INTEGRIS Cancer Institute

Clinical Trials

INTEGRIS Cancer Institute - Proton Campus
Clinical Research List - August 2018

If you have a potential patient, please call Kellie Larsen Dyer, BA, CCRP CCRC at 405-773-6613.

ADVANCED BREAST

NCI-CIRB S1416 : “A Phase II, Randomized, Placebo-Controlled Trial of Cisplatin with or without ABT-888 (Veliparib) in Metastatic Triple Negative Breast Cancer and/or BRCA Mutation Associated Breast Cancer.” Reopened for Accrual!

NCI-CIRB S1418/BR006 : “A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 as Adjuvant Therapy for Triple Receptor Negative Breast Cancer with > or = 1 cm Residual Invasive Cancer or Positive Lymph Nodes (>pN1mic) After Neoadjuvant Chemotherapy

 

BLOOD DISORDERS

INCYTE INCB 18424-272 (RESET): “A Double-Blind, Double-Dummy, Phase II Randomized Study to Evaluate the Efficacy and Safety of Ruxolitinib vs Anagrelide in Subjects with Essential Thrombocythemia who are Resistant to or Intolerant of Hydroxyurea.”

ADVANCED/METASTATIC COLORECTAL CANCER

SWOG S1613: “A Randomized Phase II Study of Trastuzumab and Pertuzumab (TP) Compared to Cetuximab and Irinotecan (CETIRI) in Advanced/Metastatic Colorectal Cancer (mCRC) with HER-2 Amplification.”

ABBVIE M14-064: “A Phase II Study Comparing Efficacy and Safety of ABT-165 plus FOLFIRI vs Bevacizumab plus FOLFIRI in Metastatic Colorectal Cancer Previously Treated with Fluopyrimidine/Oxaliplatin and Bevacizumab.”

 

ADVANCED LUNG

EA5152 “ A Randomized Phase II Trial of Nivolumab, Cabozantinib Plus Nivolumab, and Cabozantinib Plus Nivolumab Plus Ipilimumab in Patients with Previously Treated Non-Squamous NSCLC

“ALCHEMIST” INTEGRATED TRIALS – Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials

A151216 – Screening Trial for AO81105, E4512, and EA5142: Observational Trial for Genetic Testing in Screening Patients with Stage IB-IIIA Non-Small Cell Lung Cancer that has been or will be removed by Surgery

A081105 – Randomized, Phase III Trial of Erlotinib Hydrochloride vs Placebo in Patients with Stage IB-IIIA Non-Small Cell Lung Cancer that has been completely removed by Surgery

E4512 – A Randomized, Phase III Trial for Surgically Resected, Early Stage Non-Small Cell Lung Cancer: Crizotinib vs Observation for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

EA5142 – Adjuvant Nivolumab in Resected Lung Cancers – A Randomized, Phase III Study of Nivolumab After Resection and Adjuvant Chemotherapy in Non-Small Cell Lung Cancers

SIGNATURE NOVARTIS CINC280A2201: “A Phase II, Multicenter, four cohort study of oral cMET inhibitor capmatinib (INCB280) in adult patients with EGFR wild-type, advanced Non-Small Cell Cancer (NSCLC) who have received one or two prior lines of systemic therapy for advanced/metastatic disease.” For second and third line treatment options

 

LYMPHOMA

MORPHOSYS B-MIND, MOR208C204: “A Phase II/III, Randomized, Multicenter Study of MOR00208 with Bendamustine versus Rutuximab with Bendamustine in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL) Who are not eligible for High-Dose Chemotherapy and Autologous Stem-Cell Transplantation.”

AMGEN JASMINE NHL ABP-798: “A Randomized, Double-Blind Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 798 vs Rutiximab in Subjects with CD20 Positive B-Cell Non-Hodgkin Lymphoma.”

 

BRAF V600 E/K MUTANT MELANOMA

NCI-CIRB S1320 ”A Randomized Phase II Trial of Intermittent versus Continuous Dosing of Dabrafenib (NSC-763760) and  Trametinib  (NSC-763093) in BRAF V600E/K Mutant Melanoma

NCI-CIRB EA6134 : "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"

 

NEWLY DIAGNOSED MYELOMA

NCI-CIRB E1A11:  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)

 

REGISTRIES

AZA-MDS-006  CONNECT MDS AND AML: “The Myelodysplastic Syndromes  (MDS) and Acute Myeloid Leukemia (AML) Disease Registry”  Screening upon diagnosis of MDS, ICUS or AMC.  Informed consent within 60 days of diagnosis. Standardized confirmation of eligibility and cohort. Patient enrollment.  Baseline and quarterly FU for 8 years.

BMS CA209-655: “A Molecular Profiling Observational Study of Patients with Classical Hodgkins Lymphoma to Describe Current Treatment Patterns and Sequences and to Evaluate Clinical Outcomes in cHL Patients across a Range of Clinical Practice Settings.”

