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  • A 5-year Longitudinal Observational Study of the Natural History and Management of Patients with Hepatocellular Carcinoma - NCT02954094

    Primary Aims 1. Establish a longitudinal observational cohort to understand the natural history and management of HCC, including the safety and outcomes of HCC treatment interventions utilized in usual clinical practice Secondary Aims 1. Evaluate the impact of HCC treatment interventions and concomitant medications on comorbid conditions and liver function 2. Evaluate patient-reported outcomes measures during the natural course of HCC and management with HRQoL questionnaires 3. Establish a Biorepository Specimen Bank (BSB) Exploratory Aims 1. Investigate optimal type, duration, and sequence/combination of treatment interventions for HCC used in usual clinical practice 2. Perform biomarker analyses to identify potential markers predictive of response patterns or side effect profiles 3. Generate hypotheses that may lead to further investigations regarding natural course and treatment of HCC

    View All Details

    • Protocol Number:
      001720

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Liver

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Male or female patients, age ≥18 years 2. Patients with a histological/cytological or radiological diagnosis of HCC (mixed HCC cholangiocarcinoma may be included; patients who are candidates for surgical and non-surgical treatment, as well as those being followed without specific HCC therapy may be included)

    Exclusion Criteria:

      1. Inability to provide written informed consent

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Robert Wood Johnson University Hospital
    • Rutgers Cancer Institute
  • A Phase I/II Study of M3814 and Avelumab in Combination with Hypofractionated Radiation in Patients with Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies. - NCT04068194

    Primary Objective: Phase I: (1) To determine the safety and tolerability and recommended phase 2 dose (RP2D) of M3814 in combination with hypofractionated radiation and avelumab in patients with advanced/metastatic solid tumors. Phase II: (1) To determine the efficacy of the combination of hypofractionated radiation, M3814, and avelumab as compared to the combination of hypofractionated radiation and avelumab in patients with advanced/metastatic hepatobiliary tumors by objective response rate (ORR) in non-irradiated lesions. All lesions (target and non-target) except the one or two lesions that were irradiated are to be included in the assessment of overall response using RECIST v1.1. Secondary Objective(s): Phase I: (1) To observe and record anti-tumor activity. Although the clinical benefit of this combination has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability. Specifically, to determine efficacy of the combination by measurement of disease control rate (DCR), duration of response (DOR), progression free survival (PFS), PFS outside the irradiated field, and overall survival (OS) in patients with advanced/metastatic solid tumors. (2) To characterize the pharmacokinetic (PK) profile of M3814 in combination with avelumab. Phase II: (1) To determine the efficacy and safety of the combination of hypofractionated radiation, M3814, and avelumab as compared to hypofractionated radiation and avelumab by measurement of DCR, DOR, PFS, PFS outside the irradiated field, and OS in patients with advanced/metastatic hepatobiliary tumors. (2) To determine if baseline DNA repair defects inherent to some cholangiocarcinomas correlate with a more dramatic response to radiation compared to those without as measured by H2AX pNBS1 multiplex IFA assay. (3) To characterize the pharmacokinetic (PK) profiles of M3814 and avelumab.

    View All Details

    • Protocol Number:
      052002

    • Principal Investigator:
      Salma Jabbour

    • Phase:
      Phase I/II

    • Scope:
      National

    • Applicable Disease Sites:
      Any Site, Liver, Other Digestive Organ

    • Therapies Involved:
      Chemotherapy multiple agents systemic Chemotherapy single agent systemic Radiotherapy

