Clinical Trials – February 2011 · 2020. 12. 10. · Panova-3: Pivotal, randomized, open-label study of Tumor Treating Fields (TTFields, 150kHz) concomitant with gemcitabine and

Lynn Cancer Institute Oncology Trials Clinical Trials – December 2020

Eugene M. and Christine E. Lynn Office of Research Administration 561.955.4800 Center for Hematology-Oncology 561.955.6400 Radiation Oncology 561.955.4111

Updated: 07Dec2020; 12Nov2020 Page 1 of 22

BREAST

Primary Site Sponsor/Study ID NCT # Protocol Description Eligibility

Radiation Oncology

NCI Alliance A011401 NCT02750826

Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer (BWEL)

• Histologic diagnosis of invasive breast cancer within the past 12 months

• Her-2 negative • Stage II or III breast cancer • ER and PR negative: T2-3N0 or T0-3N1-3 • ER and/or PR positive: T0-3N1-3 or T3N0 • No history of other malignancy within past 4 years • No comorbid conditions that would cause life

expectancy ≤ 5 years • No diabetes mellitus currently treated • BMI ≥ 27

Breast Cancer: Gene expression profiling

Agendia FLEX Registry NCT03053193

MammaPrint, BluePrint, and Full-genome Data Linked with Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX Registry)

• Stage I, II, or III patients who receive MammaPrint, with or without BluePrint testing (male or female)

• New primary lesion • No metastatic disease • No recurrent disease • No Stage 0 disease

https://clinicaltrials.gov/show/NCT02750826





Breast Cancer: Post mastectomy chest/nodal XRT vs. lumpectomy nodal XRT

NRG Oncology NSABP B-51 NCT01872975

A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy

• Clinically T1-3, N1 breast cancer at the time of diagnosis (before neoadjuvant therapy)

• Pathologic confirmation of axillary nodal involvement at presentation (before neoadjuvant therapy)

• At the time of definitive surgery, all removed axillary nodes must be histologically free from cancer.

• If negative for ER, assessment of PgR must also be performed.

• HER2-positive or HER2-negative are eligible. • Complete a min of 8 wks of neoadjuvant therapy with

an anthracycline and/or taxane-based regimen. • Patients with HER2-positive tumors must have received

neoadjuvant anti-HER2 therapy (with all or with a portion of the neoadjuvant chemotherapy regimen),

• Patients with pathologic staging of ypN0(i+) or ypN0(mol+) are eligible.

• Patients who have undergone a total mastectomy or lumpectomy are eligible





Breast Cancer: Reconstruction

Alliance A221505 NCT03414970

RT Charm: Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation with Breast Reconstruction

• Histologically confirmed invasive carcinoma of the breast of any of the following histologies (ductal, lobular, mammary, medullary, or tubular). Metaplastic breast cancer are not eligible.

• For patients not receiving neoadjuvant chemotherapy, pathologic staging must be T0N1-2a, T1N1-2a, T2N1-2a, T3N0-2a, and all M0 status. o For patients receiving neoadjuvant

chemotherapy, clinical pre-chemo staging and post mastectomy pathological staging is required for all patients.

o Patients who have received neoadjuvant chemotherapy and are pathologically cT0-2 and N0 are only eligible if biopsy-proven clinically N1 or N2 disease is documented prior to the start of neoadjuvant chemotherapy. cT3N0 patients or ypT3N0 patients who receive neoadjuvant chemotherapy may be eligible based on clinical or pathological T stage, and do not require pathologically positive lymph nodes.

o Note: Higher of the clinical or pathological T and N stage are used for final staging, if receiving neoadjuvant chemotherapy.

o All patients with clinical, radiographic or pathological T4, N3 or involved internal mammary disease (N1b, N1c, and N2b) are not eligible.

• No prior therapeutic radiation therapy to the chest, neck or axilla. Prior radioactive oral iodine is permitted.

• No prior history of ipsilateral breast cancer (invasive disease or DCIS). LCIS and benign breast disease is allowed.