 


 

INTEGRIS Cancer Institute - INTEGRIS Southwest Medical Center Campus
Clinical Research List -August 2018

If you have a potential patient, please call Kellie Larsen Dyer, BA, CCRP CCRC at 405-773-6613

 

ADVANCED BREAST

NCI-CIRB S1416 : “A Phase II, Randomized, Placebo-Controlled Trial of Cisplatin with or without ABT-888 (Veliparib) in Metastatic Triple Negative Breast Cancer and/or BRCA Mutation Associated Breast Cancer.” Reopened for Accrual!

NCI-CIRB S1418/BR006 : “A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 as Adjuvant Therapy for Triple Receptor Negative Breast Cancer with > or = 1 cm Residual Invasive Cancer or Positive Lymph Nodes (>pN1mic) After Neoadjuvant Chemotherapy”

 

BLOOD DISORDERS

INCYTE INCB 18424-272 (RESET): “A Double-Blind, Double-Dummy, Phase II Randomized Study to Evaluate the Efficacy and Safety of Ruxolitinib vs Anagrelide in Subjects with Essential Thrombocythemia who are Resistant to or Intolerant of Hydroxyurea.”

 

ADVANCED/METASTATIC COLORECTAL CANCER

SWOG S1613: “A Randomized Phase II Study of Trastuzumab and Pertuzumab (TP) Compared to Cetuximab and Irinotecan (CETIRI) in Advanced/Metastatic Colorectal Cancer (mCRC) with HER-2 Amplification.”

ABBVIE M14-064: “A Phase II Study Comparing Efficacy and Safety of ABT-165 plus FOLFIRI vs Bevacizumab plus FOLFIRI in Metastatic Colorectal Cancer Previously Treated with Fluopyrimidine/Oxaliplatin and Bevacizumab.”

 

ADVANCED LUNG

EA5152 “ A Randomized Phase II Trial of Nivolumab, Cabozantinib Plus Nivolumab, and Cabozantinib Plus Nivolumab Plus Ipilimumab in Patients with Previously Treated Non-Squamous NSCLC

“ALCHEMIST” INTEGRATED TRIALS – Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials

A151216 – Screening Trial for AO81105, E4512, and EA5142: Observational Trial for Genetic Testing in Screening Patients with Stage IB-IIIA Non-Small Cell Lung Cancer that has been or will be removed by Surgery

A081105 – Randomized, Phase III Trial of Erlotinib Hydrochloride vs Placebo in Patients with Stage IB-IIIA Non-Small Cell Lung Cancer that has been completely removed by Surgery

E4512 – A Randomized, Phase III Trial for Surgically Resected, Early Stage Non-Small Cell Lung Cancer: Crizotinib vs Observation for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

EA5142 – Adjuvant Nivolumab in Resected Lung Cancers – A Randomized, Phase III Study of Nivolumab After Resection and Adjuvant Chemotherapy in Non-Small Cell Lung Cancers

 

SIGNATURE NOVARTIS CINC280A2201: “A Phase II, Multicenter, four cohort study of oral cMET inhibitor capmatinib (INCB280) in adult patients with EGFR wild-type, advanced Non-Small Cell Cancer (NSCLC) who have received one or two prior lines of systemic therapy for advanced/metastatic disease.” For second and third line treatment options

 

LYMPHOMA

MORPHOSYS B-MIND, MOR208C204: “A Phase II/III, Randomized, Multicenter Study of MOR00208 with Bendamustine versus Rutuximab with Bendamustine in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL) Who are not eligible for High-Dose Chemotherapy and Autologous Stem-Cell Transplantation.”

AMGEN JASMINE NHL ABP-798: “A Randomized, Double-Blind Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 798 vs Rutiximab in Subjects with CD20 Positive B-Cell Non-Hodgkin Lymphoma.”

 

BRAF V600 E/K MUTANT MELANOMA

NCI-CIRB S1320 ”A Randomized Phase II Trial of Intermittent versus Continuous Dosing of Dabrafenib (NSC-763760) and  Trametinib  (NSC-763093) in BRAF V600E/K Mutant Melanoma

NCI-CIRB EA6134 : "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"

 

NEWLY DIAGNOSED MYELOMA

NCI-CIRB E1A11:  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)

 

REGISTRIES

AZA-MDS-006  CONNECT MDS AND AML : “The Myelodysplastic Syndromes  (MDS) and Acute Myeloid Leukemia (AML) Disease Registry”  Screening upon diagnosis of MDS, ICUS or AMC.  Informed consent within 60 days of diagnosis. Standardized confirmation of eligibility and cohort. Patient enrollment.  Baseline and quarterly FU for 8 years.

BMS CA209-655: “A Molecular Profiling Observational Study of Patients with Classical Hodgkins Lymphoma to Describe Current Treatment Patterns and Sequences and to Evaluate Clinical Outcomes in cHL Patients across a Range of Clinical Practice Settings.”