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New treatment option for Solid Tumor
Official title Intratumoral Injection of Autologous CD1c (BDCA-1)+ MyDC, Avelumab, and Ipilimumab Plus Systemic Nivolumab
ClinicalTrials.gov ID: NCT03707808
What this study is testing
What is intratumoral injection of autologous CD1c (BDCA-1)+ myDC?
intratumoral injection of autologous CD1c (BDCA-1)+ myDC is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumor.
Also referred to as intratumoral injection of ipilimumab and avelumab, intravenous nivolumab.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- Known active central nervous system (CNS) metastases. people with previously treated brain metastases may participate provided they are stable...
- History or evidence of active autoimmune disease that requires systemic treatment (ie, with use of disease modifying agents, corticosteroids or...
- 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...
- 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...
See the full eligibility criteria
Who can 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...
- ECOG performance status of 0 or 1
- 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...
- 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...
- 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...
- 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...
- 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. people with a non-evaluable...
- Adequate vascular access to undergo a leucapheresis.
What rules you out
- Known active central nervous system (CNS) metastases. people with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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 people will be considered to be of...
- 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...
- 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...
- 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. (people 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
The study team makes the final eligibility decision.
Where it's taking place
- Jette, Brabant, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jette, Brabant, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.