• No other malignancy within 5 years of registration • ECOG (Zubrod) Performance Status 0-1

GASTROINTESTINAL




Primary Site Sponsor/Study ID NCT #

Protocol Description Eligibility

Liver Humanitarian Device TX

MDS Nordion Contact Dr. George Khoriaty No NCT#

Treatment of Unresectable Hepatocellular Carcinoma with TheraSphere® (Yttrium-90 Glass Microspheres): An HDE Treatment Protocol

• Hepatocellular carcinoma of the liver • ECOG PS score of ≤ 2 with a life expectancy of > 3

months • > 4 weeks since prior RT or surgery • > 1 month post other chemotherapy. • Excludes contraindications to angiography and

selective visceral catheterization • Excludes extra-hepatic disease representing an

imminent life-threatening outcome or active infection Metastatic pancreatic adenocarcinoma 1st Line

Astellas 8951-CL-5201 NCT03816163

A Phase 2, Open-Label, Randomized Study to Assess the Antitumor Activity and Safety of Zolbetuximab (IMAB362) in Combination with Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects with Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma

• Subject has histologically or cytologically confirmed adenocarcinoma of pancreas.

• Subjects must have metastatic pancreatic cancer that has not been previously treated with chemotherapy. o Prior treatment with fluorouracil (5-FU) or GEM

administered as a radiation sensitizer during and up to 4 weeks after radiation therapy is allowed

o If a subject received therapy in the adjuvant setting, tumor recurrence or disease progression must have occurred at least 6 months after completing the last dose of adjuvant therapy.

• Subject has a measurable lesion(s) on at least 1 metastatic site based on RECIST 1.1 within 28 days prior to the first dose of study treatment. For subjects with only 1 measureable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy.

• Subject's tumor sample has CLDN18.2 expression in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central immunohistochemistry (IHC) testing

• Subject has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1





Pancreatic adenocarcinoma 2nd Line

ERYTECH Pharma GRASPANC 2018-01 NCT03665441

A Randomized, Phase 3 Study of Eryaspase in Combination with Chemotherapy versus Chemotherapy Alone as Second-Line Treatment in Patients with Pancreatic Adenocarcinoma TRYbeCA-1 – TRial of erYaspase in pancreatic CAncer

• 18 years of age or older • Histologically confirmed pancreatic ductal

adenocarcinoma • Stage III or IV disease • Received 1 line of systemic chemotherapy in advanced

setting with or without targeted agents, immunotherapy or radiotherapy

• Archival or fresh tumor tissue • Radiological evidence of disease progression following

most recent prior treatment





Locally-advanced pancreatic adenocarcinoma

Novocure EF-27 NCT03377491

Panova-3: Pivotal, randomized, open-label study of Tumor Treating Fields (TTFields, 150kHz) concomitant with gemcitabine and nab-paclitaxel for front-line treatment of locally-advanced pancreatic adenocarcinoma

• Unresectable, locally advanced stage disease according to the following criteria:

• Head/uncinate process:

o Solid tumor contact with SMA>180° o Solid tumor contact with the CA>180° o Solid tumor contact with the first jejunal SMA

branch o Unreconstructible SMV/PV due to tumor

involvement or occlusion (can be d/t tumor or bland thrombus)

o Contact with most proximal draining jejunal branch into SMV

• Body and tail

o Solid tumor contact of >180° with the SMA or CA

o Solid tumor contact with the CA and aortic involvement

o Unreconstructible SMV/PV due to tumor involvement or occlusion (can be d/t tumor or bland thrombus)

• No distant metastasis, including non-regional lymph node metastasis

HEMATOLOGY

ANEMIA Primary Site Sponsor/Study ID

NCT # Protocol Description Eligibility

•

MULTIPLE MYELOMA





LYMPHOMA/LEUKEMIA


CLL, PD while on UTX-TGR-304

TG Therapeutics UTX-TGR-204 NCT02656303

A multi-center, open-label, study to evaluate the safety and efficacy of Ublituximab (TG-1101) in combination with TGR-1202 for patients previously enrolled in protocol UTX-TGR-304

• ECOG PS ≤ 2 • Prior treatment in clinical trial UTX-TGR-304

NHL TG Therapeutics UTX-TGR-205 NCT 02793583

A Phase 2b Randomized Study To Assess the Efficacy and Safety of the Combination of Ublituximab + TGR-1202 with or without Bendamustine and TGR-1202 alone in Patients with previously Treated Non-Hodgkin's Lymphoma.

