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Solid TumorPhase 1/2myDAvIpNiNCT03707808

Intratumoral Injection of Autologous CD1c (BDCA-1)+ myDC, AS01B, and Ipilimumab Plus Systemic Nivolumab

A Phase 1/2 study testing intratumoral injection of autologous CD1c (BDCA-1)+ myDC, Intratumoral injection of ipilimumab and AS01b and IV nivolumab in people with Solid Tumor and Metastases to Soft Tissue, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This phase II trial aims at investigating the role and effect of autologous CD1c (BDCA-1)+ myeloid dendritic cells in combination with intratumoral injection of the CTLA-4 blocking monoclonal antibody (mAb) ipilimumab and the immunoligand AS01B compared to a combinatorial immunotherapy regimen using intratumoral… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor, Metastases to Soft Tissue
What is being tested?
intratumoral injection of autologous CD1c (BDCA-1)+ myDC, Intratumoral injection of ipilimumab and AS01b and IV nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteBelgium
Study dates
29 Jan 2018to 23 Dec 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
  • Male or female age ≥ 18 years at the time of informed consent
  • Histologically confirmed advanced solid tumor that cannot be completely surgically resected
  • Failing all standard curative and live prolonging therapy.
  • Presence of skin- or lymphnode metastatic disease amenable to intratumoral injection by manual palpation, US or CT-guidance. At least one metastatic lesion should be amenable to a safe post-injection biopsy (by core needle biopsy, partial- or complete surgical resection).
  • ECOG performance status of 0 or 1
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  • Candidate for intralesional therapy defined as either one of the following:
  • At least 1 injectable skin or lymph node metastatic lesion with a longest diameter of ≥ 10 mm
  • Multiple injectable tumor lesions that in aggregate have a longest diameter of ≥ 10 mm injectable disease
  • Adequate organ function determined within 14 days prior to enrollment, defined as follows:
  • Hematological: absolute neutrophil count ≥ 1500/mm3 (1.5x109/L), platelet count: ≥ 100.000/mm3 (7.5x109/L), hemoglobin: ≥ 9 g/dL (without need for hematopoietic growth factor or transfusion support)
  • Renal: serum creatinine: 1.5 x upper limit of normal (ULN), OR 24-hour creatinine clearance ≥ 60 mL/min for subject with creatinine levels > 1.5 x ULN. (Note: Creatinine clearance need not be determined if the baseline serum creatinine is within normal limits. Creatinine clearance should be calculated per institutional standard).
  • Hepatic: serum bilirubin: 1.5 x ULN OR direct bilirubin ≤ ULN for a subject with total bilirubin level > 1.5 x ULN, aspartate aminotransferase (AST): 2.5 x ULN OR ≤ 5 x ULN for subject with liver metastases, alanine aminotransferase (ALT): 2.5 x ULN OR ≤ 5 x ULN for subject with liver metastases
  • Coagulation: international normalization ratio (INR) or prothrombin time (PT): 1.5 x ULN unless the subject is receiving anticoagulant therapy as long as PT and partial thromboplastin time (PTT)/ activated PTT (aPTT) is within therapeutic range of intended use of anticoagulants, PTT or aPTT: 1.5 x ULN unless the subject is receiving anticoagulant therapy as long as PT and PTT/aPTT is within therapeutic range of intended use of anticoagulants
  • Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to enrollment. If urine pregnancy test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Availability of a tumor sample (archival sample obtained within 3 months prior to study participation or newly obtained biopsy). Subject must submit the tumor sample during screening. Subjects with a non-evaluable archival sample may obtain a new biopsy and subjects with a non-evaluable newly obtained biopsy may undergo re-biopsy at the discretion of the investigator.
  • Adequate vascular access to undergo a leucapheresis.

