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Compares treatment options for Advanced Esophageal Squamous Cell Carcinoma
Official title Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program
ClinicalTrials.gov ID: NCT06265285
What this study is testing
What is Nivolumab?
Nivolumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for advanced esophageal squamous cell carcinoma.
Also referred to as ABP 206, BMS-936558.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial compares the impact of subcutaneous (SC) nivolumab given in an in-home setting to an in-clinic setting on cancer care and quality of life. Currently, most drug-related cancer care is conducted in clinic type centers or hospitals which may isolate patients from family, friends and familiar surroundings for many hours per day.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 1 year
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Histologically confirmed malignancies for which treatment with intravenous nivolumab is currently Food and Drug Administration (FDA) approved and who...
- Single agent nivolumab administered in the adjuvant setting for one of the following indications:
- Completely resected stage IIB/C, III or IV melanoma
- Urothelial carcinoma status post radical resection and have a high risk of recurrence
You likely can't join if
- Patients receiving any other investigational or standard of care agent which would be considered as a treatment for the primary neoplasm and is not...
- Patients requiring 24/7 assistance with activities of daily living (ADLs)
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for...
- Uncontrolled intercurrent illness including, but not limited to:
- Ongoing or active infection
- Symptomatic congestive heart failure
See the full eligibility criteria
Who can join
- Age ≥ 18 years
- Histologically confirmed malignancies for which treatment with intravenous nivolumab is currently Food and Drug Administration (FDA) approved and who are recommended to initiate a new treatment regimen with single agent...
- Single agent nivolumab administered in the adjuvant setting for one of the following indications:
- Completely resected stage IIB/C, III or IV melanoma
- Urothelial carcinoma status post radical resection and have a high risk of recurrence
- Completely resected esophageal or gastroesophageal junction carcinoma with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT)
- Single agent nivolumab for advanced/metastatic cancer for one or more of the following indications:
- Renal cell carcinoma (RCC) patients who have received prior anti-angiogenic therapy
- Non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy (Note: patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these...
- Unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy
- Unresectable or metastatic cutaneous melanoma
- Locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment...
- Unresectable or metastatic urothelial carcinoma, as first-line treatment in combination with cisplatin and gemcitabine.
- Subcutaneous nivolumab to be initiated as monotherapy following six cycles of cisplatin + gemcitabine
- Recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy
- Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
- Patients transitioning to maintenance nivolumab and who are willing to switch to subcutaneous nivolumab after completion of Ipilimumab and nivolumab combination therapy for one or more of the indications listed below...
- First-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC)
- Unresectable or metastatic cutaneous melanoma
- Hepatocellular carcinoma (HCC) previously treated with sorafenib
- Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
- Single agent nivolumab administered in the adjuvant setting following neoadjuvant nivolumab with platinum doublet chemotherapy for patients with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer...
- Patients have recovered from the effects of any previous chemotherapy, immunotherapy, other prior systemic anticancer therapy, radiotherapy, and/or surgery (i.e., residual toxicity no worse than grade 1 [grade 2...
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- Aspartate transaminase (AST) values ≤ 3 × the upper limit of normal (ULN). For patients with documented baseline liver metastasis, the following limits will apply: 5 × ULN for transaminase
- Alanine transaminase (ALT) values ≤ 3 x the upper limit of normal (ULN). For patients with documented baseline liver metastasis, the following limits will apply: 5 x ULN for transaminase
- Serum total bilirubin values of ≤ 1.5 x ULN ( ≤ 2 x ULN for patients with known Gilbert's syndrome). For patients with documented baseline liver metastasis, the following limits will apply: 2 x ULN for bilirubin
- Absolute neutrophil count (ANC) of ≥ 1500/μL
- Platelet count of ≥ 100,000/μL
- Hemoglobin of ≥ 9 g/dL (patients may be transfused to this level, if necessary, but transfusion must occur \> 1 week prior to registration)
- Serum creatinine ≤ 2.0 x the ULN for the reference laboratory or a calculated creatinine clearance of ≥ 30 mL/min by the Cockcroft-Gault Equation measured ≤ 7 days prior to registration
- Patients are residing ≤ 35 miles of clinic (hub) or within the area serviced by supplier and paramedic network
- Residence has Wi-Fi to enable a reliable connection with the remote command center
- Patients have signed Informed Consent Form (ICF)
- Patients are willing and able to comply with the study protocol in the investigator's judgment
- Patients are able and willing to complete study questionnaire(s) by themselves or with assistance
- Women of childbearing potential (WOCBP) must:
- Have a negative pregnancy test (serum or urine) ≤ 3 days before the first dose of study drug
- Be agreeable to use a contraceptive method that is highly effective during the intervention period and for at least 5 months after the last dose and agrees not to donate eggs (ova, oocytes) for the purpose of...
What rules you out
- Patients receiving any other investigational or standard of care agent which would be considered as a treatment for the primary neoplasm and is not part of the eligible treatment regimen
- Patients requiring 24/7 assistance with activities of daily living (ADLs)
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper...
- Uncontrolled intercurrent illness including, but not limited to:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Myocardial infarction ≤ 6 months
- Wound healing disorder
- Psychiatric illness/social situations that would limit compliance with study requirements
- Patients with any severe infection ≤ 4 weeks prior to registration including, but not limited to, hospitalization for complications of infections
- Patients with an active, known or suspected autoimmune disease. Patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not...
- Patients with a condition requiring systemic treatment with either corticosteroids ( \> 10 mg daily prednisone equivalent) ≤ 14 days or other immunosuppressive medications ≤ 30 days prior to registration. Inhaled or...
- Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active ≤ 2 years prior to registration (i.e., participants with a history of prior malignancy are eligible if treatment...
- Patients have undergone prior solid organ and/or non-autologous hematopoietic stem cell or bone marrow transplant
- Patients with active brain metastases or leptomeningeal metastases, aside from the exceptions below. Participants with brain metastases are eligible if they are:
- Asymptomatic
- Have been treated and participants have neurologically returned to baseline (except for residual signs or symptoms related to the central nervous system [CNS] treatment), and
- There is no MRI evidence of progression for at least 4 weeks after CNS directed therapy is complete and ≤ 28 days prior to registration
- In addition, participants must have been either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to registration
- Participants with brain disease treated with whole brain radiation
- Anticipation of the need for major surgery during the course of study treatment
- Participants who are pregnant or breastfeeding
- Treatment with any live attenuated vaccines ≤ 30 days of registration (vaccines that are not live attenuated are allowed, including COVID-19 vaccine)
- Known human deficiency virus (HIV) positive with an AIDS defining opportunistic infection within the last year, or a current CD4 count \< 350 cells/uL, aside from the exceptions below. Participants with HIV are eligible...
- They have received antiviral therapy (ART) for at least 4 weeks prior to treatment assignment as clinically indicated while enrolled in the study
- They continue on ART as clinically indicated while enrolled on study
- CD4 counts and viral load are monitored per standard of care by a local healthcare provider
- History of allergy or hypersensitivity to study drug components
- Any positive test result for hepatitis B virus (HBV) indicating presence of virus (e.g., hepatitis B surface antigen [HBsAg, Australia antigen]) positive
- Any positive test result for hepatitis C virus (HCV) indicating presence of active viral replication (detectable HCV-ribonucleic acid [RNA]). Note: Participants with positive HCV antibody and an undetectable HCV RNA are...
The study team makes the final eligibility decision.
Where it's taking place
- Jacksonville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jacksonville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.