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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
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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.
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A bilingual virtually-based intervention (PEDALL) for the prevention of weight gain in childhood ALL patients considering key genetic and sociodemographic risk factors
- NCT05963971
Primary Objective
To prevent the development of overweight and obesity (OW/OB) during maintenance chemotherapy using a six-month virtually delivered dietary education intervention (PEDALL) in English and Spanish speaking families of children and adolescents undergoing treatment for ALL.
Exploratory Objectives
To assess the effect of intervention on BMI z-score trajectories over time (from time zero to one-year post-completion of treatment for ALL) and modification of this effect by genetic and sociodemographic factors.
To examine the modifying effect of genetic predisposition to OW/OB, defined by a genome-wide polygenic score (GPS) for obesity optimized for Hispanic and Non-Hispanic application, on the efficacy of PEDALL for the prevention of OW/OB in children and adolescents undergoing treatment for ALL.
To examine the modifying effect of multi-level sociodemographic factors on the efficacy of PEDALL for the prevention of OW/OB in children and adolescents undergoing treatment for ALL.
To understand the effect of intervention on reported lifestyle behaviors as measured by World Cancer Research Foundation/American Institute for Cancer Research lifestyle guidelines.
To understand contextual factors that shaped the recruitment and retainment of participants and to identify strategies that may hinder or support implementation within routine care at their site including resource, training and technological needs using a one-time, brief structured survey at the end of the study with study site designate.
To understand individual factors and site-specific factors that shaped both experience with and response to the intervention using a one-time, brief open-ended questionnaire to patients and caregivers.
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Inclusion Criteria:
- Age: 5-21 years old at enrollment
- Diagnosis and Treatment: Plan to receive or are receiving maintenance or continuation chemotherapy for B- or T-cell ALL, or mixed phenotype acute leukemia.
- Timing: Patient is eligible for entry only if it is feasible to start the study intervention during the first month of the maintenance phase of ALL therapy.
- Language: Fluency in English or Spanish
- Weight Status: Healthy weight at baseline as determined by BMI z-score < 1.04 and >-1.04 for those under 5-18, and BMI between 19 and 25 for those >18.
- Ethnicity: Hispanic or Non-Hispanic of any race.
Exclusion Criteria:
- Patients on nutrition support (enteral or parenteral nutrition)
- Patients with a history of eating disorder
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.
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A Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (LUNG-MAP).
- NCT02154490
The overarching goal for this protocol is to establish a National Clinical Trials Network (NCTN) mechanism for genomically screening large but homogeneous cancer populations and subsequently assigning and accruing simultaneously to a multi-sub-study Master Protocol .
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A Digital Intervention to Improve Skin Self-Examination Among Melanoma Survivors.
- NCT05373823
Aim 1. To enhance MSS by collaborating with multi-level stakeholders. We will collaborate with stakeholders in enhancing MSS through qualitative interviews and usability testing of potential enhancements. Enhancements are based on empirically validated behavior change techniques (BCTs) and our prior study. We will utilize an iterative process that includes: (1) key informant interviews with survivors, providers, and professional organizations regarding proposed enhancements; (2) conversion to an enhanced mobile-based delivery platform; (3) usability testing, and; (4) iterative program refinements.
Aim 2. To evaluate the effects of enhanced MSS on thorough SSE in an RCT and examine its impact on the diagnosis of new/recurrent melanomas (N= 300). We will conduct a RCT comparing MSS and a non-interactive educational webpage with 300 survivors to test its effects on SSE. We propose that MSS participants will be more likely to perform thorough SSE over the 18-month follow-up. We will explore the impact of MSS on new/recurrent melanomas. We propose that there will be more earlier stage melanomas diagnosed in MSS as compared with UC.
Aim 3. To assess selected implementation outcomes and identify factors relevant to future scale-up for widespread dissemination and implementation. We will use mixed methods to assess implementation outcomes and explore perspectives from survivors, care providers, and professional organizations about how to best disseminate and implement MSS on a broad scale. The sub-aims are: 3a) To estimate program costs and assess cost-effectiveness of MSS relative to control. We hypothesize that MSS costs will be higher than UC. We expect that MSS will be a more cost-effective strategy, given its greater effectiveness to increase SSE and identify new or recurrent melanoma. If our findings support this as expected, exploratory cost-effectiveness analyses from the health care and societal perspectives will be conducted using simulation models of melanoma-related costs, disease progression, and survival over 5- and 10-year analysis horizons. 3b) To examine MSS reach, adoption, engagement, acceptability, appropriateness, feasibility, and maintenance. For reach, we predict that demographic variables will not differ from the general population of melanoma survivors. For adoption, we propose that the proportion of contacted/eligible survivors randomized to MSS who consent, complete the baseline, and log into MSS will be equal or greater than the efficacy trial. For engagement, we propose that 80% of MSS participants will log in. For acceptability, we predict MSS will be rated as highly acceptable. 3c) To identify and describe contextual factors from multilevel stakeholders as key to scale-up and widespread implementation of MSS, including consideration of potential delivery settings, timing of delivery, and needed resources to promote its implementation and sustainability.
