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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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Read Inclusion & Exclusion Criteria
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 Multi-Level Investigation of US Indoor Tanning Policy Enactment, Implementation, Compliance, Impact, and Economics.
1. Identify factors contributing to adoption or rejection of indoor tanning legislation through document analysis of indoor tanning bills and key informant interviews.
2. Assess indoor tanning law implementation.
3. Investigate important economic factors relevant to Indoor tanning law maintenance.
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A Phase I Study to Evaluate the Safety of Naltrexone and Propranolol in Combination with Standard of Care Ipilimumab and Nivolumab in Patients with Advanced Melanoma.
- NCT05968690
The primary objective is to assess the safety, recommended phase 2 dose (RP2D) of naltrexone, and dose-limiting toxicity (DLT) of naltrexone in combination with propranolol and ipilimumab (IPI) plus nivolumab (NIVO) in patients with advanced melanoma.
The secondary objectives are to assess the objective response rate (ORR) by RECIST v1.1, progression-free survival (PFS), and overall survival (OS).
Exploratory objectives are to assess the impact of propranolol + naltrexone on the anti-tumor immune response through correlative biomarker studies performed on tumor and blood.
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Protocol Number:
092302
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Phase:
Phase I
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Scope:
Local
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Applicable Disease Sites:
Melanoma, Skin
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Therapies Involved:
Chemotherapy multiple agents systemic
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Drugs Involved:
IPILIMUMAB (MDX-010)
Opdivo (Nivolumab)
Propranolol
Naltrexone
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Contacts:
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Rutgers Cancer Institute of New Jersey
Prinicipal Investigator:
Sarah Weiss MD
Read Inclusion & Exclusion Criteria
Inclusion Criteria:
- Age of 18 years or older and able to understand and sign the informed consent form.
- Histologically confirmed diagnosis of unresectable stage III or stage IV melanoma.
- Candidate for standard of care therapy with ipilimumab 3 mg/kg + nivolumab 1 mg/kg.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Treatment-naïve or has received any number of prior lines of therapy. Prior targeted therapy is allowed, but small molecule inhibitors must be discontinued within two weeks before starting the study.
- Life expectancy of at least 6 months.
- Presence of at least one accessible site of disease to provide an on-study biopsy for tumor tissue. The biopsy may be waived after discussion with the Principal Investigator (PI) if it is deemed unfeasible. The site may be a target lesion as long as it will not be rendered unmeasurable by the biopsy procedure.
- Willingness to undergo tumor biopsy (if archival tumor is not available) prior to initiation of therapy and while on the study.
- Willingness to provide an archival specimen block, if available, for research purposes.
- Normal organ function, defined as: 1. Absolute neutrophil count (ANC) >1500/mcL 2. Platelets >100,000/mcL 3. Hemoglobin (Hb) >9 g/dL 4. Albumin >2.5 mg/dL 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5 times the upper limit of normal (ULN) 6. Serum total bilirubin <1.5 times ULN or direct bilirubin < ULN for subjects with total bilirubin levels >1.5 times ULN.
- Female participants of childbearing potential should have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study medication.
- Female participants of childbearing potential should be willing to use a highly effective form of contraception (hormonal or intrauterine device) along with a condom in their male partner, or be surgically sterile, or abstain from heterosexual activity for a period of at least six months after the last dose of study medication.
- Male participants should agree to use an adequate method of contraception starting with the first dose of study therapy through at least six months after the last dose of study drug.
- Participants must have at least one measurable lesion at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Tumor sites situated in a previously irradiated area or in an area subjected to other loco-regional therapy are not considered measurable unless there has been demonstrated progression in the lesion.
- Prior focal radiotherapy is allowed.
Exclusion Criteria:
- Presence of untreated brain metastases, unless discussed with the Principal Investigator (PI) and meet specific criteria for inclusion (treatment-naïve patients with brain metastases <10 mm, asymptomatic, without significant edema, hemorrhage, shift, or requirement for steroids or anti-seizure medications, and not in eloquent areas). These patients may potentially forego initial local treatment of the brain metastases and have them reassessed after consultation with the Neurosurgery and Radiation Oncology teams.
- Use of corticosteroids to control immune-related adverse events at enrollment. Participants who previously required corticosteroids for symptom control must be off steroids for at least two weeks. Low-dose steroid use (=10 mg of prednisone or equivalent) as corticosteroid replacement therapy for primary or secondary adrenal insufficiency is allowed.
