PATIENT ALERT:  The front entrance and adjacent parking lot at the Brock Cancer Center in Norfolk will be closed for construction from 4/17-5/2. Please use the side entrance (Kempsville) during this time. Masks are now optional in our VOA offices. If you are immunocompromised or feeling ill, masking is strongly encouraged. Thank you. CLICK HERE for more details​​​​​​.

Virginia Oncology Associates

Virginia Oncology Associates

USO 23156

Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta TCell Infusions in Combination with Low Dose Radiotherapy in Subjects with Stage 4 Metastatic Non-Small Cell Lung Cancer.(DELTACEL-01)

 

Disease Types: Cellular & Gene

Eligibility Requirements:

- Signed and dated informed consent form.
- Male or female, > 18 years old.
- Minimum body weight of 50 kilograms (kg).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Histologically or cytologically confirmed stage 4 metastatic NSCLC
- Progressed on at least 2 lines of SOC therapy including platinum-based chemotherapy and immune checkpoint inhibitors.
- Genomic screening, with tumors with known actionable molecular alterations, such as EGFR, ALK, ROS-1, BRAF, RET, MET, and KRAS etc., must have progressed on appropriate target-directed molecular therapy.
- At least one measurable target lesion based on RECIST v1.1

Available at:

USO 23160

A Phase 3, Randomized, Open-Label, Multicenter Study Of ARV-471 (PF-07850327) Plus Palbociclib Versus Letrozole Plus Palbociclib For The Treatment Of Participants With Estrogen Receptor-Positive, HER2-Negative Breast Cancer Who Have Not Received Any Prior Systemic Anti-Cancer Treatment For Advanced Disease (VERITAC-3)(C4891002)

 

Disease Types: Breast Cancer Research

Eligibility Requirements:

Inclusion Criteria 1. Participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at screening. a. Female participants under 60 years of age, with cessation of regular menses for 12 consecutive months and with no other alternative medical cause, must have a FSH level within the post-menopausal level, as per local laboratory reference range. b. Pre-/peri-menopausal female participants and male participants must agree to initiate or continue an LHRH agonist as per SoA and Section 6.9.1 c. WOCBP participants and male participants must 2. Participants who are willing and able, to comply with all scheduled visits, treatment plans, laboratory tests, lifestyle considerations, and other study procedures. a. Phase 3 ONLY. Participants must provide a blood sample AND a tumor sample collected at the time of diagnosis of locally advanced/metastatic disease. If not available, a de novo biopsy is required. The sole exception is those patients with bone only disease for whom archival tumor sample at initial diagnosis is acceptable. Refer to Section 8.7 for further details. 3. Histological or cytological confirmation of BC with evidence of locoregionally advanced or metastatic disease, not amenable to surgical resection or radiation therapy with curative intent. a. Documented ER(+), defined as ER(+) ≥1% stained cells by an assay consistent with local standards, on the most recent tumor biopsy, ie, at diagnosis of recurrence or metastatic disease (Allison et al, 2020). The sole exception is those patients with bone only disease for whom ER(+) using archival tissue at initial diagnosis is acceptable. b. Documented HER2(-) tumor by either IHC or in-situ hybridization per ASCO/CAP guideline (Wolff et al, 2018). c. Participants who have bilateral BCs which are both ER(+)/HER2(-) are eligible. 4. No prior systemic anti-cancer therapy for their locoregionally advanced or metastatic disease. 5. At least 1 measurable lesion as defined by RECIST v1.1. Bone only disease:participants with only non-measurable lesions are eligible. 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2Exclusion Criteria 1. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigatorÂ’s judgment, make the participant inappropriate for the study. 2. Any other solid tumors within the past 3 years, except for the following: 1) adequately treated basal or squamous cell carcinoma of the skin; and 2) curatively treated in situ carcinoma of the cervix. For all other solid tumors, they must have been curatively treated and with no evidence of disease for >3 years. Participants with inflammatory BC, prior hematopoietic stem cell or bone marrow transplantation are excluded. 3. Participants with newly diagnosed brain metastasis or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Participants with a history of CNS metastases or cord compression are eligible if they have been definitively treated (eg, radiotherapy, stereotactic surgery), are clinically stable (including participants with residual CNS symptoms/deficits) and off enzymeinducing anticonvulsants and steroids for at least 14 days prior to randomization. 4. Participants in visceral crisis at risk of immediately life-threatening complications in the short term, including participants with massive uncontrolled effusions (pleural, pericardial & peritoneal), pulmonary lymphangitis, or liver involvement >50%. 5. Impaired cardiovascular function or clinically significant cardiovascular diseases, defined as: a. Symptomatic cardiac valve disease. Participants with mitral valve prolapse that is asymptomatic or not associated with clinically significant sequalae (eg, mitral regurgitation) are eligible. b. Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association Class III or IV), cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism or other clinically significant episode of thromboembolic disease, congenital long QT syndrome, Torsade de Pointes, clinical important arrhythmias, left anterior hemiblock (bifascicular block), ongoing cardiac dysrhythmias of NCI CTCAE Grade ≥2, atrial fibrillation of any grade. c. Cardiac rhythm device/pacemaker. Participants with cardiac rhythm device/pacemaker must be discussed in detail with sponsor medical monitor to determine eligibility. d. QTcF >470 msec on screening ECG. 