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Inclusion Criteria:
- Diagnosis of primary pathologic stage 0-III cutaneous malignant melanoma
- Three months to five years post-surgery
- No current evidence of cancer
- Not adherent to thorough SSE (i.e., did not check entire body at least once during the past three months)
- ≥ 18 years old
- Internet access
- Able to speak/read English
- Able to provide informed consent
Exclusion Criteria:
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.
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A Dose Escalation and Expansion Study of XB371 Administered in Participants with Locally Advanced or Metastatic Solid Tumors
- NCT07123103
Primary:
To characterize the safety and tolerability of XB371
Secondary:
To characterize the PK of XB371, total antibody (unconjugated and conjugated), and unconjugated payload (belotecan)
To characterize the immunogenicity of XB371
To determine the RDE of XB37a
To characterize the preliminary antitumor activity of XB371b
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Protocol Number:
052504
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Principal Investigator:
Sanjay Goel
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Phase:
Phase I
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Scope:
National
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Applicable Disease Sites:
Any Site
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Therapies Involved:
Chemotherapy multiple agents systemic
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Drugs Involved:
XB371
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Read Inclusion & Exclusion Criteria
Key Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Minimum life expectancy of ≥ 12 weeks.
- Recurrent locally advanced or metastatic solid tumors.
- Adequate end organ and bone marrow function.
Key Exclusion Criteria:
- Primary brain tumors or known active brain metastases, leptomeningeal, or cranial epidural disease.
- History of interstitial lung disease (ILD) of any grade or history of organizing pneumonia.
- Has acute ocular infection, acute or chronic ulcerative/cicatricial condition of conjunctiva or cornea.
- Known history of immunodeficiency virus (HIV) unless specific criteria are met.
- Active infection with hepatitis C virus (HCV) defined as positive for HCV antibody.
- Major surgery within 4 weeks before the first dose of study treatment.
- Received radiation therapy within 2 weeks before the first dose of study treatment.
- Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study treatment.NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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.
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A Feasibility and Randomized Phase 2/3 Study of the VEFGR2/MET Inhibitor Cabozantinib in Combination with Cytotoxic Chemotherapy for Newly Diagnosed Osteosarcoma.
- NCT05691478
Primary Objectives:
1. To determine the feasibility of adding cabozantinib to standard MAP (high dose methotrexate, doxorubicin, and cisplatin) chemotherapy in patients with newly diagnosed metastatic osteosarcoma with a resectable primary tumor.
2. To determine whether MAP chemotherapy plus cabozantinib results in more favorable event-free survival (EFS) than MAP chemotherapy alone in patients with localized, resectable osteosarcoma.
3. To determine whether MAP chemotherapy plus cabozantinib results in more favorable event-free survival (EFS) than MAP chemotherapy alone in patients with metastatic, pelvic and unresectable osteosarcoma.
Secondary Objectives:
1. To determine whether MAP chemotherapy plus cabozantinib results in more favorable overall survival (OS) than MAP chemotherapy alone in patients with localized, resectable osteosarcoma.
2. To determine whether MAP chemotherapy plus cabozantinib results in more favorable overall survival (OS) than MAP chemotherapy alone in patients with metastatic, pelvic and unresectable osteosarcoma.
Exploratory Objectives:
1. To determine the rate of good histologic response (> 90%) of resected primary tumor specimens following neoadjuvant chemotherapy with MAP plus cabozantinib and compare with response rates for MAP chemotherapy alone.
2. To describe the toxicities of the addition of cabozantinib to MAP chemotherapy in patients with newly diagnosed osteosarcoma.
3. To describe frequency of application of local control methods (surgery, hypofractionated stereotactic body radiotherapy, or radiofrequency ablation) for extrapulmonary metastatic osteosarcoma.
4. To compare total cumulative delivered doses of MAP chemotherapy agents between standard and experimental arms across multiple phases of therapy.
5. To assess the pharmacokinetics of cabozantinib when administered concomitantly with standard chemotherapy agents during feasibility.
6. To collect pulmonary metastatic lesions, paired primary tumor tissue, and serial blood samples for tumor profiling, liquid biopsies, and future testing of correlative biology studies.
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Protocol Number:
112303
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Principal Investigator:
Scott A Moerdler
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Phase:
Phase II/III
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Scope:
Local
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Applicable Disease Sites:
Bones and Joints
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Therapies Involved:
Chemotherapy multiple agents systemic
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Drugs Involved:
Cabozantinib (XL184)
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Read Inclusion & Exclusion Criteria
Inclusion Criteria:
- Patients must be < 40 years of age at the time of enrollment.
