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Prostate CancerPhase 1NCT03412786

Bcl-XL_42-CAF09b Vaccination for Patients With Prostate Cancer With Lymph Node Metastases

A Phase 1 study testing Bcl-Xl_42-CAF09b vaccine in people with Prostate Cancer, run by Herlev Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this Phase I study, patients with hormone-sensitive Prostate Cancer (PC) and lymph node metastases are treated with the cancer vaccine Bcl-xl_42-CAF09b. The aim of the study is to clarify the safety and toxicity of the vaccine and also the immunological effect. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Bcl-Xl_42-CAF09b vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteDenmark
Study dates
1 May 2018to 8 Dec 2021
Phase
Phase 1
Are there results?
None posted in the registry

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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Histologically Verified Adenocarcinoma Prostatae
  • Diagnostic and / or histologically verified lymph node metastases
  • ECOG Performance Status ≤2
  • Primary anti-androgen treatment started
  • Adequate haematological, renal and hepatic function:
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  • Neutrophil granulocytes ≥ 1.5 x 109 / l
  • Platelet counts ≥ 100 x 109 / l
  • hemoglobin ≥ 5.6 mmol / l
  • Serum creatinine ≤ 1.5 times upper normal limit
  • AST or ALAT ≤ 2.5 times upper normal limit
  • serum bilirubin ≤ 1.5 times upper normal limit
  • Alkaline phosphatase ≤ 2.5 times upper normal limit
  • INR <1.5 / PP <40

Who cannot join

  • Verified bone or visceral metastases
  • Serious allergy or previous anaphylactic reactions
  • Known hypersensitivity to any of the active substances or to any of the excipients.
  • Other malignant disease within the last three years, rendering planocellular and basocellular skin carcinoma
  • Known infection with HIV, hepatitis B and C virus, regardless of whether the infection is kept calm with medical treatment
  • Severe medical disorder, severe asthma, severe COPD, poorly regulated cardiovascular disease or diabetes
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  • Active autoimmune disease, e.g. autoimmune neutropenia / thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, scleroderma, myasthenia gravis, goodpasture syndrome, Addison's disease, Hashimoto's thyroiditis, active grave disease, morbus chrohn or ulcerative colitis
  • Major gastrointestinal surgical procedures within the last 3 months
  • Previous treatment with other cancer vaccine
  • Concomitant immunosuppressive treatment including prednisolone and methotrexate
  • Ongoing anticoagulant treatment (treatment with acetylsalicylic acid and clopidogrel is allowed)
  • Psychiatric disease which, according to the investigator's discretion, may affect compliance
  • Co-administration with other experimental drugs.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Herlev Hospital

    Herlev, 2730

Other trials in Denmark

About this study

Official title: A Phase I Study of the Bcl-XL_42-CAF09b Vaccine to Test Safety and Immunological Effect in Patients With Prostate Cancer With Lymph Node Metastases

In this Phase I study, patients with hormone-sensitive Prostate Cancer (PC) and lymph node metastases are treated with the cancer vaccine Bcl-xl_42-CAF09b. The aim of the study is to clarify the safety and toxicity of the vaccine and also the immunological effect.

The vaccine Bcl-xl_42-CAF09b is composed of the peptide Bcl-xl_42 and the adjuvant CAF09b. The B-cell lymphoma extra large protein (Bcl-xl) protein plays a vital role in the cancer cell's ability to avoid programmed cell death (apoptosis) and is upregulated in a variety of cancerous diseases. Bcl-xl_42 is a peptide fragment of the full protein and preclinical studies have shown that vaccination with this peptide (Bcl-xl) can activate the immune system and thereby lead to the death of cancer cells. In order to improve the activation of the immune system, adjuvant CAF09b is added; Preclinical studies have shown that special intraperitoneal (IP) injections of CAF09b improve the activation of the immune system.

Read the detailed description

Background:

In this Phase I study, patients with hormone-sensitive Prostate Cancer (PC) and lymph node metastases are treated with the cancer vaccine Bcl-xl_42-CAF09b. The aim of the study is to clarify the safety and toxicity of the vaccine and also the immunological effect.

Patients included should be on Bicalutamid treatment upon inclusion. The vaccine Bcl-xl_42-CAF09b is composed of the peptide Bcl-xl_42 and the adjuvant CAF09b. The B-cell lymphoma extra large protein (Bcl-xl) protein plays a vital role in the cancer cell's ability to avoid programmed cell death (apoptosis) and is upregulated in a variety of cancerous diseases. Bcl-xl_42 is a peptide fragment of the full protein and preclinical studies have shown that vaccination with this peptide (Bcl-xl) can activate the immune system and thereby lead to the death of cancer cells.