Available at:

USO 23055

ICT01-101: A first-in-human, two-part, open-label, clinical study to assess the safety, tolerability and activity of intravenous doses of ICT01 as monotherapy and in combination with an immune checkpoint inhibitor, in patients with advanced-stage, relapsed/refractory cancer (EVICTION Study) (ICT01-101)

 

Disease Types: Cellular & Gene

Eligibility Requirements:

1.Voluntarily signed informed consent form.
2.Relapsed/refractory patients with histologically or cytologically confirmed diagnosis of advanced-stage or recurrent cancer, including:

Group A: bladder, breast, colon, gastric, melanoma, ovarian, prostate and PDAC Group B: hematologic malignancies including acute myeloid leukemia, acute lymphocytic leukemia, Diffuse large B cell lymphoma and follicular lymphoma Group C: melanoma, cervical, bladder, gastric, head and neck SCC, and lymphoma (according to the approved package labeling of the ICI) Part 2, Group D: Ovarian cancer (2L/3L) with baseline g9d2 T cells > 20K Part 2, Group E: metastatic castrate resistant prostate cancer (2L/3L) with baseline g9d2 T cells > 20K Part 2, Group G: checkpoint-refractory metastatic melanoma with g9d2 T cells >5K Part 2, Group H: chemotx-refractory or Pt-ineligible urotherlial cancer (bladder) with g9d2 T cells >5K Part 2, Group I: checkpoint-refractory, metastatic HNSCC with g9d2 T cells >5K

3.Eastern Cooperative Oncology Group (ECOG) performance status < 1
4.Life expectancy > 3 months as assessed by the Investigator
5.At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST)/ Response Evaluation Criteria in Lymphoma (RECIL) or >5% marrow blasts

Available at:

USO 23080

Phase 3, Two-stage, Randomized Study of ONC-392 Versus Docetaxel in Metastatic Non-Small Cell Lung Cancers that Progressed on PD-1/PD-L1 Inhibitors (PRESERVE-003)

 

Disease Types: Lung Cancer Research

Eligibility Requirements:

1. Adult (> 18 years), all genders, capable of signing informed consent.
2. Histologically- or cytologically- confirmed diagnosis of metastatic NSCLC, metastasis can be regional lymph nodes or distant organs.
3. Radiographic progression after treatment with the most recent line of treatment being either 3a or 3b:
1. At least 12 weeks of PD-1/PD-L1 inhibitor in combination with platinum-based chemotherapy;
2. Prior treatment with at least 2 cycles of a platinum-based chemotherapy, followed by at least 12 weeks of standard doses of PD-1 or PD-L1 inhibitor-based immunotherapy.
Antibodies against CTLA-4, LAG-3, TIGIT, VEGF or VEGFR in combination with PD-1/PD-L1 inhibitor are allowed. 4. At least one measurable tumor lesion according to RECIST 1.1. 5. ECOG score of 0 or 1. 6. Adequate organ functions. Serum LDH level < 2xULN. 7. Life expectancy > 3 months.

Available at:

USO 22331

Multicohort Study to Customize Ibrutinib Treatment Regimens for Patients with Previously Untreated Chronic Lymphocytic Leukemia (TAILOR) (54179060CLL2032)

 

Disease Types: Leukemia & Lymphoma Research

Eligibility Requirements:

- Diagnosis of chronic lymphocytic leukemia/ small lymphocytic lymphoma (CLL/SLL) as per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 diagnostic criteria

- For ibruinib + venetocIax (I+V) cohorts: eastern cooperative oncology group (ECOG) performance status of 0-1. For ibrutinib monotherapy cohorts: ECOG performance status of 0-2

- Measurable nodal disease by computed tomography (CT), defined as at least 1 lymph node greater than and equal to (>=) 1.5 centimeters (cm) in longest diameter

- A participant using oral contraceptives must use an additional contraceptive method

- A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 3 months after the last dose of study treatment

Available at:

USO 21176

LOXO-BTK-20022: A Phase 3 Open-Label, Randomized Study of Fixed Duration Pirtobrutinib (LOXO-305) plus Venetoclax and Rituximab versus Venetoclax and Rituximab in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-322)

 

Disease Types: Leukemia & Lymphoma Research

Eligibility Requirements:

- Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria

- Previous treatment with at least one line of therapy that may include a covalent Bruton's tyrosine kinase (BTK) inhibitor

- Platelets greater than or equal to (>)50 x 10^9/liter (L), hemoglobin > 8 grams/deciliter (g/dL) and absolute neutrophil count > 1.0 x 10^9/L

- Adequate organ function

- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

- Estimated creatinine clearance > 30 milliliters per minute (mL/min)

Available at:

USO 22284

Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Longitudinal Prospective Study (MYLUNG Consortium: Part 3) Module A: Project ENGAGE: Increasing Biomarker Testing Awareness in Patients with Non-Small-Cell Lung Cancer Through Patient Education

 

Disease Types: Lung Cancer Research

Eligibility Requirements:

- Written informed consent, according to local guidelines, signed and dated by the participant or by a legal guardian prior to the performance of any study-specific procedures, sampling, or analyses

- Adult participants (18 years and older at the time of signature of the Informed Consent Form [ICF]) with early-stage, locally advanced, or metastatic NSCLC

- Must be eligible for systemic therapy based on the treating provider assessment. If systemic therapy was recommended and documented by the treating provider but the participant declined, they can still be eligible for the study

- Participants who developed locally advanced or metastatic disease after receiving adjuvant or neoadjuvant therapy (including chemoradiation) are eligible if the therapy was completed at least 12 months prior to the development of locally advanced or metastatic disease.

- Participants with early-stage, locally advanced, and metastatic disease must be enrolled prior to start of first systemic treatment. For participants previously given neoadjuvant/adjuvant treatment, please refer to Inclusion #4.

- Must be able to read and answer survey questions in English or Spanish

- Agree to participate in the LUNGevity Biomarker Participant Survey and Registry

Available at:

uso 22326

CAMBRIA-2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) vs Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients With ER+/HER2- Early Breast Cancer and an Intermediate-high or High risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease (D8535C00001)

 

Disease Types: Breast Cancer Research

Eligibility Requirements:

-Women and Men, >18 years at the time of screening (or per national guidelines)                                                                                                                                                                              -Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with high or intermediate risk of recurrence, based on clinical-pathological risk features, as defined in the protocol.                                                                                                                                                                                                                                                                                                  -Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy                                --Completed at least 2 years but no more than 5 years (+3 months) of adjuvant ET (+/- CDK4/6 inhibitor)                                                                                                                                          -Eastern Cooperative Oncology Group (ECOG) performance status of < 1                                                                                                                                                                                          -Adequate organ and marrow function

Available at:

USO 22329

A Phase 1b/2, Open-Label Umbrella Study to Evaluate Safety and Efficacy of Elacestrant in Various Combinations in Patients with Metastatic Breast Cancer (ELEVATE) (STML-ELA-0222)

 

Disease Types: Breast Cancer Research

Eligibility Requirements:

- Patient has signed the informed consent before all study specific activities are conducted.

