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NeuVax vaccine · 1 trial · 1 indication
Compare invasive DFS between the two treatment groups from time of initiation of trastuzumab maintenance therapy (trasuzumab monotherapy) to time of invasive local, regional or distant recurrence, new primary, or death due to any cause. Disease state will be determined by the patients' own physicians at the individual study sites during their routine follow-up screening. This will occur for all enrolled patients, regardless of randomization, approximately every three months for the first 24 months after completion of primary therapies and every six months thereafter with clinical exam, and laboratory and radiographic surveillance. The primary outcome measure of the trial is invasive DFS.
| Arm | Type | Description |
|---|---|---|
| Trastuzumab + NeuVax | EXPERIMENTAL | Patients randomized to this arm will receive vaccinations of nelipepimut-S (1000 μg) and GM-CSF (250 μg) (NeuVax vaccine) administered intradermally every three weeks for six total vaccinations, 30-120 minutes after completion of trastuzumab infusion. The first vaccination will be given with the third dose of maintenance trastuzumab administered as monotherapy optimally, but may be given with later maintenance doses of trastuzumab, provided there are at least six remaining doses of trastuzumbab to overlap with the PVS. Upon completion of the primary vaccination series (PVS), booster inoculations (same dose and route) will be administered every six months x 4. The first booster inoculation will occur 6 months ± 2 weeks after the completion of the PVS, with subsequent boosters timed every six months + 2 weeks. Boosters will therefore occur at the following time points after completion of the PVS: 6 months ± 2 weeks, 12 months ± 2 weeks, 18 months ± 2 weeks and 24 months ± 2 weeks. |
| Trastuzumab + GM-CSF | ACTIVE_COMPARATOR | Patients randomized to this arm will receive inoculations of GM-CSF (250 μg) administered in an identical manner to those receiving nelipepimut-S/GM-CSF (NeuVax). Patients will be blinded as to whether they are receiving nelipepimut-S/GM-CSF or GM-CSF alone. Upon completion of the primary vaccination series (PVS), booster inoculations (same dose and route) will be administered every six months x 4. The first booster inoculation will occur 6 months ± 2 weeks after the completion of the PVS, with subsequent boosters timed every six months + 2 weeks. Boosters will therefore occur at the following time points after completion of the PVS: 6 months ± 2 weeks, 12 months ± 2 weeks, 18 months ± 2 weeks and 24 months ± 2 weeks. |
| Name | Type | Description |
|---|---|---|
| NeuVax vaccine | BIOLOGICAL | At the time of vaccine administration, a frozen solution of E75 acetate (1.5 mg/mL) is thawed and 1000mcg E75 peptide mixed thoroughly with 250mcg GM-CSF. This constitutes the NeuVax vaccine. Patients randomized to this arm will receive vaccinations of nelipepimut-S/GM-CSF administered intradermally every three weeks for six total vaccinations, 30-120 minutes after completion of trastuzumab infusion. The first vaccination will be given with the third dose of maintenance trastuzumab administered as monotherapy optimally, but may be given with later maintenance doses of trastuzumab, provided there are at least six remaining doses of trastuzumab to overlap with the primary vaccine series. |
| Trastuzumab | DRUG | Herceptin will be administered to patients every three weeks as monotherapy for one year, to be given upon completion of standard of care chemotherapy/radiotherapy. The first trastuzumab infusion will be given no sooner than three weeks and no later than 12 weeks after completion of chemotherapy/radiotherapy. Trastuzumab will be dosed at the recommended initial loading dose of 8 mg/kg and at recommended maintenance doses of 6 mg/kg q3wk. |
| GM-CSF | DRUG | For patients randomized to the GM-CSF alone arm, they will receive inoculations of GM-CSF (250mcg) administered intradermally every three weeks for six total vaccinations, 30-120 minutes after completion of trastuzumab infusion. The first injection will be given with the third dose of maintenance trastuzumab administered as monotherapy optimally, but may be given with later maintenance doses of trastuzumab, provided there are at least six remaining doses of trastuzumab to overlap with the primary vaccine series. |
Inclusion criteria: * 18 years or older * Eastern Cooperative Oncology Group (ECOG) performance status 0,1 * AJCC stage I - III non-inflammatory, HER2-positive (according to ASCO-CAP guidelines 5) breast cancer * Completed neoadjuvant therapy with an approved regimen that includes trastuzumab and a...
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NeuVax vaccine is an investigational immunotherapy being studied for the treatment of breast cancer, specifically in high-risk HER2-positive breast cancer patients. It is being evaluated as a combination therapy with trastuzumab to potentially improve outcomes in this patient population.
NeuVax vaccine is being developed by SELLAS Life Sciences Group, Inc., a biopharmaceutical company focused on cancer therapies. The company's stock is traded under the ticker symbol SLS on the Nasdaq exchange.
NeuVax vaccine is currently in Phase 2 clinical development. It has completed a Phase 2 trial in breast cancer, and it remains an investigational drug that has not yet been approved by regulatory authorities.
NeuVax vaccine has been studied in one completed Phase 2 clinical trial, identified as NCT02297698. This trial evaluated the combination of NeuVax with trastuzumab in high-risk HER2-positive breast cancer patients and enrolled 100 participants in the United States.
No, NeuVax vaccine is not the same as trastuzumab. NeuVax is an investigational vaccine being studied in combination with trastuzumab, which is an established monoclonal antibody therapy for HER2-positive breast cancer. The two agents have different mechanisms of action and are used together in clinical trials.