- Patients must have a body surface area of >= 0.8 m^2 at the time of enrollment.
- Patients must have histologic diagnosis (by institutional pathologist) of newly diagnosed high grade osteosarcoma. Primary tumors of all extremity and axial sites are eligible as long as diagnosis of high-grade osteosarcoma is established. Osteosarcoma as a second malignancy is eligible if no prior exposure to systemic chemotherapies.
- Feasibility Phase (NOTE: as of Amendment #2B, the feasibility phase has been completed) Patients must have metastatic disease and a resectable primary tumor. Designation of a primary tumor as resectable will be determined at the time of diagnosis by the institutional multidisciplinary team.For this study, metastatic disease is defined as one or more of the following:
- Lesions which are discontinuous from the primary tumor, are not regional lymph nodes, and do not share a bone or body cavity with the primary tumor. Skip lesions in the same bone as the primary tumor do not constitute metastatic disease. Skip lesions in an adjacent bone are considered bone metastases.
- Lung metastases: defined as biopsy-proven metastasis or the presence of one or more pulmonary lesions >= 5 mm, OR multiple pulmonary lesions >= 3 mm or greater in size.
- Bone metastases: Areas suspicious for bone metastasis based on fludeoxyglucose F-18 (18F-FDG)-positron emission tomography (PET) scan (or whole body technetium-99 bone scan if 18F-FDG-PET is unavailable at the treating institution) require confirmatory biopsy or supportive anatomic imaging of at least one suspicious site with either magnetic resonance imaging (MRI) or computed tomography (CT) (whole body 18F-FDG-PET/CT or 18F-FDG-PET/MR scans are acceptable).
- Efficacy Phases (Phase 2/3) NOTE: as of Amendment #2B, the efficacy phase is open for enrollment.Patients with both localized and metastatic disease are eligible for the efficacy phase,regardless of resectability. Patients will be enrolled to two separate cohorts:
- Cohort 1 (Standard Risk): Patients with non-pelvic primary osteosarcoma deemed to be resectable at the time of diagnosis by the institutional multidisciplinary team, without evidence of metastatic lesions.
- Cohort 2 (High-Risk): Patients with a primary pelvic tumor, a primary tumor designated as unresectable by the institutional multidisciplinary team, AND/OR radiographic evidence of metastatic lesions.
- A serum creatinine based on age/sex as follows (within 7 days prior to enrollment unless otherwise indicated):
- (Age: Maximum Serum Creatinine [mg/dL]; Sex)
- 1 month to < 6 months: 0.4 (male); 0.4 (female)
- 6 months to < 1 year: 0.5 (male); 0.5 (female)
- 1 to < 2 years: 0.6 (male); 0.6 (female)
- 2 to < 6 years: 0.8 (male); 0.8 (female)
- 6 to < 10 years: 1 (male); 1 (female)
- 10 to < 13 years: 1.2 (male); 1.2 (female)
- 13 to < 16 years: 1.5 (male); 1.4 (female)
- >= 16 years: 1.7 (male); 1.4 (female)
- OR - a 24 hour urine creatinine clearance >= 70 mL/min/1.73 m^2
- OR - a glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2. GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard).
- Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility.
- Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment unless otherwise indicated)
- Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L (within 7 days prior to enrollment unless otherwise indicated)
- Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L
- No history of congenital prolonged corrected QT (QTc) syndrome, New York Heart Association (NYHA) Class III or IV congestive heart failure, unstable angina pectoris, serious cardiac arrhythmias
- Shortening fraction of >= 27%, or
- Ejection fraction of >= 50%
- Corrected QT interval by Fridericia (QTcF) < 480 msec on electrocardiogram. Patients with Grade 1 prolonged QTc (450-480 msec) at time of study enrollment should have correctable causes of prolonged QTc addressed if possible (i.e., electrolytes, medications).
- Peripheral absolute neutrophil count (ANC) >= 1000/uL (within 7 days prior to enrollment unless otherwise indicated)
- Platelet count >= 100,000/uL (transfusion independent, defined as not receiving platelet transfusions within a 7-day period prior to enrollment) (within 7 days prior to enrollment unless otherwise indicated)
- Hemoglobin >= 8.0 g/dL (within 7 days prior to enrollment unless otherwise indicated)
- International normalized ratio (INR) =< 1.5 (within 7 days prior to enrollment unless otherwise indicated)
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible as long as they are NOT receiving anti-retroviral agents that are strong inhibitors or inducers of CYP3A4, CYP2D6, and/or MRP2 transporter protein.
