SKCN E-Newsletter Volume 10 ISSUE 5 Regional Network Office

Transcription

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 Registration is now OPEN for the NRG Oncology Semiannual Meeting in Philadelphia! For more information, Anthony Roberts, BS CCRP or Anthony.Roberts@jefferson.edu Online pre-registration for the meeting ends June 22, Registration and meeting information available on the NRG Website NRG Oncology Meeting Registration IN THIS ISSUE Center Stage SKCC Featured Trials NCTN Updates Upcoming Events REFERRING A PATIENT? The SKCN has launched a new referral address to streamline the process for working together to provide our patients with personalized oncology treatment care. Please information to clinical-trial-referrals@jefferson.edu Regional Network Office SKCN E-News 1

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 DNArepair anomalies based on the sponsor s blood-based assay. For Part 1, two doses of JNJ will be explored. At least 6 evaluable subjects will be treated with niraparib 200 mg orally once daily in combination with JNJ 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 mg IV once every 4 weeks (does regimen 2). These 2 dose regimens will be enrolled simultaneously Eligibility: At least 1, but no more than 2, lines of novel ARtargeted 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 bloodbased 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 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 Traci Southwell, RN Clinical Research Coordinator Traci.Southwell@jefferson.edu Regional Network Office SKCN E-News 2

3 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 Daniel Vernau Clinical Research Coordinator, CTO Daniel.Vernau@jefferson.edu Eligibility: 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 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 Regional Network Office SKCN E-News 3

4 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: 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 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 Suzanne O Hara Clinical Research Coordinator, CTO Suzanne.Ohara@jefferson.edu Regional Network Office SKCN E-News 4

5 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). Sarah Shaw Clinical Research Coordinator, CTO Sarah.Shaw@jefferson.edu Eligibility 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 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 halflives 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 Regional Network Office SKCN E-News 5

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 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, 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. 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, 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, The hotel registration deadline is June 20, 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 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 and are also available upon request to the TJU Protocol Support Unit (PSU) via the RNOregulatory@jefferson.edu address. Urgent requests can be made using the RNO cell Regional Network Office SKCN E-News 6

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: Anthony Roberts, BS CCRP JOG Coordinator, RNO Editor, E-Newsletter Laura Romeu, BS Project Manager, RNO Co-Editor, E-Newsletter Joshua Schoppe, MPH, CCRP Senior Director, RNO Erin Tello, BS Regulatory Coordinator Office: Office: Office: Office: NCTN, JOG, RNO, E-Newsletter inquiries NCTN, JOG, RNO inquiries RNO and SKCN inquiries Regulatory Update inquiries o CIRB Protocol Support Unit RNORegulatory@jefferson.edu Regulatory Related inquires For URGENT ISSUES, Please call the RNO cellphone at Regional Network Office SKCN E-News 7