Temozolomide plus Survivin long‑peptide vaccine (SurVaxM) for progressing metastatic neuroendocrine carcinomas
A Phase II Study of Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) in Patients With Progressing Metastatic Neuroendocrine Carcinomas (NECs)
This trial tests whether adding the Survivin peptide vaccine SurVaxM to temozolomide helps people with progressing metastatic neuroendocrine tumors live longer without their cancer getting worse.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Roswell Park Cancer Institute Academic / other |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT06202066 on ClinicalTrials.gov |
What this trial studies
This phase IIa trial compares temozolomide alone to temozolomide combined with the survivin long peptide vaccine SurVaxM in patients with progressing metastatic neuroendocrine tumors. Patients take temozolomide orally on days 1–5 of each 28‑day cycle for up to one year while receiving SurVaxM subcutaneously with incomplete Freund's adjuvant and sargramostim every two weeks for four doses. The primary endpoint is progression‑free survival, with secondary endpoints including objective response rates by RECIST v1.1 and anti‑survivin IgG titers. Exploratory analyses will examine immune markers in blood, tumor MGMT status, and tumor growth rate on imaging.
Who should consider this trial
Good fit: Adults with measurable, pathologically confirmed gastrointestinal, pancreatic, or thoracic neuroendocrine tumors (well‑differentiated G3 with Ki‑67>20% or neuroendocrine carcinoma excluding small cell lung), who have radiographic progression within the past 12 months, a KPS ≥80/ECOG ≤1, and prior systemic therapy failure are ideal candidates.
Not a fit: Patients with small cell lung carcinoma, those without recent documented progression, those unable to tolerate temozolomide or injections, or those with poor performance status are unlikely to benefit from this regimen.
Why it matters
Potential benefit: If successful, the combination could prolong progression‑free survival and increase tumor responses for patients with progressing metastatic NETs.
How similar studies have performed: SurVaxM has induced immune responses and shown preliminary clinical signals in early‑phase trials in other cancers, but combining it with temozolomide for metastatic NETs is novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years of age * Have a Karnofsky performance status ≥ 80 or Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (i.e. the patient must be able to care for himself/ herself with occasional help from others) * Measurable, pathologically confirmed diagnosis of neuroendocrine tumor of gastrointestinal, pancreatic, or thoracic origin with ki67\>20% (well-differentiated G3 NETs) or neuroendocrine carcinoma of any origin excluding small cell lung carcinoma * Patients must have documented radiographic progression, determined as clinically significant by the treating provider, within the last twelve months on two CT or MRI scans performed at least four weeks apart per RECIST v1.1 criteria. In the case of retreatment, progression may be defined by the treating provider (e.g., clinical, radiographic, biochemical) * Patients must have failed at least one prior systemic therapy * Patients who have been on somatostatin analogues (SSA) may continue to take SSA while on study treatment * Archival neuroendocrine tumor tissue must test positive for survivin presence by clinical immunohistochemistry prior to study enrollment * Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L (obtained within 14 days prior to enrollment) * Platelets ≥ 100 x 10\^9/L (obtained within 14 days prior to enrollment) * Hemoglobin (Hgb) \> 9g/dL (obtained within 14 days prior to enrollment) * Plasma total bilirubin: ≤ 1.5 x upper limit of normal (ULN) (obtained within 14 days prior to enrollment) * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 4 x ULN (obtained within 14 days prior to enrollment) * Creatinine clearance ≥ 60 mL/min (per Cockroft-Gault equation) (obtained within 14 days prior to enrollment) * Patients on full-dose anticoagulants (e.g., warfarin or low molecular weight \[LMW\] heparin) must meet the following criteria: * No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices, which carries a significant risk of bleeding in investigator's opinion) * Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately * Participant must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: * Patients who have received temozolomide in the advanced disease setting either alone or as part of a combination therapy will be excluded if they progressed while on it * Has received prior treatment with SurVaxM * Received an investigational agent within 30 days prior to enrollment * Participants who have received checkpoint inhibitors within 3 months prior to study enrollment or, those who have not recovered from adverse events due to agents administered more than 4 weeks earlier * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, bradycardia, tachycardia or psychiatric illness/social situations that would limit compliance with study requirements and, which in the treating physicians' opinion would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety * Patients with a concurrent or prior malignancy are ineligible unless they are patients with curatively treated carcinoma-in-situ or basal cell carcinoma of the skin. Patients who have been free of disease (any prior malignancy) for at least 3 years are eligible for this study * Known history of an autoimmune disorder * Known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS) related illness or other serious medical illness * Systemic corticosteroid therapy \> 2mg of dexamethasone or equivalent per day at study entry * Pregnant or nursing female participants * Unwilling or unable to follow protocol requirements * Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug * Patients with Hepatitis B or Hepatitis C may be included if there are adequately controlled viral titers and no drug-drug interactions, testing not required
Where this trial is running
Buffalo, New York
- Roswell Park Cancer Institute — Buffalo, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jasmeet Kaur, MD — Roswell Park Cancer Institute
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.