- Women or men aged > 18 years (or the minimum age of consent in accordance with the local law), at the time of informed consent signature. Female patients may be either postmenopausal, premenopausal, or perimenopausal.

-Postmenopausal status is defined by:

- Age >60 years

Age <60 years and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) or a follicle-stimulating hormone (FSH) value >40 mIU/mL and an estradiol value<40 pg/mL (140 pmol/L) or in postmenopausal ranges per local reference ranges

- Documentation of prior surgical sterilization (i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, at least 1 month before first dose of trial therapy).

- Premenopausal and perimenopausal women and men must be concurrently receiving a luteinizing hormone-releasing hormone (LHRH) agonist initiated at least 4 weeks before the start of trial therapy and are planning to continue LHRH agonist treatment during the study.

- For perimenopausal women to be considered of non-childbearing potential, FSH levels must be >40 mIU/ml.

- Histopathologically or cytologically confirmed ER+, HER2-, breast cancer, per local laboratory, as per the American Society of Clinical Oncology (ASCO)/College of American Pathologists(CAP) guidelines (Allison et al, 2020, Wolff et al, 2018).Note: In the context of this trial, ER status will be considered positive if > 10% of tumor cells demonstrate positive nuclear staining by immunohistochemistry.

- At least one measurable lesion as per RECIST version 1.1 or a mainly lytic bone lesion. Note: Patients with stable brain or subdural metastases are allowed if the patient has completed local therapy and was on a stable or decreasing dose of corticosteroids at baseline for management of brain metastasis for at least 4 weeks before starting treatment in this study. The dose must be < 2.0 mg/day of dexamethasone or equivalent. Any signs (e.g., radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment.

- ECOG performance status of 0 or 1

Available at:

USO 21493

A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib + Docetaxel Versus Placebo + Docetaxel as Treatment for Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC) (D361EC00001)

 

Disease Types: Genitourinary Cancer Research

Eligibility Requirements:

- Histologically-confirmed prostate adenocarcinoma without neuroendocrine or small cell cancers

- Metastatic disease documented prior to randomisation by clear evidence of ≥ 1 bone lesion (defined as 1 lesion with positive uptake on bone scan) and/or ≥ 1 soft tissue lesion (measurable or non-measurable)

- Patient must have been previously treated with a next generation hormonal agent (NHA), ie, abiraterone, enzalutamide, apalutamide or darolutamide, for prostate cancer for at least 3 months and shown evidence of disease progression (radiological or via PSA assessment) while receiving the NHA

- Evidence of mCRPC with progression of disease despite androgen deprivation therapy (ADT) and after anti-androgen withdrawal if applicable

- Serum testosterone level ≤ 50 ng/dL

- Candidate for docetaxel and steroid therapy

- Ongoing ADT with LHRH agonist, LHRH antagonist, or bilateral orchiectomy

- Eastern Cooperative Oncology Group (ECOG)/World Health Organisation (WHO) performance status 0 to 1 and anticipated minimum life expectancy of 12 weeks

- Confirmation that archival formalin-fixed paraffin-embedded (FFPE) tumour tissue sample which meets the minimum pathology and sample requirements is available to send to the central laboratory

- Able and willing to swallow and retain oral medication

- Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm

Available at:

USO 23062

Study Full Title: A Phase 3, Open-label, Randomized, Prospective Study of Apalutamide with Continued Versus Intermittent Androgen-Deprivation Therapy (ADT) following PSA Response in Participants with Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

 

Disease Types: Genitourinary Cancer Research

Eligibility Requirements:

- Diagnosis of prostate cancer prior to screening with histologically or cytologically confirmed adenocarcinoma of the prostate

- Metastatic prostate cancer disease documented by conventional imaging (example, computed tomography [CT], magnetic resonance imaging [MRI], or bone scan) and/or next-generation imaging [NGI] demonstrating greater than equal (>=) 2 distinct extraprostatic sites of metastasis

- Have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. Participants with ECOG PS 2 or 3 are eligible for the study if the ECOG PS score is related to stable physical limitations (example, wheelchair-bound due to prior spinal cord injury) and not related to prostate cancer or associated therapy

- A participant must agree not to plan to conceive a child while enrolled in this study or within 3 months after the last dose of study treatment

- Must be able to take whole apalutamide tablets by swallowing alone or with another vehicle (example, applesauce)

- Assigned male at birth, inclusive of all gender identities

- Participants who have undergone a bilateral orchidectomy and/or who are actively taking gender-affirming hormone therapy as part of their gender affirming care

Available at:

USO 18263

A Phase 2, Multicenter, Single-arm Study of Zanubrutinib (BGB-3111) in Patients with Previously Treated B-Cell Lymphoma Intolerant of Prior Treatment with Ibrutinib and/or Acalabrutinib (BGB-3111-215)

 

Disease Types:

Eligibility Requirements:

- Confirmed diagnosis with at least one criterion for treatment according to IWCLL

- ECOG performance status of 0-2

- Measurable disease by contrast enhanced CT/MRI

- Previously treated with a minimum of 1 prior line of standard chemotherapy-containing regimen (with completion of >2 treatment cycles).

- Documented failure to achieve at least partial response (PR) or documented disease progression after response to the most recent treatment regimen. Refractory disease is defined as treatment failure (stable disease, non-response, progressive disease [PD]) or disease progression within 6 months after the most recent prior therapy (Hallek et al, 2008).

- Neutrophils > 0.75 x 109/L independent of growth factor support within 7 days of study entry

- Platelets > 50 x 109/L, independent of growth factor support or transfusion within 7 days of study entry

- Creatinine clearance of > 30 ml/min (as estimated by the Cockcroft-Gault equation or estimated glomerular filtration rate [eGFR] from the Modification of Diet in Renal Disease [MDRD])

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <3 x ULN

- Bilirubin <2 x ULN (unless documented Gilbert's syndrome)

- International normalized ratio (INR) <1.5 and activated partial thromboplastin time (APTT) <1.5 x ULN.