    • Drugs Involved:
      Avelumab M3814

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • PHASE 1: Patients must have a histologically confirmed metastatic or locally advanced unresectable solid tumor that has progressed on or after available standard of care therapy or for which no acceptable standard of care therapy exists, or in which the patient declines standard of care therapy (each patient that declines standard of care therapy will be documented in the case report form)
    • PHASE 2: Patients must have a histologically confirmed metastatic or locally advanced unresectable cholangiocarcinoma/gallbladder carcinoma that has progressed on gemcitabine, cisplatin, and durvalumab/pembrolizumab.
    • Age >= 18 years
    • Because no dosing or adverse event data are currently available on the use of peposertib (M3814) in combination with avelumab in patients < 18 years of age
    • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
    • Patients with at least 1 index lesion to irradiate for whom palliative radiation treatment is indicated (including but not limited to pain and/or symptom control, prevention of disease -related complications, and preservation of organ function). Lung and liver lesions are preferred, though alternate lesions may be considered after discussion with trial principal investigator (PI). Up to 2 lesions may be considered for irradiation provided at least 1 lesion will receive the study treatment of total of 60 Gy and all prescribed irradiation will be completed within the radiation window
    • Patients with at least 1 Response Evaluation Criteria in Solid Tumors (RECIST) measurable lesion (to be unirradiated) (defined as those accurately measured in at least one dimension, with the longest diameter to be recorded for non-nodal lesions and the shortest diameter for nodal lesions). Measurable is defined as at least 10 mm in longest diameter for solid tumors, at least 15 mm in shortest diameter for lymph nodes
    • Patients must be willing to undergo fresh biopsies at baseline (as opposed to using archival tissue), in the event their baseline tissue was obtained > 12 months prior to study consent and/or they are randomized to the gamma H2AX, pNBS1 and pKAP1 IFA with beta CATN segmentation assay
    • Absolute neutrophil count (ANC) >= 1,500/mcL
    • Platelet count >= 100,000/mcL
    • Hemoglobin >= 9.0 g/dL
    • Serum creatinine =< 1.5 x upper limit of normal (ULN) OR calculated serum creatinine clearance (glomerular filtration rate [GFR] can be used in place of creatinine or creatinine clearance) >= 60 mL/min for participants with creatinine levels > 1.5 x institutional ULN
    • Calculate serum creatinine clearance using the standard Cockcroft-Gault formula
    • Serum total bilirubin =< 1.5 x ULN or direct bilirubin =< ULN for participants with total bilirubin > 1.5 x ULN
    • Patients with known Gilbert disease with serum bilirubin level =< 3 x ULN are eligible
    • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN or =< 5.0 x ULN for patients with hepatobiliary tumors/liver metastases
    • Albumin >= 2.8 g/L
    • International normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) =< 1.5 x ULN
    • This applies only to patients not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose
    • Participants must have the ability to swallow and retain oral medication and not have any clinically significant gastrointestinal abnormalities that might alter absorption
    • Female patients of childbearing potential must have a negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. The effects of peposertib (M3814) and avelumab on the developing human fetus are unknown and there is the potential for teratogenic or abortifacient effects. For this reason, women and men of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study treatment, and for 6 months after completion of peposertib (M3814) and avelumab administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with peposertib (M3814) and avelumab, breastfeeding should be discontinued if the mother is treated with peposertib (M3814) and avelumab
    • Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a close caregiver or legally authorized representative (LAR) and/or family member available will also be eligible

    Exclusion Criteria:

