Safety of UV1 Vaccination in Combination With Ipilimumab in Patients With Unresectable or Metastatic Malignant Melanoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02275416|
Recruitment Status : Active, not recruiting
First Posted : October 27, 2014
Last Update Posted : April 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Malignant Melanoma||Drug: Ipilimumab Biological: UV1 vaccine Biological: GM-CSF||Phase 1 Phase 2|
This is a phase I/IIa, national, open label, single arm, interventional study examining safety and tolerability for the ipilimumab/UV1 combination in patients with unresectable or metastatic malignant melanoma. Patients that have signed the informed consent form will be asked to take part in the study. All patients will receive ipilimumab together with the UV1 vaccine and rranulocyte-macrophage colony-stimulating factor (GM-CSF). Ipilimumab will be given every 3rd week for a total of 4 doses. The UV1 vaccine and GM-CSF will be given before and between treatments of ipilimumab. The maximum number of UV1/GM-CSF will be 10 doses.
Immunoresponders maybe followed up every third months for 5 years after the first UV1 treatment. Follow-up is onging.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety of UV1 Vaccination in Combination With Ipilimumab in Patients With Unresectable or Metastatic Malignant Melanoma|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2019|
Experimental: Ipilimumab & UV1 vaccine & GM-CSF
Ipilimumab (3 mg/kg) every 3rd week for a total of 4 doses. GM-CSF (75 μg) followed by UV1 vaccine (300 μg) will be injected intradermally in the lower abdomen before and between treatments of ipilimumab and thereafter every 4th week up to 28 weeks, and thereafter at week 36 and 48.
Other Name: YervoyBiological: UV1 vaccine
Other Name: UV1Biological: GM-CSF
Other Name: Leukine
- Safety and tolerability profile. Frequency/ severity of adverse and serious adverse events. Biochemistry and hematology results, vital signs and ECOG [ Time Frame: Up to 53 weeks ]Frequency and severity of adverse events and serious adverse events. Biochemistry and hematology results, vital signs and ECOG performance status will be assessed.
- Immunological response. Number of T-cell responses including time to T-cell response, level of response and duration of response. [ Time Frame: Up to 53 weeks ]Number of T-cell responses including time to T-cell response, level of response and duration of response.
- Treatment response. Tumour response evaluated by CT scan every 12th week. [ Time Frame: Up to 48 weeks ]Tumour response evaluated by CT scan every 12th week.
- Health Related Quality of Life (HRQL) [ Time Frame: Up to 53 weeks ]HRQL measured by use of patient questionnaire EORTC QLQ-C30
- Explore potential biomarkers for efficacy and safety of the ipilimumab/UV1 combination [ Time Frame: Up to 48 weeks ]Exploratory biomarker analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02275416
|Oslo University Hospital, Radiumhospitalet|
|Oslo, Norway, 0379|
|Principal Investigator:||Tormod Guren, MD PhD||Oslo University Hospital|