Regional Network Office SKCN E-News | 1

SKCN E-Newsletter Volume 9 | ISSUE 11 | 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

215-955-4325 or Anthony.Roberts@jefferson.edu

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

to streamline the process for 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

Clinical Trials App

SKCC Featured Trials

NCTN Updates

Upcoming Events

The SKCN Annual Jefferson Oncology Group (JOG) Meeting Presents:

Registration is now CLOSED

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Title: SWOG 1609 “DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors”

Sponsor: NCI (National Cancer Institute)

PI: Russell Schilder, M.D. Primary Objective: To evaluate the RECIST 1.1 overall response rate (ORR) in subsets of patients with advanced rare cancers treated with ipilimumab plus nivolumab combination immunotherapy Treatment: Patients receive nivolumab IV over 30 minutes on days 1, 15, and 29 and ipilimumab IV over 60 minutes on day 1. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity Eligibility: Inclusion Criteria Disease Related Criteria

Patients must have protocol specific histologically

confirmed rare cancer that did not have a match to a

molecularly-guided therapy on EAY131 “NCI MATCH”

or who progressed on molecularly-guided therapy and

have no further molecularly-matched treatment

recommendations per EAY131 “NCI MATCH”

Patients who meet disease criteria and are determined

to have a rare cancer with unknown primary site are

eligible under “tumor of unknown primary” provided

that there is histological documentation of metastatic

malignancy with no discernible primary site identified

from histopathologic review, physical exam, or cross

sectional imaging of the chest, abdomen and pelvis

Patients must have progressed following at least one

line of standard systemic therapy and there must not

be other approved/standard therapy available that has

been shown to prolong overall survival. Patients who

cannot receive other standard therapy that has been

shown to prolong survival due to medical issues will

be eligible, if other eligibility criteria are met OR

patients for whose disease no standard treatment

exists that has been shown to improve overall survival

Prior/Concurrent Therapy Criteria

Patients may have received either prior anti-CTLA4 or other prior anti-PD-1 therapy, not both, provided that it is completed >/= 4 weeks prior to registration for monoclonal therapy, >/= 8 weeks prior to registration if therapy involved immune-stimulatory mAbs, and >/= 28 days for all other immunotherapy

Patients who had prior immune-related adverse event with prior immunotherapy are not eligible

Patients are not eligible if they have had or are planned for solid organ transplant

Patients who received allogeneic hematopoietic stem cell transplant are eligible if:

o The transplant occurred at least 90 days prior to registration

o Patient has no prior acute graft versus host disease (GCHD), and

o Within 48 hours of registration, patient demonstrates at least 90% engraftment, defined as ANC >/= 500mcl, measured over 3 consecutive days or 1 day with an ANC >/= 1,000 mcl, or platelets >/= 50,000 mcl measured, wherein the patient did not receive any platelet transfusion within 7 days prior to laboratory assessment

Clinical/Laboratory Criteria

Patients must have adequate hepatic function as evidenced by all of the following within 28 days prior to registration: ANC >/= 1,000/mcl; platelets >/= 75,000/mcl; hemoglobin >/= 8 g/dL

Patients must have evidence of adequate renal function, as defined by ONE of the following within 28 days prior to registration:

o Serum creatinine </= 2.0 x ULN o Creatinine Clearance (CrCl) >/= 50 mL/min as

estimated by Cockcroft-Gault formula

For more Information,

Please contact

Karah Williams

Clinical Research Coordinator

Karah.Williams@jefferson.edu

215-955-0017

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Title: (NRG-GU003) A Randomized Phase III Trial of Hypofractionated Post-Prostatectomy Radiation Therapy (Hyport) Versus Conventional Post-Prostatectomy Radiation Therapy (Coport)

Sponsor: NRG

PI: Robert Den, M.D. Primary Objective: To demonstrate that hypofractionated post-prostatectomy radiotherapy (Hyport) does not increase patient-reported GI and GU symptoms over conventionally fractionated post-prostatectomy (Coport) at the 2-year time point Treatment: This is a randomized, phase III trial of hypofractionated post-prostatectomy radiation (Hyport) versus conventional post-prostatectomy radiation therapy (Coport). Patients will be randomized to 1 of 2 arms:

