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

NCT03412786 | Completed Phase 1 DMC

• 1 other identifier: UR1534
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (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

  0-30 weeks

Secondary Outcomes (1)

• Treatment related immune responses

  Up to 24 months

Study Arms (2)

Arm A: IM followed by IP

EXPERIMENTAL

Will be administered first 3 vaccines biweekly IM and thereafter 3 vaccines biweekly IP.

Biological: Bcl-Xl_42-CAF09b vaccine

Arm B: IP followed by IM

EXPERIMENTAL

Will be administered first 3 vaccines biweekly IP and thereafter 3 vaccines biweekly IM.

Biological: Bcl-Xl_42-CAF09b vaccine

Interventions

Bcl-Xl_42-CAF09b vaccine BIOLOGICAL

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

Arm A: IM followed by IP; Arm B: IP followed by IM

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (1)

Herlev Hospital

Herlev, 2730, Denmark

Location

Related Publications (1)

• 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.

  PMID: 36999039 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Inge Marie svane

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Not a randomized study. The first 10 patients included will be treated in arm A - the last 10 will be treated in arm B.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof., MD

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: January 26, 2018
• Study Start: May 1, 2018
• Primary Completion: December 8, 2021
• Study Completion: December 8, 2021
• Last Updated: January 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)