Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Carcinoma, Squamous Cell

Uterine Cervical Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Head and Neck Neoplasms

All Drugs and Chemicals

Antineoplastic Agents

Anticoagulants

Vaccines

Immunomodulating Agents

Atezolizumab

Edetic Acid

Pentetic Acid

Monatide (IMS 3015)

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Induction phase:

* Atezolizumab 1200 mg intravenous (IV) every 3 weeks since day 1
* UCPVax (combined with Montanide ISA51 as adjuvant) at 1 mg subcutaneously in two separate sites (one site per peptide) at day 1, 8, 15, 29, 36 and 43 (induction phase).

Boost phase:

* UCPVax boosts vaccine every 6 weeks for the 2 first boosts (boost 1 and boost 2) and then every 9 weeks (boost 3 to boost 5)
* Atezolizumab 1200 mg IV every 3 weeks until disease progression or unacceptable toxicity until disease progression or unacceptable toxicity.

Four blood samples will be collected at:

* baseline
* 2 months from inclusion (+/- 1 week)
* 4 months from inclusion (+/- 1 week)
* the end of vaccination visit (+/- 1 week).

A total of 8 EDTA (ethylenediaminetetraacetic acid) tubes of 6 ml will be collected at each time point to perform:

PBMC collection: 6 EDTA tubes of 6 ml of peripheral blood mononuclear cell \[PBMC\] will be sent to the central laboratory (Biomonitoring Platform of Besançon, CHRU de Besançon located at Etablissement Français du Sang) at room temperature within 24 hours via an approved carrier for their processing, storage and immunomonitoring analysis. A sending sheet of the samples will be attached to each single sample.

Plasma collection: One 6 ml EDTA tube should be frozen in each investigation center for plasma collection.

Plasma for circulating tumoral DNA (ctDNA) collection: One 6 ml EDTA tube should be frozen in each investigation center for ctDNA collection.

Blood sample collection

A tumor biopsy will be realized and centralized at baseline and at 2 months. Collection of tumor biopsies will be guided by ultrasound or CT scan

Tumor biopsies

A CT scan will be planned

* at baseline
* at tumor evaluation visit (8 weeks)
* every 8 weeks (+/- 1 week)
* at end of treatment visit.

CT scan

Induction phase: Atezolizumab 1200 mg intravenous every 3 weeks since day 1

Boost phase: Atezolizumab 1200 mg intravenous every 3 weeks until disease progression or unacceptable toxicity until disease progression or unacceptable toxicity.

Induction phase: UCPVax (combined with Montanide ISA51 as adjuvant) at 1 mg subcutaneously in two separate sites (one site per peptide) at day 1, 8, 15, 29, 36 and 43 (induction phase).

Boost phase: UCPVax boosts vaccine every 6 weeks for the 2 first boosts (boost 1 and boost 2) and then every 9 weeks (boost 3 to boost 5).

UCPVax

Christophe BORG, Pr

70% all cases of cervical cancer, 95% of anal cancers and about 70% of oropharyngeal cancers are linked to Human Papillomavirus (HPV) infection. HPV oncogenic proteins are trans-activators of telomerase. Indeed, E6 oncoprotein transactivates the human telomerase (hTert). Our group has conducted a clinical trial (NCT02402842) in advanced squamous cell anal cancer (SCCA) and investigators have shown a correlation between the presence of anti-HPV immunity and anti-telomerase T helpher 1 (TH1) CD4 T cell responses, establishing telomerase as an appropriate antigen in HPV-related cancers.

Tumor-reactive CD4+ T cells have been found to ensure efficient effector Cytotoxic T Lymphocytes (CTL) recruitment at the tumor site. Promoting tumor specific TH1 CD4 activation might be an attractive therapeutic option to enhance anti-PD-1/PD-L1 (Programmed cell Death-1/Programmed cell Death-Ligand1) efficacy. However, no option is currently available to expand tumor specific TH1 lymphocytes in most patients. Then, investigators have identified four novel MHC (Major Histocompatibility Complex) class II-restricted peptides derived from human telomerase reverse transcriptase (TERT) referred as "Universal Cancer Peptides" (UCP). UCPVax is a therapeutic cancer vaccine developed by our team and composed of two separate peptides called UCP2 and UCP4 derived from telomerase. This UCPVax vaccine is currently evaluated in a multicenter phase I/II study in Non Small Lung Cancer (NSCLC) (NCT2818426) and seems to show to be safe and immunogenic.

PD-1/PD-L1 immune checkpoint is a relevant candidate target for immunotherapy in HPV+ cancers, based on the prominent role of PD-1 and its ligand PD-L1 in HPV-driven immune-evasion. There is a strong rational of using PD-1 therapy in HPV+ cancers, however anti-PD-1/PD-L1 treatment induces a limited number of long term responses in HPV disease. Combining anti-PD-1/PD-L1 therapy with an antitumor vaccine gains serious consideration in HPV+ cancers. Indeed, anti-cancer vaccines can induce tumor-specific T cells expansion and activation and therefore restore the cancer-immunity cycle in patients lacking pre-existing anti-tumor responses.

