skcn e-newsletter...alveolar soft part sarcoma. please contact sarah shaw bone). metastatic synovial...

SKCN E-Newsletter Volume 9 | ISSUE 10 | 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 [email protected]

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 [email protected]

IN THIS ISSUE

Center Stage

Clinical Trials App

SKCC Featured Trials

NCTN Updates

Upcoming Events

On behalf of the Thomas Jefferson University’s Sidney

Kimmel Cancer Network, Cynthia Perez, BS, CCRP

Poster Presented, “The Development of the TJU NRG

Oncology Reimbursement Process” at the Society of

Clinical Research Associates (SoCRA) on October 6-8,

2017.

mailto:[email protected]


Regional Network Office SKCN E-News | 2

Title: A Randomized Controlled Trial Evaluating the Use of G-CSF after Plerixafor-Mobilized Autologous Stem Cell Transplant (Auto HSCT)

Sponsor: Thomas Jefferson University (TJU)

PI: Neal Flomenberg, MD

Primary Objective: To demonstrate non-inferiority in the number of days to discharge readiness after a G-CSF + Plerixafor mobilized autologous stem cell transplant in patients not receiving post-transplant G-CSF support versus those receiving post-transplant G-CSF growth factor support.

Treatment: G-CSF + Plerixafor

Eligibility: Inclusion Criteria

Age ≥18 years

Undergoing autologous stem cell transplant for one

of the following diagnoses:

o Multiple myeloma

o Non-Hodgkin lymphoma

Karnofsky performance status of ≥ 70%

Patients must meet the TJUH BMT SOP guidelines

for “Patient Criteria for Autologous HSCT.”

Adequate organ function:

LVEF of >40%

DLCO >45% of predicted corrected for hemoglobin

Adequate liver function as defined by a serum

bilirubin <1.8, AST or ALT < 2.5X upper limit of

normal

Serum creatinine ≤ 2.0 mg/dl and/or creatinine clearance of > 40 ml/min (excludes multiple myeloma patients receiving high dose Melphalan conditioning)

Willingness to use contraception if childbearing potential

Has the ability to give informed consent, or for cognitively or decisionally impaired individuals (vulnerable population), the availability of a family member or guardian to give consent and assist in the consent process

Life expectancy of > 12 months (exclusive of the disease for which the Auto HSCT is being performed)

Patients must have undergone stem cell mobilization with the combination of G-CSF and plerixafor as per TJUH BMT SOP guidelines

Collection of an adequate number of CD34+ stem cells, i.e. ≥ 4-6 × 106/kg from apheresis

Exclusion Criteria:

Uncontrolled HIV

Uncontrolled bacterial infection

Active CNS disease

Pregnancy or lactation

Evidence of another malignancy, exclusive of a

skin cancer that requires only local treatment

For more Information,

Please contact

Gina Mateja

Clinical Research Coordinator

[email protected]

215-713-5825



Title: A Phase III Study of AL3818 (Anlotinib) Hydrochloride Monotherapy in Subjects with Metastatic or Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma and Synovial Sarcoma

Sponsor: Advenchen Laboratories, LLC

PI: Atrayee Basu-Mallick, MD

Primary Objective:

Indication A: To evaluate the efficacy of AL3818 for the treatment of ASPS, as measured by objective response rate (ORR) to exclude an ORR of 17% at the lower limit of the 95% confidence interval with an actual ORR of 31.1%.

Indication B: To compare the efficacy of AL3818 versus dacarbazine for the treatment of LMS, as measured by progression-free survival (PFS).

Indication C: To compare the efficacy of AL3818 versus dacarbazine for the treatment of SS, as measured by progression-free survival (PFS).

Treatment:

Indication A: Subjects with ASPS will receive AL3818 administered as one 12 mg capsule orally once daily in 21-day cycles for 14 days on treatment (Days 1-14) and 7 days off treatment (Days 15-21). Dose may be reduced to 10 mg or 8 mg, if needed.

Indication B: Subjects with LMS will be randomized in a 2:1 ratio to receive either AL3818 or dacarbazine.

