A Phase 1/2 interventional study of VB10.NEO and Bempegaldesleukin in Locally Advanced or Metastatic Solid Tumours, sponsored by Nykode Therapeutics ASA. Completed at 6 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-21.
Sponsored by Nykode Therapeutics ASA · Phase 1/2, Interventional, and Treatment
This open labelled first in human dose phase 1/2a study is designed to evaluate safety, feasibility and efficacy of multiple dosing with individualised VB10.NEO and bempegaldesleukin (NKTR-214) immunotherapy in patients with locally advanced or metastatic solid tumours.
This open labelled first in human dose phase 1/2a study is designed to evaluate safety, feasibility and efficacy of multiple dosing with individualised VB10.NEO immunotherapy in patients with locally advanced or metastatic solid tumours including melanoma, non-small cell lung cancer (NSCLC), clear renal cell carcinoma, urothelial cancer or squamous cell carcinoma of the head and neck (SCCHN), who did not reach complete responses with immune checkpoint inhibitor (CPI) therapy as their standard of care (SOC) treatment.
Patients with melanoma, NSCLC, RCC and urothelial carcinoma must upon screening, have been receiving a CPI (anti-PD-1 or anti-PD-L1) for at least 12 weeks as the patient's standard of care. Patients with SCCHN can be screened as long as they have initiated treatment with CPI as SOC. The VB10.NEO vaccine will be added to continuing CPI treatment and shall not replace, omit, postpone or terminate the standard therapy. Patients who have been treated with CPI for at least 12 weeks, will be enrolled in case of some benefit to CPI treatment is expected, as defined by partial response, stable disease or disease progression (in case of a mixed response to CPI, provided at least one lesion shows measurable regression and patient, according to the investigator, would have a clinical benefit of continued immunotherapy).
The assumption is to combine the immuno-stimulating effect of CPIs with immune responses towards specific neo-antigens in the vaccine, which may possibly increase the anti-tumour effect to reach durable efficacy.
One arm of the study patients with SCCHN will have the option to be treated with bempegaldesleukin (NKTR-214) in combination with personalised VB10.NEO. This arm is open for enrollment from November 2019.
The study will be conducted in two parts. Part A will evaluate safety, feasibility and efficacy of individualised VB10.NEO and bempegaldesleukin (NKTR-214) immunotherapy in SCCHN patients. The expansion part B will explore efficacy and safety in further patients with selected types of cancer showing signs of efficacy during part A.
Nykode Therapeutics ASA is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria for all arms
Inclusion criteria for SCCHN only
All arms
Patients who have been on CPI for longer than 12 weeks at screening need to be per RECIST:
Exclusion criteria
Other protocol defined inclusion exclusion criteria may apply
Treatment with individualized VB10.NEO immunotherapy will commence as soon as the patient-specific VB10.NEO vaccine is available and if the patient-specific vaccine meets all pre-specified product release criteria after manufacturing to patients within the selected tumor types.
Biological: VB10.NEO
Bempegaldesleukin (NKTR-214) will be given in combination with VB10.NEO in up to 10 patients with SCCHN. Treatment with individualized VB10.NEO immunotherapy will commence as soon as the patient-specific VB10.NEO vaccine is available and if the patient-specific vaccine meets all pre-specified product release criteria after manufacturing. Bempegaldesleukin (NKTR-214) will be given after at least 4 doses of VB10.NEO.
Biological: VB10.NEO · Drug: Bempegaldesleukin
VB10.NEO is a vaccine and is supplied as a sterile, ready to use solution (14 vaccinations will be given).
0.006 mg/kg bempegaldesleukin (NKTR-214) will be administered intravenously q4w for up to 11 doses starting from week 11 or at any dosing visit up to week 34 and for up to week 50 (up to 11 doses). The first 2 doses will be in a Q3W interval and following doses in Q4W intervals.
Also known as: NKTR-214
Rate of Adverse Events including SAEs (Safety/tolerability) of VB10.NEO and the combination of VB10.NEO and bempegaldesleukin (NKTR-214)
Total number, severity (CTCAE grade) of adverse events (AEs), and if AE is leading to treatment discontinuation.
Time frame: Up to 24 months
Immunogenicity by T-cell activity to each neoepitope of VB10.NEO and the combination of VB10.NEO and bempegaldesleukin (NKTR-214)
Descriptive analyses for each patient of the immune-response to each neoepiotope
Time frame: Up to 24 months
Objective Response Rate (ORR)
Description of tumor response by iRECIST at regular intervals
Time frame: Up to 24 months
Duration of Response (DOR)
Descriptive analysis of DOR by iRECIST at regular intervals
Time frame: Up to 24 months
Progression-free survival (PFS)
Descriptive analysis of PFS by iRECIST at regular intervals
Time frame: Up to 24 months
Survival at end of treatment (EoT) and end of study (EoS)
Proportion of patients who are alive at EoT and EoS
Time frame: At 14 months and 24 months
Plan to share: No
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Nykode Therapeutics ASA