- Participants may be enrolled who relapse after autologous stem cell transplant if they are at least 6 months after transplant.

- Life expectancy of >4 months

- LVEF >50% by ECHO

Available at:

USO 23095

A Randomized, Controlled, Multiregional Phase 3 Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Squamous NSCLC (HARMONi-3)(SMT112-3003)

 

Disease Types: Lung Cancer Research

Eligibility Requirements:

- Age > 18 years old at the time of enrollmen

- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

- Expected life expectancy > 3 months

- Metastatic (Stage IV) NSCLC

- Histologically or cytologically confirmed squamous NSCLC

- Tumor Proportion Score (TPS) with PD-L1 expression percent

- At least one measurable noncerebral lesion according to RECIST 1.1

- No prior systemic treatment for metastatic NSCLC

Available at:

USO 22074

A Phase 3 Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects with Relapsed/Refractory Follicular Lymphoma (KT-US-473-0133)

 

Disease Types: Cellular & Gene

Eligibility Requirements:

- Histologically-confirmed follicular lymphoma (FL) (Grade 1, 2, or 3a)

- Clinical indication for treatment.

- At least 1 measurable lesion per the Lugano Classification {Cheson 2014}

- Adequate renal, hepatic, pulmonary, and cardiac function

Available at:

USO 22002

A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination with Immuno-Oncology Agents in Subjects with Unresectable Advanced or Metastatic Solid Tumors (XL092-002)

 

Disease Types: Solid Tumors Research

Eligibility Requirements:

- Cytologically or histologically confirmed solid tumor that is unresectable, locally advanced or metastatic.

- Recovery to baseline or < Grade 1 CTCAE v5 from AE(s) related to any prior treatments unless AE(s) are deemed clinically nonsignificant by the Investigator and/or stable on supportive therapy.

- Karnofsky Performance Status (KPS) >= 70%.

- Adequate organ and marrow function.

- Sexually active fertile subjects and partner agree to use highly effective methods of contraception.

- Female subjects of childbearing potential must not be pregnant at screening.

Available at:

USO 22083

A Phase 1, Multicenter, Open-Label Study of CNTY-101 in Subjects with Relapsed or Refractory CD19-Positive B-Cell Malignancies (CNTY-101-111-01 (ELiPSE-1)

 

Disease Types: Leukemia & Lymphoma Research

Eligibility Requirements:

-  Diagnosis of CD19-positive relapsed or refractory (R/R) B-cell Non-Hodgkin's Lymphoma (NHL).

Must have met the following criteria for prior treatment:

- Participants with aggressive NHL must have received at least 2 lines of systemic therapy (if not intended for transplant, have already undergone or be unwilling or unable to undergo chimeric antigen receptor [CAR] T-cell therapy to be eligible), or at least 3 lines of systemic therapy. Previous therapy must have included a CD20-targeted agent and an anthracycline or alkylator.

- Participants with follicular lymphoma (FL) must have received at least 2 lines of systemic therapy and have high-risk disease. Previous therapy must have included a CD20-targeted agent and an alkylator.

- Participants with marginal zone lymphoma (MZL) must have received at least 2 prior systemic therapies.

- Measurable disease on screening evaluations.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Adequate organ function.

Available at:

USO 22167

AN OPEN-LABEL, MULTICENTER, PHASE 1a/1b STUDY OF IGM-8444 AS A SINGLE AGENT AND IN COMBINATION IN SUBJECTS WITH RELAPSED, REFRACTORY, OR NEWLY DIAGNOSED CANCERS (IGM-8444-001)

 

Disease Types: Gastrointestinal Cancer Research

Available at:

USO 22283

A phase IIIb, multi-center, open-label, randomized study of tolerability and efficacy of oral asciminib versus nilotinib in patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (CABL001J12302)

 

Disease Types: Leukemia & Lymphoma Research

Eligibility Requirements:

Eligibility Criteria:

- Patients with CML-CP within 3 months of diagnosis.

- Diagnosis of CML-CP (ELN 2020 criteria) with cytogenetic confirmation of the Philadelphia chromosome.

- Evidence of typical BCR::ABL1 transcript which is amenable to standardized RQ-PCR quantification by the central laboratory assessment.

- ECOG performance status of 0 or 1.

-  Adequate end organ function.  

- Patients must have the following laboratory values within normal limits or corrected to within normal limits with supplements prior to randomization:

  Potassium 

  Total calcium 

  Magnesium 

Available at:

USO 23031

A Study of Outpatient Administration of Teclistamab, a BCMA-targeting Bispecific Antibody, in Multiple Myeloma Patients (64007957MMY2010)

 

Disease Types: Multiple Myeloma

Eligibility Requirements:

Inclusion Requirements:

- Has documented diagnosis of MM according to the IMWG diagnostic criteria (Rajkumar 2011).

- Has received 4 or more prior MM therapies including a PI, IMiD and CD38 antibody.

- Adequate organ system function

- A participant of childbearing potential must have a negative highly sensitive serum (B-hCG) at screening and within 72 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study.

- A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 5 months after the last dose of study treatment.

- A participant must be:

A:  Not of childbearing potential. If a participant becomes of childbearing potential after start of the study the participant must comply with point (b) as described below.

B:  Of childbearing potential and Practicing at least 1 highly effective method of contraception (failure rate of <1% per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study treatment and until 3 months after last dose - the end of relevant systemic exposure. Participant must agree to continue the above throughout the study and for 5 months after the last dose of study treatment.

Available at:

USO 22269

A Phase III, Randomised, Open-label, Multicentre, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Durvalumab and Carboplatin Versus Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Locally Advanced or Metastatic NSCLC Without Actionable Genomic Alterations (D926NC00001; AVANZAR)

 

Disease Types: Lung Cancer Research

Eligibility Requirements:

Eligibility Requirements: 

- Participants with histologically or cytologically documented NSCLC that is Stage IIIB or IIIC disease not amenable for surgical resection or definitive chemoradiation or Stage IV metastatic NSCLC disease at the time of randomisation, who have not received prior chemotherapy or other systemic therapy for first-line Stage IIIB, IIIC or IV

- Lacks sensitising EGFR tumour tissue mutation and ALK and ROS1 rearrangements and has no documented tumour genomic alterations in NTRK, BRAF, RET, MET or other actionable driver oncogenes with approved therapies (actionable genomic alterations).