• Diagnosis of Non-Hodgkin’s Lymphoma (NHL) including Diffuse Large B-cell Lymphoma, Follicular, Small Lymphocytic and Marginal Zone Lymphoma

• Relapsed or refractory to prior standard therapy and subjects who are not candidates for high-dose therapy or autologous stem cell transplant

• ECOG performance status 0 - 2. NHL Relapsed

Nordic Nanovector LYMRIT-37-01 NCT01796171

A phase I/II study of lutetium (177Lu)-lilotomab satetraxetan (Betalutin ® ) antibody-radionuclide conjugate for treatment of relapsed non-Hodgkin lymphoma

• Histologically confirmed (by WHO classification) relapsed incurable non-Hodgkin B-cell lymphoma of follicular grade I-IIIA.

• Age ≥ 18 years • A pre-study WHO performance status of 0-1 • Life expectancy should be ≥ 3 months • <25% tumor cells in bone marrow biopsy • Measurable disease by radiological methods

General Oncology








High risk Genetics Registry

City of Hope National Medical Center 96144 No NCT # GENETICS STUDY

Molecular Genetic Studies of Cancer Patients and Their Relatives

• Personal history or family history of cancer suggestive of presence of an inherited predisposition

• In a group known or suspected to have increased risk of carrying genetic alteration or of sustaining exposure that would place them at risk of cancer

• Willing historian to provide information or access • Young age cancer diagnosis • Multiple primary neoplasms in affected member • Presence of rare tumor types in family • Congenital malformations • Any other family clustering of cancer • Any other cancer-predisposing genetic

disease/conditions LUNG


IIIA, II or IB Resected Non-Squamous NSCLC

NCI A151216 ALCHEMIST NCT02194738

Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST) This is the pre-registration study which randomizes to either A081105 or E4512

• ECOG PS: 0 or 1 • No neoadjuvant (chemo or radio-therapy) for this lung

cancer • No prior treatment with agents targeting EGFR

mutation or ALK rearrangement • Pre-surgical: Suspected clinical stage of IIIA, II or

large IB (defined as size ≥4cm) • Post-surgical: Pathologic stage IIIA, II or IB (defined

as size ≥4 cm) • No recurrence of lung cancer after prior resection





IIIA, II or IB Resected Non-Squamous NSCLC

NCI A081105 ALCHEMIST NCT02193282

Randomized study of erlotinib vs observation in patients with completely resected epidermal growth factor receptor (EGFR) mutant non-small cell lung center (NSCLC) Effective 6/15/2020: temporary enrollment suspension for all patients.

• ECOG PS: 0 or 1 • Registered to A151216 with result of EGFR exon 19

deletion or L858R mutation • Completely resected stage IB (≥ 4cm), II, or IIIA non-

squamous NSCLC with negative margins • Patients with known resistant mutations in the EGFR

TK domain (T790M) are not eligible. • Patients that are both EGFR mutant and ALK

rearrangements will be registered to A081105

IIIA, II or IB Resected Non-Squamous NSCLC Adjuvant

NCI E4512 ALCHEMIST NCT02201992

A Randomized Phase III Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Observation for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

• ECOG PS: 0 or 1 • Pre-registered to A151216 • Completely resected stage IB (≥ 4cm), II, or IIIA non-

squamous NSCLC with negative margins • Positive for translocation or inversion events involving

the ALK gene locus • No prior treatment with crizotinib or another ALK

inhibitor • No known interstitial fibrosis or interstitial lung

disease. NSCLC Unknown EGFR status

Biodesix

BDX-00146

NCT03289780

An Observational Study Assessing the Clinical Effectiveness of VeriStrat® and Validating Immunotherapy Tests in Subjects with Non-Small Cell Lung Cancer