In order to improve the activation of the immune system, adjuvant CAF09b is added; Preclinical studies have shown that special intraperitoneal (IP) injections of CAF09b improve the activation of the immune system.

The CAF09 adjuvant has been developed by Statens Serum Institut (SSI). It is a three-component adjuvant system, composed of cationic liposomes (DDA-MMG1) with complex bound synthetic double-stranded RNA (Poly(I:C)2). The adjuvant was developed as a means to induce cytotoxic CD8+ T-cell responses against vaccine antigens and intended for use in vaccines against disease targets such as cancers, human immunodeficiency virus or Hepatitis C virus. The Poly(I:C) component has previously been in clinical studies as a cancer treatment. Poly(I:C) is known for its pyrogenic activity but upon formulation in the cationic liposome system, CAF09, the pyrogenic effect is significantly reduced.

Methods:

20 patients will be included in this phase I trial. 10 patients will be included in arm A and 10 patients in arm B. Arm a will recieve 3 vaccines every second week IM and thereafter 3 vaccines every second week IP. Arm B will first receive 3 vaccines every second week IP and thereafter every second week IM. All 20 patients will recieve 6 vaccines all in all. This is not randomized - the first 10 patients included will be in arm A and the last 10 patients included will be in arm B.

Patients will be followed with clinical controls every second week.

Conditions
Prostate Cancer
Being tested
Bcl-Xl_42-CAF09b vaccine
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Bcl-Xl_42-CAF09b vaccineBiological

    The vaccine consists of 0.05 mg peptide (bcl-xl_42) and 625 μg DDA, 125 μg MMG og 31 μg Poly I:C (CAF09b) mixed in a 0.5 ml emulsion

Study groups in NCT03412786
Study groupRoleWhat they receive
Arm A: IM followed by IPExperimentalWill be administered first 3 vaccines biweekly IM and thereafter 3 vaccines biweekly IP.
Receives: Biological: Bcl-Xl_42-CAF09b vaccine
Arm B: IP followed by IMExperimentalWill be administered first 3 vaccines biweekly IP and thereafter 3 vaccines biweekly IM.
Receives: Biological: Bcl-Xl_42-CAF09b vaccine

What is being measured

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

  1. Number and type of reported adverse events

    Determine the safety of the Bcl-XL_42-CAF09b vaccine for patients with prostate cancer with lymph node involvement who are on Bicalutamid treatment by reporting adverse events according to CTCAE v. 4.0

    Measured: 0-30 weeks

Secondary outcomes (1)

  1. Treatment related immune responses

    To evaluate the immunological impact of the treatment in both arm A and arm B. Elispot and tetramer staining methods will be Applied to identify Bcl-XL_42 peptide specific T cells in the blood over time

    Measured: Up to 24 months

Timeline

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

  1. First posted26 Jan 2018
  2. Study start1 May 2018
  3. Primary completion8 Dec 2021
  4. Study completion8 Dec 2021

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03412786
Sponsor's protocol ID
UR1534
Status last verified
Jan 2022
First submitted
2 Jan 2018
Last updated
11 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mork SK, Kongsted P, Westergaard MCW, Albieri B, Granhoj JS, Donia M, Martinenaite E, Holmstrom MO, Madsen K, Kverneland AH, Kjeldsen JW, Holmstroem RB, Lorentzen CL, Norgaard N, Andreasen LV, Wood GK, Christensen D, Klausen MS, Hadrup SR, Thor Straten P, Andersen MH, Svane IM. First in man study: Bcl-Xl_42-CAF(R)09b vaccines in patients with locally advanced prostate cancer. Front Immunol. 2023 Mar 14;14:1122977. doi: 10.3389/fimmu.2023.1122977. eCollection 2023.

    PubMed 36999039

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bcl-Xl_42-CAF09b vaccine in people with Prostate Cancer, run by Herlev Hospital at 1 site in Denmark.

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 14 inclusion and 13 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: finished, as of the sponsor's last update on 11 Jan 2022. 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 Denmark. 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 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.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number and type of reported adverse events (time frame: 0-30 weeks). 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 NCT03412786, 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 11 Jan 2022.

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