- All patients and/or their parents or legal guardians must sign a written informed consent.
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.
Exclusion Criteria:
- Patients who have received previous systemic therapy for osteosarcoma or a prior oncologic diagnosis.
- Patients who have central nervous system metastases.
- Patients with central cavitating pulmonary lesions invading or encasing any major blood vessels in the lung.
- Patients who are unable to swallow tablets. Tablets cannot be crushed or chewed.
- Patients with gastrointestinal disorders including active disorders associated with a high risk of perforation or fistula formation. Specifically, no clinically significant gastrointestinal (GI) bleeding, GI perforation, bowel obstruction, intra-abdominal abscess or fistula for 6 months prior to enrollment, no hemoptysis or other signs of pulmonary hemorrhage for 3 months prior to enrollment.
- Patients with active bleeding or bleeding diathesis. No clinically significant hematuria, hematemesis, or hemoptysis or other history of significant bleeding within 3 months prior to enrollment.
- Patients with uncompensated or symptomatic hypothyroidism. Patients who have hypothyroidism controlled with thyroid replacement hormone are eligible.
- Patients with moderate to severe hepatic impairment (Child-Pugh B or C).
- Patients who have had primary tumor resection or attempted curative resection of metastases prior to enrollment.
- Patients who have undergone other major surgical procedure (eg, laparotomy) within 14 days prior to enrollment. Thoracoscopic procedures for diagnostic purposes (biopsy of lung nodule) and central access such as port-a-cath placement are allowed.
- Patients with a history of serious or non-healing wound or bone fracture (pathologic fracture of primary tumor is not considered exclusion).
- Patients with any medical or surgical conditions that would interfere with gastrointestinal absorption of cabozantinib.
- Patients with previously identify allergy or hypersensitivity to components of the study treatment formulations.
- Patients who are receiving any other investigational agent not defined within this protocol are not eligible.
- Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible.
- Patients who received enzyme-inducing anticonvulsants within 14 days prior to enrollment.
- Patients with a prior history of hypertension (> 95th percentile for age, height, and sex for patients < 18 years and > 140/90 mmHg for patients >= 18 years requiring medication for blood pressure control.
- Patients who are receiving drugs that prolong QTc.
- Patients receiving anticoagulation with oral coumarin agents (eg warfarin), direct thrombin inhibitors (eg dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (eg, clopidogrel). Low dose aspirin for cardioprotection (per local applicable guidelines) and low dose, low molecular weight heparins (LMWH) are permitted. Anticoagulation with therapeutic doses of LMWH and direct factor Xa inhibitors rivaroxaban or apixaban are allowed in subjects who are on a stable dose for at least 6 weeks before the first dose of study treatment, and who have had no complications from a thromboembolic event or the anticoagulation regimen.
- Patients receiving strong CYP3A4 inducers or strong CYP3A4 inhibitors.
- Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.
- Lactating females who plan to breastfeed their infants.
- Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of protocol therapy.
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.
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A Feasibility Study of E7 TCR-T Cell Induction Therapy for Locoregionally Advanced HPV-Associated Cancers
- NCT05639972
Primary Objective:
- To determine the feasibility of administering E7 TCR-T cell therapy as induction treatment for LAHPVC
Secondary Objectives:
- To determine the objective tumor response rate at 6-weeks after treatment
- To assess 2-year and 5-year disease free survival (DFS)
- To collect biospecimens for exploratory translational research
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Protocol Number:
192104
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Principal Investigator:
Christian Hinrichs
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Phase:
Phase I
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Scope:
Local
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Applicable Disease Sites:
Breast, Cervix, Lip, Oral Cavity and Pharynx, Other Female Genital, Other Male Genital, Stomach
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Therapies Involved:
Immunotherapy
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Drugs Involved:
TCR-T Cell infusion
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Read Inclusion & Exclusion Criteria
Inclusion Criteria:
1. Histologically confirmed carcinoma of a primary tumor site and stage indicated in Table 3 of the protocol. 2. Tumor with HPV16 genotype as determined by testing performed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory. 3. HLA-A*02:01 allele determined by testing performed in a CLIA certified laboratory. Participants may be enrolled based on low resolution typing (i.e., HLA-A*02) but the HLA-A*02:01 allele type must be confirmed prior to apheresis. 4. Measurable disease per RECIST Criteria Version 1.1 or PERCIST. 5. Age > 18 years. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening. 7. Negative pregnancy test for women under 55 and all women who have had a menstrual period in the last 12 months. A pregnancy tests is not required for women who have had a bilateral oophorectomy or hysterectomy. 8. Men and women of child-bearing potential must agree to use adequate contraception (i.e., intrauterine device, hormonal barrier method of birth control; abstinence; tubal ligation or vasectomy) prior to study entry and for four months after treatment. Should a women become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. 9. Seronegative for HIV antibody, hepatitis B surface antigen (sAg), and hepatitis C antibody. If a hepatitis C antibody test is positive, then testing for antigen by reverse transcription polymerase chain reaction (RT-PCR) must be negative. 10. Participants must have organ and marrow function as defined below: 1. Leukocytes > 3,000/Mantle cell lymphoma (mcL) 2. Absolute neutrophil count > 1,500/mcL 3. Platelets > 100,000/mcL 4. Hemoglobin > 9.0 g/dL 5. Total bilirubin within normal institutional limits except in participants with Gilbert's Syndrome who must have a total bilirubin < 3.0 mg/dL. 6. Serum aspartate aminotransferase (AST) (SGOT)/ alanine transaminase (ALT)(SGPT) < 2.5 x upper limit of normal (ULN) 7. Calculated creatinine clearance (CrCl) >50 mL/min/1.73 m2for participants with creatinine levels above institutional normal (by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation). 8. international normalized ratio (INR) or activated partial thromboplastin time ( aPTT) ≤1.5 X ULN unless the subject is receiving anticoagulant therapy. Subjects on anticoagulant therapy must have a PT or aPTT within therapeutic range and no history of severe hemorrhage. 11. Participants must be able to understand and be willing to sign the written informed consent document. 12. Participants must agree to participate in protocol CINJ 192103 (Pro2021002307) for gene therapy long term follow up and in protocol Cancer Institute of New Jersey (CINJ) 192002 (Pro2021000281) for biospecimen collection study.Note: Patients may have undergone minor surgical procedures with the past three weeks, aslong as all toxicities have recovered to Grade 1 or less.
Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from
participation in this study: 1. Prior systemic therapy or definitive chemoradiation for the cancer that is being treated on this protocol. 2. Current treatment with another investigational agent. 3. History of severe allergic reactions to compounds of similar chemical or biological composition to agents used in this study. 4. Uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations at the time of treatment that would limit compliance with study requirements. 5. Subjects with HLA-A*02:01 damaging mutation or allele loss or other molecular resistance detected by research or clinical sequencing will not be eligible. 6. Documented LVEF of less than or equal to 45% tested. The following participants will undergo cardiac evaluations: 1. Clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or 2. Age > 50 years old 7. Participants with baseline screening pulse oxygen level of <92% on room air will not be eligible. If the underlying cause of hypoxia improves, they may be reevaluated. 8. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with E7 TCR T cells, breastfeeding should be discontinued if the mother is treated with E7 TCR T cells. These potential risks may also apply to other agents used in this study. 9. Participants with a systemic immunodeficiency including acquired deficiency such as HIV or primary immunodeficiency such as Severe Combined Immunodeficiency Disease are ineligible. The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune competence may be less responsive to the treatment. 10. Participants on immunosuppressive drugs including corticosteroids unless meeting criteria outlined in Section 6.1 (Prohibited Medications). 11. Participants with potentially severe autoimmune diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmune pancreatitis, or systemic lupus erythematosus are not eligible. Patients with less severe autoimmune diseases such as hypothyroidism, vitiligo, and other minor autoimmune disorders are eligible. 12. Participants with prior or concurrent malignancy whose natural history or treatment is unlikely to interfere with the safety or efficacy assessments of the investigational regimen are eligible for this trial. Examples include, but are not limited to: 1. Carcinoma in situ 2. Cutaneous skin cancers requiring only local excision 3. Low grade non-muscle invasive bladder cancer 4. Low grade prostate cancer 13. Subjects who received a live vaccine within 30 days prior to enrollment are not eligible. 14. Determination by the Principal Investigator that participation is not in the best interest of the research subject or may jeopardize the safety of the subject or integrity of the clinical trial data.
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.
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A First-in-Human Study of Mutant-Selective PI3K Alpha Inhibitor, RLY-2608, as a Single Agent in Advanced Solid Tumor Patients and in Combination with Fulvestrant in Patients with Advanced Breast Cancer.
