INTEGRIS Cancer Institute

Clinical Trials

INTEGRIS Cancer Institute - Proton Campus
June 2021

If you have a potential patient, please call 405-773-6613


STUDY NAME

DZ SITE

STUDY Description

ARMS

# PTS

S1418/BR006
R#5 7/30/19

TNBC

“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
Phase III for pts with Triple Negative Breast Cancer, > 1 cm residual invasive breast cancer, or any positive lymph nodes after neoadjuvant chemotherapy. Followed by surgery. Step 1 registration requires enough tissue to evaluate PD-L1.  Pts must complete adjuvant chemo prior to starting therapy with pembrolizumab.  

Randomization to Arm 1
Observation
Randomization to Arm 2
Pembrolizumab
Radiation may be given concurrently on either arm.

1

 

NRGBR004

HER2+
Hormone Receptor status can either positive or negative

“A Randomized, Double Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in 1st Line HER2 Positive Metastatic Breast Cancer.”
Prior neoadjuvant or adjuvant therapy with trastuzumab (no; yes with neither pertuzumab or delayed adjuvant neratinib **Estrogen receptor status positive or negative**PD-L1 status (positive; negative or indeterminant)**Diease sites (any visceral without brain metastasis; non-visceral only without brain metastasis; brain mestastasis)
Placebo/Atezolizumab provided by the Sponsor

ARM 1 – Paclitaxel* Days 1, 8, 15, 22, 29 and 36 every 6 weeks for 4 cycles PLUS
Trastuzumab + Pertuzumab Days 1 and 22 every 6 weeks until progression
**Placebo Days 1 and 22 every 6 weeks until progression or for 2 years.
ARM2 -  Paclitaxel* Days 1, 8, 15, 22, 29 and 36 every 6 weeks for 4 cycles PLUS
Trastuzumab + Pertuzumab Days 1 and 22 every 6 weeks until progression
**Atezolizumab Days 1 and 22 every 6 weeks until progression or for 2 years.

0

ALLIANCE
A011202

 

Breast Cancer Patients with
( cT1-3 N1)

“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. 

ARM 1 – ALND + Nodal XRT (w/o XRT to dissected axilla)
ARM 2 – Axillary XRT and Nodal XRT

0

ALCHEMIST A151216

Non-Squamous Lung

A 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

Pre-Register give 3 blood specimens btw post-surgery to 30 days post registration.  Step 1 FFPE Block Collected.
If EGFR confirmed enroll in  A081105.
If ALK+ enroll in E4512

1

ALCHEMIST A081105

EGFR Lung

Randomized 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.
TEMPORARILY SUSPENDED 12.22.2020

Randomization to Group 1
Ertotinib 150 mg/day for up to 2 yrs.
Randomization to Group  2
Observation
1 cycle = 21 days
Study Drug provided by the Sponsor

0

ALCHEMIST
A081801

 

NSCLC

Integration 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. 

Initial Therapy:
Arm A: 4 Cycles of Platinum doublet
With Observation afterwards.
Arm B: 4 Cycles of Platinum doublet with 17 cycles of Keytruda
Amr C: 4 Cycles of Platinum doublet + Keytruda with 13 more cycles of Keytruda.  

0

ALCHEMIST
E4512

ALK
Lung

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” (IRB # 18-027)
ALK Positive, Stage 1B (> 4 cm) / II / /IIIA NSCLC. Complete surgical resection & registered to A151216  . Complete surgical resection. Max time btw surg and randomization is 3 months if no adjvant chemo,        8 months if adjuvant chemo and 10 months if adjuvant chemo + RT

Randomization to Arm A
Crizotinib 250 mg PO BID Days 1-21 until recurrence, toxicity or 2 yr treatment.

