INTEGRIS Cancer Institute

Clinical Trials

INTEGRIS Cancer Institute - Proton Campus
Clinical Research List- December 2020 

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

Advanced Breast

  • S1418/BR006 R#5 7/30/19:“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 (IRB # 17-021
  • NRGBR004“A Randomized, Double Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in 1st Line HER2 Positive Metastatic Breast Cancer.”
  • ALLIANCE A011202“A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After NeoAdjuvant Chemotherapy. Waiting on RT Credentialing

Advanced Lung

  • ALCHEMIST A151216A Screening Trial for AO81105, and E4512 Observational Trial for Genetic Testing in Screening Patients with Stage IB-IIIA Non-Small Cell (Non-Squamous) Lung Cancer that has been or will be removed by Surgery” No neoadjuvant chemo or RT. No locally advanced or met cancer
  • ALCHEMIST A081105Randomized Study of Erlotinib or Observation in Pts with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC)
    Central Lab finds EGFR exon 19 deletion or L858R mutation. Known resistant mutations (T790M) are NOT eligible. No neoadjuvant chemo or RT. No corneal abnormalities, no locally advanced or metastatic cancer.
  • ALCHEMIST A081801Integration of Immunotherapy into Adjuvant Therapy for Resected NSCLC: ALCHEMIST-IO
    Pending IRB ratification

    Must have EGRF, ALK, PD-LI IHC local testing with no identified arrangements. Must have completely resected dz IB (>/= 4cm), II or IIIA NSCLC with negative margins Patients with N2 Disease completely resected are eligible. However, patients with known N2 dz prior to surgery or ineligible.
  • ALCHEMIST E4512A 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” (IRB # 18-027)
  • S1929“Phase II Randomized Study of Maintenance Aezolizumab vs. Atezolizumab in Combination with Talazoparib in Patients with SLFN11 Positive Extensive Stage Small Cell Lung Cancer (ES-SCLC)”
  • ECOG EA5181EA5181 – “Randomized Phase III Trial of MED14736 (Durvalumab)as Concurrent and Consolidative Therapy or Consolidative Therapy Alone for Unresectable Stage 3 NSCLC.” RT Credentialing when patient is identified
  • S1914“A Randomized Phase III Trial of Induction/Consolidation Atezolizumab + SBRT vs. SBRT Alone in High Risk Early Stage NSCLC.” Waiting for RT Credentialing and IRB ratification

Advanced Biliary Cancers

  • S1815“A Phase III Randomized Trial of Gemcitabine, Cisplatin, and NAB-PACLITAXEL vs. Gemcitabine and Cisplatin in Newly Diagnosed, Advanced Biliary Duct Tract Cancers.”

Colon Cancer

  • NRG-GI005“A Phase II/III Study of Circulating Tumor DNA as a Predictive Biomarker in Adjuvant Chemotherapy in Patients with Stage IIA Colon Cancer (COBRA)

Metastatic Colon

  • SWOG 1613Two Step Registration for this Randomized Phase II Study of Trastuzumab & Pertuzumab compared to Cetuximab and Irinotecan in Advanced/MET Colorectal Cancer with Her2 Amplification

Lymphoma

  • MORPHOSYS B-MINDA Phase II/III, Randomized, Multicenter Study of MOR00208 with Bendamustine vs. Rituximab with Bendamustine in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL) Who are not eligible for High-Dose Chemotherapy (HDC) and Autologous Stem-Cell Transplantation (ASCT) B-Mind

MDS/AML

  • CONNECT Observational Registry“The Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry” (IRB # 17-011)
    Pts receive $20 gift card for each QoL questionnaire they complete!

Just In time Clinical Trial Portal

  • CARIS

A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 Solid Tumors with KRAS G12C Mutation

Enzastaurin + R-CHOP vs. R-CHOP in Treatment Naïve Subjects with High Risk DLBC Lymphoma with DGM1 biomarker

APL 101 in Subjects with NSCL with c-Met EXON 14 Skip mutations and c-Met Dysregulation Advanced Solid Tumors

Seribantumab in Adults Patients with Neuregulin-1 Fusion Positive Locally Advanced or Metastatic Solid Tumors.

Sitravatinib in Combination with Nivolumab vs. Docetaxel in Patients with Advanced Non Squamous NCLC with Disease Progression on or after Platinum based Chemotherapy and Checkpoint Inhibitor Therapy (SAPPHIRE)

MRTX849 in Combination Keytruda NSCLC with KRAS G12C Mut

MCLA-128 Targeting HER2 and HER2 Solid Tumors

IDE196 Solid Tumors GNAQ/11 mutations or PRKC fusions

INTEGRIS Cancer Institute - INTEGRIS Southwest Medical Center Campus
Clinical Research List -December 2020