- NCT05216432
RLY-2608 Single Agent Arm:
Primary Objectives:
- To determine the MTD and/or RP2D of RLY-2608 as a single agent
- To determine the safety and tolerability of RLY-2608 as a single agent
RLY-2608 + Fulvestrant Arm:
Primary Objectives:
- To determine the MTD and/or RP2D of RLY-2608 in combination with fulvestrant
- To determine the safety and tolerability of RLY-2608 in combination with fulvestrant
Triple Combination Arms:
Primary Objectives:
- To determine the MTD and/or RP2D of RLY-2608 in combination with CDK4/6 inhibitor (palbociclib or ribociclib) and fulvestrant
- To determine the safety and tolerability of RLY-2608 in combination with CDK4/6 inhibitor (palbociclib, ribociclib) and fulvestrant
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Protocol Number:
042402
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Principal Investigator:
Mridula A George
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Phase:
Phase I
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Scope:
National
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Applicable Disease Sites:
Breast
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Therapies Involved:
Chemotherapy single agent systemic
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Drugs Involved:
RLY-2608
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Read Inclusion & Exclusion Criteria
Key Inclusion Criteria
Patient has ECOG performance status of 0-1One or more documented primary oncogenic PIK3CA mutation(s) in blood and/or tumor perlocal assessmentOther potentially oncogenic PIK3CA mutations may be considered but must be approved bythe Sponsor prior to enrollment.Part 1 [Escalation] - Ability to provide archived tumor tissue or be willing to undergopretreatment tumor biopsy to assess PIK3CA status retrospectively Part 2 [Expansion] -Submit tumor tissue prior to study drug initiation for determination of PIK3CA mutationretrospectively.Key Inclusion for RLY-2608 Single Agent Arm - [For Part 1: Escalation]: Evaluable disease per RECIST v1.1
- [For Part 2: Expansion]: Measurable disease per RECIST v1.1
- Disease that is refractory to standard therapy, intolerant to standard therapy, or has declined standard therapy.
- Part 1- histologically or cytologically confirmed diagnosis of unresectable or metastatic solid tumor
- Part 2 - Unresectable or metastatic solid tumor with PIK3CA mutation(s) and one of the following tumor types:Group 1: clear cell ovarian cancer Group 2: head and neck squamous cell carcinoma Group3: cervical cancer Group 4: other solid tumors, excluding colorectal, clear cell ovarian,head and neck squamous cell, and cervical cancers Group 5: unresectable or metastaticsolid tumors with PIK3CA double mutations In addition, the SRC (with Sponsor approval)may choose to open additional group(s) of 20 participants to study the clinical activity,safety, and PK/PD with other specified solid tumor types.Key Inclusion for Combination Arms:
- Doublet combination arms [Part 1 and Part 2]: Evaluable disease per RECIST v1.1
- Triplet combination arms:
- [Part 1 and Part 2 Dose Expansion, Group 1]: Evaluable disease per RECIST.
- [Part 2 Dose Expansion, Group 2]: Measurable disease per RECIST. Bone-only lytic or lytic/blastic disease with at least 1 measurable soft-tissue component per RECIST may be eligible.
- [For Part 1 and Part 2]: Male or female with histologically or cytologically confirmed diagnosis of HR+, HER2- unresectable or metastatic breast cancer that is not amenable to curative therapy. Females may be postmenopausal, premenopausal, or perimenopausal. Premenopausal or perimenopausal females must have a histologically or cytologically confirmed diagnosis of HR+ HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy and must have initiated treatment with a gonadotropin-releasing hormone (GnRH) agonist at least 4 weeks prior to start of study drug with continuation of GnRH agonist for the duration of study treatment (GnRH agonist recommended for males).
- Had previous treatment for breast cancer with: [Does not apply to triplet combination arms, Part 2 Dose Expansion, Group 2]: 1. ≤1 line of chemotherapy in the metastatic setting 2. ≥1 CDK4/6 inhibitor in either the adjuvant and/or metastatic setting 3. ≥1 antiestrogen therapy in either adjuvant and/or metastatic setting, including, but not limited to, selective estrogen-receptor degraders (eg, fulvestrant), selective estrogen receptor modulators (eg, tamoxifen), and aromatase inhibitors (AI) (letrozole, anastrozole, exemestane), and 4. ≥1 PARP inhibitor, if appropriate, if documented germline BRCA1/2 mutation Note: Systemic local, loco-regional, or adjuvant treatment with chemotherapy and PARP inhibitors is not to be included in enumeration or previous treatment[For double combination arm; Part 2 Dose Expansion, Group 2]: Received prior treatmentwith a PI3Kα, AKT, or mTOR inhibitor and discontinued the inhibitor due to intoleranceand not disease progression, where intolerance is defined as treatment discontinuationdue to treatment related AE (eg. hyperglycemia, rash, diarrhea, stomatitis) other thansevere hypersensitivity reaction and/or life-threatening reactions, such as anaphylaxisand Stevens-Johnson syndrome.