Who cannot join

  • Known active central nervous system (CNS) metastases. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids >8 mg/day of methylprednisone or equivalent. The exception does not include carcinomatosus meningitis which is excluded regardless of clinical stability.
  • History or evidence of active autoimmune disease that requires systemic treatment (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • History or evidence of immunodeficiency states (eg, hereditary immune deficiency, organ transplant, or leukemia)
  • History of other malignancy within the past 5 years with the following exceptions: malignancy treated with curative intent and with no known active disease present and has not received chemotherapy for > 5 years before enrollment and felt to be at low risk for recurrence by the treating physician, adequately treated non-melanoma skin cancer without evidence of disease at the time of enrollment, adequately treated cervical carcinoma in situ without evidence of disease at the time of enrollment, adequately treated breast ductal carcinoma in situ without evidence of disease at the time of enrollment , prostatic intraepithelial neoplasia without evidence of prostate cancer at the time of enrollment, adequately treated superficial or in-situ carcinoma of the bladder without evidence of disease at the time of enrollment
  • Prior treatment of other tumor vaccine
  • Prior chemotherapy, radiotherapy, biological cancer therapy, targeted therapy, or major surgery within 28 days prior to enrollment or has not recovered to CTCAE grade 1 or better from adverse event due to cancer therapy administered more than 28 days prior to enrollment.
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  • Currently receiving treatment in another investigational device or drug study, or less than 28 days since ending treatment on another investigational device or drug study
  • Expected to require other cancer therapy while on study with the exception of local radiation treatment to the site of bone and other metastasis for palliative pain management
  • Other investigational procedures while participating in this study are excluded.
  • History or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other symptomatic autoimmune disease, or active autoimmune disease or syndrome that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Evidence of clinically significant immunosuppression such as the following: diagnosis of immunodeficiency, concurrent opportunistic infection, receiving systemic immunosuppressive therapy (> 2 weeks) or within 7 days prior to the first dose of study treatment, including oral steroid doses > 10 mg/day of prednisone or equivalent except for management of adverse events and central nervous system (CNS) metastases during the course of the study. Subjects that require intermittent use of bronchodilators or local steroid injection will not be excluded from the study.
  • Known human immunodeficiency virus (HIV) disease
  • Known acute or chronic hepatitis B or hepatitis C infection
  • Female subject is pregnant or breast-feeding, or planning to become pregnant during study treatment and through 3 months after the last dose of study treatment
  • Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through 3 months after the last dose of study treatment. Note: Women not of childbearing potential are defined as: postmenopausal (defined as at least 12 months with no menses without an alternative medical cause; in women < 45 years of age a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.) OR have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 6 weeks prior to screening; OR has a congenital or acquired condition that prevents childbearing. Note: Acceptable methods of effective contraception are defined in the informed consent form.
  • Male subject unwilling to use acceptable method of effective contraception during trial participation and through 3 months after the last dose of study treatment. For this trial, male subjects will be considered to be of non-reproductive potential if they have azoospermia (whether due to having had a vasectomy or due to an underlying medical condition). Note: Acceptable methods of effective contraception are defined in the informed consent form.
  • Subject has known sensitivity to any of the products or components to be administered during dosing
  • Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge
  • History or evidence of psychiatric, substance abuse, or any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
  • Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or sponsor staff directly involved in the this trial, unless prospective institutional review board (IRB)/independent ethics committee (IEC) approval (by chair or designee) is given allowing exception to this criterion for a specific subject
  • Sexually active subject who is unwilling to use a barrier method to avoid potential viral transmission during sexual contact during and within 3 months after study treatment.
  • Prior allogeneic hematopoietic stem cell transplantation within the last 5 years. (Subjects who have had a transplant > 5 years ago are eligible as long as there are no symptoms of Graft versus Host Disease.)
  • Known history of active Bacillus tuberculosis

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • UZ Brussel

    Jette, Brabant, 1090

Other trials in Belgium

About this study

Official title: A Randomized Phase II Clinical Trial on Intratumoral AS01B/Ipilimumab Plus Intravenous Nivolumab With or Without Autologous CD1c(BDCA-1)+ / CD141(BDCA-3)+ Myeloid Dendritic Cells.

This phase II trial aims at investigating the role and effect of autologous CD1c (BDCA-1)+ myeloid dendritic cells in combination with intratumoral injection of the CTLA-4 blocking monoclonal antibody (mAb) ipilimumab and the immunoligand AS01B compared to a combinatorial immunotherapy regimen using intratumoral injection of the CTLA-4 blocking monoclonal antibody (mAb) ipilimumab and the immunoligand AS01B. Concomitantly, nivolumab (a PD-1 blocking mAb) will be administered intravenously in both arms.

Read the detailed description

This phase II trial aims at investigating the role and effect of autologous CD1c (BDCA-1)+ myeloid dendritic cells in combination with intratumoral injection of the CTLA-4 blocking monoclonal antibody (mAb) ipilimumab and the immunoligand AS01B compared to a combinatorial immunotherapy regimen using intratumoral injection of the CTLA-4 blocking monoclonal antibody (mAb) ipilimumab and the immunoligand AS01B. Concomitantly, nivolumab (a PD-1 blocking mAb) will be administered intravenously in both arms.

CD1c (BDCA-1)+ myeloid dendritic (myDC) cells will be obtained by immunomagnetic isolation from PBMC obtained by leukapheresis. The CD1c (BDCA-1)+ myDC will not be substantially manipulated prior to autologous intratumoral injection, immediately following the isolation and concentration (isolation and administration will be performed in the same procedure). The investigators consider that the isolation represents a non-substantial manipulation of this somatic cell therapy product. The intended use of CD1c (BDCA-1)+ myDC in this clinical protocol is to enrich their presence within the injected metastasis where they should execute their physiological role of coordinating the anti-tumor immune response. Based on recent preclinical data, absence of myeloid dendritic cells in the tumor microenvironment is an important immune escape mechanism of malignant tumors.

