Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT05969860
Eligibility Criteria:
Inclusion Criteria:
* Female or male patients with histologically confirmed malignancy who are currently receiving treatment with one of the following eligible treatment regimens. Note, patients diagnosed with any of the following disease types may receive any of the eligible regimens listed. Additionally, patients receiving immunotherapy, such as nivolumab or pembrolizumab, may receive these infusions in home supplemental to any of the regimens identified. Patients may receive any combination of any above listed medications or regimens:
* Eligible disease cancer types:
* Anal cancer
* Appendiceal carcinoma
* Basal cell carcinoma
* Bladder cancer
* Biliary cancer
* Breast cancer
* Central Nervous System malignancy including glioblastoma
* Cervical cancer
* Cholangiocarcinoma
* Colorectal carcinoma
* Endometrial cancer
* Fallopian tube cancer
* Gastroesophageal cancer
* Germ cell carcinoma
* Head and Neck cancer
* Hepatocellular Carcinoma
* Liver
* Lung
* Lymphoma
* Melanoma
* Merkel Cell
* Multiple Myeloma
* Myelodysplastic syndrome
* Myeloid Disorders
* Neuroendocrine carcinoma
* Ovarian cancer
* Pancreatic adenocarcinoma
* Penile carcinoma
* Peritoneal carcinoma
* Prostate cancer
* Renal cell cancer
* Sarcoma
* Squamous cell Carcinoma of the Skin
* Testicular cancer
* Urethral carcinoma
* Vaginal carcinoma
* Vulvar carcinoma
* Eligible Regimens
* Fluorouracil (5-FU) +/- leucovorin +/- bevacizumab +/- trastuzumab
* 5FU +/- leucovorin +/- bevacizumab +/- nivolumab
* Atezolizumab +/- bevacizumab
* Atezolizumab +/- bevacizumab + cobimetinib, atezolizumab +/- bevacizumab + vermurafenib, atezolizumab +/- bevacizumab + cobimetinib + vermurafenib
* Avelumab
* Avelumab + axitinib
* Bevacizumab
* Bevacizumab + capecitabine
* Bevacizumab + irinotecan (+/- capecitabine)
* Bevacizumab + olaparib, bevacizumab + lenvatinib, bevacizumab + niraparib, bevacizumab + rucaparib
* Bevacizumab + Temozolomide, Bevacizumab + Lomustine, or Bevacizumab + everolimus
* Bevacizumab + trifluridine/tipiracil
* Bortezomib
* Bortezomib + cyclophosphamide, bortezomib + lenalidomide, bortezomib + pomalidomide, bortezomib + selinexor
* Bortezomib + venetoclax
* Carfilzomib
* Carfilzomib + cyclophosphamide, carfilzomib + lenalidomide, carfilzomib + pomalidomide, carfilzomib + selinexor
* Carfilzomib + venetoclax
* Cemiplimab
* Cisplatin
* Cisplatin/5-FU
* Cisplatin/etoposide
* Cisplatin + durvalumab
* Cisplatin + gemcitabine
* Cisplatin + gemcitabine + durvalumab
* Daratumumab (+ oral \[PO\] cyclophosphamide, lenalidomide, pomalidomide, or selinexor)
* Daratumumab + bortezomib (+ PO cyclophosphamide, lenalidomide, pomalidomide, or selinexor)
* Daratumumab + carfilzomib (+ PO cyclophosphamide, lenalidomide, pomalidomide, or selinexor)
* Degarelix
* Durvalumab
* Durvalumab + tremelimumab
* Eribulin
* FOLFIRI +/- bevacizumab (5FU +/- leucovorin + irinotecan)
* Fam-trastuzumab deruxtecan
* Fulvestrant
* Fulvestrant + ribociclib, fulvestrant + abemaciclib, fulvestrant + palbociclib, fulvestrant + alpelisib, or fulvestrant + capivasertib
* Gemcitabine
* Gemcitabine + durvalumab
* Gemcitabine + paclitaxel protein-bound
* Goserelin acetate
* Irinotecan
* Irinotecan + capecitabine
* Lanreotide
* Leuprolide
* Nivolumab
* Nivolumab + cabozantinib
* Nivolumab-relatlimab
* Octreotide
* Paclitaxel
* Pembrolizumab
* Pembrolizumab + axitinib, pembrolizumab + lenvatinib, pembrolizumab + capecitabine, pembrolizumab + dabrafenib +/- trametinib, pembrolizumab + trametinib)
* Pemetrexed
* Pertuzumab
* Pemetrexed + pembrolizumab
* Rituximab
* Trastuzumab + paclitaxel
* Trastuzumab with or without pertuzumab maintenance (SQ or IV) (+/- tucatinib +/- capecitabine)
* Decitabine
* These regimens can be used only if patients are receiving one of the regimens above:
* Darbepoetin-alfa
* Epoetin
* Filgrastim
* Note: Female or male patients with histologically confirmed malignancy who are currently receiving treatment with one of the above eligible regimens may receive supportive care medications for treatment or prevention of bone metastases, including agents such as:
* Zoledronic acid
* Denosumab
* Patient has had adequate tolerability of their clinical standard of care cancer treatment in the opinion of their treating physician and no drug-related infusion reactions prior to consent
* Patients who according to documentation from their treating provider plan to continue the treatment regimen they are currently prescribed for at least 24 weeks from the start of cycle following randomization.
* Residing within the area serviced by supplier and paramedic network
* Residence has wireless fidelity (wifi) to enable a reliable connection with the remote Command Center or it is suitable for connection through a wireless network solution
* Age \>= 18 years at time of registration
* Signed informed consent form by patient
* Willing and able to comply with the study protocol in the investigator's judgement
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2
* Ability to complete questionnaire(s) by themselves or with assistance
* RANDOMIZATION ELIGIBILITY CRITERIA: In addition to the criteria above, confirmation by the CCBW Command Center that the patient has adequate tolerability to the standard of care cancer therapy and no drug-related infusion reactions since pre-registration and prior to registration
Exclusion Criteria:
* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm. Note: Patients are permitted concomitant standard of care oral drugs such as ribociclib, abemaciclib, or palbociclib in combination with endocrine therapy (e.g., Leuprolide, fulvestrant intramuscular \[IM\], etc.); tucatinib and capecitabine in combination with trastuzumab and pertuzumab for HER2 positive breast cancer; dexamethasone, cyclophosphamide, lenalidomide or pomalidomide for multiple myeloma; temozolomide, lomustine, or afinitor in combination with avastin for glioblastoma. In addition, all oral anti-hormonal agents for breast and prostate cancer are permitted (e.g., tamoxifen, arimidex, abiraterone, etc.) if used in combination with any of the drugs
* Requiring 24/7 assistance with activities of daily living (ADLs)
* Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)
* 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 assessment of safety and toxicity of the prescribed regimens
* 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
* Or psychiatric illness/social situations that would limit compliance with study requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05969860
Study Brief:
Protocol Section:
NCT05969860