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Clinical Trials

S1404 A Phase III Randomized Trial Comparing High Dose Interferon to MK-3475 (Pembrolizumab) in Patients with High Risk Resected Melanoma.
Disease Site: Melanoma
Protocol Number: S1404
Status: OPEN
Key Eligibility: Completely resected melanoma of cutaneous origin or of unknown primary; Stage IIIA (N2a), IIIB, IIIC, or Stage IV; melanoma of mucosal or other non-cutaneous origin ok; no ocular melanoma or brain mets
Description:
Randomized Phase II/III Study of Nivolumab plus Ipilimumab plus Sargramostim versus Nivolumab plus Ipilimumab in Patients with Unresectable Stage III or Stage IV Melanoma
Disease Site: Melanoma
Protocol Number: EA6141
Status: OPEN
Key Eligibility: Known BRAF; wild-type or mutated; prior adjuvant tx ok; no prior ipilimumab or PD-1/PD-L1 in adjuvant setting
Description:
A Randomized Phase III trial of Dabrafenib + Trametinib followed by Ipilimumab + Nivolumab at Progression vs. Ipilimumab + Nivolumab followed by Dabrafenib + Trametinib at Progression in Patients With Advanced BRAFV600 Mutant Melanoma
Disease Site: Melanoma
Protocol Number: EA6134
Status: Pending IRB Approval
Key Eligibility: Unresectable stage III or IV disease; metastatic or unresectable, clearly progressive; BRAFV600E mutations; no previous CTLA4 or PD1 pathway blocking or BRAF/MEK inhibitor
Description:
A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer
Disease Site: Breast
Protocol Number: NRG-BR003
Status: OPEN
Key Eligibility: pT1-3; pN0, pN1, pN2a-b; pN3a-b, HER2-, ER/PgR-, no T4, no met disease
Description:
RADIATION THERAPY FACILITY INVENTORY FORM REQUIRED TO BE SENT TO CTSU PRIOR TO ENROLLMENT. PLEASE SEND COPY TO MVCC OFFICE ONCE COMPLETE
Regorafenib Dose Optimization Study (ReDOS): A Phase II Randomized Study of Lower Dose Regorafenib Compared to Standard Dose Regorafenib in Patients with Refractory Metastatic Colorectal Cancer (mCRC)
Disease Site: Gastrointestinal
Protocol Number: RU021407I
Status: PENDING ACCRU ACTIVATION
Key Eligibility: Adenocarcinoma of colon or rectum; no previous regorafenib
Description:
PARTICIPATING PHYSICIANS:  SOORI, DUNDER, BERG, AVERY, HUTCHINS, TILFORD, PETERSON, MIDATHADA, BLOCK, SU, HUYCK, LANGDON all non-approved physicians must enroll any eligible subjects through these physicians at the following locations: NCS (BERGAN, LEGACY, PAPILLION), HOC, SENCC, NHO.