Being tested
intratumoral injection of autologous CD1c (BDCA-1)+ myDC, Intratumoral injection of ipilimumab and AS01b, IV nivolumab
Keywords
solid tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intratumoral injection of autologous CD1c (BDCA-1)+ myDCDrug

    intratumoral injections plus intravenous administration

  • Intratumoral injection of ipilimumab and AS01bDrug

    Also called intratumoral injection of ipilimumab and AS01B, intravenous nivolumab, intratumoral injection of ipilimumab and avelumab, intravenous nivolumab

    Intratumoral injection of ipilimumab and AS01b

  • IV nivolumabDrug

    Also called Nivolumab intravenous administration

    Nivolumab administered intravenously

Study groups in NCT03707808
Study groupRoleWhat they receive
Immediate treatmentExperimentalIT injection of MyDC, ipilimumab and AS01b + IV nivolumab
Receives: Drug: intratumoral injection of autologous CD1c (BDCA-1)+ myDC; Drug: Intratumoral injection of ipilimumab and AS01b; Drug: IV nivolumab
Delayed treatmentActive comparatorIT injection of ipilimumab and AS01b + IV nivolumab
Receives: Drug: Intratumoral injection of ipilimumab and AS01b; Drug: IV nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of Treatment-related Adverse Events graded according to CTCAE of intratumoral injection of autologous CD1c (BDCA-1)+ myDC plus AS01B and ipilimumab in combination with IV nivolumab

    Participants with treatment-related adverse events will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

    Measured: 1 year

  2. To assess the therapeutic efficacy and toxicity of the AS01B adjuvants in combination with systemic PD-1 blockade and intratumoral CTLA-4 inhibition plus intratumoral administration of CD1c (BDCA-1)+ / CD141 (BDCA-3)+ myDC co-product in patients

    1-year progression free survival (PFS) rate following randomization.

    Measured: 1 year

  3. Feasibility of treatment strategy

    Percentage of study patients that can receive the planned CD1c (BDCA-1)+ / CD141(BDCA-3)+ myDC intratumoral injection.

    Measured: 1 year

Secondary outcomes (6)

  1. Objective response rate (ORR) of intratumoral injected CD1c (BDCA-1)+ myDC, avelumab, and ipilimumab plus iv nivolumab

    Objective response rate (ORR, defined as the percentage of subjects with a confirmed complete response (CR), or partial response at any time per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1

    Measured: 1 year

  2. Treatment disposition

    Number/volume of administered CD1c (BDCA-1)+ / CD141 (BDCA-3)+ myDC Administered dose of AS01, ipilimumab, and nivolumab

    Measured: 1 year

  3. Anti-tumor activity

    Tumor response (ORR) according to RECISTv1.1 and iRECIST Tumor response and duration of response of CD1c (BDCA-1)+

    / CD141 (BDCA-3)+ myDC, AS01, and ipilimumab injected and non-injected metastases (reported descriptively)

    Measured: 1 year

  4. Duration of response (DOR)

    Duration of response of CD1c (BDCA-1)+ / CD141 (BDCA-3)+ myDC, AS01B and ipilimumab in injected and non-injected metastases (reported descriptively)

    Measured: 1 year

  5. Progression-free survival (PFS)

    Time from first study treatment administration to progression of disease according to RECISTv1.1 and iRECIST (and possibly itRECIST)

    Measured: 1 year

  6. Overall survival

    Time from first study treatment administration to death

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2018
  2. Study start29 Jan 2018
  3. Primary completion23 Apr 2027 (estimated)
  4. Study completion23 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
There are 2 arms that are given treatment in parallel. But pts from the second arm without the myDC are able to crossover to the first arm with the myDC's. But not the other way around.
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03707808
Sponsor's protocol ID
2017-BN-003
Acronym
myDAvIpNi
Status last verified
Sep 2026
First submitted
5 Feb 2018
Last updated
29 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tijtgat J, Geeraerts X, Boisson A, Stevens L, Vounckx M, Dirven I, Schwarze JK, Raeymaeckers S, Forsyth R, Van Riet I, Tuyaerts S, Willard-Gallo K, Neyns B. Intratumoral administration of the immunologic adjuvant AS01B in combination with autologous CD1c (BDCA-1)+/CD141 (BDCA-3)+ myeloid dendritic cells plus ipilimumab and intravenous nivolumab in patients with refractory advanced melanoma. J Immunother Cancer. 2024 Jan 11;12(1):e008148. doi: 10.1136/jitc-2023-008148.

    PubMed 38212127

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing intratumoral injection of autologous CD1c (BDCA-1)+ myDC, Intratumoral injection of ipilimumab and AS01b and IV nivolumab in people with Solid Tumor and Metastases to Soft Tissue, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of Treatment-related Adverse Events graded according to CTCAE of intratumoral injection of autologous CD1c (BDCA-1)+ myDC plus AS01B and ipilimumab in combination with IV nivolumab (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03707808, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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