• 18 years of age or older • Diagnosis of NSCLC • EGFR mutation status wildtype or unknown • If prior treatment for local disease, then documented

disease progression and treatment completed prior to VeriStrat







NSCLC Stage III

EMD Serono MS200647_0005

NCT03840902

A Multicenter, Double Blind, Randomized, Controlled Study of M7824 with Concurrent Chemoradiation Followed by M7824 versus Concurrent Chemoradiation Plus Placebo Followed by Durvalumab in Participants with Unresectable Stage III Non-small Cell Lung Cancer

• Participants must have histologically documented NSCLC who present with Stage III locally advanced, unresectable disease (International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology

• Participants with tumor harboring an Epidermal growth factor receptor (EGFR) sensitizing (activating) mutation, Anaplastic lymphoma kinase (ALK) translocation, ROS-1 rearrangement are eligible.

• Participants must have adequate pulmonary function defined as a forced expiratory volume in 1 second (FEV1) greater than equals to (>=) 1.2 liters or >= 50% of predicted normal volume measured within 3 weeks prior to randomization.

• Adequate hematological, hepatic and renal function as defined in the protocol.

• Contraceptive use by males or females will be consistent with local regulations on contraception methods for those participating in clinical studies.





NSCLC Stage III

Merck MK-7339-006 NCT03976323

A Phase III Study of Pembrolizumab in Combination with Pemetrexed/Platinum (Carboplatin or Cisplatin) Followed by Pembrolizumab and Maintenance Olaparib vs Maintenance Pemetrexed in the First-Line Treatment of Participants with Metastatic Nonsquamous Non-Small-Cell Lung Cancer

• Have a histologically or cytologically confirmed diagnosis nonsquamous NSCLC.

• Have stage IV nonsquamous NSCLC. • Have confirmation that epidermal growth factor

receptor (EGFR), anaplastic lymphoma kinase (ALK), or Proto-oncogene tyrosine-protein kinase (ROS1)-directed therapy is not indicated.

• Have measurable disease based on RECIST 1.1. • Have provided archival tumor tissue sample or

newly obtained core or incisional biopsy of a tumor lesion not previously irradiated.

• Have a life expectancy of at least 3 months. • Have a performance status of 0 or 1 on the

Eastern Cooperative Oncology Group (ECOG) Performance Status assessed within 7 days prior to the administration of study intervention.

• Have not received prior systemic treatment for their advanced/metastatic NSCLC.

• Have adequate organ function. • Male and female participants who are not

pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for 180 days afterwards.

• Male participants must refrain from donating sperm during the treatment period and for 180 days afterwards.




NSCLC Stage III

Merck MK-7339-008 NCT03976362

A Phase 3 Study of Pembrolizumab in Combination with Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab with or without Maintenance Olaparib in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)

• Have a histologically or cytologically confirmed diagnosis squamous NSCLC.

• Have stage IV squamous NSCLC. • Have measurable disease based on RECIST 1.1. • Have not received prior systemic treatment for

their advanced/metastatic NSCLC. • Have provided archival tumor tissue sample or

newly obtained core or incisional biopsy of a tumor lesion not previously irradiated.

• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status assessed within 7 days prior to the administration of study intervention.

• Have a life expectancy of at least 3 months. • Has adequate organ function. • Male and female participants who are not

pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for 180 days afterwards.

• Male participants must refrain from donating sperm during the treatment period and for 180 days afterwards.

