WithdrawnPhase 2

Efficacy and Safety of VB10.16 Alone or in Combination With Atezolizumab in Patients With Advanced Cervical Cancer.

Stopped: Trial VB-C-04 was stopped due to company strategic reasons and recent changes in standard of care in the recurrent and metastatic cervical cancer setting.

0Started 2024-04-18

Plain-language 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 (pembrolizumab with chemotherapy with/without bevacizumab). The trial is designed to investigate VB10.16 alone or in combination with the immune checkpoint inhibitor, atezolizumab. The trial consist of 2 parts: the first part which investigates VB10.16 + placebo versus VB10.16 + atezolizumab. Approximately 30 patients will be included in each group. The goal of this part is to evaluate which of the two treatments is the best. The second part of the study will select the best treatment from part 1 and investigate the safety and efficacy of additional 70 patients.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. 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.

Exclusion criteria

What they're measuring

Objective Response Rate (ORR)

Timeframe: Up to 1 year

Trial details

NCT IDNCT06099418

SponsorNykode Therapeutics ASA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-05

View on ClinicalTrials.gov More HPV-Related Cervical Carcinoma trials