So investigators propose to determine the clinical interest and immunological efficacy of a treatment combining the CD4 helper T-inducer cancer vaccine (UCPVax) with atezolizumab in patients with HPV+ cancers by evaluation of the objective response rate at 4 months according to iRecist criteria.

Combination of UCPVax Vaccine and Atezolizumab for the Treatment of Human Papillomavirus Positive Cancers (VolATIL)

A Phase II Study Evaluating the Interest to Combine UCPVax a CD4 TH1-inducer Cancer Vaccine and Atezolizumab for the Treatment of Human PapillomaVirus Positive Cancers

The main objective of this clinical trial is to assess the efficacy of a strategy combining UCPVax and atezolizumab treatment in patients with HPV+ cancer by evaluation of the objective response rate at 4 months according to iRecist.

Delay from the date of inclusion to death from any cause

Delay from the date of inclusion to the disease progression or death from any cause whichever occurs first

Health related quality of life will be assessed using EORTC (European Organisation for Research and Treatment of Cancer) questionnaire

Toxicities graded according to NCI-CTCAE criteria version 5

Roche Pharma AG

National Cancer Institute, France

Centre Hospitalier Universitaire de Besancon

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

UCPVax is a therapeutic cancer vaccine composed of two peptides called UCP2 and UCP4 derived from telomerase combined with Montanide ISA 51 VG as adjuvant.

The two peptides UCP2 and UCP4 will be emulsified in Montanide ISA 51 and injected subcutaneously in separate sites (one site per peptide), at days 1, 8, 15, 29, 36 and 43 (priming phase) following by boost vaccination every 8 weeks for 12 months.

UCPVAx is a therapeutic vaccine based on the telomerase-derived UCP designed to induce strong TH1 CD4 T cell responses in cancer patients.

Three doses of UCPVax (0,25 mg, 0,5 mg and 1 mg) will be tested in this phase I/II study by using Continuous Reassessment Method (CRML) dose escalation design model.

The phase I is a dose escalation study designed to evaluate safety of use of UCPVax and to estimate its Maximum Tolerated Dose (MTD).

The phase II is a dose deescalation designed to evaluate the immunogenicity of UCPVax according to the dose level.

UCPVax study is a prospective multicenter phase I/II study: 54 patients with metastatic NSCLC will be enrolled in 5 centers in France.

A translational research program will be performed to better define the eligibility criteria and predictive biomarkers needed for randomized phase II and Phase III trials.

Universal Cancer Peptide-based Vaccination in Metastatic NSCLC

Anticancer Therapeutic Vaccination Using Telomerase-derives Universal Cancer Peptides in Metastatic Non Small Cell Lung Cancer : A Phase I/II Study

The following adverse events graded according to CTCAE v 4.03 will be classified as DLTs :

* Hematologic:

  * Grade 4 neutropenia (ANC \<0.5 x 109/L) lasting \>5 days;
  * Febrile neutropenia (defined as neutropenia ≥Grade 3 \[ANC \<1000 cells/mm3\] and a body temperature ≥38.5°C);
  * Grade ≥3 thrombocytopenia (\<50.0 - 25.0 x 109/L) with bleeding;
  * Grade 4 thrombocytopenia (\<25.0 x 109/L) \>5 days;
  * Grade 4 anemia (hemoglobin \<6.5 g/dL or 4.0 nmol/L);
* Non-hematologic:

  o Grade ≥3 toxicities, except for alopecia and those grade 3 events that respond to treatment (eg. grade 3 nausea, vomiting, diarrhea that responds to standard medical supportive care within 48 hours will not be considered a DLT).
* Immune system disorder:

  * Grade ≥2 allergic reaction (except for local reaction at the injection site : grade ≥ 3)
  * Grade ≥2 autoimmune disease (colitis, thyroidis...)
  * Grade ≥2 cytokine release syndrome (nausea, headache, tachycardia, hypotension, rash and shortness of breath)

Antigen-specific T cell responses measured using IFN-gamma ELISPOT.

Tumor response evaluated per RECIST v1.1.

delay from the date of inclusion to the disease progression (RECIST) or death from any cause whichever occurs first,

delay from the date of inclusion to death from any cause.

HrQoL will be assessed using EORTC QLQ-C30 and LC13 modules specific to lung cancer

Invectys

Rare Diseases

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neuroepithelioma

Temozolomide

Antineoplastic Agents, Alkylating

Alkylating Agents

UCPVax

+ Temozolomide according to standard of care

The UCPVax vaccination protocol will start at least one month after glioblastoma patients have completed the concomitant radiochemotherapy (Radiotherapy + Temozolomide RT/TMZ).