- Failure to recover (i.e., Grade 1 or at baseline) from adverse events due to prior treatment.
- History of grade 3-4 neurologic or cardiac toxicity or life-threatening liver toxicity poorly responsive to steroids with prior anti-PD-1 therapy.
- Presence of leptomeningeal disease.
- Active autoimmune disease unrelated to the use of immune checkpoint inhibitors that has required systemic treatment in the past year (e.g., use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
- Contraindications to the use of propranolol, including: 1. Cardiogenic shock. 2. Sinus bradycardia greater than first-degree block. 3. Severe bronchial asthma. 4. Known hypersensitivity to propranolol. 5. Requirement for current use of an alternative beta-blocker. 6. Uncontrolled diabetes. 7. Uncontrolled depression. 8. Unstable angina or myocardial infarction within 3 months of Day 1 Cycle 1.
- For enrollment into Cohort 2-4 ONLY: Contraindications to the use of naltrexone, including: 1. Participants currently receiving opioid analgesics or anticipated to require opioid analgesics in the near future. 2. Participants currently dependent on opioids, including those currently maintained on opiate agonists (e.g., methadone) or partial agonists (e.g., buprenorphine). 3. Participants in acute opioid withdrawal. 4. Individuals with a history of sensitivity to naltrexone.
- Pregnancy or breastfeeding. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she should inform her treating physician immediately. Breastfeeding must be discontinued if the mother is enrolled in this trial due to the potential risk for adverse events in nursing infants.
- Receipt of any other investigational agents or participation in a study of an investigational agent or use of an investigational device within four weeks of the first dose of treatment.
- Concurrent condition (including medical illness, active infection requiring treatment with intravenous antibiotics, or presence of laboratory abnormalities) or history of a prior condition that places the patient at unacceptable risk if treated with the study drug or confounds the ability to interpret data from the study.
- Concurrent, active malignancies in addition to those being studied, except for cutaneous squamous cell carcinoma or basal cell carcinoma.
- Active (non-infectious) pneumonitis.
- Hepatitis B (HBV) or Hepatitis C (HCV) acute or chronic infection.
- Receipt of a live vaccine
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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Cutaneous Oncology Clinical Database and Biospecimen Bank
The Melanoma/Cutaneous Oncology Group at CINJ has the goal of advancing the scientific knowledge of skin cancers including melanoma, merkel cell carcinoma, basal cell carcinoma, and squamous cell carcinoma to develop more effective prevention and therapy strategies.
The main objective of this clinical database and biospecimen bank is to collect and store clinical information on patients with skin cancer, with or without associated biospecimens, that we will use for future research focused on prevention, prognosis, treatment, and quality of life for patients with skin cancer.
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Facebook Intervention for Young Onset Melanoma Patients and Families.
- NCT03677739
The study has one primary and two secondary aims.
1)The primary aim (FDRs) is to examine the efficacy of the Young Melanoma Family
Facebook intervention versus the Healthy Lifestyle Facebook intervention on total cutaneous exam (primary outcome), skin self-exam frequency and comprehensiveness, and sun protection practices (secondary outcomes) of FDRs of young melanoma survivors.
2)A secondary aim (survivors) is to examine the efficacy of the Young Melanoma Family Facebook intervention on patients skin self-exam frequency and comprehensiveness and sun protection habits.
3)Another secondary aim is to examine the mechanisms of intervention efficacy.
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Read Inclusion & Exclusion Criteria
Inclusion Criteria:
- PATIENT: Diagnosed with stage 0-3 melanoma in the last 5 years
- PATIENT: Age at diagnosis 18-39 years
- PATIENT: Completed treatment at least 3 months previously
- PATIENT: Recruited from New Jersey or California State Cancer Registry or MD Anderson Cancer Center
- PATIENT: Does not have a concurrent cancer diagnosis
- PATIENT: Able to speak and read English
- PATIENT: Access to computer, internet, and has a Facebook account
- PATIENT: At least one family member consents
- FDR: Current age 18-80 years
- FDR: Does not have a personal history of melanoma
- FDR: Able to speak and read English
- FDR: Access to computer, internet, and has a Facebook account
- FDR: Has only one FDR with melanoma (patient)
- FDR: Has not had a total cutaneous examination (TCE) in the past 3 years, has done skin self-exam (SSE) fewer than three times in the past year, OR has a sun protection habits average score less than or equal to 4 (?often?)