    • PHASE I: Patients who have received prior anti-CTLA-4, anti-PD-1, anti-PD-L1 or other immune checkpoint inhibitor therapeutic antibodies or pathway-targeting agents
    • PHASE II: Patients who have received prior anti-CTLA-4, anti-PD-1, anti-PD-L1 or other immune checkpoint inhibitor therapeutic antibodies or pathway-targeting agents with the following exceptions:
    • Patients who have only received previous durvalumab (anti-PD-L1) in combination with gemcitabine +/- cisplatin as part of first line therapy (TOPAZ-1 regimen) are eligible
    • Patients who have only received previous pembrolizumab (anti-PD-1) in combination with gemcitabine +/- cisplatin as part of first line therapy (KEYNOTE-966 regimen) are eligible
    • Patients who have had chemotherapy, definitive radiation, biological cancer therapy, or investigational agent/device within 21 days of first planned dose of study therapy (within 14 days for palliative radiation). Previously irradiated lesions may be re-irradiated provided there is disease progression in the irradiated lesion and the prescribed radiation dosage can safely be re- administered
    • Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Common Terminology Criteria for Adverse Events [CTCAE] grade 1) with the exception of alopecia
    • Patients with untreated/uncontrolled central nervous system (CNS)/leptomeningeal disease. Patients with asymptomatic, treated CNS disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy and the following criteria are met:
    • Radiographic demonstration of clinical stability upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study done >= 4 weeks from completion of radiotherapy and >= 2 weeks from discontinuation of corticosteroids
    • No stereotactic radiation or whole-brain radiation within 28 days prior to randomization
    • Patients with active autoimmune disease requiring systemic corticosteroids greater than the equivalent of prednisone 10 mg daily including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, colitis, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis, with the following exceptions:
    • Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible
    • Patients with controlled type 1 diabetes mellitus on a stable insulin regimen are eligible
    • Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only who require only low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%) are eligible
    • Patients receiving treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 6 weeks must discontinue these medications prior to starting peposertib (M3814) and avelumab on day 7, with the exception of:
    • Patients with active autoimmune disease managed with systemic corticosteroids less than the equivalent of prednisone 10 mg daily
    • Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea)
    • The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension and adrenocortical insufficiency
    • Patients who have undergone prior solid organ or bone marrow transplant with the exception of patients with prior renal transplant for whom dialysis may be employed in the event of graft rejection
    • Patients with uncontrolled intercurrent illness (e.g., including but not limited to uncontrolled hypertension [HTN] [systolic blood pressure (BP) > 150, diastolic BP > 100], symptomatic congestive heart failure [CHF], unstable angina pectoris, ischemic myocardial infarction [MI] within 6 months, cardiac arrhythmia, recent transient ischemic attack [TIA or cerebrovascular accident (CVA)]) within 6 months
    • Patients with serious active infection (e.g. requiring hospitalization and/or intravenous [IV] antibiotics) within 4 weeks prior to starting peposertib (M3814) and avelumab, or signs/symptoms of infection or receiving oral or IV antibiotics for the treatment of active systemic infection within 2 weeks prior to starting peposertib (M3814) and avelumab. Patients receiving prophylactic antibiotics are eligible
    • Patients with known chronic hepatitis B virus (HBV) infection must have an undetectable viral load on suppressive therapy if indicated. Patients with known chronic hepatitis C (HCV) infection must have been treated and cured. Patients who are currently on curative treatment are eligible if they have an undetectable HCV viral load
    • Patients with known human immunodeficiency virus (HIV) are allowed on study provided they have:
    • A stable regimen of highly active anti-retroviral therapy (HAART)
    • No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infection
    • A CD4 count above 250 cells/mcL
    • An undetectable HIV viral load on standard polymerase chain reaction (PCR)-based testing
    • Patients with history of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (e.g., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest computed tomography (CT) scan
    • Patients with known concurrent malignancy that is expected to require active treatment within two years, or may interfere with the interpretation of the efficacy and safety outcomes of this study in the opinion of the treating investigator. Superficial bladder cancer, nonmelanoma skin cancers, and low-grade prostate cancer not requiring cytotoxic therapy should not exclude participation in this trial. Patients with chronic lymphocytic leukemia (CLL) may be enrolled if they do not require active chemotherapy and their hematologic, renal and hepatic function meets criteria previously mentioned
    • Patients with psychiatric illness/social situations that would limit compliance with study requirements
    • History of allergic reactions attributed to compounds of similar chemical or biologic composition to peposertib (M3814) or avelumab
    • Patients unable to discontinue medications or substances that are potent inhibitors, inducers or sensitive substrates of CYP3A4/5 or CYP2C19 prior to starting peposertib (M3814) and avelumab are ineligible. Medications or substances that are strong inhibitors of CYP3A4/5 or CYP2C19 must be discontinued at least 1 week prior to first peposertib (M3814) dose. Strong inducers of CYP3A4/5 or CYP2C19 must be stopped at least 3 weeks prior to the first dose. Drugs mainly metabolized by CYP3A with a narrow therapeutic index as judged by the investigator must stop at least 1 day prior to first peposertib (M3814) dose. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product. The primary elimination mechanism of avelumab is proteolytic degradation, thus there are no contraindicated medications with respect to avelumab
    • Patients who cannot discontinue concomitant proton-pump inhibitors (PPIs) prior to starting peposertib (M3814) and avelumab. These must be discontinued >= 5 days prior to starting peposertib (M3814) and avelumab. Patients do not need to discontinue calcium carbonate. H2 blockers are allowed provided they are taken at least 2 hours after peposertib (M3814) dose
    • Patients receiving sorivudine or any chemically related analogues (such as brivudine) and not able to discontinue prior to starting peposertib (M3814) and avelumab are excluded
    • Pregnant and lactating women are excluded from this study because peposertib (M3814) and avelumab are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with peposertib (M3814) and avelumab, breastfeeding should be discontinued if the mother is treated with peposertib (M3814) and avelumab
    • Patients who have received live vaccination within 30 days before starting peposertib (M3814) and avelumab

