Regional Network Office SKCN E-News | 1

SKCN E-Newsletter Volume 10 | ISSUE 5 | Regional Network Office

Clinical Trials at your

Fingertips

The Jefferson Clinical Trials app

allows you to quickly reference the

TJU clinical trials database, including

access to contact information for all

trials. Download the app by searching

Jefferson Clinical Trials

For more information,

Please contact Anthony Roberts, BS CCRP

215-955-4235 or Anthony.Roberts@jefferson.edu

REFERRING A PATIENT? The SKCN has launched a new referral email address

to streamline the process for working together to provide our patients with personalized

oncology treatment care.

Please email information to clinical-trial-referrals@jefferson.edu

IN THIS ISSUE

Center Stage

SKCC Featured Trials

NCTN Updates

Upcoming Events

Registration is now OPEN for the NRG Oncology

Semiannual Meeting in Philadelphia!

Online pre-registration for the meeting ends June 22, 2018.

Registration and meeting information available on the NRG Website

NRG Oncology Meeting Registration

Regional Network Office SKCN E-News | 2

Title: A Phase Ib/II Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer (mCRPC) Sponsor: Janssen Research and Development PI: W. Kevin Kelly, DO Primary Objectives: Part 1 Objectives

To evaluate the tolerability of niraparib combination therapies for the treatment of mCRPC

Determine the RP2D of niraparib combination therapies

Part 2 Objectives

To evaluate the antitumor effect of the RP2D of niraparib combination therapies for the treatment of mCRPC

To evaluate the safety of the RP2D of niraparib combination therapies for the treatment of mCRPC

Treatment: The study will enroll patients with mCRPC who are either BM+ (cohort 1a) or BM- (cohort 1b) for DNA-repair anomalies based on the sponsor’s blood-based assay. For Part 1, two doses of JNJ-63723283 will be explored. At least 6 evaluable subjects will be treated with niraparib 200 mg orally once daily in combination with JNJ-63723283 240 mg IV once every 2 weeks (does regimen 1) and at least 6 evaluable subjects will be treated with niraparib 200 mg orally once daily in combination with JNJ-63723283 480 mg IV once every 4 weeks (does regimen 2). These 2 dose regimens will be enrolled simultaneously

Eligibility: Inclusion Criteria

At least 1, but no more than 2, lines of novel AR-targeted therapy for prostate cancer. Subjects must have had at least 4 weeks of AR-targeted therapy

Diagnosis of prostate adenocarcinoma as confirmed by the investigator

Must have determination of biomarker status (either BM+ or BM-) by the sponsor’s blood-based assay

Subjects must have measurable disease as defined by RECIST 1.1 (soft tissue lesion of ≥ 10mm in the long axis or extrapelvic lymph node of ≥ 15mm in the short axis

Progression of metastatic prostate cancer at study entry defined as having one or more of the following:

o PSA progression defined by minimum of 2 rising PSA levels with an interval of ≥ 1 week between each determination. The prostate cancer at the screening visit should be ≥ 2 µg/L (2ng/mL)

o Radiographic progression by bone scan per Prostate Cancer Working Group 3 criteria or by soft tissue per RECIST 1.1

Exclusion Criteria

Prior treatment with a PARP inhibitor

History of current diagnosis of MDS/AML

Allergies, hypersensitivity, or intolerance to niraparib or the corresponding excipients

Prior radium treatment or treatment with other therapeutic radiopharmaceuticals for prostate cancer

Symptomatic brain metastases from prostate cancer

For more Information,

Please contact

Traci Southwell, RN

Clinical Research Coordinator

Traci.Southwell@jefferson.edu

215-503-2703

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Title: Non-Randomized, Open-Label Phase II Study to Assess Olaparib Tablets as a Treatment for Subjects with Different HRD Tumor Status and with Platinum-Sensitive, Relapsed, High-Grade Serous or High-Grade Endometrioid Ovarian, Fallopian Tube, or Primary Peritoneal Cancer That Have Received at least One Prior Line of Chemotherapy Sponsor: AstraZeneca PI: Scott Richard, MD Primary Objective: To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using objective response rate (ORR) according to RECIST v1.1 criteria Secondary Objective: To determine the clinical effectiveness of olaparib treatment in each of the 4 cohorts assessed using duration of response Treatment: Olaparib 300mg tablets taken orally twice daily