Molecular Analysis for Therapy Choice (MATCH)
Disease Site:
Protocol Number: EAY131
Status: Pre-Activation
Key Eligibility: Solid tumor or lymphoma that has progressed following at least 1 line of standard therapy. Matching biopsy results to specific drug therapy
Description:
A Randomized Phase II/III Trial of Afatinib Plus Cetuximab Versus Afatinib Alone in Treatment-Naive Patients with Advanced, EGFR Mutation Positive Non-Small Cell Lung Cancer (NSCLC)
Disease Site: Lung
Protocol Number: S1403
Status: OPEN
Key Eligibility: Stage IV or recurrent NSCLC; EGFR exon 19 deletion or exon 21 substitution mutation; tissue must be available to send out; no prior anticancer therapy for advanced or metastatic disease
Description:
A Phase II/III Randomized Trial of Veliparib or Placebo in Combination with Adjuvant Temozolomide in Newly Diagnosed Glioblastoma with MGMT Promoter Hypermethylation
Disease Site: Brain
Protocol Number: A071102
Status: OPEN
Key Eligibility: Newly diagnosed grade IV; NO oligodendroglial features if 1p19q codeleted
Description:
Imaging credentialing required by each site prior to enrollment
Pilot Clinical Trial Evaluating the Utility of Minocycline as an Agent to Decrease Chemotherapy-Induced Neuropathy and Paclitaxel-induced Acute Pain Syndrome
Disease Site: Cancer Control
Protocol Number: RU221408I
Status: OPEN
Key Eligibility: Paclitaxel at a dose of 80 mg/m2 given, in the adjuvant setting every week for a planned course of 12 weeks without any other concurrent cytotoxic chemotherapy
Description:
A Randomized, Phase II Trial of Crizotinib Plus Pemetrexed Versus Pemetrexed Monotherapy in ALK-Positive Non-Squamous NSCLC Patients Who Have Progressed Systematically After Previous Clinical Benefit From Crizotinib Monotherapy
Disease Site: Lung
Protocol Number: S1300
Status: OPEN
Key Eligibility: Stage IV non-squamous NSCLC; ALK pos at time of initial crizotinib monotherapy; must have prev achieved clinical benefit with crizotinib and subsequently progressed; pemetrexed-naive
Description:
Randomized Phase II Study of Irinotecan and Cetuximab with or without Vemurafenib in BRAF Mutant Metastatic Colorectal Cancer
Disease Site: Gastrointestinal
Protocol Number: S1406
Status: OPEN
Key Eligibility: Metastatic or locally advanced/unresectable colon or rectal adenocarcinoma; BRAF mutant status; 1-2 prior metastatic or locally advanced/unresectable systemic chemo regimens
Description:
Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC)
Disease Site: Lung
Protocol Number: A081105
Status: OPEN
Key Eligibility: Prev registration to A151216; EGF exon 19 deletion or L858R mutation; completely resected stage IB, II, or IIIA non-squamous w/neg margins
Description:
Randomized Phase II Double Blind Study of Adjuvant Regorafenib vs Placebo in Patients with Node Positive Esophageal Cancer that Completed Pre-operative Therapy
Disease Site: Gastrointestinal
Protocol Number: RU021212I
Status: OPEN
Key Eligibility: Node positive (any T stage N1-3) proximal esophageal, distal esophagus or gastroesophageal (GE) junction adenocarcinoma after completing preoperative chemoradiation and surgery; No metastatic or recurrent disease; no R1 or R2 resection
Description:
A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein
Disease Site: Lung
Protocol Number: E4512
Status: OPEN
Key Eligibility: Complete resection of stage IB, II, or IIIA NSCLC; registration to ALCHEMIST-SCREEN (A151216); Positive for translocation or inversion events involving the ALK gene locus
Description:
A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Multi-Centre Phase III Study to Assess the Efficacy and Safety of Olaparib vs Placebo as Adjuvant Treatment in Patients with Germline BRCA ½ Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy
Disease Site: Breast
Protocol Number: B55
Status: OPEN
Key Eligibility: Non-metastatic triple negative; must have rcvd adjuvant therapy; documented BRCA 1 or 2 deleterious mutation; no prior PARP inhibitor
Description:
STUDY: ALLIANCE A031201 PHASE III TRIAL OF ENZALUTAMIDE (NSC # 766085) VERSUS ENZALUTAMIDE, ABIRATERONE AND PREDNISONE FOR CASTRATION RESISTANT METASTATIC PROSTATE CANCER
Disease Site: Genitourinary
Protocol Number: A031201
Status: OPEN
