Status:
WITHDRAWN
Efficacy and Safety of VB10.16 Alone or in Combination With Atezolizumab in Patients With Advanced Cervical Cancer.
Lead Sponsor:
Nykode Therapeutics ASA
Collaborating Sponsors:
Roche Pharma AG
GOG Foundation
Conditions:
HPV-Related Cervical Carcinoma
HPV-Related Malignancy
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This is a multi-center study in patients with recurrent or metastatic HPV16-positive, PD-L1 positive cervical cancer who has progressed during or after treatment with the first-line standard of care (...
Detailed Description
This is a two-arm randomized, double-blind, placebo-controlled phase 2 selection trial to evaluate the efficacy and safety of VB10.16 alone or in combination with atezolizumab in patients with HPV16-p...
Eligibility Criteria
Inclusion
- Key
- Age ≥18 years at ICF signature date.
- Persistent recurrent or metastatic (R/M) (stage IVB) PD-L1 positive cervical cancer with squamous cell, adenocarcinoma or adenosquamous histology with confirmed disease progression during or after treatment with 1st line systemic standard of care pembrolizumab + platinum-containing chemotherapy +/- bevacizumab
- Participants should have received at least 4 cycles of pembrolizumab.
- Planned treatment start should be within 12 weeks of documented radiographic disease progression.
- Participants should have received no more than 1 prior systemic anti-cancer treatment regimen for recurrent/metastatic cervical cancer (pembrolizumab + chemotherapy +/- bevacizumab).
- PD-L1-positive tumor confirmed by Ventana SP263 clone (the Food and Drug Administration approved companion diagnostic test for atezolizumab in other indications), with tumor area positivity ≥5% in designated central laboratory
- HPV16-positive tumor confirmed by nucleic acid amplification test in designated central laboratory
- At least 1 measurable lesion per RECIST v1.1 as assessed by Blinded Independent Central Review.
- Overall function and organ function:
- ECOG performance status (PS) ≤1
- Gustave Roussy Immune (GRIm) score ≤1
- Key
Exclusion
- Disease specific:
- Has disease that is suitable for local therapy with curative intent.
- Rapidly progressing disease (e.g., tumor bleeding, uncontrolled tumor pain) in the opinion of the investigator.
- Neuroendocrine carcinoma of the cervix.
- Prior, concurrent or future interventions:
- Radiotherapy (or other non-systemic therapy) ≤14 days prior to VB10.16 treatment start, or the patient has not fully recovered (i.e., Grade ≤1 at baseline) from AEs due to a previously administered treatment.
- Has received prior surgery or prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment.
- Prior solid organ or tissue transplantation (except corneal transplant).
- Prior autologous or allogeneic hematopoietic stem cell transplantation.
- Prior chimeric antigen receptor T-cell (CAR-T) therapy.
- Prior therapy with a monoclonal antibody, bispecific antibody, or antibody fragment (or other molecule with similar mechanism of action) that engages with stimulatory or co-inhibitory molecules on T cells (e.g., CD3, CTLA-4, PD-1, 4-1BB/CD137), except pembrolizumab in the metastatic setting.
- Prior therapy with CPI in the locally advanced setting.
- Prior administration with tisotumab vedotin.
- Administration of a live (attenuated replicating organism) or non-live (pathogen component or killed whole organism) vaccine, or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine within 30 days prior to VB10.16 treatment start.
- Prior administration with a therapeutic HPV16 vaccine.
- Prior severe hypersensitivity (≥ grade 3) to atezolizumab and/or any of its excipients.
- Prior persistent toxicities (≥ grade 3) related to pembrolizumab administration.
- Participants receiving systemic immunosuppression with immunosuppressive agents such as cyclosporine, azathioprine, methotrexate, or tumor necrosis factor alpha blockers for any concurrent condition.
- Chronic administration of systemic corticosteroids: prednisone \>10 mg daily (or dose equivalent) or an average cumulative dose of \>140 mg prednisone (or dose equivalent) within the last 14 consecutive days prior to VB10.16 treatment start.
- Any planned major surgery.
- Prior or concurrent morbidity:
- Malignancy:
- Past or current malignancy other than inclusion diagnosis, except for:
- Noninvasive basal cell or squamous cell skin carcinoma.
- Noninvasive, superficial bladder cancer.
- Ductal carcinoma in situ.
- Any curable cancer with a complete response of \>2 years' duration.
Key Trial Info
Start Date :
April 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2028
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06099418
Start Date
April 18 2024
End Date
May 1 2028
Last Update
September 20 2024
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