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

NCT02999646 | Completed DMC

• 1 other identifier: SAKK 11/16
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 4

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

head and neck squamous cell carcinoma; cancer; HNSCC; immunotherapy; MVX-ONCO-1

Outcome Measures

Primary Outcomes (1)

• Overall Survival at 26 weeks (OS)

  The primary endpoint of the trial is Overall Survival (OS) at 26 weeks defined as percentage of patients alive 26 weeks from registration. Patients who are lost to follow-up with a date they were last known to be alive less than 26 weeks after registration will be counted as failures for this endpoint.

  at 26 weeks from registration

Secondary Outcomes (12)

• Time to subsequent therapy (TST)

  assessed within 5 years

• Duration of response (DOR)

  assessed within 5 years

• Objective response rate (ORR)

  at 6, 13, 26, 39 and 52 weeks

• Disease control rate (DCR)

  at 6, 13, 26, 39 and 52 weeks

• Best overall response

  assessed within 5 years

Study Arms (1)

MVX-ONCO-1

EXPERIMENTAL

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.

Other: MVX-ONCO-1

Interventions

MVX-ONCO-1 OTHER

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

MVX-ONCO-1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maxivax SA: lead
• European Commission: collaborator

Study Sites (4)

HUG Hôpitaux Universitaires Genève

Geneva, 1211, Switzerland

Location

Centre Hospitalier Universitaire Vaudois CHUV

Lausanne, CH-1011, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Universitätsspital Zürich

Zurich, 8091, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 40887652 DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Olivier Michielin, Prof

  CHUV Lausanne

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: antitumor immunization MVX-ONCO-1

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: December 21, 2016
• Study Start: July 25, 2018
• Primary Completion: January 25, 2023
• Study Completion: June 29, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (4)