Recruiting nowPhase 2Ages 18 Years and up
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Sponsor: Mayo Clinic · NCT05969860 on ClinicalTrials.gov ↗
Conditions studied
Advanced Anal CarcinomaAdvanced Biliary Tract CarcinomaAdvanced Bladder CarcinomaAdvanced Breast CarcinomaAdvanced Carcinoid TumorAdvanced Cervical CarcinomaAdvanced Colorectal CarcinomaAdvanced Gastric CarcinomaAdvanced GlioblastomaAdvanced Head and Neck CarcinomaAdvanced HER2 Positive Breast CarcinomaAdvanced Lung CarcinomaAdvanced Lung Small Cell CarcinomaAdvanced Malignant Germ Cell TumorAdvanced Malignant Solid NeoplasmAdvanced Neuroendocrine CarcinomaAdvanced Ovarian CarcinomaAdvanced Pancreatic CarcinomaAdvanced Prostate Small Cell Neuroendocrine CarcinomaAdvanced Prostate CarcinomaHematopoietic and Lymphoid System NeoplasmMultiple MyelomaMyelodysplastic SyndromeAdvanced Basal Cell CarcinomaAdvanced CholangiocarcinomaAdvanced Endometrial CarcinomaAdvanced Esophageal CarcinomaAdvanced Fallopian Tube CarcinomaAdvanced Hepatocellular CarcinomaAdvanced Liver CarcinomaAdvanced LymphomaAdvanced Malignant Testicular NeoplasmAdvanced MelanomaAdvanced Merkel Cell CarcinomaAdvanced Penile CarcinomaAdvanced Primary Malignant Central Nervous System NeoplasmAdvanced Renal Cell CarcinomaAdvanced SarcomaAdvanced Skin Squamous Cell CarcinomaAdvanced Urethral CarcinomaAdvanced Vaginal CarcinomaAdvanced Vulvar CarcinomaAdvanced Appendix CarcinomaAdvanced Gastroesophageal Junction Adenocarcinoma
What it tests
- Clinical Encounterprocedure
- Home Health Encounterother
- Quality-of-Life Assessmentother
- Questionnaire Administrationother
Where it's running2 sites
- Recruiting now
Mayo Clinic in Florida
Jacksonville, Florida 32224-9980
- Clinical Trials Referral Office(contact)855-776-0015[email protected]
- Roxana S. Dronca, MD(principal investigator)
- Recruiting now
Altru Cancer Center
Grand Forks, North Dakota 58201
- Alexis Tatum(contact)701-780-5400[email protected]
- Grant Seeger, MD(principal investigator)
See the official eligibility language
Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.
Inclusion Criteria:
* Female or male patients with histologically confirmed malignancy. Patients with hepatocellular carcinoma (HCC) are eligible based on imaging diagnosis along; histologic confirmation is not required.
* Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical practice. Specifically, it must be either a) FDA-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g. NCCN, ASCO, ASH, etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines.
* 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 \[including gastric, esophageal, and gastroesophageal junction (GEJ) cancers\]
* 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 + vemurafenib, atezolizumab +/- bevacizumab + cobimetinib + vemurafenib
* 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 requirementsUpdated 2026-04-20 on ClinicalTrials.gov. Always confirm current details with the study team or your oncologist.