Phase 2
Completed N=2
BATS With in Combination With Low Dose IL-1 and GM-CSF for Advanced Pancreatic Cancer
Source: ClinicalTrials.gov NCT02620865 ↗Enrolled (actual)
2
Serious AEs
0.0%
Results posted
May 2023
Primary outcomePrimary: Median Overall Survival (OS) — 0.934 years
Summary
This phase Ib/II trial studies the side effects and best dose of bispecific antibody armed activated T-cells when given together with aldesleukin and sargramostim and to see how well they work in treating patients with pancreatic cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic). Bispecific antibody armed activated T-cells are the patient's own T cells that are coated with a bispecific antibody comprising 2 antibodies chemically joined together. These antibodies have specific targets and binding properties that may give the T cells a greater ability to seek out, attach to, and kill more cancer cells.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Overall Survival (OS) |
0.934 | — |
| SECONDARY Biomarker Analysis (Including CD3, CD4, CD8, PD1, PDL1, Monocytes, MDSC, IFN-gamma, IL-10, and TILs) Assessed Using Immunohistochemistry |
— | — |
| SECONDARY Incidence of Toxicity (CTCAE Version 4.0) |
1; 1; 2; 1; 2; 1 | — |
| SECONDARY Progression Free Survival (PFS) |
0.934 | — |
| SECONDARY Quantitative Immune Response |
— | — |
| SECONDARY TTP |
— | — |
Eligibility Criteria
Inclusion Criteria
- Histological or cytological proof of pancreatic adenocarcinoma; must have locally advanced or metastatic pancreatic cancer who have received at least first line chemotherapy and may have responding, stable or progressive disease
- Expected survival >= 3 months
- Karnofsky performance scale (KPS) >= 70% or Southwestern Oncology Group (SWOG) performance status 0 or 1
- Absolute neutrophil count (ANC) >= 1,000/mm^3
- Lymphocyte count >= 400/mm^3
- Platelet count >= 75,000/mm^3
- Hemoglobin >= 8 g/dL
- Serum creatinine = 50 ml/mm (can be calculated or measured)
- Total bilirubin = = 45% at rest (multigated acquisition scan [MUGA] or echocardiogram [Echo])
- Females of childbearing potential, and males, must be willing to use an effective method of contraception
- Females of childbearing potential must have a negative pregnancy test within 7 days of being registered for protocol therapy
Exclusion Criteria
- Any chemotherapy related toxicities from prior treatment (> grade 2 per Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.0)
- Known hypersensitivity to cetuximab or other EGFR antibody
- Treatment with any investigational agent within 14 days prior to being registered for protocol therapy
- Symptomatic brain metastasis
- Chronic treatment with systemic steroids or another immuno-suppressive agent
- Serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to being registered for protocol therapy
- Active liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
- Known human immunodeficiency virus (HIV) infection
- Active bleeding or a pathological condition that is associated with a high risk of bleeding (therapeutic anticoagulation is allowed)
- Has an active infection requiring systemic therapy
- A serious uncontrolled medical disorder that in the opinion of the investigator may be jeopardized by the treatment with protocol therapy
- Females must not be breastfeeding
- Patient (Pt) may be excluded if, in the opinion of the principal investigator (PI) and investigator team, the pt is not capable of being compliant
Data sourced from ClinicalTrials.gov (NCT02620865). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.