Indication C: Subjects with SS will be randomized in a 2:1 ratio to receive either AL3818 or dacarbazine. o AL3818 will be administrated as one 12 mg

capsule orally once daily in 21-day cycles for 14 days on treatment (Days 1-14) and 7 days off treatment (Days 15-21). Dose may be reduced to 10 mg or 8 mg, if needed.

o Dacarbazine will be administered at a dose of 1000 mg/m2 as a 20-120 minute IV infusion on Day 1 of each 21-day treatment cycles.


Indications: o Indication A – ASPS: Histologically proven,

unresectable, locally advanced or metastatic alveolar soft part sarcoma.

o Indication B – LMS: Histologically proven, unresectable, recurrent, locally advanced or metastatic leiomyosarcoma (of soft tissue, cutaneous origin, vascular origin and of the bone).

o Indication C – SS: Histologically proven, unresectable, recurrent, locally advanced or metastatic synovial sarcoma.

Indications: o Indication A – ASPS: Subjects with no prior

therapy or subjects with prior treatment with chemotherapy or an angiogenesis inhibitor (e.g., sunitinib).

o Indication B – LMS: Subjects previously treated with at least one prior line of approved therapy.

o Indication C – SS: Subjects previously treated with at least one prior line of approved therapy, including first-line anthracycline containing regimen.

Show objective disease progression after the last

administration of the last standard therapy or have

stopped standard therapy due to intolerability

(excluding ASPS subjects who have not received

prior therapy) within 6 months of enrollment.

ECOG performance status of 0 or 1.

Has measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 confirmed by CT or MRI scan within 28 days prior to enrollment.

Exclusion Criteria:

Prior treatment with or have known hypersensitivity to AL3818. o Indication A – ASPS: Prior treatment with

cediranib. o Indication B– LMS: Prior treatment with or

have known hypersensitivity to dacarbazine. o Indication C – SS: Prior treatment with or

have known hypersensitivity to dacarbazine.

Previous or concurrent cancer that is distinct in primary site or histology from ASPS, LS, or SS within 5 years before enrollment except for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors (Ta, Tis and T1).

Received last dose of systemic cytotoxic therapy, radiation therapy or therapy with any investigational product within 28 days of enrollment.

Prior treatment with extended-field radiotherapy within 28 days prior to enrollment or prior treatment with extended-field radiotherapy for evaluating tumor lesions within 14 days prior to enrollment.


Please contact

Sarah Shaw


[email protected]

215-503-2551



Title: A Phase 1/2, Multicenter, Single Arm, Open Label, Dose Escalation Study of Birinapant in Combination with Pembrolizumab (KEYTRUDA™) in Patients with Relapsed or Refractory Solid Tumors

Sponsor: Medivir AB

PI: Russell Schilder, MD

Primary Objective: To determine the safety and tolerability of the recommended phase 2 dose (RP2D) of birinapant when given in combination with pembrolizumab IV; to confirm the RP2D of birinapant/pembrolizumab combination in defined solid tumor patient populations.

Treatment: During a 21 day treatment cycle, patients will receive 200 mg pembrolizumab intravenously (IV) on Day 1 and IV birinapant on Days 1 and 8. A week without treatment (i.e., Days 15 21) will follow the second week of treatment, immediately after which the next 21-day treatment cycle will start. All doses will be administered via a 30 minute (+10 min) IV infusion. Pembrolizumab will be administered first on Day 1. The birinapant infusion will begin 30 minutes (+ 10 minutes) following the completion of the pembrolizumab infusion on Day 1. Patients will be eligible to receive study medication for up to 35 treatment cycles or until documentation of disease progression or unacceptable toxicity.

Inter patient dose escalation of birinapant will proceed at the birinapant dose indicated in the dose escalation table, below. A minimum of 3 and up to 6 evaluable patients will be enrolled per dose level.

Dose-Escalation Schedule

Dose

Level Pembrolizumab + Birinapant (per 21-day cycle)

Level -1 200 mg pembrolizumab on Day 1 + birinapant

2.8 mg/m2/week on Days 1 and 8

Level 1 200 mg pembrolizumab on Day 1 + birinapant

5.6 mg/m2/week on Days 1 and 8


11 mg/m2/week on Days 1 and 8






The patient must have a histologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. Patients with tumors with mutations for which there are FDA-approved therapies must have progressed following these therapies in order to be eligible for this study. Patients with metastatic colorectal cancer should have progressed on prior fluoropyrimidine-based therapies, and have no curative therapies available to them, in order to be eligible for this study. Colorectal cancer patients should be assessed for microsatellite instability (MSI) status as per the local site routines.