All Stages of Lung Cancer

Fujirebio Diagnostics, Inc. FDI-209 No NCT number

A Prospective Longitudinal Collection of Peripheral Blood to Support the Validation of Biomarkers as an Aid in Monitoring Disease in Patients with all Stages of Lung Cancer

• Age ≥ 22 years • Histologic/pathologic confirmation of lung cancer • Any stage of disease • Any treatment time point • Individuals with a history of malignant disease other

than lung cancer that was resected greater than 5 yeaars ago and are currently in remission are eligible




Limited Stage Small Cell Lung Cancer

NRG Oncology NRG-LU005 NCT03811002

Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase II/III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab

• Histologically or cytologically proven Limited stage SCLC

• Must have received one pre-reg cycle of platinum/etoposide chemo prior to study entry

o PET/CT scan for staging and CT chest/abdomen with IV contrast (can be obtained as part of PET/CT if diagnostic quality)

• ECOG 0-2 within 30 days prior to registration • No prior atezolizumab or other immunotherapy

agent • No prior radiotherapy to the lungs or

mediastinum that would result in clinically significant overlap of radiation therapy fields

• Patients with cytologically positive pleural or pericardial fluid are not eligible

• No active, known or suspected autoimmune disease.

• No Active or prior documented inflammatory bowel disease

• No Hx of primary immunodeficiency o No clinically significant ILD




Stage 1 NSCLC

JoLT-Ca (Joint Lung Cancer Trialist’s Coalition) STU 022015-069

A Randomized Phase III Study of Sublobular Resection (SR) versus Stereotactic Ablative Radiotherapy (SAbR) in High Risk Patients with Stage I Non-Small Cell Lung Cancer (NSCLC)

• Primary tumor in the lung must be biopsy confirmed non-small cell lung cancer

• Tumor ≤ 4 cm maximum diameter, including clinical stage IA and selected IB by PET/CT scan

• Tumor verified by a thoracic surgeon to be in a location that will permit sublobar resection

• Tumor located peripherally within the lung • No evidence of distant metastases • Availability of pulmonary function tests • No prior intra-thoracic radiation therapy for

previously identified intra-thoracic primary tumor

• Previous chemotherapy, radiotherapy, or surgical resection specifically for the lung cancer being treated on this protocol is NOT permitted

• No prior lung resection on the ipsilateral side

Ileana Vargas

Steph, please add this study to the list.




Unresectable Stage III Non-Small Cell Lung Cancer

Astra Zeneca D4194C00008 NCT04381494

Prospective, Interventional Pilot Study of Mobile Devices and Digital Applications to Detect Early Pneumonitis and Other Pulmonary Adverse Events in Unresectable Stage III Non-Small Cell Lung Cancer Patients on Durvalumab

• Patient has unresectable Stage III NSCLC that has not progressed following concurrent platinum-based chemotherapy and radiation therapy and is eligible to receive durvalumab according to the US FDA approved package insert.

• Patient will initiate durvalumab treatment within 2 weeks of Baseline and receive at least 1 dose of durvalumab.

• Patient is able and willing to use the mobile application and connected devices on a daily basis for up to 12 months.

• Patient is able to complete QoL assessments once every 2 weeks for the first 3 months of the study and monthly thereafter.

GENITOURINARY





Observational study: locally advanced / unresectable, or metastatic urothelial carcinoma

AstraZeneca D419BR00008 NCT03788746

PREVAIL A Prospective, Non-Interventional Study to Assess the Prevalence of PD-L1 Expression in the First-Line Setting of Locally Advanced/Unresectable or Metastatic Urothelial Carcinoma As requested on 06Nov2020, all sites must stop enrollment of patients who are currently receiving 1L therapy and only continue enrolling newly diagnosed patients who have not yet started first line treatment. Only patients who have provided consent for the baseline blood draw are enrolled.

• Provision of written informed consent • Age ≥18 years old • Patients with histologically-confirmed diagnosis of UC

and healthcare provider (HCP)-confirmed advanced UC prior to or during 1L therapy (primary histology UC; mixed histologies are allowed).

Where the 1L therapy setting is defined as: o Patients with no prior systemic therapy given for

advanced UC; 1L is the first systemic therapy given for advanced UC

o Patients who received neoadjuvant or adjuvant platinum-based chemotherapy with recurrence more than 12 months from the last chemotherapy dose

• Patients with available tumor tissue sample (fresh or archival - up to 3 years old) that was collected as part of SoC any time prior to 1L treatment for advanced UC with a target of 18 slides available for biomarker testing (PD-L1 and tTMB).