- FDR: Patient consents
Exclusion Criteria:
- Physical Activity Readiness Questionnaire (Thomas, et. al., 1992): This 7-item scale will be used to screen out individuals who will need to consult a physician for medical clearance before engaging in physical activity. If a participant checks off any of the items, the investigators will ask for a physician clearance before consenting to 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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Melanoma Margins Trial (MelMarT): A Phase III, Multi-Centre, Multi-National Randomised Control Trial Investigating 1cm v 2cm Wide Excision Margins for Primary Cutaneous Melanoma.
- NCT03860883
This study will determine whether there is a difference in disease free survival for patients treated with either a 1cm excision margin or 2cm margin for clinical stage II (pT2b-pT4b) primary cutaneous melanoma (AJCC 8th edition, Table 1). The study is designed to be able to prove or disprove that there is no difference in risk of melanoma recurrence between the two groups of patients. This study is designed to show that the risk of long-term pain associated with surgery can be reduced. If the study achieves its primary objective and demonstrates safety with a narrower margin, then we will also be able to determine how much of an impact the narrower excision has on patients in terms of improved quality of life and reduced side effects from the surgery and melanoma disease. This trial will also evaluate and determine the economic impact of narrower excision margins on the health services and society in general.
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Protocol Number:
092202
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Principal Investigator:
Adam Berger
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Phase:
Phase III
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Scope:
National
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Applicable Disease Sites:
Melanoma, Skin
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Therapies Involved:
Radiotherapy
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Contacts:
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Rutgers University
Prinicipal Investigator:
Adam Berger
Read Inclusion & Exclusion Criteria
Inclusion Criteria:
1. Patients must have a stage II primary invasive cutaneous melanoma with Breslow thickness >2mm without ulceration), or >1mm (with ulceration only) (pT2b-pT4b, AJCC 8th edition) as determined by diagnostic biopsy (narrow excision, incision or punch biopsy) and subsequent histopathological analysis. 2. Must have a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm or sole). 3. An uninterrupted 2cm margin must be technically feasible around biopsy scar or primary melanoma. 4. Surgery (which refers to the staging sentinel node biopsy and wide local excision as these are both to be done on the same day) must be completed within 120 days of the original diagnosis. 5. Patients must be 18 years or older at time of consent. 6. Patient must be able to give informed consent and comply with the treatment protocol and follow-up plan. 7. Life expectancy of at least 5 years from the time of diagnosis, not considering the melanoma in question, as determined by the PI. 8. Patients must have an ECOG performance score between 0 and 1. 9. A survivor of prior cancer is eligible provided that ALL of the following criteria are met and documented: - The patient has undergone potentially curative therapy for all prior malignancies,
- There has been no evidence of recurrence of any prior malignancies for at least FIVE years (except for successfully treated cervical or non-melanoma skin cancer with no evidence of recurrence), and
- The patient is deemed by their treating physician to be at low risk of recurrence from previous malignancies.
Exclusion Criteria:
Patients will be excluded from the study for ANY of the following reasons: 1. Uncertain diagnosis of melanoma i.e. so-called 'melanocytic lesion of unknown malignant potential'. 2. Patient has already undergone wide local excision at the site of the primary index lesion. 3. Patient unable or ineligible to undergo staging sentinel lymph node biopsy of the primary index lesion. 4. Desmoplastic or neurotropic melanoma: with any patient where pathology determines melanoma as PURE desmoplastic (as per WHO definition of >90% desmoplasia), they are not eligible for this study. However other desmoplasia or mixed subtypes are eligible unless there is neurotropism present (peri-neural invasion).Peri-neural invasion does not include entrapment of nerves within the main primary tumour mass. Microsatellitosis as per AJCC 8th edition definition 5. Subungual melanoma 6. Patient has already undergone a local flap reconstruction of the defect after excision of the primary and determination of an accurate excision margin is impossible. 7. History of previous or concurrent (i.e., second primary) invasive melanoma. 8. Melanoma located distal to the metacarpophalangeal joint; on the tip of the nose; the eyelids or on the ear; genitalia, perineum or anus; mucous membranes or internal viscera. 9. Physical, clinical, radiographic or pathologic evidence of satellite, in-transit, regional, or distant metastatic melanoma. 10. Patient has undergone surgery on a separate occasion to clear the lymph nodes of the probable draining lymphatic field, including sentinel lymph node biopsy, of the index melanoma. 