SAKK 11/16 – Personalized and cell-based anticancer vaccination with MVX-ONCO-1 in advanced squamous cell carcinomas of the head and neck region. An open-label, multicenter phase II study

Switzerland (ICTRP)

ID di studio ICTRP
NCT02999646 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
non disponibile

Titolo accademico
Personalized and Cell-based Antitumor Immunization MVX-ONCO-1 in Advanced Head and Neck Squamous Cell Carcinoma. A Single Arm, Open Label, Multicenter Phase II Trial. (ICTRP)

Titolo pubblico
Personalized and Cell-based Antitumor Immunization MVX-ONCO-1 in Advanced HNSCC (ICTRP)

Malattie studiate
Head and Neck Squamous Cell Carcinoma (ICTRP)

Intervento studiato
Other: MVX-ONCO-1 (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Criteri di inclusione/esclusione
Gender: All
Maximum age: N/A
Minimum age: 18 Years

Inclusion Criteria for pre-registration:

- Written informed consent according to ICH/GCP regulations before pre-registration

- Histologically confirmed diagnosis of head and neck squamous carcinoma (oral cavity,
pharynx, larynx), Stage III/IV in recurrent or metastatic stage. Patients with local
relapse for whom a curative treatment is available cannot be enrolled. Furthermore,
all patients should have no other therapeutic option left.

- At least one line of prior anticancer therapy for recurrent or metastatic disease.
Patients with locally advanced disease experiencing local relapse within 6 months of
last dose of curative intended, platinum-based chemo-radiation with or without prior
surgery can also be included.

- Primary tumor and/or metastasis amenable for partial/total surgery or tap

- Measurable or evaluable disease according to RECIST 1.1 criteria

- Patients age = 18 years

- WHO performance status 0-2

- Adequate hematological values: neutrophils =1x10^9/L, platelets =70x10^9/L

- Adequate hepatic function: bilirubin =2 x ULN; AST and ALT and AP =2.5 x ULN (except
for patients with liver metastasis: =5 x ULN)

- Adequate renal function (creatinine clearance >40mL/min/1.73m^2, calculated according
to the corrected formula of Cockcroft-Gault

- Women with child-bearing potential are using effective contraception, are not pregnant
and agree not to become pregnant after pre-registration, during trial treatment and
during the 6 months thereafter. A negative blood pregnancy test before inclusion into
the trial is required for all women with child-bearing potential

- Men agree not to father a child during trial treatment and during 6 months thereafter

Exclusion Criteria for pre-registration:

- Known or suspected CNS metastases or active leptomeningeal disease

- History of hematologic or primary solid tumor malignancy, unless in remission for at
least 3 years from registration with the exception of T1-2 prostate cancer Gleason
score <6 (PSA<10 ng/mL), adequately treated cervical carcinoma in situ or localized
non-melanoma skin cancer

- Participated in any other investigational study or received an experimental
therapeutic procedure considered to interfere with the study in the 4 preceding weeks
of the pre-registration

- Concomitant use of other anti-cancer drugs

- Planned radiotherapy (other than symptom control)

- Severe or uncontrolled cardiovascular disease uncontrolled hypertension (sustained
systolic blood pressure > 150 mm Hg and/or diastolic > 100 mm Hg despite
antihypertensive therapy)

- History of cerebrovascular accident or intracranial hemorrhage within 6 months prior
to pre-registration

- Any history of HIV

- Known history of HTLV-1, HTLV-2, or active chronic Hepatitis C or Hepatitis B Virus
infection or any uncontrolled active systemic infection requiring intravenous (iv)
antimicrobial treatment

- Known severe allergy to reagents in the study product (MVX-ONCO-1)

- Systemic disease other than cancer that is not controlled by approved medication

- Patient with active autoimmune disease

- Chronic immunosuppressive treatment exceeding 20 mg/day of prednisone or an equivalent
corticosteroid. Note: In acute situations prednison exceeding 20mg/day or
equivalent(day is allowed during 7 days)

- Women who are pregnant or breast feeding

- Any other serious underlying medical, psychiatric, psychological, familial or
geographical condition, which in the judgment of the investigator may interfere with
the planned staging, treatment and follow-up, affect patient compliance or place the
patient at high risk from treatment-related complications

Inclusion criteria for registration:

- Primary tumor and/or metastasis amenable for partial/total surgery or tap and
subsequent cell harvest > 26x10^6 cells

- Measurable or evaluable disease according to RECIST 1.1 criteria

- WHO performance status 0-2

- Baseline QoL forms have been completed

- Adequate hematological values: neutrophils =1x10^9/L, platelets =70x10^9/L

- Adequate hepatic function: bilirubin =2 x ULN; AST and ALT and AP = 2.5 x ULN (except
for patients with liver metastasis: =5 x ULN)

- Adequate renal function (creatinine clearance >40 mL/min/1.73m^2, calculated according
to the corrected formula of Cockcroft-Gault

- Women with child-bearing potential are using effective contraception, are not pregnant
or lactating and agree not to become pregnant after registration, during trial
treatment, and during the 6 months thereafter. A negative blood pregnancy

Exclusion criteria for registration:

- Known or suspected CNS metastases or active leptomeningeal disease

- Concomitant use of other anti-cancer drugs

- Planned radiotherapy (other than symptom control)

- Any one full cycle of anti-cancer chemotherapy treatment in the 3 preceding weeks of
the registration

- Systemic disease other than cancer, that is not controlled by approved medication

- Chronic immunosuppressive treatment exceeding 20 mg/day of prednisone or an equivalent
corticosteroid. Note: In acute situations prednisone exceeding 20 mg/day or equivalent
is allowed during 7 days

- Any other serious underlying medical, psychiatric, psychological, familial or
geographical condition, which in the judgment of the investigator may interfere with
the planned staging, treatment and follow-up, affect patient compliance or place the
patient at high risk from treatment-related complications

- Women who are pregnant or breastfeeding
(ICTRP)

non disponibile

Endpoint primari e secondari
Overall Survival at 26 weeks (OS) (ICTRP)

Time to subsequent therapy (TST);Duration of response (DOR);Objective response rate (ORR);Disease control rate (DCR);Best overall response;Objective response according to iRECIST (iOR);Progression Free Survival (PFS);Progression-free survival according to iRECIST (iPFS);PFS at 6, 13, 26, 39, and 52 weeks;OS;PFS under the first subsequent treatment;Adverse and serious adverse events (ICTRP)

Data di registrazione
19.12.2016 (ICTRP)

Inclusione del primo partecipante
non disponibile

Sponsor secondari
European Commission (ICTRP)

Contatti aggiuntivi
Olivier Michielin, Prof, CHUV Lausanne (ICTRP)

ID secondari
SAKK 11/16 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT02999646 (ICTRP)