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute
  • A Phase II Study of Nivolumab + Ipilimumab in Advanced HCC Patients Who Have Progressed on First Line Atezolizumab + Bevacizumab. - NCT05199285

    The objectives of the study are to: To investigate the confirmed objective response rate (ORR) of nivolumab and ipilimumab in patients with hepatocellular carcinoma (HCC) who have progressed radiographically on atezolizumab/bevacizumab that necessitates change in treatment. To determine the overall survival (OS) in hepatocellular carcinoma (HCC) patients treated with nivolumab and ipilimumab who have progressed radiographically on atezolizumab/bevacizumab that necessitates change in treatment . To determine the progression free survival (PFS) in hepatocellular carcinoma (HCC) patients treated with nivolumab and ipilimumab who have progressed radiographically on atezolizumab/bevacizumab that necessitates change in treatment. To determine the disease control rate in hepatocellular carcinoma (HCC) patients treated with nivolumab and ipilimumab who have progressed radiographically on atezolizumab/bevacizumab that necessitates change in treatment. To assess the frequency and severity of adverse events in hepatocellular carcinoma (HCC) patients treated with nivolumab and ipilimumab who have progressed radiographically on atezolizumab/bevacizumab that necessitates change in treatment.

    View All Details

    • Protocol Number:
      072213

    • Principal Investigator:
      Sharon Li

    • Phase:
      Phase I/II

    • Scope:
      National

    • Applicable Disease Sites:
      Liver

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      IPILIMUMAB (MDX-010) Opdivo (Nivolumab)

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Age >= 18 years.
    • HCC diagnosis confirmed by histology/cytology or clinically by American Association for Study of Liver Diseases (AASLD) criteria in cirrhotic patients.
    • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
    • Locally advanced, metastatic, or unresectable disease.
    • Child Pugh class A.
    • Barcelona clinic liver cancer (BCLC) stage B (not amenable to liver directed therapy) or stage C.
    • Prior treatment with atezolizumab and bevacizumab combination with radiographic progression that necessitates change in treatment per treating physician. Patients with rapid progression on atezolizumab and bevacizumab (defined as patients who progressed radiographically in the first restaging scan that necessitates change in treatment) are excluded.
    • Washout period >= 4 weeks prior to registration is required since last atezolizumab and bevacizumab dose.
    • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. (Form is available on the Academic and Community Cancer Research United [ACCRU] website).
    • Absolute neutrophil count (ANC) >= 1000/mm ^ 3 (obtained =< 28 days prior to registration).
    • Platelet count >= 60,000/mm^3 (obtained =< 28 days prior to registration).
    • Hemoglobin >= 8.5 g/dL (obtained =< 28 days prior to registration).
    • Total bilirubin =< 3 x upper limit of normal (ULN) (obtained =< 28 days prior to registration).
    • Alanine aminotransferase (ALT) and aspartate transaminase (AST) =< 5 x ULN (obtained =< 28 days prior to registration).
    • International normalized ratio (INR) =< 2.3 or Prothrombin time (PT) =< 6 seconds above control OR if patient is receiving anticoagulant therapy and INR is within target range of therapy creatinine =< 1.5x ULN (obtained =< 28 days prior to registration).
    • Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only.
    • Note: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
    • Provide informed written consent =< 28 days prior to registration.
    • Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study).
    • Note: During the active monitoring phase of a study (i.e., active treatment), participants must be willing to return to the consenting institution for follow-up.
    • Willing to provide mandatory tissue specimens and blood specimens for correlative research purposes.

    Exclusion Criteria:

    • Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown
    • Pregnant persons
    • Nursing persons
    • Persons of childbearing potential who are unwilling to employ adequate contraception.
    • Major surgery =< 4 weeks prior to registration.
    • Liver directed therapy (transarterial chemoembolization [TACE], Y-90, liver directed radiation) =< 28 days prior to registration. Prior liver directed therapy > 28 days prior to registration is allowed as long as patient has at least one measurable untreated lesion by RECIST v1.1.
    • Patients with rapid progression on atezolizumab and bevacizumab (who progressed radiographically in the first restaging scan that necessitates change in treatment) are excluded.
    • Prior treatment =< 4 weeks prior to registration with anti-CTLA-4 antibody for HCC.
    • Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
    • Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy.
    • Note: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
    • Uncontrolled intercurrent illness including, but not limited to:
    • Ongoing or active infection excluding hepatitis C virus (HCV)
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Unstable cardiac arrhythmia
    • Psychiatric illness/social situations that would limit compliance with study requirements.
    • Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis [TB] testing in line with local practice), hepatitis B (known positive hepatitis B virus [HBV] surface antigen [HBsAg] result). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients with chronic HBV infection as evidenced by detectable HBV surface antigen or HBV deoxyribonucleic acid (DNA) are eligible if on antiviral therapy and have HBV DNA < 100 IU/mL. Patients with active or resolved hepatitis C (HCV) infection as evidenced by detectable HCV ribonucleic acid (RNA) or antibody are eligible.
    • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm =< 4 weeks prior to registration.
    • Other active malignancy =< 2 years prior to registration. Exceptions: Non-melanotic skin cancer or carcinoma-in-situ of the cervix.
    • History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
    • History of allogenic organ transplantation.
    • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
    • Patients with vitiligo or alopecia
    • Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
    • Any chronic skin condition that does not require systemic therapy
    • Patients without active disease in the last 5 years may be included but only after consultation with the study physician
    • Patients with celiac disease controlled by diet alone
    • History of leptomeningeal carcinomatosis.
    • Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
    • Current or prior use of immunosuppressive medication =< 14 days prior to registration. The following are exceptions to this criterion:
    • Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
    • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
    • Steroids as premedication for hypersensitivity reactions (e.g., computed tomography [CT] scan premedication).
    • Receipt of live attenuated vaccine =< 30 days prior to registration; Note: Patients, if enrolled, should not receive live vaccine whilst on study treatment and up to 30 days after the last dose of study treatment.
    • Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade >= 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.
    • History of grade 3 or 4 immunotherapy related toxicity NCI CTCAE v5.0 due to prior regimen attributed to atezolizumab.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Cooperman Barnabas Medical Center
    • Newark Beth Israel Medical Center
    • Jersey City Medical Center
  • A Phase II Trial of Tislelizumab Consolidation after Liver-Directed Therapy for Hepatocellular Carcinoma. - NCT05366829

    Primary Objective: To determine if consolidation therapy with Tislelizumab following local therapy improves 1-year progression-free survival in patients with locally advanced, unresectable HCC. PFS is defined as the time from registration until the criteria for disease progression is met by mRECIST and RECIST v1.1 or death as a result of any cause. Secondary Objectives: 1.To determine if consolidation therapy with Tislelizumab after definitive therapy improves time to metastatic disease and overall survival (OS) and local control in subjects with localized, inoperable HCC. 2.To assess objective response rate, disease control rate, duration of response with consolidation therapy with Tislelizumab after local therapy in subjects with localized, inoperable HCC. 3.To assess the safety profile of Tislelizumab after definitive therapy. 4. To assess biomarker response as measured by Alpha fetoprotein (AFP), should the patient s tumor produce AFP. Exploratory Objectives: 1.To determine the strength by which the tumor molecular profile from NGS tissue prior to initiation of therapy correlates with treatment response. 2.To analyze ctDNA as a biomarker of response to therapy and early detection of disease progression.

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    • Protocol Number:
      072105

    • Principal Investigator:
      Salma Jabbour

    • Phase:
      Phase II

    • Scope:
      Local

    • Applicable Disease Sites:
      Liver

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      Tislelizumab (BGB-A317)

