SAKK 11/16 – Personalisierte und zellbasierte antitumorale Impfung mit MVX-ONCO-1 bei fortgeschrittenen Plattenepithelkarzinomen des Kopf-Hals-Bereiches. Eine einarmige, offene, multizentrische Phase II Studie

Other: MVX-ONCO-1

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