastric. 1 prior line of chemo in the metastatic setting is required; no prior taxane or anti‐angiogenesis treatment allowed. Anti‐angiogenesis exclusions (hypertension, bleeding, etc); no peripheral neuropahty ≥ grade 2. PI: Jaswinder Singh, MD
Facility: Menorah Medical Center, Research Medical Center

GI 221: Lanreotide supplied - Metastatic well-to-moderately differentiated (or low-grade) neuroendocrine cancers, including typical carcinoid or pancreatic islet cell, candidate for liver-directed radioembolization with SIR-spheres therapy, patients receiving or previously received lanreotide or another somatostatin analogue are eligible, though this is not required for study entry, no limit on prior therapres. PI: Jaswinder Singh, MD
Facility: Menorah Medical Center, Research Medical Center

GI 222: GS-5745 Combined with mFOLFOX6 - inoperable, locally advanced or metastatic disease, not amenable to curative therapy, Adenocarcinoma of the stomach or GEJ; locally advanced or metastatic disease (GEJ is defined as tumors that have their center within 5cm proximal and distal of the anatomic esophago-gastric junction as described in Siewert classification); HER 2 Negative; No prior therapy for locally advanced or metastatic disease. Prior neoadjuvant or adjuvant therapy is allowed as long it was completed at least 6 months prior to randomization, Known or suspected CNS mets are excluded. PI: Joseph Stilwill, MD
Facility: Menorah Medical Center, Research Medical Center

GU 118: MEDI4736 and AZD4547 provided - Multi-arm study, 1-2 prior therapies with progression on the most recent treatment; no prior immunotherapy, FGFR inhibitors (Module A), parp inhibitors (Module B), Wee 1 inhibitors (Module C), or mTOR inhibitors (Module E). Patients may be second- or third-line patients. Patients must have received 1 I accepted first-line treatment (eg, methotrexate, vinblastine, doxorubicin, and cisplatin/gemcitabine) in a metastatic setting. All patients must have documented radiological progression on the last treatment administered prior to enrolling in the study. Brain mets ecxcluded unless asymptomatic, treated/stable, and not requiring steroids for 4 weeks prior to treatment. PI: Peter Van Veldhuizen, MD
Facility: Menorah Medical Center, Research Medical Center

GU 135: Pembrolizumab provided - Advanced/unresectable (inoperable) or metastatic urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra. Both transitional cell and mixed transitional/nontransitional cell histologies are allowed, but transitional... PI: Peter Van Veldhuizen, MD
Facility: Menorah Medical Center, Research Medical Center

GU 136: Nivolumab and Ipilimumab provided - Advanced or metastatic not amenable to curative surgery or RT, Predominant clear-cell, Non-clear cell including papillary, chromophobe, translocation associated, collecting duct, medullary or any pathology unclassified. One prior adjuvant or neoadjuvant therapy for completely resectable RCC if it did not include 1 checkpoint inhibitors and if recurrence occurred at least 6 months after the last dose. Asymptomatic brain mets allowed. No prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways. Includes in the neo-adjuvant or adjuvant setting. PI: Peter Van Veldhuizen, MD
Facility: Menorah Medical Center, Research Medical Center

GU 137: Lenvatinib, Everolimus, Pembrolizuma and Sunitinib provided. Histological or cytological confirmation of RCC with a clear-cell component, KPS of >/=70, calculated creatinine clearance ≥30 mL/min. No systemic anticancer therapy for RCC, including anti-VEGF therapy, or any systemic investigational anticancer agent. Prior adjuvant treatment with an investigational anticancer agent is not allowed unless the investigator can provide evidence of subject's randomization to placebo arm. CNS metastases are not eligible, unless they have completed local therapy (eg, whole brain radiation therapy [WBRT], surgery or radiosurgery) and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment. PI: Peter Van Veldhuizen, MD
Facility: Menorah Medical Center, Research Medical Center

GU 141: MOXR0916 and Atezolizumab provided - PD-L1 expression per IHC, Histologically or cytologically confirmed locally advanced (T4b, any N; or any T, N 2-3) or metastatic UC (M1, Stage IV) (also termed transitional cell carcinoma [TCC] or urothelial cell carcinoma [UCC] of the urinary tract; including renal pelvis, ureters, urinary bladder, and urethra), No prior systemic therapy for inoperable locally advanced or metastatic UC. Must be ineligible for cisplatin-based chemotherapy. No prior treatment with CD137 or OX40 agonists, anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-CD-27, anti-GITR therapeutic antibody or pathway-targeting agents, For patients who received prior adjuvant/neoadjuvant chemotherapy or chemo-radiation for UC, a treatment-free interval > 12 months between the last treatment administration and Cycle 1, Day 1 is required in order to be considered treatment naive in the metastatic setting, Patients with previously treated asymptomatic CNS metastases are eligible if they have measurable disease outside the CNS, no ongoing requirement for corticosteroids, stable dose of anticonvulsants, no interim progression, no stereotactic radiation within 7 day. PI: Peter Van Veldhuizen, MD
Facility: Menorah Medical Center, Research Medical Center

GU 142: Rucaparib is provided - Pure small-cell histologies or pure high-grade neuroendocrine histologies excluded; neuroendocrine differentiation allowed, must be surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL (1.73 nM). Disease progression after treatment with at least 1 but not more than 2 prior next generation AR-targeted therapies (abiraterone acetate, enzalutamide, or investigational AR-targeted agent) for castrate-resistant disease (treatment with the older anti-androgen therapies such as bicalutamide, flutamide, and nilutamide are not counted toward this limit). AND Disease progression after treatment with 1 line of taxane-based chemotherapy for castration-resistant disease. Prior taxane therapy administered for hormonesensitive disease is permitted and is not counted toward this limit. No prior treatment with any PARP inhibitor, mitoxantrone, cyclophosphamide, or any platinum-based chemotherapy. PI: Peter Van Veldhuizen, MD
Facility: Menorah Medical Center, Research Medical Center

CNS 25: Elflornithine provided - Surgical or biopsy-proven diagnosis of WHO grade 3 AA, unequivocal evidence of first AA tumor progression or recurrence ≤ 3 months prior to randomization based on MRI criteria for tumor progression using enlarging Gd-contrast enhancement and/or T2 hypersensitivity. First tumor progression or recurrence following surgical resection or biopsy, if resection is not feasible, EBRT and temozolomide chemotherapy. PI: Amandeep Kalra, MD
Facility: Menorah Medical Center, Research Medical Center

REFMAL 365: INC280 provided - Advanced GBM (progressed during or after ≥ 1st line therapy), mCRC (progressed during or after ≥ 2nd line therapy) and mRCC (progressed during or after ≥ 1st line therapy. Met alteration preferred (c-Met mutation or amplification by FISH or RT-PCR or Met IHC score of 2-3+), Progression during or after standard 1st line therapy (surgery and radiation). No prior treatment with bevacizumab or any other VEGF or VEGFR inhibitors. PI: Amandeep Kalra, MD
Facility: Menorah Medical Center, Research Medical Center