Key Eligibility: Progressive CRPC; no prior taxane-based chemo for met disease; no prior antiandrogen or androgen synthesis inhibitor
Description:
A Randomized Phase III Trial of Eribulin Compared to Standard Weekly Paclitaxel as First- or Second-Line Therapy for Locally Recurrent or Metastatic Breast Cancer
Disease Site: Breast
Protocol Number: RU011201I
Status: OPEN
Key Eligibility: Stage IIIC or IV not amenable to local therapy; HER2-; no more than 1 prior therapy for advanced disease
Description:
**THE FOLLOWING PHYSICIANS HAVE BEEN APPROVED TO ENROLL: SOORI, BLOCK, Berg, Peterson, Avery – all non-approved physicians must enroll any eligible subjects through these physicians at the following sites: NCS (BERGAN, LEGACY), NHO, SENCC
A Randomized Phase III Study of Ibrutinib (PCI-32765)-based Therapy vs Standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) Chemoimmunotherapy in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL)
Disease Site: Hematology
Protocol Number: E1912
Status: OPEN
Key Eligibility: CLL; no prior tx for CLL/SLL; >19 and <70; no corticosteroids for CLL
Description:
A Randomized, Double-Blinded, Placebo-Controlled Phase II Study of Adjuvant Everolimus Following the Resection of Metastatic Pancreatic Neuroendocrine Tumors to the Liver
Disease Site: Neuroendocrine
Protocol Number: E2212
Status: OPEN
Key Eligibility: Histologically or pathologically confirmed metastatic low or intermediate grade pancreatic neuroendocrine tumor(s) to liver
Description:
APHASE III, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF SORAFENIB IN DESMOID TUMORS OR AGGRESSIVE FIBROMATOSIS (DT/DF)
Disease Site: Carcinoid
Protocol Number: A091105
Status: OPEN
Key Eligibility: DT/DF; prev locoregional therapy; no sorafenib; no con tx w/CYP3A4 inhibitors or inducers
Description:
Phase I and Randomized Phase II Double Blind Clinical Trial of Cisplatin and Etoposide in Combination with Veliparib (ABT-888) or Placebo as Frontline Therapy for Extensive Stage Small Cell Lung Cancer
Disease Site: Lung
Protocol Number: E2511
Status: OPEN
Key Eligibility: Extensive stage SCLC; no prior SCLC therapy
Description:
Randomized Phase III Trial of Bortezomib, LENalidomide and Dexamethasone (VRd) Versus Carfilzomib, Lenalidomide and Dexamethasone (CRd) Followed by Limited or Indefinite DURation Lenalidomide MaintenANCE in Patients with Newly Diagnosed Symptomatic Multiple Myeloma (ENDURANCE)
Disease Site: Hematology
Protocol Number: E1A11
Status: OPEN
Key Eligibility: Symptomatic standard-risk multiple myeloma
Description:
Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer. e3 Breast Cancer Study- evaluating everolimus with endocrine therapy.
Disease Site: Breast
Protocol Number: S1207
Status: OPEN
Key Eligibility: ER/PR, HER-2 negative invasive breast carcinoma; no metastatic disease; high risk
Description:
A Randomized Phase I/II Study of Optimal Induction Therapy of Bortezomib, Dexamethasone and Lenalidomide with or without Elotuzumab (NSC-764479) for Newly Diagnosed High Risk Multiple Myeloma (HRMM)
Disease Site: Hematology
Protocol Number: S1211
Status: OPEN
Key Eligibility: Newly diagnosed, high risk, active MM; one prior cycle of chemo ok
Description:
A Randomized Placebo-Controlled Phase III Study of Duloxetine for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Women with Early Stage Breast Cancer
Disease Site: Cancer Control
Protocol Number: S1202
Status: OPEN
Key Eligibility: ER and/or PgR+, Stage I-III Brca; mastectomy or breast sparing surgery, post-menopausal
Description:
A Randomized Phase II Trial of Ipilimumab with or without Bevacizumab in Patients with Unresectable Stage III or Stage IV Melanoma
Disease Site: Melanoma
Protocol Number: E3612
Status: OPEN
Key Eligibility: Untreated or prev recvd 1 tx for measurable, unresectable Stage III or IV melanoma
Description:
Randomized Phase II Open Label Study of Lenalidomide R-CHOP (R2CHOP) vs RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) in Patients with Newly Diagnosed Diffuse Large B Cell Lymphoma
Disease Site: Hematology
Protocol Number: E1412
Status: OPEN
Key Eligibility: Confirmed DLBCL expressing CD20 antigen; NO primary mediastinal large B-cell lymphoma; NO stage II-IV non-bulky disease
Description:
