Personalized and Cell-based Antitumor Immunization MVX-ONCO-1 in Advanced HNSCC

NCT ID: NCT02999646

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-25
• Study Completion Date: 2023-06-29

Brief Summary

The purpose of this trial is to determine the efficacy of the immunotherapy with MVX-ONCO-1 in patients with advanced head and neck squamous cell carcinoma. MVX-ONCO-1 consists of dead tumor cells from the patient itself and genetically modified cells within a capsule. The whole treatment takes 9 weeks. At weeks 1, 2, 3, 4, 6 and 8, the tumor cells are injected underneath the skin and two capsules are implanted for a week. At weeks 2, 3, 4, 5, 7 and 9 the capsules are removed again. The patients are then followed-up for 5 years.

Detailed Description

Patients with advanced HNSCC after platinum-based palliative chemotherapy have a poor prognosis, with no well-defined standard treatment and a survival between 6 to 9 months.

MVX-ONCO-1 is a patient specific, cell-based, active immunotherapy, where the patient's immune response to tumor cells is stimulated and/or increased by triggering an immune response against the patients' cancer cells.

Rationale for this trial is:

1. HNSCC: there is a clear medical need in this patient population,

2. Relapsing HNSCC often have accessible tumor tissue,

3. HNSCC is considered an immunogenic tumor.

This phase II study is a first step towards a potentially innovative immunotherapy for HNSCC.

MVX-ONCO-1 is composed of:

1. An immune-modulator (GM-CSF: granulocyte-macrophage colony stimulating factor) released from an immuno-protected, encapsulated, allogeneic, genetically modified cell line (MVX-1), and

2. Irradiated, autologous tumor cells as source of antigen.

Each treatment consists of two macrocapsules containing the MVX-1 cell line implanted subcutaneously and lethally irradiated autologous tumor cells injected subcutaneously. Eligible patients will receive a treatment once weekly starting on week 1 for 4 weeks followed by two additional treatments 2 weeks apart (total 6 treatments over 8 weeks). Each pair of macrocapsules is removed after 1 week, and the last implanted capsules are removed in week 9. The patients are then followed-up for 5 years.

The project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 880194.

Conditions

Head and Neck Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MVX-ONCO-1

MVX-ONCO-1 vaccine treatment once weekly starting on week 1 for 4 weeks followed by two additional treatments 2 weeks apart (total 6 treatments over 8 weeks). Each treatment consists of two macrocapsules containing the MVX-1 cell line and lethally irradiated autologous tumor cells.

Group Type: EXPERIMENTAL

MVX-ONCO-1

Intervention Type: OTHER

Autologous cells: 1 vial containing 4x10\^6 irradiated tumor cells Capsules: 2 biocompatible capsules loaded with 8x10\^5 MVX-1 cells

Interventions

MVX-ONCO-1

Autologous cells: 1 vial containing 4x10\^6 irradiated tumor cells Capsules: 2 biocompatible capsules loaded with 8x10\^5 MVX-1 cells

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Commission

OTHER

Sponsor Role: collaborator

Maxivax SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivier Michielin, Prof

Role: STUDY_CHAIR

CHUV Lausanne

Locations

HUG Hôpitaux Universitaires Genève

Geneva, , Switzerland

Centre Hospitalier Universitaire Vaudois CHUV

Lausanne, , Switzerland

Kantonsspital St. Gallen

Sankt Gallen, , Switzerland

Universitätsspital Zürich

Zurich, , Switzerland

Countries

Switzerland

References

Fernandez E, Vernet R, Urwyler M, Von Rohr O, Charrier E, Belkouch MC, Saingier V, Courtout F, DeVito C, Ancrenaz V, Dulguerov N, Karenovics W, Grogg J, Renaux J, Gobat K, Muller G, Brezina T, Rordorf T, Joerger M, Michielin O, Villard J, Mach N. Overall survival of recurrent/metastatic head & neck squamous cell carcinoma patients progressing after >/= 1 line of systemic therapy, treated with MVX-ONCO-1, a novel, first in class cell encapsulation-based immunotherapy: results of SAKK 11/16, a phase IIa trial. Exp Hematol Oncol. 2025 Aug 31;14(1):113. doi: 10.1186/s40164-025-00703-x.

Reference Type: DERIVED

PMID: 40887652 (View on PubMed)

Other Identifiers

SAKK 11/16

Identifier Type: -

Identifier Source: org_study_id