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Immunological aspects of combined chemotherapy and immunotherapy with HPV16 E6/E7 Synthetic Long Peptide vaccination in patients with advanced cervical cancer.

Immunological aspects of combined chemotherapy and immunotherapy with HPV16 E6/E7 Synthetic Long Peptide vaccination in patients with advanced cervical cancer. - Immunological aspects of combined chemo-immunotherapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON36470
Enrollment
18
Registered
2010-06-01
Start date
2011-01-24
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer of the cervix cervical cancer

Interventions

In the second part of the study, patient will be vaccinated after completion of the 2nd cycle of chemotherapy. Further chemotherapeutic treatment will continue according to the oncology protocol.

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients should be at least 18 years of age; - Patients should be able and willing to provide informed consent; - Patients with a diagnosis of histologically confirmed cervical cancer that is clinically and/or radiologically proven advanced, recurrent or metastatic for whom no curative treatment (surgery or radiotherapy) options are available; - Patients scheduled for standard chemotherapy with Carboplatin / Paclitaxel;

Exclusion criteria

Exclusion criteria: For all patients (first and second cohort) the following exclusion criteria apply: - Any condition that in the opinion of the treating physician(s) is likely to jeopardise the well-being of health status of the patient; - Another active malignancy - Positive test result for HIV

Design outcomes

Primary

MeasureTime frame
• The time related immune response during and after standard chemotherapy in patients with advanced, recurrent or metastatic cervical cancer; • The time and treatment related response to an HPV16 Synthetic Long Peptide (SLP) immunization in cervical cancer patients, after completion of the standard chemotherapy.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)