[For triple combination arms; Part 1 dose escalation]: Participants who had previoustreatment for breast cancer with PI3Kα, AKT, mTOR inhibitors and discontiuned due toparticipant/physician decision, intolerance, or disease progression will be considered.[For triple combination arms, Part 2 Dose Expansion, Group 2]: Participants must beintolerant to or have declined standard therapy for locally advanced or metastaticHR+/HER2- PIK3CA-mutated breast cancer. Prior endocrine therapy and CDK4/6inhibitors areallowed as follows: 1. Participants must have progressed during (neo)adjuvant endocrine therapy or within12 months of completing (neo)adjuvant endocrine therapy with an AI or tamoxifen. 2. If a CDK4/6 inhibitor was included as part of (neo)adjuvant therapy, disease must have recurred/progressed >12 months after completion of the CDK4/6 inhibitor portion of (neo)adjuvant therapy
Key Exclusion Criteria
Prior treatment with: 1. PI3Kα, AKT, or mTOR inhibitors (all arms except for doublet RLY-2608 + fulvestrant arm, Part 2, Group 2; and triplet combinations, Part 1 dose escalation). 2. Immune checkpoint inhibitors. 3. Triplet combinations RLY-2608 + CDK4 or CDK4/6 inhibitor + fulvestrant, Part 2 expansion, Group 2 only:i. Prior systemic chemotherapy or antibody drug conjugate for locally advanced ormetastatic disease. ii. Prior CDK2, CDK4, or CDK4/6 inhibitor as treatment for locallyadvanced or metastatic disease.iii. Prior treatment with fulvestrant or any selective ER degrader, with the exception ofpatients who have received fulvestrant or any selective ER degrader as part ofneoadjuvant therapy only and with treatment duration ≤6 months.Type 1 or Type 2 diabetes requiring antihyperglycemic medication, or fasting plasmaglucose ≥140 mg/dL and glycosylated hemoglobin (HbA1c) ≥7.0%.History of allergy or hypersensitivity to any components or excipients of PI3Kinhibitors. For combination arms only: allergy or hypersensitivity to any components orexcipients of fulvestrant, palbociclib, ribociclib, and/or PF-07220060 as appropriate forthe combination.Past medical history of or ongoing ILD, or pneumonitis requiring intervention.Participants with past history of resolved Grade 1 pneumonitis may be considered, exceptin triple combination arms.The following cardiac criteria: - Mean resting corrected QT interval (QTc) >460 msec
- For triple combination arm with ribociclib: Mean QTcF ≥450 msec (this is what we confirmed is shown in the redacted version of the protocol.CNS metastases or primary CNS tumor that is associated with progressive neurologicsymptoms
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.
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A First-in-Human, Open-Label, Phase 1/2 Dose-Escalation with Enrichment and Dose-Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of GIM-122 as a Single Agent in Adult Subjects with Advanced Solid Malignancies.
- NCT06028074
Primary Objective Part A and B:
- To characterize the safety and tolerability of GIM-122 as a single agent in subjects with programmed cell death protein-1 (PD-1) programmed cell death ligand-1 (PD-L1) refractory/resistant advanced solid tumor malignancies that have a Food and Drug Administration (FDA) approval for anti-PD-1/PD-L1 therapy at time of recruitment.
Primary Objectives Dose Expansion (Part B):
- To identify a recommended dose for future studies (RP2D)
- To assess the anti-tumor activity of GIM-122 as a single agent in subjects with programmed cell death protein-1 (PD-1)/programmed cell death ligand-1 (PD-L1) refractory/resistant advanced solid tumor malignancies that have FDA approval for anti-PD-1/PD-L1 therapy at time of recruitment.
Secondary Objectives:
- To assess safety and tolerability (Part B only)
- To characterize the pharmacokinetic (PK) profile of GIM-122 (Part A and Part B)
- To assess the emergence and persistence of anti-drug antibodies (ADA) and the mpact on GIM-122 exposure (Part A and Part B)
- To assess the change from baseline in tumor tissue markers as potential predictors of efficacy of GIM-122 (Part A and Part B)
- To evaluate the preliminary anti-tumor activity of GIM-122 (Part A only)
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Protocol Number:
052401
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Principal Investigator:
Sanjay Goel
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Phase:
Phase I
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Scope:
National
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Applicable Disease Sites:
Any Site
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Therapies Involved:
Chemotherapy single agent systemic
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Drugs Involved:
GIM-122
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Read Inclusion & Exclusion Criteria
Inclusion Criteria:
General - Written informed consent
- ECOG performance status 0-1.