Arm 1: (Coport) Patients receive 66.6 Gy in 37 fractions of 1.8 Gy to the prostate bed

Arm 2: (Hyport) Patients receive 62.5 Gy in 25 fractions of 2.5 Gy to the prostate bed

Eligibility: Inclusion Criteria

Adenocarcinoma of the prostate treated primarily with radical prostatectomy

Any type of radical prostatectomy is permitted including retropubic, perineal, laparoscopic or robotically assisted

One of the following pathologic T-classifications: pT2 or pT3

One of the following pathologic N-classifications: pN0 or pNX

No clinical evidence of regional lymph node metastasis

No evidence of local recurrence in the prostate fossa based on a digital rectal examination (DRE) within 60 days prior to step 1 registration

No evidence of bone metastases (M0) on bone scan within 120 days prior to step 1 registration

Exclusion Criteria

A post-prostatectomy PSA nadir >/= 0.2ng/mL AND Gleason >/= 7

pT2 with negative surgical margin AND PSA < 0.1ng/mL

Androgen deprivation therapy (ADT) started prior to prostatectomy for > 6 months duration

o Note: the use of finasteride or dutasteride (+/- tamsulosin) for longer periods prior to prostatectomy is acceptable

Androgen deprivation therapy started after prostatectomy and prior to step 1 registration for > 6 weeks (42 days)

Neoadjuvant chemotherapy before or after prostatectomy

Prior invasive (except non-melanoma skin cancer) malignancy unless disease free for a minimum of 3 years and not in the pelvis; prior hematological malignancy is not allowed

For more Information,

Please contact

Sherin Philipose

Clinical Research Coordinator, CTO

Sherin.Philipose@jefferson.edu

215-516-9424

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Eligibility: Inclusion Criteria

Participants with a histological or cytological confirmed diagnosis of an advanced solid tumor as defined below:

Phase Ib o Arm A Metastatic Colorectal Cancer o Arm B Metastatic Pancreatic

Adenocarcinoma previously untreated o Arm C Metastatic Pancreatic

Adenocarcinoma previously treated with one line of systemic therapy or progressing after adjuvant therapy

Phase II o Arm A – Cohort 1 (1L Colorectal) o Arm A – Cohort 2 (3L Colorectal) o Arm B – Cohort 3 (1L Pancreatic) o Arm C – Cohort 4 (2L Pancreatic) o Arm C – Cohort 5 (2L or 3L Colorectal) o Arm C – Cohort 6 (MSI-H Colorectal)

Participants must have measureable disease by RECIST v1.1

Adequate bone marrow and other organ function as defined in the protocol

Exclusion Criteria

Histology other than adenocarcinoma (neuroendocrine or acinar cell)

Suspected, known, or progressive CNS metastases

Prior treatment with CCR2 and/or CCR5 inhibitors

Any anti-cancer therapy (eg chemotherapy, biologics, vaccines, or hormonal treatment) including investigational drugs within 4 weeks prior to the first dose of study treatment, except for non-cytotoxic therapies, for which at least 4 weeks or 5 half-lives (whichever is shorter) must have elapsed between last dose and first treatment with any study treatments; if 5 half-lives is shorter than 4 weeks, agreement with the medical monitor must be obtained

Title: A Phase Ib/2 Study of BMS-813160 in Combination with Chemotherapy or Nivolumab in Patients with Advanced Solid Tumors

Sponsor: Bristol-Myers Squibb Research and Development

PI: Atrayee Basu-Mallick, M.D. Primary Objective: To evaluate the safety profile, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of BMS-813160 in combination with either chemotherapy or nivolumab in participants with metastatic colorectal cancer and pancreatic cancer. Treatment: The study will be conducted in 2 parts. Part 1 will evaluate safety, tolerability, PK and PD of two different doses of BMS-813160 (ie, 300mg BID or 600mg QD) in combination with either FOLFIRI (Arm A), Gem/ABRAXANE (nab-paclitaxel) (Arm B), or nivolumab (Arm C). Part 2 is a dose expansion study to assess efficacy of BMS-813160 in combination with either chemotherapy or nivolumab