Patients must have measurable disease based on RECIST 1.1 as determined by the site study team. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.

ECOG score of 0 or 1 at screening.

Exclusion Criteria:

Patients who have had a prior anti-cancer

monoclonal antibody (mAb) within 4 weeks prior to

study Day 1 or who has not recovered from adverse

events due to agents administered more than 4

weeks earlier prior to study Day 1.

Patients who have had prior chemotherapy,

targeted small molecule therapy, or radiation

therapy within 2 weeks prior to study Day 1 or who

have not recovered from adverse events due to a

previously administered agent.

Patients who are currently participating and

receiving study therapy or who have participated in

a study of an investigational agent and received

study therapy or who have used an investigational

device within 4 weeks of the first dose of treatment.

Patients who have received prior therapy with an

anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or

anti-Cytotoxic T-lymphocyte-associated antigen-4

(CTLA-4) antibody or if the patient has previously

participated in Merck MK-3475 clinical trials.


Please contact

Yuko Nishida


[email protected]

215-554-0694



Title: Phase 2, Randomized, Open-Label Study Comparing Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone (D-RVd) Versus Lenalidomide, Bortezomib, and Dexamethasone (RVd) in Subjects with Newly Diagnosed Multiple Myeloma Eligible for High-Dose Chemotherapy and Autologous Stem Cell Transplantation

Sponsor: Janssen

PI: Joanne Filicko-O’Hara, MD

Primary Objective: To determine if the addition of daratumumab to lenalidomide, bortezomib, and dexamethasone (D-RVd) will increase the proportion of subjects achieving stringent complete response (sCR), as defined by the International Myeloma Working Group (IMWG) criteria, by the time of completion of post-autologous stem cell transplantation (ASCT) consolidation treatment, compared with RVd alone.

Treatment: Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone (D-RVd) Versus Lenalidomide, Bortezomib, and Dexamethasone (RVd) Eligibility: Inclusion Criteria

Documented multiple myeloma as defined by the IMWG 2015 criteria including: Clonal bone marrow plasma cells ≥10%*. In addition, the patient must meet one of the criteria in 3a or 3b: o Evidence of end organ damage that can be

attributed to the underlying plasma cell proliferative disorder, specifically (one or more of the following): Hypercalcemia: serum calcium >0.25 mmol/L

(>1 mg/dL) higher than the upper limit of normal (ULN) or >2.75 mmol/L (>11 mg/dL)

Renal insufficiency: CrCl <40 mL/min (measured or estimated by validated equations, Attachment 2) or serum creatinine >177 μmol/L (>2 mg/dL)

Anemia: hemoglobin value of >20 g/L below the lower limit of normal, or a hemoglobin value <100 g/L

Bone lesions: 1 or more osteolytic lesions on skeletal radiography, computed tomography (CT), or magnetic resonance imaging (MRI).

o Any one or more of the following: Clonal bone marrow plasma cell percentage

≥60% Involved:uninvolved serum FLC ratio>100 >1 focal lesions on MRI studies; Each focal

lesion must be 5 mm or more in size.

Measurable disease as defined by any of the following:

o Serum M-protein level 1.0 g/dL or urine M-

protein level 200 mg/24 hours. Note: All

attempts should be made to determine

eligibility of the subject based on the central

laboratory results of screening blood and

urine M-protein measurements. In

exceptional circumstances, the local

laboratory results for blood and urine M-

protein measurements may be used to

determine eligibility, but only if the results are

clearly above the thresholds for

measurability; or

o IgA, IgD, IgE, or IgM multiple myeloma:

serum M-protein level 0.5 g/dL or urine M-

Light

chain multiple myeloma without measurable

disease in the urine: serum Ig FLC 10 mg/dL

and abnormal serum Ig kappa/lambda FLC

ratio.

Has not had prior systemic therapy for multiple

myeloma. An emergency course of steroids is

permitted. In addition, radiation therapy is

permitted prior to study entry, during screening,

and during Cycles 1-2 of study treatment as

needed for lytic bone disease.

