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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

A Phase II Study on Adjuvant Vaccination with Dendritic Cells Loaded with Autologous Tumor Homogenate in Resected Stage IV Rare Cancers.

A Phase II Study on Adjuvant Vaccination with Dendritic Cells Loaded with Autologous Tumor Homogenate in Resected Stage IV Rare Cancers: Head&Neck (H&N), Neuroendocrine Tumors (NET) and Soft Tissue Sarcoma (STS).

A Phase II Study on Adjuvant Vaccination with Dendritic Cells Loaded with Autologous Tumor Homogenate in Resected Stage IV Rare Cancers. (NCT04166006) is a Phase 2 interventional studying Head Neck Tumors and Neuroendocrine Tumors, sponsored by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS. 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

Single-arm, monocentric trial to assess safety and immunological efficacy of adjuvant vaccination with autologous dendritic cells loaded with autologous tumour homogenate after curative resection for stage IV rare cancers (In Head/Neck tumors (H\&N), NEuroendocrine Tumors (NET) and Soft Tissue Sarcomas (STS).

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Head Neck Tumors 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 51 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Head Neck Tumors 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: 1. Patients must have diagnosed by tissue sample (biopsy-confirmed) stage IV Head\&Neck Squamous Cell Carcinoma (HNSCC), NeuroEndocrine Tumors (NET) or Soft Tissue Sarcoma (STS) surgically treated with radical intent. 2. The autologous surgical specimen must have been collected and sent to the Somatic Cell Therapy Lab and must fulfil all the acceptance criteria prescribed by the Good Manufactory Practice (GMP) procedures. 3. The patient must be disease-free, as assessed by CT scan or MRI of the chest, abdomen, pelvis performed within 60 days before enrolment. If the resected lesions occurred in other sites, these must be also included in the baseline CT scan and in all the subsequent evaluations. 4. Patients disease-free candidates for only observation as per clinical practice (no standard treatment is available after surgery) 5. The patient must have recovered from all the adverse events related to previous surgery. 6. Age ≥18 years. 7. Performance status Eastern Cooperative Oncology Group (ECOG) 0 or 1. 8. Patient must have acceptable organ function, defined as: 1. Haemoglobin \>10 g/dl 2. White blood cells ≥3000/μl. 3. Absolute neutrophil count ≥1500/μl. 4. platelet count at least 75000/μl. 5. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<3 times the upper institutional reference level. 6. Total bilirubin \<1.5 times the upper institutional reference level. 7. Serum creatinine \<1.5 times the upper institutional reference level. 9. Patients aged 70 years or older must have left ventricular ejection fraction not lower than 55% as assessed by echocardiography. ...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: 1. Patients must have histologically confirmed stage IV Head\&Neck Squamous Cell Carcinoma (HNSCC), NeuroEndocrine Tumors (NET) or Soft Tissue Sarcoma (STS) surgically treated with radical intent. 2. The autologous surgical specimen must have been collected and sent to the Somatic Cell Therapy Lab and must fulfil all the acceptance criteria prescribed by the Good Manufactory Practice (GMP) procedures. 3. The patient must be disease-free, as assessed by CT scan or MRI of the chest, abdomen, pelvis performed within 60 days before enrolment. If the resected lesions occurred in other sites, these must be also included in the baseline CT scan and in all the subsequent evaluations. 4. Patients disease-free candidates for only observation as per clinical practice (no standard treatment is available after surgery) 5. The patient must have recovered from all the adverse events related to previous surgery. 6. Age ≥18 years. 7. Performance status Eastern Cooperative Oncology Group (ECOG) 0 or 1. 8. Patient must have acceptable organ function, defined as: 1. Haemoglobin \>10 g/dl 2. White blood cells ≥3000/μl. 3. Absolute neutrophil count ≥1500/μl. 4. Platelets≥75000/μl. 5. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<3 times the upper institutional reference level. 6. Total bilirubin \<1.5 times the upper institutional reference level. 7. Serum creatinine \<1.5 times the upper institutional reference level. 9. Patients aged 70 years or older must have left ventricular ejection fraction not lower than 55% as assessed by echocardiography. 10. Female patients of childbearing potential and all male patients must accept and be compliant with an highly effective contraceptive method (i.e. with a failure rate of \<1% per year: double barrier method, one barrier method plus spermicidal, intrauterine device, or oral contraception) from informed consent signature and up to three months after end of study. For this purpose are considered of childbearing potential all female subjects after puberty unless they are post-menopausal for at least two years or are surgically sterile. Complete abstinence from sexual intercourses is acceptable if patients' lifestyle guarantees his/her strict compliance with this prescription in the judgement of the Investigator. 11. The patient is willing and able to give written informed consent for the study. Exclusion Criteria: 1. Patients with residual disease after surgery. Marginal resection of any lesion in the absence of clinically evident residual disease is acceptable. 2. Patient who completed surgery more than 90 days before study enrolment. 3. History of other neoplastic diseases in the previous 5 years, except basal cell carcinoma of the skin and in situ carcinoma of the cervix uteri treated with curative surgery. 4. History of congenital or acquired immunodeficiency, including history of organ transplantation. 5. Any positivity for the serologic markers of hepatitis B virus (HBV) (including at least anti- Hepatitis B surface antibodies (HBs) and hepatitis B core (HBc) antibodies, hepatitis C virus (HCV), HIV or Treponema pallidum. The serologic tests must have been performed within 30 days before any GMP-regulated activity (i.e. surgical resection and leukapheresis). The sole positivity for antibodies against the HBV surface antigen (i.e. with all other HBV markers negative) is indicative of previous HBV vaccination and therefore is acceptable. 6. Female patients who are pregnant or nursing. 7. Participation in another clinical trial with any investigational agent within 30 days prior to study screening. 8. Any active inflammatory or autoimmune disease requiring systemic steroids or other immunomodulatory agents as detailed in section 6.4, or potentially requiring such treatments during the study treatment in the judgement of the Investigator. 9. Any clinical condition that, in the opinion of the Investigator or the Transfusion Medicine specialist, is a contraindication to leukapheresis. In addition, all patients aged 70 or older must be evaluated by a cardiology specialist before the procedure to exclude any clinically relevant cardiac condition and any grade 3-4 cardiac arrhythmia, even if asymptomatic. 10. Any uncontrolled serious 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 potentially impacting patient safety and compliance in the opinion of the Investigator. 11. Refusal of giving written informed consent.

Treatments Being Tested

BIOLOGICAL

Autologous DC vaccine

7-14×106 autologous dendritic cells loaded with autologous tumour homogenate given by intradermal injection (day 1)

DRUG

Interleukin-2

Autologous DC vaccine is followed by IL-2, at a dose of 3 MU, given by subcutaneous injection daily for five days (days 3-7).

Locations (1)

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.

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola, FC, Italy

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04166006), the sponsor (Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS), 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 NCT04166006 clinical trial studying?

Single-arm, monocentric trial to assess safety and immunological efficacy of adjuvant vaccination with autologous dendritic cells loaded with autologous tumour homogenate after curative resection for stage IV rare cancers (In Head/Neck tumors (H\&N), NEuroendocrine Tumors (NET) and Soft Tissue Sarcomas (STS). The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04166006?

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 NCT04166006?

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 NCT04166006. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04166006. 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.