UCPVax vaccine will injected subcutaneously at days 1, 8, 15, 29, 36 and 43 (priming phase) following by boost vaccination one month after the last injection and then every 8 weeks for 12 months maximum.

6 additional monthly cures of Temozolomide (after concomitant radiotherapy and temozolomide) according to standard of care

Clotilde VERLUT, Dr

Glioblastoma (GBM) is the most frequent primary brain tumor and the brain tumor with the poorest prognosis. The current treatment relies on surgical resection of gross tumor followed by radiochemotherapy and adjuvant therapy with temozolomide.

After such therapy, most patients experiment recurrence and few therapeutic option are available. Despite such therapies, median survival only reaches around fifteen months.

There is a strong rational to develop telomerase vaccine in GBM. Telomerase (TERT) is a major oncogene, particularly in primary brain tumors 24. Alterations in TERT are very frequent in central nervous system tumors, seen most commonly in gliomas25. Mutations in the TERT promoter are found in approximately 80% of primary glioblastoma (GBM). These findings strongly support the rational to develop vaccine targeting telomerase in GBM.

The aim of this project is to evaluate UCPVax treatment in glioblastoma. 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).

Anticancer Therapeutic Vaccination Using Telomerase-derived Universal Cancer Peptides in Glioblastoma

Anti-TERT specific T cell responses measured in peripheral blood using IFN-gamma ELISPOT

Digestive System Diseases

Carcinoma, Hepatocellular

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Bevacizumab

Angiogenesis Inhibitors

Growth Inhibitors

1200 mg IV every 3 weeks until disease progression or unacceptable toxicity

15 mg/kg IV every 3 weeks until disease progression or unacceptable toxicity

UCPVax vaccine (combined with Montanide ISA51 as adjuvant) at 0.5 mg subcutaneously

Borg Christophe, Pr

Angélique VIENOT, Dr

Hélène REGNAULT, Dr

François GHIRINGHELLI, Pr

Serge FRATTE, Dr

Eric ASSENAT, Pr

Eric RAYMOND, Pr

Manon ALLAIRE, Dr

Mohamed BOUATTOUR, Dr

Emilie SOULARUE, Dr

Pascal HAMMEL, Dr

Olivier ROSMORDUC, Dr

The TERTIO trial will propose to determine the clinical interest and immunological efficacy of a treatment combining the CD4 helper T-inducer cancer anti-telomerase vaccine (UCPVax) with anti-PD-L1 therapy (atezolizumab) and bevacizumab in unresectable HCC by evaluation of the objective response rate at 6 months (randomized phase II, 10 centers, 105 patients)

Evaluation of the Interest to Combine a CD4 Th1-inducer Cancer Vaccine Derived From Telomerase and Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma

Evaluation of the Interest to Combine a CD4 Th1-inducer Cancer Vaccine Derived From Telomerase and Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma: a Proof of Concept Randomized Phase II Study (TERTIO - Prodige 82)

addition of complete response (CR) and partial response (PR) rates, evaluated by RECIST criteria v1.1

delay from the date of randomization to death from any cause.

delay from the date of randomization to the disease progression or death from any cause whichever occurs first

addition of complete response (CR), partial response (PR), and stable disease (SD) rates, evaluated by RECIST criteria v1.1 and imRECIST

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Combination of UCPVax Vaccine and Atezolizumab for the Treatment of Human Papillomavirus Positive Cancers (VolATIL)	NCT03946358	Squamous Cell C... Anal Canal Canc... Cervical Cancer	Blood sample co... Tumor biopsies CT scan Atezolizumab UCPVax	18 Years - 75 Years	Centre Hospitalier Universitaire de Besancon
Combination of UCPVax Vaccine and Atezolizumab for the Treatment of Human Papillomavirus Positive Cancers (VolATIL)	NCT03946358	Squamous Cell C... Anal Canal Canc... Cervical Cancer	Blood sample co... Tumor biopsies CT scan Atezolizumab UCPVax	18 Years - 75 Years	Centre Hospitalier Universitaire de Besancon
Universal Cancer Peptide-based Vaccination in Metastatic NSCLC	NCT02818426	Metastatic Non-...	UCPVax	18 Years - 89 Years	Centre Hospitalier Universitaire de Besancon
Anticancer Therapeutic Vaccination Using Telomerase-derived Universal Cancer Peptides in Glioblastoma	NCT04280848	Glioblastoma	UCPVax Temozolomide	18 Years - 75 Years	Centre Hospitalier Universitaire de Besancon
Evaluation of the Interest to Combine a CD4 Th1-inducer Cancer Vaccine Derived From Telomerase and Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma	NCT05528952	Hepatocellular ...	Atezolizumab Bevacizumab UCPVax	18 Years -	Centre Hospitalier Universitaire de Besancon

Spots Global Cancer Trial Database for ucpvax

Every month we try and update this database with for ucpvax cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ucpvax

Every month we try and update this database with for ucpvax cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ucpvax cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.