11. Any additional solid tumour or hematologic malignancy during the past 5 years except T1 skin lesions of squamous cell carcinoma, basal cell carcinoma, or uterine/cervical cancer. 12. Melanoma-related operative procedures not corresponding to criteria described in the protocol. 13. Planned adjuvant radiotherapy to the primary melanoma site after Wide Local Excision is not permitted as part of the protocol and any patients given this treatment would be excluded from the study. 14. History of organ transplantation. 15. Oral or parenteral immunosuppressive agents (not topical or inhaled steroids) at enrolment or within 6 months prior to enrolment.Pregnancy is not a specific exclusion criterion for this trial, though it may not beclinically appropriate to perform a wide excision and sentinel node biopsy until thepregnancy has been completed, which is likely to exclude the patient due to violation ofinclusion criterion 4. We would advise careful counselling of the patient prior toenrolling the patient, which would include a discussion at the treating centre'smultidisciplinary team meeting or tumour board. We would strongly advise contacting thecentral trial office to discuss the case prior to enrolling on the 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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NCI 10204 - A Phase 1b Study of Nivolumab in Patients with Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)
- NCT03816345
Primary Objective
To assess the overall safety, and toxicities associated with the use of the anti-programmed death 1 (PD-1) antibody nivolumab in patients with varying severity of DM/SSc, RA, SLE, IBD (ulcerative colitis [UC] and Crohn s disease [CD]), MS, Sjogren s syndrome [SjS], Psoriasis (PsO)/Psoriatic Arthritis (PsA), and other autoimmune diseases.
Secondary Objectives
To evaluate the efficacy of nivolumab in terms of objective response rates (ORRs), progressionfree survival (PFS), and overall survival (OS) in patients with cancer and DM/SSc, RA, SLE, IBD (UC and CD), MS, SjS, PsO/PsA, and other autoimmune diseases. To observe and record anti-tumor activity.
To propose dosing recommendations for anti-PD-1 antibodies based on the severity of the
autoimmune disorder.
To evaluate the impact of nivolumab on the disease severity indices for:
DM/SSc
RA
SLE
IBD: UC and CD
NS
MS
SjS
PsO/PsA
To identify biomarkers of response and toxicity
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Protocol Number:
092305
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Phase:
Phase I
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Scope:
Local
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Applicable Disease Sites:
Melanoma, Skin
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Therapies Involved:
Chemotherapy single agent systemic
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Drugs Involved:
Opdivo (Nivolumab)
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Contacts:
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Rutgers Cancer Institute of New Jersey
Prinicipal Investigator:
Sarah Weiss MD
Read Inclusion & Exclusion Criteria
Inclusion Criteria:
- Patients can have either histologically confirmed malignancy that is radiologically evaluable and metastatic or unresectable, or have a malignancy for which a PD-1/PD-L1 inhibitor has been approved in the adjuvant setting. Eligible tumor types include solid tumors and malignancies in which there is known evidence of clinical activity for single agent PD-1 or PD-L1 antibodies. Nivolumab is Food and Drug Administration (FDA)-approved for the treatment of melanoma, non-small cell lung cancer (NSCLC), Merkel cell cancer, bladder cancer, renal cell carcinoma (RCC), gastric cancer, hepatocellular carcinoma (HCC), cervical cancer, head and neck cancer, Hodgkin lymphoma (HL), metastatic small cell lung cancer (SCLC), and any solid tumor with microsatellite instability (MSI)-high status confirmed. Patients with HL are eligible but must follow standard response criteria. Additional tumor types may be eligible on a case by case basis upon discussion with principal investigator (PI). Patients enrolling on the trial for adjuvant use will be restricted to those with histology for which a PD-1/PD-L1 inhibitor has been approved in the adjuvant setting including but not limited to NSCLC, melanoma, RCC, cervical cancer, and bladder cancer
- Patients who have previously received other forms of immunotherapy (high-dose [HD] IL-2, IFN, CTLA-4) are allowed. Patients must not have received cytokine immunotherapy for at least 4 weeks before nivolumab administration. Patients who have received prior anti-CTLA4 will be allowed and the washout period is 6 weeks
- Age >= 18 years; children are excluded from this study but may be eligible for future pediatric phase 1 combination trials
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Karnofsky >= 60)
- Life expectancy of greater than 12 weeks
- Leukocytes >= 1,000/mcL
- Absolute neutrophil count >= 500/mcL
- Platelets >= 50,000/mcL
- Total bilirubin =< 2 x institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 5 x institutional ULN or =< 8 x institutional ULN for patients with liver metastases or an autoimmune disease that is contributing to the elevation of these values
- Creatinine ULN OR glomerular filtration rate (GFR) >= 30 mL/min (if using the Cockcroft-Gault formula)
- Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial
- If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy if indicated
- If history of hepatitis C virus (HCV) infection, must be treated with undetectable HCV viral load
- Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate central nervous system (CNS) specific treatment is not required and is unlikely to be required for at least 4 weeks (or scheduled assessment after the first cycle of treatment), and a risk-benefit analysis (discussion) by the patient and the investigator favors participation in the clinical trial
- The effects of nivolumab on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 5 months after the last dose of investigational product. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product. Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of nivolumab. Women must not be breastfeeding. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL. These durations have been calculated using the upper limit of the half-life for nivolumab (25 days) and are based on the protocol requirement that WOCBP use contraception for 5 half-lives plus 30 days, and men who are sexually active with WOCBP use contraception for 5 half-lives plus 90 days. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately
- Ability to understand and the willingness to sign a written informed consent document
- Patients with more than one autoimmune disease are eligible. The treating physician would determine which autoimmune disease is dominant and the patient would be treated under that specific cohort
Exclusion Criteria:
- Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (AEs) due to agents administered more than 4 weeks earlier have not resolved or stabilized. Palliative (limited-field) radiation therapy (RT) is permitted (2 week washout from start of treatment), if all of the following criteria are met:
- Repeat imaging demonstrates no new sites of bone metastases
- The lesion being considered for palliative radiation is not a target lesion
- Patients with prior therapy with an anti-PD-1 or anti-PD-L1
- Patients with prior allogeneic hematologic transplant
- Patients who are receiving any other anticancer investigational agents
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
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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Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination with Pembrolizumab Versus Investigator's Choice in HLAA*02:01-Positive Participants with Previously Treated Advanced Melanoma.
- NCT05549297
Phase 2 Objectives
Primary:
- To demonstrate ctDNA reduction in a greater percentage of participants for tebentafusp regimens versus investigator s choice
- To demonstrate improved survival in tebentafusp regimens versus investigator s choice
Secondary:
- To characterize the safety and tolerability of tebentafusp as monotherapy and in combination with pembrolizumab in participants with non-ocular advanced melanoma
- To assess the incidence of Grade ≥ 2 CRS following standardized steroid premedication regimen
- To characterize the PK of tebentafusp
- To characterize the ADA to tebentafusp
Phase 3 Objectives
Primary:
- To demonstrate survival superiority of tebentafusp regimens versus investigator s choice of therapy
Secondary:
- To demonstrate ctDNA reduction in a greater percentage of participants for tebentafusp regimens versus investigators choice
- To characterize the safety and tolerability of a tebentafusp regimen in participants with non-ocular advanced melanoma
- To assess the incidence of Grade ≥ 2 CRS following standardized steroid premedication regimen
- To characterize the ADA to tebentafusp
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Protocol Number:
092203
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Phase:
Phase II/III
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Scope:
National
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Applicable Disease Sites:
Melanoma, Skin
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Therapies Involved:
Chemotherapy single agent systemic
Chemotherapy multiple agents systemic
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Drugs Involved:
Tebentafusp
Pembrolizumab (MK-3475)
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Contacts:
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Rutgers Cancer Institute of New Jersey
Prinicipal Investigator:
Sarah Weiss MD
Read Inclusion & Exclusion Criteria
Inclusion Criteria:
- HLA-A*02:01-positive.
- unresectable Stage III or Stage IV non-ocular melanoma
- archival tumor tissue sample or a newly obtained biopsy of a tumor lesion not previously irradiated has been provided.
- measurable or non-measurable disease per RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- If applicable, must agree to use highly effective contraception
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent (ICF) and protocol
- Must agree to provide protocol specified samples for biomarker analyses.
Exclusion Criteria:
- Pregnant or lactating women
- diagnosis of ocular or metastatic uveal melanoma
- history of a malignant disease other than those being treated in this study
- ineligible to be retreated with pembrolizumab due to a treatment-related AE
- known untreated or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis
- previous severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb)
- active autoimmune disease requiring immunosuppressive treatment with clinically significant cardiac disease or impaired cardiac function
- known psychiatric or substance abuse disorders
- received prior treatment with a licensed or investigative Immune-mobilizing monoclonal T-cell receptor Against Cancer (ImmTAC) medication who have not completed adequate washout from prior medications.