Randomization to Arm B
Observation
Study Drug Provided by the Sponsor

1

S1929

SCLC

“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)”
SLFN11 Testing During Induction Treatment.  If SLFN11 positive, then patients are randomized to either Arm A or Arm B

Arm A Atezolizumab Maintenance Treatment.
ARM B      Atezolizumab plus Talazoparib Maintenance Treatment

On HOLD per RT due to new machine

 

ECOG
EA5181

 

LUNG

EA5181 – “Randomized Phase III Trial of MED14736 (Durvalumab)as Concurrent and Consolidative Therapy or Consolidative Therapy Alone for Unresectable Stage 3 NSCLC.”
On HOLD per RT due to new machine

Arm A:   Durvalaumab 750 mg IV q2 weeks x 3, Platinum Doublet and concurrent RT to 60 Gy.
ARM B:   Platinum Doublet and Concurrent RT to 60 Gy
Step 2 Registration: Consolodation
Arm C:  Consolidative durvalumab 1500 mg IV q4 weeks for 1 year after the end of Step 1 CRT

0

S1933

LUNG

“A Pilot Study of Hypofranctionated Radiotherapy Followed by Atezolizumab Consolidation in Stage II or III NSCLC patients with Boderfl ine Performance Status.” 

On HOLD per RT due to new machine

60 GY Hypofractionated radiotherapy in 15 fractions over 3 weeks
 2-5 weeks after completion of RT
Progression Disease – Off Treatment
Registration Step 2 - Atezolizumab

 

S1914

 

LUNG

“A Randomized Phase III Trial of Induction/Consolidation Atezolizumab + SBRT vs. SBRT Alone in High Risk Early Stage NSCLC.”  
On HOLD per RT due to new machine

ARM A:   Atezolizumab 8 cycles + SBRT
ARM B:    SBRT in 3 -5 fractions

0

CARIS
Just In time Clinical Trial Portal

NSLC

A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Adjuvant Alectinib vs. Adjuvant Platinum based Chemotherapy with Completely Resected Stage IB (Tumors = 4 CM) to Stage IIIA ALK Positive NSCLC.”

Study Drug:   Alectinib
Arm A – Alectinb 600 mg bid
Arm B – Platinum based chemo

 

CARIS
Just In time Clinical Trial Portal

NSCLC

“A Phase 1 and 2 Multicenter Study of the Safety, Pharmacokinetics and Preliminary Efficacy of APL-101 in Subjects with NSCLC with c-Met EXON 14 skip Mutations and c-Met Dysregulation Advanced Solid Tumor.”   Stage 3b or 4 cancer

Open Label:    APL-101 or Bozitinib

 

CARIS
Just In time Clinical Trial Portal

Non Squamous NCLC

“A Randomized Phase 3 Study of Sitravatinib in Combination with Nivolumab vs. Docetaxel in Patients with Advanced Non-Squamous NSCLC with disease progression on or after platinum based chemotherapy and Checkpoint Inhibtor Therapy (SAPPHIRE)
Biomarker:  N/A

Arm A:  Sitravatinib + Nivolumab
Arm B:   Docetaxel

 

CARIS
Just In time Clinical Trial Portal

NSCLC

“A Randomized Phase 3 Study of MRTX849 vs. Docetaxel in Patients with Previously Treated Non Small Cell Lung Cancer with KRAS G12C Mutation.”  

Arm A:    MRTX849
Arm B:   Docetaxel

 

CARIS
Just In time Clinical Trial Portal

NSCLC

“A Phase 2 Trial of MRTX849 in Combination with Pembrolizumab in Patients with Advanced NSCLC with KRAS G12C

MRTX849 + Pembrolizumab

 

    S1815

Advanced Biliary Cancers

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

ARM I Gemcitabine + Cisplatin + Nab-Paclitaxel
ARM II Gemcitabine + Cisplatin
Nab-Paclitaxel provided by the Sponsor

0

NRG-GI005

Stage IIA Colon Cancer

“A Phase II/III Study of Circulating Tumor DNA as a Predictive Biomarker in Adjuvant Chemotherapy in Patients with Stage IIA Colon Cancer (COBRA)
Temporarily Suspended as of 12.28.2020

ARM 1  SOC – Active Surveillance
ARM 2 – Assay directed Therapy
ctDNA detected – mFOLFOX6 or CAPOX
ctDNA not detected – Active Surveillance

0

SWOG 1613

Metastatic Colon

Two Step Registration for this Randomized Phase II Study of Trastuzumab & Pertuzumab compared to Cetuximab and Irinotecan in Advanced/MET Colorectal Cancer with Her2 Amplification
Met or locally advanced and unresectable colorectal cancer. KRAS & NRAS Wild Type – no mutations in exon 2, exon 3, exon 4 No BRAF V60E exon 15 mutation.  Step 1 tests for H2N amplification .  Step 2 test immunotherapy vs chem.  Step 3 is optional crossover from CETITI to TP. 