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Each patient eligible to participate in this study must meet all the following criteria: 1. Written informed consent 2. Primary diagnosis of HCC, planned to receive radiation, treatment naïve to systemic therapy for HCC, prior TACE permitted 3. Hepatocellular carcinoma diagnosis by histologic findings and/or imaging criteria of LI-RADS 5 4. Eastern Cooperative Oncology Group performance status score of 0-2 5. Age>/=18 years 6. Child-Pugh class A liver function or B7, BCLC A-C or deemed not a candidate for surgery or liver transplantation 7. No extrahepatic metastasis detected on CT chest with or without IV contrast, abdomen and pelvis with IV and oral contrast (triphasic-if feasible based on kidney function), or MRI abdomen/liver and chest CT. 8. Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and ≥ 6 months after the last dose of tislelizumab, and have a negative urine or serum pregnancy test ≤ 7 days of first dose of study drug 9. Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 6 months after the last dose of tislelizumab. Males must agree not to donate or bank sperm during treatment with tislelizumab and for > 6 months after treatment stop. 10. Must have 1 target lesion measurable in 1 dimension according to RECIST 1.1. 11. Demonstrate adequate bone marrow and organ function as defined below: 1. Hematologic - Absolute neutrophil count (ANC) ≥ 1,500/mcL, Hemoglobin > 8.5 g/dL, Platelet count ≥ 75,000/mcL 2. Renal - Serum creatinine OR calculated* serum creatinine clearance (GFR can be used in place of creatinine or creatinine clearance) ≤ 1.5x upper limit of normal (ULN) OR ≥ 30 mL/min for participants with creatinine levels > 1.5x institutional ULN
    • Calculate serum creatinine clearance using the standard Cockcroft-Gault formula. Urine protein Urine dipstick for proteinuria < 2+ within 7 days prior to start of study treatment *Participants with ≥ 2+ proteinuria on dipstick analysis at baseline should undergo a 24-hour urine collection which must demonstrate < 1g of protein in 24 hours 3. Hepatic - Serum total bilirubin ≤ 3 mg/dL , AST (SGOT) and ALT (SGPT) ≤ 5x ULN , Alkaline phosphatase (ALP) ≤ 8x ULN Coagulation - International Normalized Ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤ 2.0x ULN *This applies only to participants not receiving therapeutic anticoagulation; participants receiving therapeutic anticoagulation should be on a stable dose.

    Exclusion Criteria:

      1. Prior radiotherapy to the region of the liver that would result in excessive doses to normal tissues due to overlap of radiation therapy fields 2. Prior selective internal radiotherapy/hepatic arterial Yttrium therapy, at any time 3. Severe, active co-morbidity as per investigator 4. More than five discrete intrahepatic parenchymal foci of definite HCC or left/right or main portal vein thrombus 5. Direct tumor extension into the stomach, duodenum, small bowel or large bowel 6. Measurable common or main branch biliary duct involvement with HCC 7. Extrahepatic metastases or malignant nodes (that enhance with typical features of HCC) > 3.0 cm, in sum of maximal diameters (e.g. presence of one 3.4 cm metastatic lymph node or two 2 cm lung lesions). Note: benign non-enhancing periportal lymphadenopathy is not unusual in the presence of hepatitis and is permitted, even if the sum of enlarged nodes is > 2.0 cm. 8. Prior liver transplant 9. HIV positive 10. Immunodeficiency requiring chronic systemic therapy or that may relapse 11. Participants who have received prior immunotherapy. 12. Participants with clinically meaningful ascites, defined as ascites requiring non-pharmacologic intervention (e.g. paracentesis) to maintain symptomatic control a. Note: Participants with ascites who require pharmacologic intervention (e.g. diuretics) to maintain symptomatic control and who have been on stable doses of diuretics for two months days prior to the first dose of study treatment are eligible. 13. Participants with clinically meaningful encephalopathy 14. Participants who have undergone prior solid organ or bone marrow transplant except for patients with prior renal transplant for whom dialysis may be employed in the event of graft rejection. 15. Patients must have documented hepatitis virology status. a. Participants with active hepatitis B virus (HBV) infection must have a viral load < 500 IU/mL within 28 days prior to start of Tislelizumab and be on suppressive therapy (per local standard of care) for a minimum of fourteen days prior to start of study treatment and for the length of the study. b. Participants with co-infection with HBV and hepatitis C virus (HCV) are excluded. c. Participants with a history of HCV infection but with negative HCV RNA by PCR are considered non-infected with HCV and can enroll. 16. Participants with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible. 17. Participants with controlled Type 1 diabetes mellitus on a stable insulin regimen are eligible. 18. Participants with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only are eligible provided: 1) rash covers < 10% of body surface area (BSA), disease is well controlled at baseline and requires only low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%). 19. Any malignancy ≤ 5 years before first dose of study drug except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (e.g. resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast). 20. Treatment with a live, attenuated vaccine within four weeks prior to initiation of study treatment with Tislelizumab. 1. Note: Seasonal vaccines for influenza and COVID-19 are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed. 21. Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before first dose of study drug a. Note: Participants who are currently or have previously been on any of the following steroid regimens are not excluded: i. Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent) ii. Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption iii. Short course (≤ 7 days) of corticosteroid prescribed prophylactically (e.g., for contrast dye allergy) or for the treatment of a non- autoimmune condition (e.g., delayed-type hypersensitivity reaction caused by contact allergen) 22. With uncontrolled diabetes or > Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium despite standard medical management or ≥ Grade 3 hypoalbuminemia ≤ 14 days before first dose of study drug 23. With history of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc. 24. With severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc. 25. Severe infections within 4 weeks before first dose of study drug, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia. 26. Received therapeutic oral or intravenous antibiotics within two weeks before first dose of study drug 27. Any major surgical procedure requiring general anesthesia ≤ 28 days before first dose of study drug 28. Any of the following cardiovascular risk factors: a. Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤ 28 days before first dose of study drug b. Pulmonary embolism ≤ 28 days before first dose of study drug c. Any history of acute myocardial infarction ≤ 6 months before first dose of study drug d. Any history of heart failure meeting New York Heart Association (NYHA) Classification III or IV (Appendix 4) ≤ 6 months before first dose of study drug e .Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months before first dose of study drug f. Any history of cerebrovascular accident ≤ 6 months before first dose of study drug 29. Has received any herbal medicine used to control cancer within fourteen days of the first study drug administration 30. Participants with toxicities (because of prior anticancer therapy) which have not recovered to baseline or stabilized, except for AEs not considered a likely safety risk (e.g., alopecia, neuropathy and specific laboratory abnormalities) 31. Underlying medical conditions (including laboratory abnormalities) or alcohol or drug abuse or dependence that, will be unfavorable for the administration of study drug or affect the explanation of drug toxicity or AEs or result in insufficient or might impair compliance with study c conduct. 32. Concurrent participation in another therapeutic clinical study.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Monmouth Medical Center
    • Community Medical Center
    • RWJ University Hospital Hamilton
    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute
  • A Phase II, Open-Label, Multi-Cohort, Multicenter Study in Patients with Unresectable Heptocellular Carcinoma and CHILDPUGH B7 and B8 Cirrhosis. - NCT06096779

