Clinical Trials – Metro Minnesota Community Oncology Research Consortium

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Brain Breast Cancer Control Gastrointestinal Genitourinary Gynecology Head and Neck Hematology Lung Melanoma MNCCTN Sarcoma Other

Brain

November 29, 2022 in Brain

BN012

A Randomized Phase III Trial of Pre-Operative Compared to Post-Operative Stereotactic Radiosurgery in Patients with Resectable Brain Metastases (NCT05438212)

September 14, 2022 in Brain

A071401

PHASE II TRIAL OF SMO/AKT/NF2/CDK INHIBITORS IN PROGRESSIVE MENINGIOMAS WITH SMO/AKT/NF2/CDK PATHWAY MUTATIONS

June 30, 2022 in Brain

CE.7

A phase III trial of stereotactic radiosurgery compared with whole brain radiotherapy (WBRT) for 5-15 brain metastases.

June 30, 2022 in Brain

BN011

BN011: A Phase III Trial of Lomustine-Temozolomide Combination Therapy Versus Standard Temozolomide in Patients With Methylated MGMT Promoter Glioblastoma (NCT 05095376)

June 30, 2022 in Brain

BN003

Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by Surgery

June 30, 2022 in Brain

A071702

A071702: A Phase II Study of Checkpoint Blockade Immunotherapy in Patients with Somatically Hypermutated Recurrent Glioblastoma (NCT04145115)

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Breast

June 27, 2024 in Breast

B-64/EXActDNA-003

EXActDNA-003: Breast Cancer Clinical Validation Study to Predict Recurrence of High-Risk Early Breast Cancer Treated with Neoadjuvant Therapy Using a Bespoke Circulating Tumor DNA Assay to Detect Molecular Residual Disease…

June 12, 2024 in Breast

OPERA-01 (Part 1 Regions only)

A PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF OP-1250 MONOTHERAPY VS STANDARD OF CARE FOR THE TREATMENT OF ER+, HER2– ADVANCED OR METASTATIC BREAST CANCER FOLLOWING ENDOCRINE AND CDK 4/6 INHIBITOR…

May 28, 2024 in Breast

I-SPY 2 (Open at HCMC Only)

I-SPY 2 TRIAL - Investigation of Serial Studies to Predict your Therapeutic Response with Imaging and Molecular Analysis 2

April 17, 2024 in Breast

S2206

Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) plus Chemotherapy versus Chemotherapy Alone for Adults with MammaPrint Ultrahigh (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2)…

January 30, 2024 in Breast

S2212

Shorter Anthracycline-Free Chemo Immunotherapy Adapted to Pathological Response in Early Triple Negative Breast Cancer (SCARLET), A Randomized Phase III Study

January 2, 2024 in Breast

BR009

A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression plus Endocrine Therapy in Premenopausal Patients with pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence…

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Cancer Control / Cancer Care Delivery Research (CCDR)

April 10, 2024 in Cancer Control / CCDR

WF-2202

Optimizing Psychosocial Intervention for Breast Cancer-related Sexual Morbidity: The Sexual Health and Intimacy Education (SHINE) Trial

March 26, 2024 in Cancer Control / CCDR

CC011

Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors: A Multi-Center Randomized Double-Blinded Controlled Trial (NCT05896189)

December 19, 2023 in Cancer Control / CCDR

EAQ221CD

Improving Medication Adherence in Metastatic Breast Cancer using a CONnected CUstomized Treatment Platform (CONCURxP)

November 15, 2023 in Cancer Control / CCDR

U22063

LOTUS-CC: Longitudinal Observational Trial to Uncover Subtypes of Cancer Cachexia

November 15, 2023 in Cancer Control / CCDR

EAQ211

Social genomic mechanisms of health disparities among Adolescent and Young Adult (AYA) cancer survivors

October 9, 2023 in Cancer Control / CCDR

U22053

High-dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients

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Gastrointestinal

May 29, 2024 in Gastrointestinal (GI)

A022106

Phase II/III second-line NABPLAGEM vs. nab-paclitaxel/gemcitabine in BRCA1/2 or PALB2 mutant metastatic pancreatic ductal adenocarcinoma (PLATINUM)

April 22, 2024 in Gastrointestinal (GI)

EAY191-A6

A ComboMATCH Treatment Trial: FOLFOX in Combination with Binimetinib as 2nd Line Therapy for Patients with Advanced Biliary Tract Cancers with MAPK Pathway Alterations

March 11, 2024 in Gastrointestinal (GI)

A022004

Randomized trial of consolidation targeted adjuvant therapy with encorafenib and cetuximab versus usual care for patients with stage II/III BRAF V600E colon cancer

January 8, 2024 in Gastrointestinal (GI)

M24-052/LIVIGNO-2

A Phase 2/3, Randomized Study to Evaluate the Dose Optimization, Safety, and Efficacy of Livmoniplimab in Combination with Budigalimab in Subjects with Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Who…

May 31, 2023 in Gastrointestinal (GI)