ARM 1 Trastuzumab + Pertuzumab
ARM II Cetuximab + Irinotecan

0

CARIS
Just In time Clinical Trial Portal

Advanced CRC

“A Randomized Phase 3 study of MRTX849 in Combination with Cetuximab vs. Chemotherapy in Patients with Advanced Colorectal Cancer with KRASG12C Mutation with Disease Progression On or After Standard First-Line Therapy.” 
Biomarker:  KRAS G12C

Arm A:  Cetuximab + MRTX849
Arm B:  FOLFOX6 or FOLFIRI

 

CARIS
Just In time Clinical Trial Portal

GI Solid Tumors

“A Phase I Open-Label Dose Escalation and Dose Expansion Study of CGX1321 in Subjects with Advanced Solid Tumors and Phase Ib Study of CGX1321 in Combination with Pembrolizumab in Subjects with Advanced Gastrointestinal Tumors.”  
Biomarkers:   RSPO2, RSPO3

Phase I Single Agent CGX1321
Phase IB CGX1321 in combination with Pembrolizumab after progression on single agent CGX1321.  

 

MORPHOSYS
B-MIND

R-R DLBC Lymphoma

A 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

Open Label, randomized trial to evaluate the efficacy and safety of MOR00208 with Bendamustine (BEN) vs. Rituximab (RTX) with BEN in adult patients with R-R DLBCL.
Study Drugs provided by the Sponsor

1

CONNECT
Observational Registry

MDS/AML

“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! 

Newly Diagnosed    MDS / ICUS / AML
Bone Marrow Path sent to Central Lab
AML=20% blasts in BM or <20% blasts but have evident recurrent cytogenetic abnormalities.
Informed Consent within 60 days of Diag. 
Pt Enrollment – Baseline Report
Quarterly FU (Clinical/Tx data & QoL)

0

CARIS
Just In time Clinical Trial Portal

Advanced Solid Tumors

Tumor-Agnostic Precision Immuunooncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial
Biomarkers:  NTRK, ROS1, ALK, TMB, AKT, HER2, PIK3CA

Study drugs: Entrectinib, Alectinib, Atezolizumab, Ipatasertib, Trastuzumab Ematansine, GDC-0077

0

CARIS
Just In time Clinical Trial Portal

Advanced Solid Tumors

“A Phase 2 study of Seribantumab in Adult Patients with Neuregulin-1 (NRG1) Fusion Positive Locally Advanced or Metastatic Solid Tumors.”  

Seribantumab 3,000 mg IV every 2 weeks x 6 doses 9Days 36, 50, 64, 78, 92 and 106)

Maintenance:   Seribantumab 3,000 mg IV every 3 weeks initiating 21 days after the final consolidation treatment

 

CARIS
Just In time Clinical Trial Portal

Solid Tumors

“A Phase 1 and 2 Study of MCLA-128 a full length IgG1 Bispecific Antibody Targeting HER2 and HER3 in Patients with Solid Tumors.”

Biomarkers:   NRG1

Study Drug:   MCLA-128

 

CARIS
Just In time Clinical Trial Portal

Solid Tumors

“A Phase 1 and 2 study of IDE196 in patients with solid tumors harboring GNQ/11 mutations or PRKC fusions.”

Biomarkers:   GNAQ, GNA11

Study Drug:  IDE196

 

CARIS
Just In time Clinical Trial Portal

Solid Tumors

“A Phase 1 and 2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation.”

Biomarker:   KRAS G12C 

Open to NSCLC only.  All other Cohorts closed for accrual.

Study Drug:   MRTX849

 

CARIS
Just In time Clinical Trial Portal

Solid Tumors

“A Phase 1 and 2 Study of Highly Selective RET Inhibitor, BLU-667 in patients with thyroid cancer, NSCLC and other Advanced Solid Tumors.”  

Biomarker:   RET

Study Drug:  Pralsetinib