Eligibility: Inclusion Criteria

Female subjects with histologically diagnosed relapsed high-grade serous ovarian cancer (including primary peritoneal and/or fallopian tube cancer) or high-grade endometrioid cancer

At least one lesion (measurable by RECIST v1.1) that can be accurately assessed at baseline by CT/MRI and is suitable for repeated assessment

Subjects must have received at least one prior platinum-based line of chemotherapy for ovarian cancer. Note: There is no limit on the number of lines of chemotherapy

Subjects must be partially-platinum-sensitive (defined as progression 6 to 12 months after the end of the last platinum-based chemotherapy) or platinum-sensitive (defined as progression > 12 months after the end of the last platinum-based chemotherapy)

ECOG performance status 0 to 1

Subjects must have a life expectancy of ≥ 16 weeks

Exclusion Criteria

Exposure to any investigational product (IP) within 30 days or 5 half-lives (whichever is longer) prior to start of study treatment

Any previous treatment with a PARP inhibitor, including olaparib

Subjects who have platinum-resistant or refractory disease defined as progression during or within 6 months of the last platinum-based chemotherapy

Resting ECG with clinically significant abnormal findings

Subjects receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment

Subjects with MDS/AML or with features suggestive of MDS/AML

Subjects with pneumonitis or at risk of pneumonitis

Subjects with uncontrolled brain metastases

Subjects with a known hypersensitivity to olaparib or any of the excipients of the product

Previous allogenic bone marrow transplant or double umbilical cord blood transplantation

Whole blood transfusions in the last 120 days prior to study entry

For more Information,

Please contact

Daniel Vernau

Clinical Research Coordinator, CTO

Daniel.Vernau@jefferson.edu

215-516-9165

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Title: SPARE – Scalp Preservation and Radiation Plus Alternating Electric Tumor Treatment Field (novoTTF, Optune) for Patients with Glioblastoma: A Pilot Study Sponsor: Novocure PI: Wenyin Shi, MD, PhD Primary Objective: To evaluate the safety and toxicity of combination chemoradiotherapy with Optune treatment in newly diagnosed glioblastoma Secondary Objectives:

To determine the median progression-free survival of patients with newly diagnosed glioblastoma treated with radiotherapy with concurrent and adjuvant temozolomide plus Optune

To determine the median overall survival, 1-year survival and event-free survival

Treatment: Concurrent Phase

Scalp Sparing Radiation Therapy – 60 Gy in 2 Gy fractions + concurrent daily Temozolomide 75 mg/m2 PO + Optune Tumor Treatment Fields (TTFields) for at least 18 hours/day

Maintenance Phase

Temozolomide daily at standard of care dose for up to 12 cycles + Optune until second disease progression

Eligibility: Inclusion Criteria

Patients with pathologically confirmed newly diagnosed WHO grade IV glioma

Karnofsky Performance Score ≥ 60

Patients must have recovered from the effects of surgery per treating physician’s judgement. There must be a minimum of 21 days from the day of surgery to the day of protocol treatment. For core or needle biopsies, a minimum of 14 days must have elapsed prior to the day of protocol treatment

Subject is able to have MRI with contrast of the brain

Exclusion Criteria

Infratentorial disease (defined as GBM derived from the cerebellum or brainstem)

Implanted pacemaker, defibrillator or deep brain stimulator, or documented clinically significant arrhythmias

A skull defect (such as, missing bone with no replacement)

Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema)

Prior radiation treatment to the brain

Prior treatment with temozolomide

Known hypersensitivity to conductive hydrogels like the gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes

Known active collagen vascular disease

Patients with non-healing surgical incisions or wounds on the scalp

For more Information,

Please contact

Suzanne O’Hara

Clinical Research Coordinator, CTO

Suzanne.Ohara@jefferson.edu

267-605-6288

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Title: A Randomized, Phase II Study of Atezolizumab in Combination with Cobimetinib versus Atezolizumab Monotherapy in Participants with Unresectable Cholangiocarcinoma Sponsor: NCI/ETCTN PI: James Posey, MD Primary Objectives: To assess the progression free survival (PFS) of patients receiving atezolizumab monotherapy and cobimetinib in combination with atezolizumab for unresectable cholangiocarcinoma

Treatment: Patients randomized to Arm A will receive treatment with atezolizumab 840 mg IV every 2 weeks. Patients randomized to Arm B will receive oral cobimetinib 60 mg daily (21 days on/7 days off) plus atezolizumab 840 mg IV every 2 weeks. Therapy on either treatment arm will be continued without interruption until progression or intolerance to therapy. For all patients, imaging scans will be performed at baseline and every 8 weeks thereafter, irrespective of the treatment schedule. Eligible subjects will be stratified according to the site of disease: 1) gallbladder cancer (GBC); 2) intrahepatic (IHC); or 3) extrahepatic cholangiocarcinoma (EHC).