A022101

A Pragmatic Randomized Phase III Trial Evaluating Total Ablative Therapy for Patients with Limited Metastatic Colorectal Cancer: Evaluating Radiation, Ablation, and Surgery (ERASUR)

April 24, 2023 in Gastrointestinal (GI)

A022102

A022102: A Randomized Phase III Trial of mFOLFIRINOX +/- Nivolumab vs. FOLFOX +/- Nivolumab for First-line Treatment of Metastatic HER2-Negative Gastroesophageal Adenocarcinoma

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Genitourinary

May 20, 2024 in Genitourinary (GU)

MK5684

A Phase 3 Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Previously Treated With Next-generation Hormonal Agent (NHA) and…

May 14, 2024 in Genitourinary (GU)

EA8211

A Phase III Trial of Stereotactic ablative radiotherapy for Oligometastatic Advanced Renal Carcinoma (SOAR)

April 30, 2024 in Genitourinary (GU)

A032103

MODERN: An Integrated Phase 2/3 and Phase 3 Trial of MRD-Based Optimization of Adjuvant Therapy in Urothelial Cancer

October 18, 2023 in Genitourinary (GU)

SGNDV-001/KN-D74

An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination with Pembrolizumab Versus Chemotherapy in Subjects with Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma that Expresses HER2…

December 14, 2022 in Genitourinary (GU)

S2200

A Phase II Randomized Trial of Cabozantinib With or Without Atezolizumab in Patients with Advanced Papillary Renal Cell Carcinoma (PAPMET2)

October 11, 2022 in Genitourinary (GU)

GU012

Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) For Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI) (NCT# 05327686)

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Gynecology

July 17, 2024 in Gynecology

EAY191-N5: A Randomized Trial of Neratinib, a Pan-ErbB Inhibitor alone or in combination with Palbociclib, a CDK4/6 Inhibitor, in Patients with HER2+ Gynecologic Cancers and other Solid Tumors A ComboMATCH Treatment Trial (NCT# 06126276)

June 17, 2024 in Gynecology

GY028: A Phase IB and Randomized Phase II Trial of Megestrol Acetate with or without Ipatasertib in Recurrent or Metastatic Endometrioid Endometrial Cancer (NCT05538897)

May 31, 2023 in Gynecology

EAY191-N4

A Randomized Trial of Selumetinib and Olaparib or Selumetinib alone in Patients with recurrent or persistent RAS Pathway Mutant Ovarian and Endometrial Cancers A ComboMATCH Treatment Trial (NCT# 05554328)

April 24, 2023 in Gynecology

A092104

A randomized phase 2/3 study of olaparib plus temozolomide versus investigator’s choice for the treatment of patients with advanced uterine leiomyosarcoma after progression on prior chemotherapy

September 21, 2022 in Gynecology

GY026

A Phase II/III study of paclitaxel/carboplatin alone or combined with either trastuzumab and hyaluronidase-oysk (HERCEPTIN HYLECTA) or pertuzumab trastuzumab and hyaluronidase-zzfx (PHESGO) in HER2 positive, stage I-IV endometrial serous carcinoma…

June 30, 2022 in Gynecology

GY019

GY019: A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum

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Head and Neck

May 22, 2024 in Head and Neck

EA3211

Phase III Randomized Trial of Immunotherapy with or without Consolidative Radiotherapy for Oligometastatic Head and Neck Squamous Cell Carcinoma (NCT04671667)

March 27, 2023 in Head and Neck

HN010

A Controlled, Randomized Phase II Trial of Docetaxel Plus Trastuzumab Versus Ado-Trastuzumab Emtansine for Recurrent, Metastatic, or Treatment-Naïve, Unresectable HER2-Positive Salivary Gland Cancer (NCT05408845)

September 14, 2022 in Head and Neck

EA3202

EA3202: A Phase II/III trial of Chemotherapy + Cetuximab vs Chemotherapy + Bevacizumab vs Atezolizumab + Bevacizumab Following Progression on Immune Checkpoint Inhibition in Recurrent/Metastatic Head and Neck Cancers

July 1, 2022 in Head and Neck

HN009

HN009: Randomized Phase II/III Trial of Radiation with High-Dose Cisplatin (100 mg/m2) Every Three Weeks versus Radiation with Low-Dose Weekly Cisplatin (40 mg/m2) for Patients with Locoregionally Advanced Squamous Cell…

June 30, 2022 in Head and Neck

EA3191

EA3191: A Phase II Randomized Trial of Adjuvant Therapy with Pembrolizumab after Resection of Recurrent/Second Primary Head and Neck Squamous Cell Carcinoma with High Risk Features

June 30, 2022 in Head and Neck

EA3161

EA3161: A Phase II/III Randomized Study of Maintenance Nivolumab versus Observation in Patients with Locally Advanced, Intermediate Risk HPV Positive OPCA