Advanced & recurrent solid tumors

IMV Inc. P1719-SUR-Z11 NCT03836352

A Phase 2, Open-label, Multicenter, Study of an Immunotherapeutic Treatment, DPXSurvivac in combination with Low Dose Cyclophosphamide and Pembrolizumab, in Subjects with Selected Advanced and Recurrent Solid Tumours Cohorts: Ovarian HCC, NSCLC, Bladder, MSI-H

• Subjects with advanced or metastatic solid tumors who have completed treatment with 1st line therapy: 1. Epithelial ovarian, fallopian tube, or peritoneal

cancer. 2. Hepatocellular carcinoma (HCC) 3. Non-small cell lung cancer (NSCLC) 4. Urothelial cancer (BlCa) 5. Microsatellite instability high (MSI-H) solid tumors,

other than the above indicators • Radiologic and/or biochemical evidence of disease

progression • Completion of pre-treatment tumor biopsy • Subjects with HCC, NSCLC, BlCa, or MSI-H subjects

other than those with gastric or colorectal cancer must have evidence of surviving expression in their pre-treatment biopsy sample

• Must have measurable disease by RECIST v1.1 • Life expectancy ≥ 6 months • Meet protocol specific laboratory requirements





Bladder Bristol-Myers Squibb CA209-901 NCT03036098

Phase 3, Open-label, Randomized Study of Nivolumab Combined with Ipilimumab, or with Standard of Care Chemotherapy, versus Standard of Care Chemotherapy in Participants with Previously Untreated Unresectable or Metastatic Urothelial Cancer Arms A & B are closed to enrollment effective 9/13/2019. Arms C & D are open for enrollment.

• Histological/cytological evidence of metastatic or surgically unresectable transitional carcinoma (TCC) of the urothelium involving the renal pelvis, ureter, bladder or urethra

• Measurable disease by CT or MRI • Prior systemic chemo for metastatic or surgically

unresectable UC is not allowed • Cisplatin-ineligible patients will receive gemcitabine-

carboplatin treatment • Fresh tumor biopsy from the primary or metastatic site.

If not available, tissue block from most recent resection acceptable if within 2 years of enrollment.

• Re-enrollment of participant that has discontinued study as pre-treatment failure is permitted.

Urothelial cancer

Seattle Genetics SGN-22e-002 NCT03288545

A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer

• Histologically documented la/mUC, including squamous differentiation or mixed cell types.

• An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2

• Participants with ECOG performance status of 2 must meet the following additional criteria: hemoglobin ≥10 g/dL, GFR ≥50 mL/min, may not have NYHA Class III heart failure.

• Eligible for pembrolizumab (Dose-escalation cohorts, Cohorts A, B, G and K Combination Arm).

• Dose-escalation cohorts: Ineligible for first-line cisplatin-based chemotherapy and no prior treatment for la/mUC, or have disease progression following at least 1 platinum-containing treatment.




Head and Neck


Oral mucositis Galera Therapeutics GTI-4419-301 NCT03689712

ROMAN: Reduction in Oral Mucositis with Avasopasem Manganese (GC4419) – Phase 3 Trial in Patients Receiving Chemoradiotherapy for Locally-Advanced, Non-Metastatic Head and Neck Cancer

• Squamous cell carcinoma of the head and neck • Treatmnent plan to receive IMRT delivered as single daily

fractions of 2.0 to 2.2 Gy with a cumulative radiation dose of 60-72 Gy

• Treatment plan to receive standard cisplatin monotherapy • Age 18 years or older • ECOG status ≤ 2 • Adequate hematologic, renal and liver function • Negative serum pregnancy test • Use of effective contraception

Skin


Locally advanced cutaneous squamous cell carcinoma (LA cSCC)