Eligibility Criteria: Inclusion Criteria

Pathologically confirmed cholangiocarcinoma or gallbladder carcinoma, having received at least one prior line of systemic therapy, and received no more than 2 prior lines of therapy in the metastatic setting (disease recurrence < 6 months from the last dose of adjuvant therapy in resected patients will be considered the first line of therapy

o Includes intrahepatic cholangiocarcinoma extrahepatic cholangiocarcinoma, and gallbladder carcinoma, but not Ampulla of Vater cancers

Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as ≥ 20mm with conventional techniques or as ≥ 10mm with spiral CT scan, MRI or calipers by clinical exam

ECOG performance status of ≤ 1 (KPS ≥ 80%)

Life expectancy of greater than 2 months

Oxygen saturation ≥ 92% on room air Exclusion Criteria

Received chemotherapy or radiotherapy within 3 weeks prior to randomization or those who have not recovered to ≤ grade 1 adverse events (other than alopecia) due to agents administered more than 3 weeks earlier. Herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to randomization. For patients who received prior immunotherapy, at least 5 drug half-lives must have passed before the patient may enroll on this study. However, the following therapies are allowed:

o Hormone-replacement therapy or oral contraceptives

o Palliative radiotherapy for bone metastases ≥ 2 weeks prior to randomization

Prior treatment with an MEK inhibitor or ERK inhibitor

Prior treatment with any anti-PD-1 or anti-PD-L1 antibody, prior allogeneic bone marrow transplantation, or prior solid organ transplantation

Allergy or hypersensitivity to components of the cobimetinib formulations

Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies

History of malabsorption syndrome or other condition that would interfere with enteral absorption

Clinically significant ascites, defined as ascites that is symptomatic or has resulted in a paracentesis in the past 3 months

For more Information,

Please contact

Sarah Shaw

Clinical Research Coordinator, CTO

Sarah.Shaw@jefferson.edu

215-519-4232

Regional Network Office SKCN E-News | 6

NRG LU002: Maintenance Systemic Therapy Versus Consolidative Stereotactic Body Radiation Therapy (SBRT) Plus Maintenance Systemic

Therapy for Limited Metastatic Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II/III Trial ECOG 1910: A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic

Leukemia in Adults Alliance A011502: A Randomized, Phase III, Double-Blind, Placebo Controlled Trial of Aspirin as Adjuvant Therapy for Node Positive HER2-

Breast Cancer: The ABC Trial

SWOG 1602: A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming with Intradermal BCG Before

Intravesical Therapy for BCG-Naïve High-Grade Non-Muscle Invasive Bladder Cancer NRG GY009: A Randomized, Phase II/III Study of Pegylated Liposomal Doxorubicin and CTEP-Supplied Atezolizumab versus Pegylated

Liposomal Doxorubicin/Bevacizumab and CTEP-Supplied Atezolizumab versus Pegylated Liposomal Doxorubicin/Bevacizumab in Platinum Resistance Ovarian Cancer ECOG EAE161: Perfusion CT to Predict Progression-Free Survival and Response Rate in Bevacizumab and Paclitaxel Treatment of Platinum-

Resistant, Persistent, or Recurrent Epithelial Ovarian, Fallopian Tube or Peritoneal Carcinoma ECOG EA9152: A Phase Ib/II Study of Venetoclax (ABT-199) in Combination with Liposomal Vincristine in Patients with Relapsed or Refractory

T-cell or B-cell Acute Lymphoblastic Leukemia

Regulatory Submission Portal Updates

Starting in mid-May, you are now able to upload forms related to membership, supply/investigtor brochure requests, abd patient transfer/enrollment requests through the Regulatory Submission Portal (RSP). The steps for uploading membership or patient enrollment forms are the same as the regulatory forms with a few important differences. For more information follow the link below: CTSU Regulatory Submission Portal

VTOC Training

The VTOC Webinar Training Series schedule and registration is available for NRG Oncology Research Associates working on RTOG 0920, 0924, NRG HN001, HN002, CC003 and CC004. Space is limited so register now and reserve your seat. The next training is scheduled for June 6, 2018. NRG Oncology Semiannual Meeting Registration is Open!