For more information,

Please contact

Jeanne Morrison

Clinical Research Coordinator, CTO

Jeanne.Morrison@jefferson.edu

215-520-1577

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NRG GU002: Phase II-III Trial of Adjuvant Radiotherapy and Androgen Deprivation Following Radical Prostatectomy with or Without Adjuvant Docetaxel SWOG 1609: DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors NRG BN003: A Phase III Trial of Observation versus Irradiation for a Gross Totally Resected Grade II Meningioma NRG GU003: A Randomized Phase III Trial of Hypofractionated Post-Prostatectomy Radiation Therapy (HYPORT) Versus Conventional Post-Prostatectomy Radiation Therapy (COPORT)

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 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 Alliance A021501: Preoperative Extended Chemotherapy vs. Chemotherapy plus Hypofractionated Radiation Therapy for Borderline Resectable Adenocarcinoma of the Head of the Pancreas

Register for the upcoming CTSU Webinar: NCTN Colorectal Cancer Trials Webinar will be held on Thursday, December 14, 2017 from

3pm-4pm EST.

The Data Quality Portal (DQP) is available on the CTSU website in

the “Data Management” tab, previously labeled “Rave/DQP”. The DQP should be utilized t omanage delinquent forms, to manage queries, and to monitor performance for Rave studies.

The Registration and Credential Repository (RCR) was released on

July 28, 2017. Information is available on the CTSU website.

Registration is now OPEN for the NRG Oncology Semiannual Meeting in Phoenix, AZ. Pre-registration deadline is January 3, 2018!

Please register online for this meeting by January 3, 2018 in order to avoid long lines at the onsite registration desk. Registering onsite will incur an additional $50 fee.

Registration and meeting information is available on the NRG Oncology Website.

VTOC Training

VTOC Webinar Series schedule and registeation is available for NRG Oncology Research Associates working on RTOG 0924, RTOG 0920, NRG-HN001, HN002, CC003, and CC004. The next training will be held at the NRG meeting on January 25th, 2018 at 1pm.

EAY131 (MATCH) Updates Subprotocol B Suspension – Suspension Date 11/9/17 Subprotocol U Suspension – Suspension Date 11/9/17 Subprotocol Z1B Suspension – Suspension Date 11/14/17

NRG-BR003, “A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer”, continuing review CIRB approved NRG-CC001, “A Randomized Phase III Trial of Memantine and Whole-Brain Radiotherapy with or without Hippocampal Avoidance in Patients with Brain Metastases”, amendments #2 and #3 CIRB approved

Please continue to pull the consents from JeffTrial. If you have anyquestions, please email RNOregulatory@jefferson.edu

Regional Network Office SKCN E-News | 6

Save the Dates:

Jefferson Oncology Group Annual Meeting: December 6, 2017 - Philadelphia PA

CRA Research Update: December 13, 2017 - Philadelphia, PA

NRG Oncology Semiannual Meeting: January 25-27, 2018 - Phoenix, AZ CRA Research Update: March 14, 2018 – Philadelphia, PA ECOG-ACRIN Semiannual Meeting: May 3-5, 2018 – Chicago, IL

The Clinical Research E-News: Archive is now located on the Sidney Kimmel Cancer Center webpage under the SKCN Member Area: http://isley.kcc.tju.edu/skcn/e-newsletters.html

Sidney Kimmel Cancer Network Homepage:

http://isley.kcc.tju.edu/skcn/ -This page contains links to the Remote Access Portal.

Contact Information:

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

Anthony Roberts, BS JOG Coordinator Editor, E-Newsletter

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

JOG E-Newsletter inquiries

Joshua Schoppe, MPH, CCRP Senior Director, RNO

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

RNO and SKCN inquiries

Suzanne Jorfi, BS, CCRP Regulatory Manager

Office: 215-955-0024 suzanne.jorfi@jefferson.edu

Regulatory Update inquiries or CIRB

Protocol Support Unit RNORegulatory@jefferson.edu

Regulatory Related inquires