- Has adequate bone marrow reserve and organ function within 7 days before randomisation

Available at:

USO 23009

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of AC699 in Patients with Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Locally Advanced or Metastatic Breast Cancer (AC699-001)

 

Disease Types: Breast Cancer Research

Eligibility Requirements:

Eligibility Criteria: 

- Confirmed diagnosis of advanced, unresectable, and/or metastatic breast cancer following disease progression on standard treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to standard therapies

- Histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive (ER+) human epidermal growth factor 2 negative (HER2-) breast cancer

- Must have received at least 2 prior endocrine or at least 1 prior line of endocrine therapy if combined with CDK4/6 inhibitor

- Prior chemotherapy is not required, but up to 3 prior regimens of cytotoxic chemotherapy will be allowed in the locally advanced/ metastatic setting

Available at:

USO 21550

A Phase II multi-center, open-label, single-arm dose escalation study of Asciminib monotherapy in 2nd Line Chronic Phase - Chronic Myelogenous Leukemia (ASC2ESCALATE)(CABL001AUS08)

 

Disease Types: Lymphoma & Hematologic

Available at:

USO 22201

IMGN853-0421: Randomized, Multicenter, Open-Label, Phase 3 Study Of Mirvetuximab Soravtansine In Combination With Bevacizumab Versus Bevacizumab Alone As Maintenance Therapy For Patients With Folate Receptor Alpha-Positive Recurrent Platinum-Sensitive Epithelial Ovarian, Fallopian Tube, Or Primary Peritoneal Cancers Who Have Not Progressed After Second Line Platinum-Based Chemotherapy Plus Bevacizumab (IMGN853-0421 GOG-3078)

 

Disease Types: GYN Cancer Research

Available at:

USO 22159

A Phase 3, Open-Label, Randomized, Two-Part Study Comparing Gedatolisib in Combination with Palbociclib and Fulvestrant to Standard-of-Care Therapies in Patients with HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated with a CDK4/6 Inhibitor in Combination with Non-Steroidal Aromatase Inhibitor Therapy (VIKTORIA-1) (CELC-G-301)

 

Disease Types: Breast Cancer Research

Available at:

USO 22200

A PHASE II, SINGLE-ARM STUDY OF GIREDESTRANT IN PATIENTS WITH GRADE 1 ENDOMETRIAL CANCER (CO44195)

 

Disease Types: GYN Cancer Research

Available at:

USO 22166

Phase 1/2 Safety and Efficacy Study of NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors (NUV-868-01)

 

Disease Types: Solid Tumors Research

Available at:

USO 22311

Harbinger Health Collection of Blood and Tissue Samples from Cancer and Non-Cancer Subjects for Validation of a Novel Blood-Based Multi-Cancer Screening Test (HH-PRT-0001)

 

Disease Types: Tissue Collection

Available at:

USO 22033

A Phase II, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of TT-00420 Tablet in Adult Patients with Advanced Cholangiocarcinoma (TT420C1206)

 

Disease Types: Lymphoma & Hematologic

Available at:

USO 21546

TiNivo-2: A Phase 3, Randomized, Controlled, Multicenter, Open-label Study to Compare Tivozanib in Combination with Nivolumab to Tivozanib Monotherapy in Subjects with Renal Cell Carcinoma Who Have Progressed Following One or Two Lines of Therapy Where One Line has an Immune Checkpoint Inhibitor (AV-951-20-304)

 

Disease Types: Genitourinary Cancer Research

Available at:

USO 21507

A Phase III, Open-label, Randomized Study of Datopotamab Deruxtecan (Dato-DXd) Versus Investigator's Choice of Chemotherapy in Patients who are not Candidates for PD 1/PD L1 Inhibitor Therapy in First-line Locally Recurrent, Inoperable or Metastatic Triple-negative Breast Cancer D926PC00001: (TROPION Breast02).

 

Disease Types: Breast Cancer Research

Available at:

USO 22285

Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Longitudinal Prospective RWE Study (MYLUNG Consortium Part 3: Observational Study)

 

Disease Types: Lung Cancer Research

Available at:

USO 22101

EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have Previously Received 2 to 5 years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer with an Increased Risk of Recurrence (J2J-MC-JZLH)

 

Disease Types: Breast Cancer Research

Eligibility Requirements:

-ER+, HER2 –  early stage, resected, invasive breast cancer without evidence of distant metastasis, must have undergone definitive loco-regional treatment, bilateral breast cancer diagnosed in both breasts simultaneously or within 6 months allowed if all tumors in both breasts are ER+, HER 2 -  and adequate surgery has been completed in both breasts, must have received at least 24 months but not more than 60 months of any adjuvant endocrine therapy, have an increased risk of disease recurrence based on clin-path features

-No: metastatic disease, inflammatory breast cancer at primary diagnosis, local or distant recurrence, different primary breast cancer, more than a 6 month consecutive gap in adjuvant endocrine therapy, completed or discontinued prior adjuvant endocrine therapy ˃ 6 months prior to screening, received endocrine therapy for breast cancer prevention (tamoxifen or aromatase inhibitors) or raloxifene, have serious pre-existing condition that in the opinion of the treating investigator would preclude participation in study, received a stem cell transplant, active bacterial or fungal infection or detectable viral infection

Available at:

uso 21412

A Phase I Study of FT576 as Monotherapy and in Combination with Daratumumab in Subjects with Relapsed/Refractory Multiple Myeloma (FT576-101)

 

Disease Types: Cellular & Gene

Available at:

USO 22018

A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy And Safety Of Giredestrant Plus Everolimus Compared With Exemestane Plus Everolimus In Patients With Estrogen Receptor (Er)-Positive, Her2-Negative, Locally Advanced Or Metastatic Breast Cancer (Ml43171)