ECOG performance status score of 0, 1, or 2

Exclusion Criteria:

Diagnosed or treated for malignancy other than multiple myeloma, except: o Malignancy treated with curative intent and

with no known active disease present for ≥3 years before randomization.

o Adequately treated non-melanoma skin cancer, lentigo maligna or in situ malignancies with no evidence of disease.

Exhibiting clinical signs of or has a known history of meningeal or central nervous system involvement by multiple myeloma.


Please contact

Jay Marshall


[email protected]

267-408-7961



Title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects with Extensive Stage Small Cell Lung Cancer (MERU) Sponsor: AbbVie

PI: Rita Axelrod M.D.

Primary Objective: Evaluate if rovalpituzumab tesirine improves progression-free and overall survival in subjects with extensive-stage SCLC who have ongoing clinical benefit (SD, PR, or CR) following the completion of 4 cycles of first-line, platinum-based chemotherapy (cisplatin or carboplatin plus irinotecan or etoposide) compared to placebo

Treatment: Subjects will receive rovalpituzumab tesirine/placebo in combination with dexamethasone/ placebo on Day 1 of a 6 week cycle, omitting every third cycle until disease progression. Rovalpituzumab tesirine/Placebo: 0.3 mg/kg, Day 1 of each 6-week cycle, omitting every third cycle. Dexamethasone/Placebo 8 mg orally (PO) twice daily

on Day –1, Day 1 (the day of dosing), and Day 2 of

each 6 week cycle, omitting every third cycle. Eligibility: Inclusion Criteria

Histologically or cytologically confirmed extensive-stage SCLC with ongoing clinical benefit (SD, PR, or CR per RECIST v.1.1) following completion of 4 cycles of first-line platinum-based therapy (cisplatin or carboplatin in combination with etoposide or irinotecan).

Subjects with a history of CNS metastases prior to the initiation of first-line platinum-based therapy must have received definitive local treatment and have documentation of stable or improved CNS disease status based on brain imaging within 28 days prior to randomization, off or on a stable dose of corticosteroids.

At least 3 but no more than 9 weeks between the administration of the last cycle of platinum-based chemotherapy and randomization.

Availability of archived or representative tumor material for assessment of DLL3 expression.

ECOG performance score of 0 or 1 Recovery to ≤ Grade 1 of any clinically significant

toxicity (excluding alopecia) prior to randomization.

Subject must have adequate bone marrow, renal and hepatic function

Exclusion Criteria:

Any prior systemic chemotherapy, small molecule inhibitors, immune checkpoint inhibitors, other monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, T-cell or other cell-based or biologic therapies, or any other anti-cancer therapy than that described in Inclusion Criteria 3 – 5 for the disease under study.

Any disease-directed radiotherapy (except PCI or pre-planned radiotherapy for CNS metastases present prior to start of first-line therapy and non-progressing) after last dose of first-line chemotherapy.

Any significant medical condition including any suggested by screening laboratory findings that in the opinion of the Investigator or Sponsor may place the subject at undue risk from the study.

Documented history of a cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association (NYHA) Class III – IV heart failure within 6 months prior to Randomization

Documented history of capillary leak syndrome.

Grade 2 or higher pleural or pericardial effusion within 4 weeks of randomization or earlier history of recurrent Grade 2 or higher effusions with ongoing requirement for pericardiocentesis or thoracentesis.

Serious infection within 2 weeks prior to randomization, including any Grade 3 or higher viral, bacterial, or fungal infection.

Systemic therapy with corticosteroids at > 10 mg/day prednisone or equivalent within 1 week prior to randomization.

Subject has a history of active malignancies other than SCLC within the past 2 years prior to study entry, with the exception of in situ cancer which was curatively treated.

Any prior exposure to a pyrrolobenzodiazepine (PBD)- or indolinobenzodiazepinebased drug, prior participation in a rovalpituzumab tesirine clinical trial, or known hypersensitivity or other contraindications to rovalpituzumab tesirine or excipient contained in the drug formulation.

Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells.