Merck MK-3475-630 NCT03833167

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants with High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC) (KEYNOTE-630)

• Histologically confirmed cSCC as the primary site of malignancy

• Must have undergone complete macroscopic resection of all known cSCC disease with or without microscopic positive margins

• Must have histologically confirmed LA cSCC with high-risk feature(s)

• Must have completed adjuvant RT for LA cSCC with last dose of RT ≥ 4 weeks and ≤ 16 weeks from randomization

• Must have completed at least 45 Gy of adjuvant RT for LA cSCC prior to study entry

• Provide tumor tissue sample adequate for PD-L1 testing






Neurology and Neuro-Oncology


Anaplastic Glioma or Low Grade Glioma

National Cancer Institute/Alliance N0577 NCT00887146

Phase III Intergroup Study of Radiotherapy with Concomitant and Adjuvant Temozolomide versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma

• ECOG PS: 0, 1 or 2 • Newly diagnosed and ≤ 3 months from surgical

diagnosis • Histological confirmation of anaplastic glioma or low

grade glioma • Surgery (partial or gross total resection or biopsy)

performed ≥ 2 weeks prior to registration and recovered from effects of surgery.

• Tumor must show 1p/19q codeletion Brain Tumor Registry

State of Florida FCBTR NCT00811148

Florida Center for Brain Tumor Research Enrollment paused due to COVID restrictions.

• Adults scheduled to undergo brain surgery to remove tumor tissue

High grade glioma Tissue collection study

Scripps 1R01CA229737-07 No NCT #

Clinical Translation of Precision Medicine Testing Utilizing 3 Dimensional Primary Tumor Cell Culture

• Patients scheduled to have surgery for removal of brain tumor.

• Age: 18 years and older.

Leptomeningeal disease registry

Penn State Registry No NCT #

NeMeRe, a Multi-Institutional Retrospective and Prospective Registry of Neoplastic Meningitis in Adults

• Adults 18 years and older diagnosed and treated with neoplastic meningitis.








SCLC NRG Oncology NRG-CC003 NCT02635009

Randomized Phase II/III Trial of Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance for Small Cell Lung Cancer

• High-grade neuroendocrine carcinoma or combined SCLC and NSCLC is permitted.

• Prior to chemotherapy +/- thoracic radiotherapy, patients must be defined as limited-stage or extensive-stage SCLC after clinical staging evaluation.

• Radiographic partial or complete response to chemotherapy in at least one disease site

• Patients must have a baseline raw score greater than 2 on the HVLT-R Delayed Recall, as determined by central assessment

• No Radiographic evidence of CNS metastases • Concurrent atezolizumab permitted with PCI







Brain Metastases

Alliance A071701 NCT03994796

Genetic Testing in Guiding Treatment for Patients with Brain Metastases

• Histologically confirmed metastatic disease to the brain from any solid tumor.

• New or progressive brain metastases defined as any one of the following:

o Untreated measurable lesions in patients who have received surgery and/or SRS to one or more other lesions.

o Residual or progressive lesions after surgery if asymptomatic.

o Patients who have had prior WBRT and.or SRS and then whose lesions have progressed by BM-RANO criteria or there are new lesions.

o Patients who have not previously been treated with cranial radiation must be asymptomatic or neurologically stable from their CNS metastases.

• Ability to obtain MRIs • Tissue available for sequencing (any brain metastasis

tissue and extracranial site from any prior resection or biopsy).

Low to Intermedium Grade Gliomas

NRG Oncology NRG-BN005 NCT03180502

Randomized Phase II Trial of Photon Therapy for Cognitive Preservation in Patients with IDH Mutant, Low to Intermediate Grade Gliomas

• Grade II and III gliomas IDH mutant. • Age 18 and over. • Trial is open to both genders. • Trial is open to English and French speaking

subjects.

Documents

Clinical Trials – February 2011 · 2020. 12. 10. · Panova-3: Pivotal, randomized, open-label study of Tumor Treating Fields (TTFields, 150kHz) concomitant with gemcitabine and