 

Disease Types: Breast Cancer Research

Eligibility Requirements:

-ER (+), HER2 (-) locally advanced or metastatic adenocarcinoma of the breast not amenable to curative treatment with measurable disease or evaluable bone metastasis

-Prior endocrine therapy with CDK4/6i in adjuvant or metastatic setting and candidate for endocrine therapy

-No: prior treatment with another oral selective estrogen receptor degrader (SERD); more than 2 lines of systemic endocrine therapy in locally advanced or metastatic setting; prior chemotherapy in locally advanced or metastatic setting; known active uncontrolled or symptomatic CNS metastasis, carcinomatous meningitis, or leptomeningeal disease; active cardiac disease or history of cardiac dysfunction; known clinically significant history of liver disease; active inflammatory bowel disease, chronic diarrhea, short bowel syndrome, or major upper gastrointestinal surgery potentially affecting absorption; interstitial lung disease or severe dyspnea at rest or requiring oxygen.

Available at:

USO 21455

A Phase Iii,Randomized, Open-Label Study Evaluating The Efficacy And Safety Of Giredestrant In Combination With Phesgo Versus Phesgo After Induction Therapy With Phesgo+Taxane In Patients With Previously Untreated Her2-Positive, Estrogen Receptor-Positive Locally-Advanced Or Metastatic Breast Cancer (Wo43571)

 

Disease Types: Breast Cancer Research

Eligibility Requirements:

-Must have locally advanced or metastatic ER+/HER2+ adenocarcinoma of the breast not amenable to curative resection
-Must have been disease free ≥ 6 months from completion of non-hormonal neoadjuvant or adjuvant systemic anti-cancer treatment with measurable and/or non-measurable disease that can be evaluated according to RECIS 1.1
-Pre or perimenopausal females and males must be able/willing to maintain treatment with lutenizing hormone-releasing hormone agonist (LHRHa) therapy or if female and not able to tolerate LHRHa therapy willing to undergo bilateral oophorectomy
-No: previous systemic non-hormonal treatment in the metastatic or advanced setting; prior treatment with selective estrogen receptor degrader (fulvestrant, etc.); disease progression within 6 months of receiving trastuzumab with or without pertuzumab or ado-trastuzumab emtansine in adjuvant setting; history of persistent grade ≥ 2 hematological toxicity from previous neoadjuvant or adjuvant anti-cancer treatment; active uncontrolled or symptomatic central nervous system (CNS) metastasis, carcinomatous meningitis, or leptomeningeal disease; dyspnea at rest due to malignant disease complications or other disease requiring continuous oxygen therapy; treated with palliative radiation within 14 days prior to start of treatment; current chronic daily treatment with corticosteroids (10 mg/day or more of methylprednisolone or equivalent, excludes inhaled steroids); poorly controlled hypertension; known clinically significant history of or active liver disease; active cardiac disease or history of cardiac dysfunction; active inflammatory bowel disease, chronic diarrhea, short bowel syndrome or major upper gastrointestinal surgery including gastric resection potentially affecting GI absorption; major surgical procedure or injury with 14 days prior to enrollment or anticipation of need for major surgery during induction therapy; concurrent, serious, uncontrolled infection or known HIV infection (HIV positive patients on stable anti-retroviral therapy with CD4 count ≥ 200 with undetectable viral load and no AIDs-defining opportunistic infection with the last 12 months are eligible); serious infection requiring oral or IV antibiotics within 7 days prior to screening. 

Available at:

USO 21537

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician¡¯s Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors do Express PD-L1 (GS-US-592-6238)

 

Disease Types: Breast Cancer Research

Eligibility Requirements:

Locally advanced (inoperable) or metastatic triple negative breast cancer that is PD-L1 negative with measurable disease, patients with PD-L1 positive tumors at screening may be eligible if they received treatment with PD-L1 inhibitor in neoadjuvant or adjuvant setting
-Must have completed treatment for stage I-III as indicated with 6 ≥ months between finishing treatment with curative intent and documented disease recurrence, de novo metastatic triple negative breast cancer allowed
-No: previous treatment for advanced disease; received systemic anticancer treatment within past 6 months or radiation treatment within last 2 weeks; received topoisomerase 1 inhibitors or antibody drug conjugatescontaining isomerase inhibitor; HIV positive patients with history of Kaposi’s sarcoma and/or multicentric Castleman’s disease; active Hep B or Hep C infection; have known active central nervous system metastasis or carcinomatous meningitis; allogenic tissue or solid organ transplant; myocardial infarction or unstable angina pectoris within last 6 months, history of ventricular arrhythmia or high grade atrioventricular block or other cardiac arrhythmias requiring antiarrhythmic medication, New York Heart Association Grade III or IV heart failure or ejection fraction < 40%, history of QT interval prolongation; have active chronic inflammatory bowel disease (ulcerative colitis or Crohn’s) or GI perforation in last 6 months

Available at:

USO 21536

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced, Inoperable, or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1 (GS-US-592-6173)

 

Disease Types: Breast Cancer Research

Eligibility Requirements:

-Locally advanced (inoperable) or metastatic triple negative breast cancer that is PD-L1 positive with measurable disease
-Must have completed treatment for stage I-III as indicated with 6 ≥ months between finishing treatment with curative intent and documented disease recurrence, de novo metastatic triple negative breast cancer allowed
-No: previous treatment for advanced disease; prior therapy with agent directed to another stimulatory or coinhibitory T Cell receptor (CTLA-4, OX-40, CD137);
received systemic anticancer treatment within past 6 months or radiation treatment within last 2 weeks; received topoisomerase 1 inhibitors or antibody drug conjugates
containing isomerase inhibitor; HIV positive patients with history of Kaposi’s sarcoma and/or multicentric Castleman’s disease; active Hep B or Hep C infection; autoimmune disease requiring 
systemic treatment within past 2 years; have known active central nervous system metastasis or carcinomatous meningitis; allogenic tissue or solid organ transplant; myocardial infarction or unstable angina pectoris within last 6 months, history of ventricular arrhythmia or high grade atrioventricular block or other cardiac arrhythmias requiring antiarrhythmic medication, New York Heart Association Grade III or IV heart failure or ejection fraction < 40%, history of QT interval prolongation; have active chronic inflammatory bowel disease (ulcerative colitis or Crohn’s) or GI perforation in last 6 months; history of or active non-infectious pneumonitis or interstitial lung disease, history of active tuberculosis. 