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

Advanced Breast

  • S1418 R#5 7/30/19Rand, Phase III to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) as Adjuvant Therapy for Triple Receptor Negative Breast Cancer with > or = 1 cm Residual Invasive . No met disease. MUST HAVE NEOADJ CHEMO FOLLOWED BY SURGERY WITH > 1 CM RESIDUAL INVASIVE BREAST CANCER, or any positive lymph nodes PTS MUST COMPLETE ADJUVANT CHEMO PRIOR TO STARTING STUDY THERAPY WITH PEMBROLIZUMAB. STEP 1 = PRE-STUDY SCREEN. STEP 2 = RANDOMIZATION
  • NRG-BR004A Randomized Double-Blind, Phase III Trial of Paclitaxel - Trastuzumab - Pertuzumab with Atezolizumab OR Placebo in First Line HER2 Positive Metastatic Breast Cancer Study provides drug ATEZOLIZUMAB Commercially Available: Paclitaxel + Trastuzumab + Pertuzumab

Metastatic Colon

  • SWOG 1613: Two Step Registration for this Randomized Phase II Study of Trastuzumab & Pertuzumab compared to Cetuximab and Irinotecan in ADVANCED / MET Colorectal Cancer with HER-2 AMPLIVICATION.

Colon Cancer

  • NRG GI005 COBRA: This study is looking at efficacy of the ctDNA test in finding circulating tumor DNA. IF randomized to Group 1 blood will be tested for ctDNA in the future and no further tx (std of care). If randomized to Group 2 pts will receive chemotherapy or no further tx depending on the detection of ctDNA in the pts blood. Chemo drugs are commercially available.

Advanced Lung

  • EA5181Pts will be randomized to either Arm A which is standard chemo/radiation with the addition of MED14735 (Durvalumab). Arm B is standard chemo/radiation. Arm C receives one year of MED14735 (Durvalumab). RT credentialing required once patient is identified
  • ALCHEMIST A151216A Screening Trial for Genetic Testing in Patients with Stage IB-IIIA Non-Small Cell (Non-Squamous) Lung Cancer that has been or will be removed by surgery. No neoadjuvant chemo or RT. No locally advanced or met cancer. If EGFR confirmed then enroll in A081105. If ALK+ enroll in E4512
  • ALCHEMIST A081105Erlotinib or Observation in Pts with Completely Resected EGFR Mutant NSCLC. Must be registered to A151216. No neoadjuvant chemo or RT. . Known resistant mutations (T790M) are NOT eligible. No corneal abnormalities, no locally advanced or metastatic cancer Uses Central Lab to find EGFR exon 19 deletion or L858R mutation
  • ALCHEMIST E4512Phase III Trial for Crizotinib vs Observation for Pts with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein” ALK Positive, Stage 1B (> 4 cm) / II / /IIIA NSCLC. Complete surgical resection.. Max time between surg and randomization: 3 months if no adjuvant chemo - 8 months if adjuvant chemo & 10 months if adjuvant chemo plus RT
  • S1929“Phase II Randomized Study of Maintenance Aezolizumab vs. Atezolizumab in Combination with Talazoparib in Patients with SLFN11 Positive Extensive Stage Small Cell Lung Cancer (ES-SCLC)”
  • A081801: NSCLC: ALCHEMIST-IO Must have EGRF, ALK, PD-LI IHC local testing with no identified arrangements. Must have completely resected dz IB (>/= 4cm), II or IIIA NSCLC with negative margins Patients with N2 Disease completely resected are eligible. However, patients with known N2 dz prior to surgery or ineligible.
  • S1914“A Randomized Phase III Trial of Induction/Consolidation Atezolizumab + SBRT vs. SBRT Alone in High Risk Early Stage NSCLC.”
    Waiting for RT Credentialing and IRB ratification

MDS/AML

  • CONNECT Observation RegistryNewly diagnosed MDS / ICUS / AML > 18 yrs Both genders
    AML=>20% blasts in bone marrow or <20% blasts but with evident recurrent cytogenetic abnormalities. We only have a 14 day window to consent AFTER patient starts treatment!

Melanoma

  • S6134Rand 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. Must have unresectable stage III or IV dz. Not previously tx for met disease. Brain mets not acceptable.. No uveitis. 42 day cycle all arms.

Just In time Clinical Trial Portal

  • CARIS:

A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 Solid Tumors with KRAS G12C Mutation

Enzastaurin + R-CHOP vs. R-CHOP in Treatment Naïve Subjects with High Risk DLBC Lymphoma with DGM1 biomarker

APL 101 in Subjects with NSCL with c-Met EXON 14 Skip mutations and c-Met Dysregulation Advanced Solid Tumors

Seribantumab in Adults Patients with Neuregulin-1 Fusion Positive Locally Advanced or Metastatic Solid Tumors.

Sitravatinib in Combination with Nivolumab vs. Docetaxel in Patients with Advanced Non Squamous NCLC with Disease Progression on or after Platinum based Chemotherapy and Checkpoint Inhibitor Therapy (SAPPHIRE)

MRTX849 in Combination Keytruda NSCLC with KRAS G12C Mut

MCLA-128 Targeting HER2 and HER2 Solid Tumors

IDE196 Solid Tumors GNAQ/11 mutations or PRKC fusions