We hope you can attend the NRG Oncology Semiannual Meeting July 12-14, 2018 at the Philadelphia Marriott Downtown in Philadelphia, PA. Pre-registration deadline is June 22, 2018. The hotel registration deadline is June 20, 2018. NRG Oncology is kindly requesting that everyone please pre-register online for this meeting before the deadline. Registration onsite will incur an additional $50 fee.

Registration and meeting information is available on the NRG Oncology Website

EAY131 (MATCH) Step 0 Biopsy Reimbursement Alert

For patients enrolled onto step 0 via the original screening process, requests for step 0 fresh biopsy reimbursements will no longer accepted after May 31, 2018. Sites must review their patient cases in OPEN to ensure they have completed entry of the procedure dates for step 0 screening biopsies applicable for reimbursement in order for funding to be considered.

RTOG 0848: “A Phase II-R and Phase III Trial Evaluating Both

Erlotinib and Chemoradiation as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma”, amendment #7 approved E2511: “A Phase I and Randomized Phase II Double Blind Clinical

Trial of Cisplatin and Etoposide in Combination with Veliparib (ABT-088) or Placebo as Frontline Therapy for Extensive Stage Small Cell Lung Cancer”, continuing review approved (study closed to accrual) Reminder: All TJU-IRB approved consents, consent addenda and approved patient materials will be sent to all participating study sites via email and are also available upon request to the TJU Protocol Support Unit (PSU) via the RNOregulatory@jefferson.edu email address. Urgent requests can be made using the RNO cell phone @ 215-600-9151

Regional Network Office SKCN E-News | 7

Save the Dates:

CRA Research Update: June 13, 2018 – Philadelphia, PA NRG Oncology Semiannual Meeting: July 12-14, 2018 – Philadelphia, PA CRA Research Update: September 12, 2018 – Philadelphia, PA SoCRA Annual Conference: September 28-30, 2018 – New Orleans, LA ECOG-ACRIN Semiannual Meeting: October 25-27, 2018 – Fort Lauderdale, FL

The Clinical Research E-News: Archive is now located on the Sidney Kimmel Cancer Center webpage under the SKCN Member Area: E-Newsletter Archive

Sidney Kimmel Cancer Network Homepage:

Cancer Network Homepage -This page contains links to the Remote Access Portal.

SKCC Clinical Trials App Update: Over the past week we have been working to resolve an issue with the SKCC Clinical Trials App that may have prevented you from being able to search SKCC trials through the app. We have resolved the issue and you can follow the instructions below to update the app on your device: Android Users: Please delete the current version of the app. Navigate to the Google Play Store, search “Jefferson Clinical Trials” and download the new version iPhone Users: If you have automatic updates enabled, the current app should update automatically. If you do not have this feature enabled, please navigate to the app store, select “updates”, find the Clinical Trials App and select update to the latest version

Contact Information:

For URGENT ISSUES, Please call the RNO cellphone at 215-600-9151

Anthony Roberts, BS CCRP JOG Coordinator, RNO Editor, E-Newsletter

Office: 215-955-4235 anthony.roberts@jefferson.edu

NCTN, JOG, RNO, E-Newsletter inquiries

Laura Romeu, BS Project Manager, RNO Co-Editor, E-Newsletter

Office: 215-955-9923 laura.romeu@jefferson.edu

NCTN, JOG, RNO inquiries

Joshua Schoppe, MPH, CCRP Senior Director, RNO

Office: 215-955-0448 joshua.schoppe@jefferson.edu

RNO and SKCN inquiries

Erin Tello, BS Regulatory Coordinator

Office: 215-955-5802 erin.tello@jefferson.edu

Regulatory Update inquiries or CIRB

Protocol Support Unit RNORegulatory@jefferson.edu

Regulatory Related inquires