Available at:

USO 21173

A Phase 3, double-blind, randomized study to assess the efficacy and safety of switching to AZD9833 (an oral SERD) + CDK4/6 inhibitors (palbociclib or abemaciclib) vs continuing aromatase inhibitor + CDK4/6 inhibitors in patients with acquired ESR1 mutation without radiological progression during 1L treatment with AI + CDK4/6i for HR+/HER2- mBC-ctDNA guided early switch study (SERENA 6) (D8534C00001)

 

Disease Types: Breast Cancer Research

Eligibility Requirements:

-ER +/Her 2 - recurrent or metastatic breast cancer not amenable to surgery or radiation therapy with curative intent
-Currently on aromatase inhibitor (AI) letrozole or anastrozole + CDK4/6 inhibitor (palbociclib or abemaciclib) ± Luteinizing hormone-releasing hormone (LHRH) agonist as initial endocrine treatment for advanced disease
-No: known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease; evidence of severe or uncontrolled systemic diseases; known or family history of severe heart disease; previous treatment with investigational Selective estrogen receptor degraders (SERDs) or fulvestrant; persistent non-hematological toxicities (Grade > 2) caused by CDK4/6 inhibitor and/or AI treatment. 

Available at:

uso 21326

A Phase 1b/3 Study of Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone in Subjects With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer With FGFR2b Overexpression (FORTITUDE-102 (20210098))

 

Disease Types: Gastrointestinal Cancer Research

Eligibility Requirements:

-Unresectable locally advanced or metastatic gastric or GE junction adenocarcinoma with evaluable disease that is eligible for treatment with mFOLFOX6 and nivolumab and study confirmed FGFR2 b overexpression 
-No: prior treatment in advanced or metastatic setting except for 1 dose of mFOLFOX6 with or without nivolumab; prior treatment with selective inhibitors of FGF-FGFR pathway; known HER2+ status; untreated or symptomatic CNS metastasis or leptomeningeal disease; clinically significant cardiac disease; peripheral sensory neuropathy grade 2 or higher; history of malignancy within last 2 years (definitively treated cancers allowed); known HIV infection with CD4+ T-cell count < 350 cells/uL, Hep C or Hep B infection (sustained virologic response after antiviral therapy allowed); history of interstitial lung disease; solid organ transplant; active autoimmune disease requiring systemic treatment within last 2 years (except for replacement therapy) or other need for chronic immunosuppressive treatment; history of or ongoing chronic use of ophthalmic steroids; ongoing ophthalmologic abnormalities or symptoms that are acute or actively progressing; not willing to abstain from contact lens use; conditions or known abnormalities of the eye that would increase risk of developing corneal ulcerations; corneal surgery or ophthalmic laser procedures within last 6 months.

Available at:

uso 21207

(PSMAddition): An international Prospective Open-label, Randomized, Phase III Study comparing [177Lu]Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with Metastatic Hormone Sensitive Prostate Cancer (mHSPC)(CAAA617C12301)

 

Disease Types: Genitourinary Cancer Research

Eligibility Requirements:

- Metastatic hormone sensitive adenocarcinoma of the prostate

- No: prior systemic cancer therapy for prostate cancer (LHRH agonist/antagonist, CYP 17 inhibitor or ARDT treatment of up to 45 days allowed); previous treatment within 6 months of randomization with Strontium-89, Samarium-153,                                                                                                                                                                                                                          Rhenium-186 or 188, Radium-223, hemibody irradiation, or previous PSMA targeted radioligand therapy; CNS metastasis that is unstable, symptomatic, or requires corticosteroid treatment; active hepatitis B or C; active clinically significant cardiac disease; unable to maintain raised arm position (if can maintain raised arms with positioning allowed)

Available at:

uso 20408

A Phase Ill, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy And Safety Of Adjuvant Giredestrant Compared With Physician's Choice Of Adjuvant Endocrine Monotherapy In Patients With Estrogen Receptor - Positive, Her2‑Negative Early Breast Cancer (Go42784)

 

Disease Types: Breast Cancer Research

Eligibility Requirements:

- ER+, HER2 – Breast Cancer, must have under definitive surgery for disease and completed adjuvant therapy prior to randomization 

- No:  active cardiac disease or history of cardiac dysfunction, metastatic breast cancer; clinically significant liver disease or active hepatitis B or C; coagulopathy or thromboembolism; inability to swallow or absorb oral medication

Available at:

USO 21225

A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients Whose Disease is Resistant or Refractory to T-DM1, and/or T-DXd, and/or Tucatinib-containing Regimens (ACE-Breast-03)

 

Disease Types: Breast Cancer Research

Eligibility Requirements:

-Her 2+ metastatic breast cancer with measurable disease, must have prior therapy with ado-trastuzumab (T-DM1), and/or trastuzumab deruxtecan (T-Dxd), and/or tucatinib containing regimen, and trastuzumab + taxane.
-No: clinically significant lung disease within the last 12 months, history of interstitial lung disease or pneumonitis; congestive heart failure, unstable angina, unstable atrial fibrillation, or cardiac arrhythmia in the last 12 months and myocardial infarction within last 6 months; unstable central nervous metastasis; peripheral neuropathy grade 2 or higher; known active HIV, Hep B, or Hep C; or ocular conditions such as keratopathy, dry eye, keratitis, corneal disorders, or current ocular infection. 