Please contact

Linda Phan


Linda [email protected]

215-490-6279

mailto:Linda%[email protected]


NRG GU003: A Randomized Phase III Trial of Hypofractionated Post-Prostatectomy Radiation Therapy (HYPORT) Versus Conventional Post-Prostatectomy Radiation Therapy (COPORT) SWOG 1609: DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors

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 Alliance 021501: Preoperative Extended Chemotherapy vs. Chemotherapy Plus Hypofractionated Radiation Therapy for Borderline Resectable Adenocarcinoma of the Head of the Pancreas

NCTN Central Nervous System Trials

The “NCTN Central Nervous System Trials” Webinar will be held on Wednesday, October 25th at 3:00pm - 4:00pm EST. The study teams

will discuss the trials’ scientific importance, research questions, trial design, key logistical and operational updates, and accrual strategies. Following each presentation, attendees will be able to ask questions and receive answers directly from the study teams. We encourage you to attend this webinar and learn more about these practice changing trials! The following protocols will be discussed:

NRG-BN003: Phase III Trial of Observation Versus Irradiation for

a Gross Totally Resected Grade II Meningioma

A071401: Phase II Trial of SMO/AKT/NF2 Inhibitors in

Progressive Meningiomas with SMO/ AKT/NF2 Mutations

A071601: Phase II Trial of BRAF/MEK Inhibitors in Papillary

Craniopharyngiomas

Effective immediately NRG-HN001, Randomized Phase II and Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA), is temporarily closed to accrual. Due to inadvertent changes made in NRG-HN001 Amendment 5 (version date May 4, 2017; broadcast date June 26, 2017) the dosimetric criteria for the optic chiasm were increased to an unacceptable level. The criteria were correct in the previous protocol version (Amendment 4; version date April 14, 2016). NRG Oncology is in the process of submitting an amended protocol to CTEP/CIRB. We will reopen the protocol and distribute the amendment to sites immediately upon CTEP/CIRB approval.

EAY131 (MATCH) Subprotocol U, is nearing the completion of its

accrual goal, and only a limited amount of available treatment assignment slots remain. Patients currently enrolled on, or assigned to, this subprotocol should be treated and followed according to the Master Protocol and Subprotocol.

ECOG E5202, A Randomized Phase III Study Comparing 5-FU,

Leucovorin and Oxaliplatin vs 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers, continuing review CIRB approved. NRG-GU002, Phase II-III Trial of Adjuvant Radiotherapy and Androgen Deprivation Following Radical Prostatectomy With or Without Adjuvant Docetaxel , continuing review CIRB approved.

ECOG 2805, ASSURE: Adjuvant Sorafenib or Sunitinib for

Unfavorable Renal Carcinoma, continuing review CIRB approved. SWOG 1207, Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One year of Everolimus in Patients with High-Risk, Hormone Receptor Positive and HER2-Neu Negative Breast Cancer. e3 Breast Cancer Study-evaluating Everolimus with Endocrine, Revision 9 action letter posted on CTSU. NRG GY004, Phase III Study Comparing Single-Agent Olaparib or the Combination of Cediranib and Olaparib to Standard Platinum-Based Chemotherapy in Women with Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer, Amendment

5 action letter posted on CTSU.

https://www.ctsu.org/Main.aspx?nodeKey=2


Upcoming SKCN Event:

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 ECOG-ACRIN Semiannual Meeting: May 3-5, 2018 - Chicago IL NRG Oncology Semiannual Meeting: July 12-14, 2018 - Philadelphia PA

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

ECOG-ACRIN

Semiannual Meeting

October 26-28, 2017

Orlando, FL

Cynthia Perez, BS, CCRP NCTN Manager Editor, E-Newsletter

Office: 215-955- 9923 [email protected]

NRG Oncology, ECOG-ACRIN, CTSU or E-Newsletter inquiries

Anthony Roberts, BS JOG Coordinator Co-Editor, E-Newsletter

Office: 215-955-4235 [email protected]

JOG E-Newsletter inquiries

Joshua Schoppe, MPH, CCRP Senior Director, RNO


RNO and SKCN inquiries

Suzanne Jorfi, BS, CCRP Regulatory Manager


Regulatory Update inquiries or CIRB

Protocol Support Unit [email protected]

Regulatory Related inquires

http://isley.kcc.tju.edu/skcn/e-newsletters.html

http://isley.kcc.tju.edu/skcn/





skcn e-newsletter...alveolar soft part sarcoma. please contact sarah shaw bone). metastatic synovial...

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