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UV1 vaccine+ leukine

Phase 2

Cancer | Monoclonal antibody | Oncology |Bristol-Myers Squibb Company|Last Updated: Feb 29, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment118

FDA Designations

No designations recorded

Clinical trial landscape

UV1 vaccine+ leukine · 1 trial · 7 indications

Phase 2 1
NCT04300244Nivolumab and Ipilimumab +/- UV1 Vaccination as Second Line Treatment in Patients With Malignant MesotheliomaCancer
ACTIVE NOT_RECRUITING118 Analytics
PHASE2ACTIVE NOT_RECRUITING
Nivolumab and Ipilimumab +/- UV1 Vaccination as Second Line Treatment in Patients With Malignant Mesothelioma
CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Evaluation of efficacy of ipilimumab and nivolumab With or without UV1 vaccine in patients With inoperable malignant pleural mesothelioma progressing after first-line platinum-based chemotherapy.
Monitoring for change in imaging evalated tumor lesions indicating progression throughout the trial until 5 years of follow-up has past.

Progression-free survival (PFS) per Modified Response Evaluation Criteria in Solid Tumors (RECIST) as determined by blinded independent central review (BICR) assessed by radiologic assessments

Secondary Endpoints

Response evaluation
Throughout the trial. Radiological assessments every 6th week during the first year, every 12th week for the next 5 years.
Evaluation of patient reported outcomes (PRO)
every other week for the first 12 weeks, every 6th week thereafter
Evaluation of Adverse Events and discontinuation rate of patients
Continuously, and until 90 days after discontinuation of study treatment.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm AEXPERIMENTALIpilimumab and nivolumab + UV1
Arm BACTIVE_COMPARATORIpilimumab and nivolumab

Interventions

NameTypeDescription
UV1 vaccine + leukineBIOLOGICALThe mode of action of UV1 is to activate the immune system to induce T cells directed against telomerase (hTERT). UV1 vaccination amplifies the pool of hTERT specific tumor-reactive T cells from the naive repertoire and has the potential to increase the breadth and diversity of the tumor-reactive T cell response (epitope spreading). Vaccination with UV1 can thus provide the basis for increased efficacy of checkpoint inhibition therapy, by augmenting the pool of tumor specific T cells in patients with limited or insufficient numbers of T cell clones spontaneously primed by tumor antigens. Reciprocally, the efficacy of UV1 vaccination may be enhanced in combination with checkpoint inhibitors, since the clonal expansion and effector activity of UV1 induced T cells will otherwise be restricted by intrinsic immune regulatory and tumor induced suppressor mechanisms.
ipilimumabBIOLOGICALThe responses to ipilimumab and nivolumab combination therapy seen in MPM is encouraging.
nivolumabBIOLOGICALThe responses to ipilimumab and nivolumab combination therapy seen in MPM is encouraging.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Histologically and/or cytologically confirmed malignant pleural mesothelioma. * Unresectable disease * Measurable disease, defined as at least 1 lesion (measurable) that can be accurately assessed at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) and ...

Countries:AustraliaDenmarkNorwaySpainSweden
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Frequently asked questions about UV1 vaccine+ leukine

What is UV1 vaccine + leukine used for?

UV1 vaccine + leukine is an investigational cancer treatment being studied in oncology. It is currently in Phase 2 clinical development for cancer, specifically being evaluated in patients with malignant mesothelioma. The drug is being tested as a combination therapy with other agents in a clinical trial setting.

Who makes UV1 vaccine + leukine?

UV1 vaccine + leukine is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company is conducting clinical trials to evaluate this investigational cancer treatment in patients with malignant mesothelioma.

What phase is UV1 vaccine + leukine in?

UV1 vaccine + leukine is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The ongoing Phase 2 trial is active but not recruiting participants.

What clinical trials is UV1 vaccine + leukine in?

UV1 vaccine + leukine is being studied in one active Phase 2 clinical trial with the identifier NCT04300244. This trial is evaluating nivolumab and ipilimumab with or without UV1 vaccination as second line treatment in patients with malignant mesothelioma. The trial has enrolled 118 participants across Australia, Denmark, Norway, Spain, and Sweden.

Is UV1 vaccine + leukine the same as UV1 vaccine + leukine?

Yes, UV1 vaccine + leukine is also known as UV1 vaccine + leukine. These names refer to the same investigational cancer treatment being developed by Bristol-Myers Squibb Company for the treatment of malignant mesothelioma.