Available at:

USO 20403

A Phase III Randomized, Open-Label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab in Combination with Tremelimumab and Enfortumab Vedotin or Durvalumab in Combination with Enfortumab Vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer D910PC00001:(VOLGA)

 

Disease Types: Genitourinary Cancer Research

Eligibility Requirements:

-Muscle invasive transitional cell cancer of bladder ineligible to receive neoadjuvant cisplatin and medically appropriate to have radical cystectomy
-No: evidence of more than 2 positive lymph nodes or metastatic disease; taking immunosuppressive medicine greater than the equivalent of 10 mg/day of prednisone within past 14 days; autoimmune or inflammatory disorders; allogenic organ transplant that requires use of immunosuppressive medication; history of allogenic stem cell transplant; 
history of active primary immunodeficiency; TB, HIV, Hepatitis B, or Hepatitis C (past or resolved hepatitis B or C allowed); ongoing significant sensory or motor neuropathy; Class IV New York Heart Association heart failure; prior radiation for bladder cancer; active keratitis or corneal ulceration (superficial punctate keratitis allowed if treated). 

Available at:

USO 20398

A Phase II, Open-Label, Multicenter, Platform Study Evaluating The Efficacy And Safety Of Biomarker-Driven Therapies In Patients With Persistent Or Recurrent Rare Epithelial Ovarian Tumors (Wo42178/Engot-Gyn2/Gog-3051)

 

Disease Types: GYN Cancer Research

Eligibility Requirements:

-persistent or recurrent epithelial ovarian carcinoma not amenable to curative surgery
-measurable disease, previous treatment with 1-4 lines of therapy with at least one that was platinum based
-No: hepatitis B, hepatitis C; pleural or pericardial effusions or ascites requiring recurrent drainage; uncontrolled and/or symptomatic hypercalcemia; symptomatic, untreated, or progressive central nervous system metastasis; history of leptomeningeal disease.

Available at:

D9673C00007 (DESTINY-Breast12)

“An Open-Label, Multinational, Multicenter, Phase 3b/4 Study of Trastuzumab Deruxtecan in Patients With or Without Baseline Brain Metastasis With Previously-Treated Advanced/Metastatic HER2-Positive Breast Cancer(DESTINY-Breast12)”

 

Disease Types: Breast Cancer Research

Eligibility Requirements:

-Her2+, unresectable advanced or metastatic breast cancer with disease progression on trastuzumab, pertuzumab, or T-DM1
-No more than 2 lines of therapy in metastatic setting, brain metastasis allowed if stable or not needing immediate therapy
-No: leptomeningeal disease; prior tucatinib therapy; chronic GI disease, refractory nausea/vomiting, significant bowel resection; known active HIV, Hep B, or Hep C;
myocardial infarction within previous 6 months, symptomatic congestive heart failure, unstable angina, recent cardiovascular event including stroke within previous 6 months; long QT syndrome,

QT prolongation requiring medication discontinuation or associated with concurrent medication, history of clinically significant arrythmia that is symptomatic or requires treatment, uncontrolled atrial fibrillation, ventricular tachycardia; history of interstitial lung disease that required steroids, current interstitial lung disease, or pneumonitis, clinically significant lung or pulmonary disease or conditions such as severe asthma or severe COPD, autoimmune or connective tissue or inflammatory disorder or disease with pulmonary involvement, prior pneumonectomy. 

Available at:

USO 20283

A Phase 2 Study Of Brentuximab Vedotin In Combination With Pembrolizumab In Subjects With Metastatic Solid Malignancies After Progression On Prior PD-1 Inhibitor Treatment (SGN35-033)

 

Disease Types: Solid Tumors Research

Eligibility Requirements:

-relapsed/refractory metastatic squamous or non-squamous metastatic NSCLC (EGFR, ALK, ROS 1, & BRAF negative) or metastatic cutaneous melanoma with measurable disease
-Must be currently on PD-1 checkpoint inhibitor therapy or must be last previous line of therapy, must have progressed on anti-PD-1 monotherapy or combination therapy 
-No: known active CNS metastasis or carcinomatous meningitis; history of progressive multifocal leukoencephalopathy; known Hep B or Hep C (treated allowed); previous treatment with brentuximab vedotin; pulmonary disease unrelated to NSCLC or melanoma; history of stroke, TIA, unstable angina, MI, congestive
heart failure class 3 or 4 within last 6 months; neuropathy grade 2+; active autoimmune disease or immunodeficiency requiring systemic immunosuppressive therapy; pneumonitis or idiopathic interstitial pneumonia; allogenic tissue or solid organ transplant; grade 3+ immune related adverse events due to 
therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, CTLA-4, OX 40, CD137 treatment

Available at:

USO 19151

A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation (849-001) STAR

 

Disease Types: Solid Tumors Research

Eligibility Requirements:

-NSCLC (squamous or non-squamous; mixed histology not allowed) or colorectal solid tumors with KRAS G12c mutations 
-must have unresectable or metastatic disease with no standard of care treatment options available
-NSCLC patients must have had platinum based chemotherapy & treatment with a check point inhibitor 
-no active brain metastasis, carcinomatous meningitis, significant hemoptysis or hemorrhage within last 4 weeks, GI condition or disease that prevents absorption of oral medication, significant heart disease, history of stroke or TIA within last 6 months, or known HIV, active Hep B or Hep C

Available at:

USO 18283

A Phase II Open Label, Study of IMMU-132 in Metastatic Urothelial Cancer After Failure of Platinum-Based Regimen or Anti-PD-1/PD-L1 Based Immunotherapy (IMMU-132-06)

 

Disease Types: Genitourinary Cancer Research

Eligibility Requirements:

-locally advanced or metastatic urothelial cancer with measurable disease
-No: immunodeficiency disease; prior anti-cancer with mono-clonal antibodies within last 4 weeks; prior treatment with irinotecan; known active CNS metastasis or carcinomatous meningitis; active serious cardiac disease (MI or unstable angina within last 6 months, serious ventricular arrhythmia, congestive heart failure class 3 or 4, ejection failure less than 40%); chronic ulcerative colitis, Crohn’s disease, or history of bowel obstruction; prior history of significant bleeding, intestinal obstruction, or GI perforation within last 6 months; known HIV, Hep B or Hep C

Available at:

Virginia Oncology Associates