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Hematology

July 18, 2024 in Hematology

MonumenTAL-6

A Phase 3 Randomized Study Comparing Talquetamab in Combination with Pomalidomide (Tal-P), Talquetamab in Combination with Teclistamab (Tal-Tec), and Investigator’s Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pomalidomide,…

May 20, 2024 in Hematology

ELEMENT-MDS/CA056-025

A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) vs Epoetin Alfa for the Treatment of Anemia Due to Revised International Prognostic Scoring System…

April 8, 2024 in Hematology

A052101

A Randomized Phase 3 Trial of Continuous vs. Intermittent Maintenance Therapy with Zanubrutinib as Upfront Treatment in Older Patients with Mantle Cell Lymphoma

March 1, 2024 in Hematology

M20-621/EPCORE DLBCL-2

A Phase 3, Randomized, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination with R-CHOP Compared to R-CHOP in Subjects with Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)…

February 28, 2024 in Hematology

S2209

A Phase III Randomized Trial for Newly Diagnosed Multiple Myeloma (NDMM) Patients Considered Frail or in a Subset of “Intermediate Fit” Comparing Upfront Three-drug Induction Regimens Followed by Double- or…

January 22, 2024 in Hematology

CVAY736I12301/VAYHIT1

A phase III, randomized, double-blind study of ianalumab (VAY736) versus placebo in addition to first-line corticosteroids in primary immune thrombocytopenia (VAYHIT1)

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Lung

June 17, 2024 in Lung

EA5221: Randomized Phase 3 Clinical Trial of Chemo-Immunotherapy vs Immunotherapy Alone for the Vulnerable Older Adult with Advanced Non-Small Cell Lung Cancer: The ACHIEVE Study

September 27, 2023 in Lung

KRYSTAL-17

A Phase 2 Trial of Combination Therapies with Adagrasib in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation

June 26, 2023 in Lung

S1900G

A Randomized Phase II Study of INC280 (Capmatinib) plus Osimertinib with or without Ramucirumab in Participants with EGFR-Mutant, MET-Amplified Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)

April 3, 2023 in Lung

S2302

Non-Chemotherapy Treatment (ramucirumab plus pembrolizumab) or Usual Care for Advanced Non-Small Cell Lung Cancer Following Immunotherapy

December 20, 2022 in Lung

HLX10-020-SCLC302

A Randomized, Double-Blind, International Multicenter, Phase III Study to Evaluate the Anti-Tumor Efficacy and Safety of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) or Placebo in Combination with Chemotherapy (Carboplatin/Cisplatin-Etoposide)…

September 15, 2022 in Lung

EMERGE-402 *Enrollment paused 31JAN2024

EMERGE 402: Phase IV Observational Study to Collect Safety and Outcome Data in Real-World Setting in Adult Patients with Extensive Stage Small Cell Lung Cancer (SCLC) Receiving Zepzelca

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Melanoma

August 16, 2022 in Melanoma

A091903

A091903: A Randomized Phase II Trial of Adjuvant Nivolumab with or without Cabozantinib in Patients with Resected Mucosal Melanoma (NCT05111574)

June 30, 2022 in Melanoma

EA6141

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

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MNCCTN

December 20, 2023 in MNCCTN

MNCCTN031

T-DM1-A Study of the Natural History of Ado-trastuzumab emtansine (T-DM1)-Induced Peripheral Neuropathy in HER2-positive Breast Cancer Patients

September 5, 2023 in MNCCTN

MNCCTN024

A Prospective, Randomized Study To Evaluate The Safety of Extending The Routine Flushing Of Implanted Port Devices From 4 Weeks To 12 Weeks

August 31, 2023 in MNCCTN

MNCCTN013

Endocrine Therapy-Induced Alopecia Natural History Evaluation Among Female Breast Cancer Survivors

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Sarcoma

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Other Sites

June 20, 2024 in Other Sites

ES2021-05 – Contact MMCORC for more information

Specimen Collection Study to Evaluate Biomarkers in Subjects with Cancer

February 19, 2024 in Other Sites

SGNDV-005

A Phase 2 Basket Study of Disitamab Vedotin in Adult Subjects with Previously Treated, Locally-Advanced Unresectable or Metastatic Solid Tumors That Express HER2

October 30, 2023 in Other Sites

EAY191-E4

ComboMATCH Treatment Trial E4: Nilotinib and Paclitaxel in Patients with Prior Taxane-Treated Solid Tumors (NCT #05554341)

June 14, 2023 in Other Sites

EAY191-S3

Phase II Study of Paclitaxel (NSC #673089) + Ipatasertib (NSC #781451) in Taxane-Refractory Participants with AKT-Altered Advanced Non-Breast Solid Tumors

May 10, 2023 in Other Sites

EAY191

Molecular Analysis for Combination Therapy Choice (ComboMATCH)

September 7, 2022 in Other Sites

TAPISTRY

TUMOR-AGNOSTIC PRECISION IMMUNOONCOLOGY AND SOMATIC TARGETING RATIONAL FOR YOU (TAPISTRY) PHASE II PLATFORM TRIAL

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