NSABP Patient Registry and Biospecimen Profiling Repository
Disease Site: Gastrointestinal
Protocol Number: MPR-1
Status: OPEN
Key Eligibility: Metastatic colorectal cancer; available block from primary tumor
Description:
A RANDOMIZED PHASE II STUDY OF INDIVIDUALIZED COMBINED MODALITY THERAPY FOR STAGE III NON-SMALL CELL LUNG CANCER (NSCLC)
Disease Site: Lung
Protocol Number: R1306
Status: PRE-ACTIVATION
Key Eligibility: Newly diagnosed NSCLC; unresectable Stage IIIA or B disease
Description:
RT CREDENTIALING REQUIRED PRIOR TO PARTICIPATION
A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients with Stage 0-III Colon Cancer, Phase III - Preventing Adenomas of the Colon with Eflornithine and Sulindac (PACES)
Disease Site: Gastrointestinal
Protocol Number: S0820
Status: OPEN
Key Eligibility: Stage 0-III; tx w/SOC w/resection alone or in combination w/adjuvant therapy
Description:
PROSPECTIVE RANDOMIZED PHASE II TRIAL OF PAZOPANIB (NSC # 737754, IND 75648) VERSUS PLACEBO IN PATIENTS WITH PROGRESSIVE CARCINOID TUMORS
Disease Site: Carcinoid
Protocol Number: A021202
Status: OPEN
Key Eligibility: low or intermediate grade neuroendocrine carcinoma; unresectable or met carcinoid in foregut, midgut, hindgut or other non-pancreatic site
Description:
A Cohort Study to Evaluate Genetic Predictors of Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS)
Disease Site: Breast
Protocol Number: E1Z11
Status: OPEN
Key Eligibility: Post-menopausal women; ER/PR + stage I-III adenocarcinoma of breast
Description:
Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Fulvestrant (Faslodex) plus Everolimus in Post-Menopausal Patients with Hormone-Receptor Positive Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy
Disease Site: Breast
Protocol Number: PrE0102
Status: OPEN
Key Eligibility: Adenocarcinoma of breast; stage IV or inoperable locally advanced disease
Description:
A Phase III Clinical Trial Comparing the Combination of Docetaxel plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer
Disease Site: Breast
Protocol Number: B49
Status: OPEN
Key Eligibility: HER2 Negative; adjuvant
Description:
A Phase III Study Evaluating the Role of Perioperative Chemotherapy in Patients with Potentially Resectable Hepatic Colorectal Metastases
Disease Site: Gastrointestinal
Protocol Number: NSABP C11
Status: OPEN
Key Eligibility: Histologic confirmation of colorectal adenocarcinoma, no anal, small bowel, or appendiceal carcinoma or any other colorectal malignant diseases (sarcoma, lymphoma, carcinoid)
Description:
A Randomized Phase III Trial of Adjuvant Therapy Comparing
Disease Site: Breast
Protocol Number: B47
Status: OPEN
Key Eligibility: The tumor must be unilateral invasive adenocarcinoma of the breast on histologic exam; HER2 status of the primary tumor must be evaluated prior to randomization; all testing performed must indicate that the tumor is HER2-low
Description:
A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer
Disease Site: Breast
Protocol Number: E2108
Status: OPEN
Key Eligibility: Patients (male or female) must have an intact primary (not recurrent) invasive
Description:
A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER-2 Negative Breast Cancer with Recurrence Score (RS) of 25 or Less
Disease Site: Breast
Protocol Number: CTSU S1007
Status: OPEN
Key Eligibility: ADJUVANT BREAST - Step 1 - hist confirmed dx of node pos(1-3 nodes) invasive br ca w/pos estrogen and/or progesterone receptor status,and neg HER-2; Step 2 - Recurrence score (RS) by Oncotype DX® must be less than or equal to 25
Description:
Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients with Asymptomatic High-Risk Smoldering Multiple Myeloma
Disease Site: Hematology
Protocol Number: E3A06
Status: OPEN
Key Eligibility: Assymptomatic, high-risk, smoldering multiple myeloma
Description:
A Randomized Phase II Study of Irinotecan and Cetuximab with or without the Anti-Angiogenic Antibody, Ramucirumab, in Advanced, K-ras Wild-type Colorectal Cancer Following Progression on Bevacizumab-Containing Chemotherapy
Disease Site: Gastrointestinal
Protocol Number: E7208
Status: OPEN
Key Eligibility: Met or adv CRC, KRAS-wild type, first line tx with Oxaliplatin-containing chemo and Avastin. PD within 90 days of last Avastin.
