Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of UCPVax Plus Nivolumab as Second Line Therapy in Advanced Non Small Cell Lung Cancer (Optim-UCPVax)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04263051
Recruitment Status : Recruiting
First Posted : February 10, 2020
Last Update Posted : June 8, 2021
Sponsor:
Collaborators:
Bristol-Myers Squibb
Fondation ARC
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Brief Summary:

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: UCPVax + Nivolumab

UCPVax vaccine (0,5 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 maximum 24 months from the first administration, 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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Age ≥ 18 years
  • Histologically or cytologically confirmed advanced NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma, undifferentiated carcinoma or other)
  • Advanced NSCLC cancer patient with progressive disease after a first line of combo chemotherapy plus anti-PD-1 or chemotherapy plus anti-PD-L1 combination
  • Measurable disease defined according to iRECIST v1.1 guidelines
  • Patients must have a mandatory treatment-free interval of at least 21 days following previous systemic anti-cancer treatments
  • Patients who have received previous systemic anticancer treatment and/or radiotherapy should have recovered from any treatment related toxicity, to a level of ≤ grade 1 with the exception of Grade 2 alopecia
  • Performance status 0 or 1 on the ECOG scale
  • Females must be using highly effective contraceptive measures and have a negative pregnancy test prior to the start of dosing if of childbearing potential, or must have evidence of non-childbearing potential. Females of childbearing potential should use reliable methods of contraception from the time of the screening until 5 months after discontinuing study treatment. Male patients with a female partner of childbearing potential should be willing to use barrier contraception during the study and for 7 months following discontinuation of study drug. Patients should refrain from donating sperm from the start of dosing until 7 months after discontinuing study treatment.
  • Registration in a national health care system.
  • Ability to comply with the study protocol, in the Investigator's judgment

Exclusion Criteria:

  • Diagnosis of additional malignancy within 2 years prior to the inclusion with the exception of curatively treated basal cell carcinoma of the skin and/or curatively resected in situ cervical or breast cancer
  • Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study
  • Participation in a clinical study with an investigational product within 4 weeks prior to the start of the study treatment
  • Patient under guardianship, curatorship or under the protection of justice
  • Uncontrolled tumor-related pain
  • Uncontrolled pleural effusion, pericardial effusion, ascites or symptomatic fistula
  • Known active central nervous system metastases and/or carcinomatous meningitis
  • Uncontrolled brain metastases
  • Presence of EGFR mutation, ALK or ROS1 translocation
  • history of hyperprogression during first line treatment with chemotherapy plus immunotherapy
  • Inadequate organ functions: known cardiac failure of unstable coronaropathy, respiratory failure, or uncontrolled infection or another life-risk condition
  • Active or chronic hepatitis B or C and/or HIV positive or known history of active Covid-19 infection, or a known history of active Tuberculosis bacillus
  • Any immunosuppressive therapy (i.e. corticosteroids >10mg of hydrocortisone or equivalent dose) within 14 days before the planned start of study therapy
  • Active autoimmune disease that has required a systemic treatment in past 2 years (i.e. corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin) is allowed
  • Active or history of autoimmune disease or immune deficiency
  • Prior allogeneic bone marrow transplantation or prior solid organ transplantation
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • Known hypersensitivity or allergy to Chinese hamster ovary cell products or any component of Nivolumab formulation
  • History of idiopathic or secondary pulmonary fibrosis or evidence of active pneumonitis requiring a systemic treatment with 28 days before the planned start of study therapy
  • Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the course of the study
  • Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
  • Treatment with therapeutic oral or IV antibiotics within 4 weeks prior to initiation of study treatment
  • Receipt of a live, attenuated vaccine within 4 weeks prior to the initiation of treatment or anticipation that such a live, attenuated vaccine will be required during the study
  • Patients requiring oxygen therapy
  • For patients with a known cardiac history or with cardiac events occurring after first-line chemoimmunotherapy: LEVF<40% ; troponin > ULN; BNP > ULN
  • Inadequate hematology, hepatic, renal functions or others inadequate laboratory values

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Olivier ADOTEVI, Pr +33381668166 olivier.adotevi@univ-fcomte.fr
Contact: Guillaume EBERST, Dr +33381668166 geberst@chu-besancon.fr

Locations
Layout table for location information
France
CHU of Besançon Recruiting
Besançon, France, 250000
Contact: Guillaume EBERST, Dr    +33381668166    geberst@chu-besancon.fr   
Principal Investigator: Guillaume EBERST, Dr         
CHU Bordeaux Recruiting
Bordeaux, France
Contact: Charlotte DOMBLIDES, Dr         
Centre Georges François Leclerc Recruiting
Dijon, France
Contact: Courèche KADERBHAI, Dr         
Institut de Cancérologie Privé CCGM Recruiting
Montpellier, France
Contact: Catherine BECHT, Dr         
CH Mulhouse Recruiting
Mulhouse, France
Contact: Didier DEBIEUVRE, Dr         
Institut Jean Godinot Recruiting
Reims, France
Contact: Alain PREVOST, Dr         
Institut de Cancérologie de l'Ouest Recruiting
Saint-Herblain, France
Contact: Ludovic DOUCET, Dr         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Bristol-Myers Squibb
Fondation ARC
Publications:
Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT04263051    
Other Study ID Numbers: P/2019/451
CA209-7CM ( Other Identifier: Bristol-Myers Squibb )
First Posted: February 10, 2020    Key Record Dates
Last Update Posted: June 8, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action