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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer

Cancer CARE Beyond Walls - A Pilot of a Randomized, Pragmatic Trial of Cancer Directed Therapy Administration in the Patients' Homes Versus in Clinic

At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer (NCT05969860) is a Phase 2 interventional studying Advanced Anal Carcinoma and Advanced Biliary Tract Carcinoma, sponsored by Mayo Clinic. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This clinical trial studies the effect of cancer directed therapy given at-home versus in the clinic for patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Currently most drug-related cancer care is conducted in infusion centers or specialty hospitals, where patients spend many hours a day isolated from family, friends, and familiar surroundings. This separation adds to the physical, emotional, social, and financial burden for patients and their families. The logistics and costs of navigating cancer treatments have become a principal contributor to patients' reduced quality of life. It is therefore important to reduce the burden of cancer in the lives of patients and their caregivers, and a vital aspect of this involves moving beyond traditional hospital and clinic-based care and evaluate innovative care delivery models with virtual capabilities. Providing cancer treatment at-home, versus in the clinic, may help reduce psychological and financial distress and increase treatment compliance, especially for marginalized patients and communities.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Advanced Anal Carcinoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 220 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Advanced Anal Carcinoma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Female or male patients with diagnosed by tissue sample (biopsy-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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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 requirements

Treatments Being Tested

PROCEDURE

Clinical Encounter

Receive treatment in clinic

OTHER

Home Health Encounter

Receive at-home treatment

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Mayo Clinic in Florida
Jacksonville, Florida, United States
Altru Cancer Center
Grand Forks, North Dakota, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05969860), the sponsor (Mayo Clinic), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05969860 clinical trial studying?

This clinical trial studies the effect of cancer directed therapy given at-home versus in the clinic for patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Currently most drug-related cancer care is conducted in infusion centers or specialty hospitals, where patients spend many hours a day isolated from family, friends, and familiar surroundings. This separation adds to the physical, emotional, social, and financial burden for patients and their families. The logistics and costs of navigating cancer trea… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05969860?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05969860?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05969860. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05969860. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.