- Laboratory assessment 28 days prior to enrollment for assessment of acceptable cardiac, renal and hepatic functions
- Recommended Double methods of contraception 90-days post treatment Cancer Specific
- Histologically or cytologically confirmed locally advanced/unresectable or metastatic solid tumor
- Received FDA approved treatment of PD-1 inhibitor or PD-L1 inhibitor for advance malignant tumors and have progressed/relapsed, are refractory, or intolerant
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1
- Had prior therapy with PD-1/PD-L1 inhibitors. Other checkpoint inhibitors (ie, CTLA4, LAG3) are permitted if they did not lead to treatment discontinuation
- No other lines of therapy that are available
Exclusion Criteria:
General - Enrolled in any other interventional clinical trial, starting within 4 weeks of the first dose of GIM-122 and throughout the duration of the study, or is receiving other therapy directed at their malignancy
- Women who are pregnant or breastfeeding
- History of cardiac issues, pulmonary embolism, active and clinically significant bacterial, fungal, or viral infection ≤ 6 months prior to dosing
- Contraindications to the imaging assessments or other study procedures that subjects will undergo or any medical or social condition that, in the opinion of the investigator, might place a subject at an increased risk, affect compliance, or confound safety or other clinical study data interpretation Cancer Specific
- Current second malignancy at other sites
- Leptomeningeal disease
- Spinal cord compression
- Symptomatic or new or enlarging central nervous system (CNS) metastases
Treatment-specific Exclusion Criteria
- Ongoing toxicity > Grade 1 from prior therapy according to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0
- Has undergone a major surgery < 1 month prior to administration of GIM-122
- Has received radiation therapy within 2 weeks prior to administration of GIM-122
- Has undergone or is anticipated to undergo organ transplantation including allogeneic or autologous stem cell transplantation at any time
- Has received systemic anti-cancer therapy within 2 weeks and cytotoxic agents that have a major delayed toxicity within 4 weeks, of the first dose of GIM-122
- Prior treatment with other immune modulating agents within < 4 weeks prior to the first dose of GIM-122.
- Has a diagnosis of immunodeficiency, either primary or acquired
- Has received treatment with systemic steroids or any form of immunosuppressive therapy within 14 days prior to administration of GIM-122
- Has active or prior history of autoimmune disease, including ulcerative colitis and Crohn's disease, or any condition that requires systemic steroids.
- Has a known severe intolerance to or hypersensitivity reactions to monoclonal antibodies, Fc-bearing proteins, or IV immunoglobulin preparations; prior history of human anti-human antibody response; known allergy to any of the study medications, or excipients in the various formulations of any agent.
- Has received live vaccines within 30 days of study initiation (inactivated vaccines are allowed; seasonal vaccines should be up to date > 30 days prior to administration of GIM-122).
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.
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A First-in-Human, Phase 1 Study to Evaluate the Safety of TTX-080, an HLA-G Antagonist, in Subjects with Advanced Solid Tumors.
- NCT04485013
Primary Objective:
To assess safety and tolerability of increasing dose levels of TTX-080 in successive cohorts of subjects with advanced solid tumors to identify the maximum tolerated dose (MTD) or maximum administered dose and select the recommended Phase 2 dose (RP2D)/schedule.
Secondary Objectives(s):
(1) To characterize the single-dose and/or multiple-dose pharmacokinetics (PK) of TTX-080 following intravenous (IV) administration in subjects with advanced solid tumors.
(2) To evaluate the immunogenicity of TTX-080 in subjects with advanced solid tumors.
(3) To evaluate the preliminary antitumor activity of TTX-080 in subjects with advanced solid tumors.
Exploratory Objective: To assess the effects of TTX-080 on pharmacodynamic biomarkers relating to mechanism of action and immune responses.
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Protocol Number:
052006
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Principal Investigator:
Sanjay Goel
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Phase:
Phase I
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Scope:
National
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Applicable Disease Sites:
Any Site
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Therapies Involved:
Chemotherapy single agent systemic
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Drugs Involved:
CETUXIMAB
Folfiri
Pembrolizumab (MK-3475)
TTX-080
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Read Inclusion & Exclusion Criteria
Abbreviated Inclusion Criteria:
1. Subject with histological diagnosis of advanced/metastatic cancer 2. Age 18 years or older, is willing and able to provide informed consent 3. Evidence of measurable disease 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 AND life expectancy of at least 12 weeks
Abbreviated Exclusion Criteria:
1. History of allergy or hypersensitivity to study treatment components. Subjects with a history of severe hypersensitivity reaction to any monoclonal antibody 2. Use of an investigational agent within 28 days prior to the first dose of study treatment and throughout the study 3. Receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy 4. History of severe autoimmune disease 5. Uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment
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.
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A Long-Term Study for Participants Previously Treated With Ciltacabtagene Autoleucel.
- NCT05201781
To collect long-term follow-up data on delayed adverse events after administration of cilta-cel, and to characterize and understand the long-term safety profile of cilta-cel.
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Read Inclusion & Exclusion Criteria
Inclusion Criteria:
- Participants who have received at least one dose of cilta-cel in a Company-sponsored clinical study
- Participants who have provided informed consent for this 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.
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A longitudinal analysis of social networks and patient-reported outcomes among adolescents and young adult cancer survivors
Objective:
To identify how changes in social network structure and composition influence health outcomes and determine factors predictive of who is vulnerable to negative effects over time among adolescent and young adult (AYA) cancer survivors.
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