    Primary objective: - To evaluate the safety of the study treatments in Cohorts A and B. Secondary Objectives: - To evaluate the efficacy of the study treatments in Cohorts A and B. - To evaluate patient-reported tolerability of the study treatments in Cohorts A and B from the participants perspective. Exploratory Objectives: To identify biomarkers as follows: - Those associated with response to atezolizumab + bevacizumab or atezolizumab monotherapy. - Those that are early surrogates of efficacy, are associated with progression to a more severe disease state (i.e., prognostic biomarkers). OR - Those that can increase the knowledge of disease biology and drug safety in Cohorts A and B.

    View All Details

    • Protocol Number:
      072309

    • Principal Investigator:
      Howard Hochster

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Liver

    • Therapies Involved:
      Chemotherapy multiple agents systemic Chemotherapy single agent systemic

    • Drugs Involved:
      Atezolizumab (MPDL3280A) BEVACIZUMAB

    Read Inclusion & Exclusion Criteria

    General Inclusion Criteria:

    • Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic participants
    • Disease that is not amenable to curative surgical and/or locoregional therapies
    • No prior systemic treatment (including systemic investigational agents) for locally advanced or metastatic and/or unresectable HCC
    • Measurable disease (at least one untreated target lesion) according to RECIST v1.1
    • ECOG Performance Status of 0-2 within 7 days prior to initiation of study treatment
    • Child-Pugh B7 or B8 cirrhosis at screening and within 7 days prior to study treatment
    • Adequate hematologic and end-organ function
    • Life expectancy of at least 12 weeks
    • Female participants of childbearing potential must be willing to avoid pregnancy and egg donation
    • Absolute neutrophil count ≥1.0 x 109/L (≥1000/μL) without granulocyte colony-stimulating factor support
    • Platelet count ≥ 50 × 109/L (50,000/μL) without transfusion
    • Hemoglobin ≥ 80 g/L (8 g/dL) AST and ALT ≤ 5 × upper limit of normal (ULN)
    • Serum bilirubin ≤ 3 × ULN
    • Creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula)
    • Serum albumin ≥ 20 g/L (2.0 g/dL) without transfusion in the prior 3 months
    • INR ≤2.3

    General Exclusion Criteria:

    • Pregnancy or breastfeeding
    • Prior treatment with CD137 agonists or immune checkpoint blockade therapies
    • Treatment with investigational therapy within 28 days prior to initiation of study treatment
    • Treatment with locoregional therapy to liver within 28 days prior to initiation of study treatment, or non-recovery from side effects of any such procedure
    • Treatment with systemic immunostimulatory agents
    • Treatment with systemic immunosuppressive medication
    • Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment
    • Inadequately controlled hypertension
    • Active or history of autoimmune disease or immune deficiency
    • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
    • Participants who have a known concurrent malignancy that is progressing or requires active treatment, who have not completely recovered from treatment, or who have a significant malignancy history that, in the opinion of the investigator, should preclude participation.
    • Participants on preventative hormonal therapies (i.e., tamoxifen and other hormonal inhibitors) are not excluded.
    • Known fibrolamellar HCC, sarcomatoid HCC, other rare HCC variant, or mixed cholangiocarcinoma and HCC
    • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
    • Prior allogeneic stem cell or solid organ transplantation
    • Actively listed for liver transplantation
    • Co-infection with hepatitis B virus (HBV) and hepatitis C virus (HCV)
    • Untreated or incompletely treated esophageal and/or gastric varices with bleeding or that are at high risk for bleeding
    • A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment
    • Grade ≥3 hemorrhage or bleeding event within 6 months prior to initiation of study treatment
    • Hepatic encephalopathy is allowed if no active symptoms or stable within 3 months of study treatment
    • History, planned, or recommended placement of transjugular intrahepatic portosystemic shunt (TIPS) is excluded from Cohort A only. TIPS is acceptable in Cohort B.
    • Diagnostic Paracentesis is allowed. Therapeutic Paracentesis within 3 months is an exclusion criteria
    • Participants with ascites controlled on diuretics are allowed.
    • History of spontaneous bacterial peritonitis within last 12 months

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Cooperman Barnabas Medical Center
    • Rutgers Cancer Institute
  • Phase II Single-Arm Study of Durvalumab and Bevacizumab Following Transarterial Radioembolization Using Yttrium-90 Glass Microspheres (TheraSphere ) in Unresectable Hepatocellular Carcinoma Amenable to Locoregional Therapy. - NCT06040099

    Primary: - To assess the efficacy of TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab by assessment of PFS in participants with unresectable HCC amenable to locoregional therapy Secondary: - To assess the safety of the sequence of TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy - To further assess ORR after TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy - To further assess OS after TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy - To further assess DoR after TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy Exploratory: - To further assess the pattern of progressive disease after TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy - To describe tumor and normal tissue absorbed radioembolization dose and its relationship with response and outcomes and liver volume changes after treatment. - To assess participant-reported diseaseand treatment-related symptoms and HRQoL in participants with unresectable HCC amenable to locoregional therapy

    View All Details

    • Protocol Number:
      072311

    • Principal Investigator:
      Sharon Li

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Liver

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      BEVACIZUMAB MEDI4736 (Durvalumab)

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Participants with confirmed unresectable HCC
    • Participants with Lung dose threshold for Yttrium 90 glass microspheres of 30 Gy (equal or less than 30 Gy per treatment for glass) and an estimated Future liver remnant volume (FLRV) ≥ 30% of whole liver volume
    • Participants with no evidence of extrahepatic disease on any available imaging
    • Participants with one or more measurable lesions, unilobar disease for participants with segmental or right anterior/posterior portal vein invasion (Vp1/Vp2) and eligible for Yttrium 90 glass microspheres TARE.
    • Participants having Child-Pugh score class A.
    • Participants having ECOG performance status of 0 or 1 at enrollment
    • Adequate organ and marrow function

    Exclusion Criteria:

    • Disease amenable to curative surgery, ablation or transplantation.
    • Participants co-infected with HBV and HDV
    • Any history of nephrotic or nephritic syndrome.
    • Clinically significant (eg, active) cardiovascular disease
    • Participants with uncontrolled hypertension
    • History of hepatic encephalopathy
    • Known hereditary predisposition to bleeding or thrombosis; any prior or current evidence of bleeding diathesis.
    • Receipt of more than 1 prior embolization (TACE or TARE) treatment/procedure
    • Participant has received any prior anticancer systemic therapy for unresectable HCC.
    • History of arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to enrollment.
    • History of abdominal fistula or gastrointestinal (GI) perforation, non-healed gastric ulcer that is refractory to treatment, or active GI bleeding within 6 months prior to enrollment

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Cooperman Barnabas Medical Center
    • Rutgers Cancer Institute