- received chemotherapy or biological cancer therapy (excluding anti-PD(L)1 mAb, ipilimumab, and BRAF TKI regimen) within 14 days of first dose
- received cellular therapies within 90 days of study intervention
- ongoing Common Terminology Criteria for Adverse Events(CTCAE) Grade ≥ 2 clinically significant who in the opinion of the investigator could affect the outcome of the study
- received systemic treatment with steroids or any other immunosuppressive drug within 2 weeks of first dose
- have not progressed on treatment with an anti-PD(L)1 mAb
- have not received prior ipilimumab
- a BRAF V600 mutation, who have not received a prior BRAF/MEK TKI regimen
- currently participating or have participated in a study of an investigational agent or using an investigational device within 30 days of the first dose
- known history of chronic viral infections such as hepatitis B virus (HBV) or hepatitis C virus (HCV)
- Out of range Laboratory values
- history of allogenic tissue/solid organ transplant
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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Understanding Sun Protection and Skin Examination Practices Among Hispanics.
Aim 1:
To assess Hispanics perceptions of skin cancer, sun protection and skin self-examination behaviors, and their attitudes and preferences towards a mobile-based and user-centered skin cancer intervention. This phase will assess perceptions of Hispanics in New Jersey (n ≈ 32) regarding their beliefs about skin cancer, sun protection, skin self-examination, culture and lifestyles, and their attitudes and preferences towards a mobile-based skin cancer intervention. Qualitative data will be collected through approximately 4 focus groups (2 in Spanish, 2 in English).
Aim 2:
To assess relationships among skin cancer risk beliefs, sun protection and skin self-examination behaviors, and Hispanic cultural values. We will conduct a survey to identify cultural values and lifestyle factors related to sun protection and skin self-examination among Hispanics (n = 400), and their perceptions of a proposed mobile skin cancer intervention. We will assess their preferences for the mobile platform, intervention title/logo, and intervention-related materials, such as texts, multimedia content, message frequency, etc. We will use an online survey to collect quantitative data on these topics.
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Video Education with Result Dependent dIsclosure (VERDI)
- NCT05225428
The overall study objective is to identify and evaluate strategies to improve the accessibility of the video education with result dependent disclosure (VERDI) model, increasingly utilized as a pre-genetic testing (pretest) education alternative in clinical practice, to better serve a more diverse patient population at risk for hereditary cancers.
This developmental work is imperative as the VERDI models utilized at DFCI in research studies #18-411 (ProActive), #17-409 (ProGen), #19-068 (OPT-IN), and #19-652 (GeneBOPP) have been overwhelmingly used in DFCI patients of Caucasian ancestry. While DFCI participants have responded well, in an effort improve the generalizability of VERDI and expand it to a diverse patient population, qualitative feedback is being sought explicitly from patients who self-identify as Black and Latinx patients.
A brief qualitative assessment among a small, cohort of English and Spanish speaking Black and Latinx participants will first be conducted to identify refinements to video education (VE) that may increase the utility of the VERDI model for patients in these traditionally underserved populations. Participants in the qualitative assessment study will receive VE exclusively for pretest education, followed by a short interview with research staff regarding their experiences with the VE model. The qualitative assessment study will precede a large-scale randomized controlled trial of VERDI vs standard genetic counseling (SGC), as informed by the results of the developmental study.
We hypothesize that the data yielded from the completion of the study objectives will assist in further refining the VERDI model and its use in clinical practices for the purpose of increasing genetic testing uptake and improving patient outcomes in minority populations that have been underrepresented in similar research to date.
View All Details
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Protocol Number:
042207
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Principal Investigator:
Deborah Toppmeyer M.D.
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Phase:
N/A
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Scope:
National
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Applicable Disease Sites:
Pancreas,Melanoma, Skin,Colon,Ovary,Soft Tissue,Prostate,Kidney,Breast
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Contacts:
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Rutgers University
Prinicipal Investigator:
Deborah Toppmeyer M.D.
Read Inclusion & Exclusion Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Current or prior diagnosis of breast cancer, ovarian cancer, pancreatic cancer, prostate cancer, colorectal cancer, renal cancer, melanoma, or sarcoma
- Ability to understand spoken or written English or Spanish in a healthcare context
- Ability to understand and the willingness to sign a written informed consent document
- Black or Latinx (qualitative assessment study only)
Exclusion Criteria:
- Prior cancer genetic testing
- Prior germline genetic testing
- Active hematologic malignancy (e.g. chronic lymphocytic leukemia)
- Currently pregnant
- Currently incarcerated
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.
