Evaluation of UCPVax Plus Nivolumab as Second Line Therapy in Advanced Non Small Cell Lung Cancer (Optim-UCPVax)
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|ClinicalTrials.gov Identifier: NCT04263051|
Recruitment Status : Recruiting
First Posted : February 10, 2020
Last Update Posted : November 23, 2020
Lung cancer is the most commonly diagnosed malignancy and the leading cause of cancer-related mortality both in men and women worldwide.
The past few years have demonstrated great progress in the field of tumor immunotherapy through agents that address mechanisms of immune escape notably, so called immune checkpoint inhibitors (ICB). Indeed, ICB have emerged as a fatal weapon in the anticancer treatment arsenal. Anti-PD-1 and anti-PD-L1 antibodies have shown promising results in several cancers including Non-small Cell Lung Cancer (NSCLC) patients. Although such ICB extend patient's survival compared with conventional systemic therapies, they fail to control cancer progression in a significant proportion of patients which can reach up to 50-60% in NSCLC. Recent literature highlights a range of factors involved in the heterogeneous responses and failures to ICB therapies. The challenge is how can ICB treatment efficacy be extended to majority patients? To respond to this question, to increase the success of immunotherapy, immuno-oncology community develops combinations approaches.
The aim of these project is to evaluate the efficacy of Nivolumab plus a novel CD4Th1 inducer anti-cancer vaccine in NSCLC patients.
Nivolumab (NIVO), which is an anti-PD-1 antibody, has shown promising results in 2nd line treatment for advanced NSCLC.
UCPVax is a therapeutic anti-cancer vaccine based on the telomerase-derived helper peptides designed to induce strong TH1 CD4 T cell responses in cancer patients (NCT02818426).
|Condition or disease||Intervention/treatment||Phase|
|Advanced Non-small Cell Lung Cancer||Drug: UCPVax + Nivolumab Drug: standard chemotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||111 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of UCPVax Plus Nivolumab as Second Line Therapy in Advanced Non Small Cell Lung : a Randomized Non Comparative Phase II Trial|
|Actual Study Start Date :||September 9, 2020|
|Estimated Primary Completion Date :||September 30, 2025|
|Estimated Study Completion Date :||September 30, 2025|
Experimental: UCPVax + Nivolumab
UCPVax vaccine (1 mg)
Nivolumab (480 mg)
Drug: UCPVax + Nivolumab
UCPVax will be administrated at day 1 of week 1 ; 2 ; 3 ; 5 ; 6 ; 7 and then week 13 and every 2 months until months 12.
Nivolumab will be administrated at the dose of 480 mg at day 1 and then every 4 weeks until disease progression or unacceptable toxicity according to label.
At the end of COMBO phase, nivolumab will be continued every 4 weeks for additional 12 months until disease progression or unacceptable toxicity according to standard of care.
Standard second line chemotherapy
Standard second line chemotherapy at the choice of the investigator.
This arm will permit to assess the good calibration of the hypothesis on the experimental arm.
Drug: standard chemotherapy
Second line chemotherapy at the choice of the investigator
- 6 months Progression-Free Survival (PFS) rate [ Time Frame: 6 months after the date of initiation of treatment (1st day of 1st cycle of chemotherapy) ]PFS is defined by the duration from the date of initiation of the treatment to the disease progression (RECIST) or death from any cause whichever occurs first, censoring cases without progression at the date of last disease assessment.
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): NCT04263051
|Contact: Olivier ADOTEVI, Prfirstname.lastname@example.org|
|Contact: Guillaume EBERST, Dremail@example.com|
|CHU of Besançon||Recruiting|
|Besançon, France, 250000|
|Contact: Guillaume EBERST, Dr +33381668166 firstname.lastname@example.org|
|Principal Investigator: Guillaume EBERST, Dr|
|Contact: Charlotte DOMBLIDES, Dr|
|Centre Georges François Leclerc||Recruiting|
|Contact: Courèche KADERBHAI, Dr|
|Institut de Cancérologie Privé CCGM||Recruiting|
|Contact: Catherine BECHT, Dr|
|Contact: Didier DEBIEUVRE, Dr|
|Institut Jean Godinot||Not yet recruiting|
|Contact: Alain PREVOST, Dr|
|Institut de Cancérologie de l'Ouest||Not yet recruiting|
|Contact: Ludovic DOUCET, Dr|