Description:
A Phase III Trial of 6 versus 12 Treatments of Adjuvant FOLFOX plus Celecoxib or Placebo for Patients with Resected Stage III Colon Cancer
Disease Site: Gastrointestinal
Protocol Number: C80702
Status: OPEN
Key Eligibility: Resected Stage III Colon
Description:
Randomized Phase III Study of Maintenance Therapy with Bevacizumab, Pemetrexed, or a Combination of Bevacizumab and Pemetrexed Following Carboplatin, Paclitaxel and Bevacizumab for Advanced Non-Squamous NSCLC
Disease Site: Lung
Protocol Number: E5508
Status: OPEN
Key Eligibility: Advanced NSCLC, Non-Squamous
Description:
Randomized, Phase III, Double-Blind Placebo-Controlled Trial of Sunitinib as Maintenance Therapy in Non-Progressing Patients following an Initial Four Cycles of Platinum-Based Combination Chemotherapy in Advanced, Stage IIIB/IV NSCLC
Disease Site: Lung
Protocol Number: C30607
Status: OPEN
Key Eligibility: NSCLC, Stage IIIB or IV First Line
Description:
A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy
Disease Site: Breast
Protocol Number: B43
Status: OPEN
Key Eligibility: DCIS HER2 testing by NSABP
Description:
Phase III Comparison of Thoracic Radiotherapy Regimens in Patients with Limited Small Cell Lung Cancer also Receiving Cisplatin and Etoposide
Disease Site: Lung
Protocol Number: C30610
Status: OPEN - Omaha sites only
Key Eligibility: SMALL CELL, Limited Stage
Description:

OMAHA:Use Omaha IC
Not avail to Lincoln yet
 

Randomized Phase III Trial Comparing the Frequency of Major Erythroid
Disease Site: Hematology
Protocol Number: E2905
Status: OPEN
Key Eligibility: Low- or Intermediate- MDS and Symptomatic Anemia
Description:
A Double Blind Phase II Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin, and Placebo in Patients with Advanced Transitional Cell Carcinoma
Disease Site: Genitourinary
Protocol Number: C90601
Status: OPEN
Key Eligibility: Advanced Bladder, Transitional Cell
Description:
Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy versus Immediate Radical Prostatectomy in Patients with High-Risk, Clinically Localized Prostate Cancer
Disease Site: Genitourinary
Protocol Number: C90203
Status: OPEN
Key Eligibility: Prostate, NeoAdjuvant, High-Risk, Clinically Localized
Description:
Phase III Intergroup Study of Radiotherapy versus Temozolomide alone versus Radiotherapy with Concomitant and Adjuvant Temozolomide for Patients with 1p/19q Codeleted Anaplastic Glioma
Disease Site: Brain
Protocol Number: N0577
Status: OPEN
Key Eligibility: 1p/19q Co-deleted Anaplastic Glioma
Description:
Phase III Study of Radiation Therapy with or without Temozolomide for Symptomatic or Progressive Low-Grade Gliomas
Disease Site: Brain
Protocol Number: E3F05
Status: OPEN
Key Eligibility: Symptomatic Gliomas
Description:
Missouri Valley Cancer Consortium
6818 Grover Street * Executive Plaza, Suite 301 * Omaha, NE 68106
(402) 991-8070