Study on the Effectiveness and Safety of VB10.16 Alone or with Atezolizumab in Patients with Advanced Cervical Cancer

Sponsor: Nykode Therapeutics ASA

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06099418

Provider View

This clinical trial is exploring whether the drug VB10.16, used alone or with the immunotherapy drug atezolizumab, can help treat advanced cervical cancer that has returned or spread after initial treatment. The study will compare the two treatments to see which works better and is safe for patients.

Patient Parameters

Program Overview

This study involves patients with advanced cervical cancer that is positive for HPV16 and PD-L1, and has returned or spread after standard treatment. The trial will test VB10.16 alone and in combination with atezolizumab, an immune checkpoint inhibitor. The study has two parts: the first part will compare VB10.16 with a placebo against VB10.16 with atezolizumab in about 30 patients per group to find the better treatment. The second part will further test the chosen treatment in 70 more patients to assess its safety and effectiveness.

Description

This clinical trial is designed to evaluate the effectiveness and safety of VB10.16, a treatment for advanced cervical cancer, either on its own or combined with atezolizumab, an immunotherapy drug. The study is for patients whose cancer is HPV16-positive and PD-L1-positive, and who have not responded to or have progressed after receiving pembrolizumab with chemotherapy, with or without bevacizumab.

The trial is divided into two parts. In the first part, patients will be randomly assigned to receive either VB10.16 with a placebo or VB10.16 with atezolizumab. This part aims to determine which treatment is more effective. Approximately 30 patients will be included in each group.

In the second part, the more effective treatment from the first part will be given to an additional 70 patients to further evaluate its safety and effectiveness. The study is double-blind, meaning neither the patients nor the researchers will know who is receiving which treatment during the first part of the trial.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have advanced cervical cancer that is HPV16-positive and PD-L1-positive, and has returned or spread after initial treatment.
  • Have received at least 4 cycles of pembrolizumab with chemotherapy, with or without bevacizumab.
  • Treatment should start within 12 weeks of cancer progression.
  • Have received no more than one prior treatment for advanced cervical cancer.
  • Have a tumor that is PD-L1-positive, confirmed by a specific test.
  • Have a tumor that is HPV16-positive, confirmed by a specific test.
  • Have at least one measurable tumor.
  • Be in good overall health with a performance status score of 1 or less.
  • Have a specific immune score of 1 or less.

Exclusion Criteria

  • Cancer that can be treated with local therapy to cure it.
  • Rapidly progressing cancer with symptoms like bleeding or uncontrolled pain.
  • Neuroendocrine cervical cancer.
  • Recent radiotherapy or other non-systemic therapy within 14 days before starting VB10.16.
  • Recent surgery or systemic anti-cancer therapy within 4 weeks before starting treatment.
  • Previous organ or tissue transplant, except corneal transplant.
  • Previous stem cell transplant.
  • Previous CAR-T cell therapy.
  • Previous treatment with certain antibodies or similar drugs, except pembrolizumab.
  • Previous treatment with a therapeutic HPV16 vaccine.
  • Severe allergy to atezolizumab or its ingredients.
  • Severe side effects from pembrolizumab.
  • Currently taking immunosuppressive drugs or high-dose corticosteroids.
  • Planned major surgery.
  • Other cancers, except for certain noninvasive or curable cancers.

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