Phase 2
Completed N=43
QUILT-3.038: Active Immunotherapy CEA Vaccine in Patients With Malignancies Expressing CEA
Colorectal Cancer · Lung Cancer · Breast Cancer · Prostate Cancer
Source: ClinicalTrials.gov NCT01147965 ↗
Enrolled (actual)
43
Serious AEs
16.3%
Results posted
Nov 2025
Primary outcomePrimary: Number of Participants With Dose Limiting Toxicities — 0; 0; 0; 0 Participants
Summary
The purpose of this study is to find out what effects (good and bad) that a cancer vaccine has on you and your cancer. The cancer vaccine is called Ad5 [E1-, E2b-]-CEA(6D)or ETBX-011 and is made by Etubics. This vaccine is based on a virus called an adenovirus but it has been changed to express the protein CEA that is found on some cancer cells. Therefore, the vaccine can tell the immune system to attack cancer cells which make CEA. The investigators are trying to determine whether giving this virus is safe and whether this causes a strong immune system attack on the cancer. ETBX-011 is an investigational drug.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose Limiting Toxicities |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Adverse Events |
2; 3; 6; 10; 6; 9 | — |
| SECONDARY Clinical Response Rate |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Immune Response Against CEA - IFN-gamma Secreting Cells by Visit |
1.0; 8.5; 183.8; 32.8; 19.2; 29.5 | — |
| SECONDARY CEA Antibody (ng/mL) by Visit |
0.0470; 0.0310; 0.0690; 0.0709; 0.3193; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed diagnosis of malignancy expressing CEA. Because this is a safety and immunogenicity study, patients are NOT required to have measurable or evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST).
- For all tumor types other than colorectal, the tumor must express CEA as defined by immunohistochemical staining (at least 50% of the tumor with at least moderate intensity of staining) or a tumor known to be universally CEA positive (i.e. colon and rectal cancer). If colorectal cancer then, pathologic or clinical confirmation of adenocarcinoma is required.
- Patients must have received treatment with standard therapy known to have a possible overall survival benefit.
For the following common cancers, the following eligibility criteria apply:
- Colorectal cancer: Must have received and progressed through at least one line of palliative chemotherapy consisting of one of the following regimens:
- Palliative chemotherapy for metastatic colorectal cancer with 5 fluorouracil (or capecitabine) and oxaliplatin.
- Palliative chemotherapy for metastatic colorectal cancer with 5 fluorouracil (or capecitabine) and irinotecan.
- Palliative chemotherapy regimen for metastatic colorectal cancer that includes bevacizumab.
- Colorectal cancer patients currently receiving palliative single-agent bevacizumab or cetuximab will be eligible for this trial and may continue these therapies concomitant with study treatment (if they have been on these single agent therapies for at least 3 months).
- Breast cancer: Must have received and progressed through at least one line of chemotherapy for metastatic breast cancer consisting of one of the following regimens:
- Palliative anthracycline- or taxane-based chemotherapy
- Patients with tumors that over express HER2 (IHC 3+ or FISH+) must have received and progressed through at least one line of palliative therapy that combines trastuzumab with chemotherapy.
- Breast cancer patients currently receiving palliative endocrine therapy or single-agent trastuzumab will be eligible for this trial and may continue these therapies concomitant with study treatment (if they have been on these single agent therapies for at least 3 months).
- Patients who have been treated or offered the options of treatment with Bevacizumab (option clearly stated in the consent form).
- Patients who have been treated or offered the options of treatment with Lapatinib (option clearly stated in the consent form).
- Lung cancer: Must have received and progressed through chemotherapy for metastatic disease consisting of one of the following regimens:
- Palliative platinum-based (cisplatin or carboplatin) chemotherapy if the patient has not received chemotherapy previously.
- Palliative taxane-based (docetaxel or paclitaxel) or vinorelbine chemotherapy if the patient has received chemotherapy previously.
- Lung cancer patients currently receiving palliative single-agent erlotinib or gefitinib will be eligible for this trial and may continue these therapies concomitant with study treatment (if they have been on these single agent therapies for at least 3 months).
- Pancreatic cancer: Must have received and progressed through chemotherapy including gemcitabine.
- Pancreatic cancer patients currently receiving palliative single-agent erlotinib will be eligible for this trial and may continue this therapy concomitant with study treatment (if they have been on this single agent therapy for at least 3 months).
- For other malignancies, if a first line therapy with survival or palliative benefit exists, it should have been administered and there should have been progressive disease.
- Patients who have received and progressed through first-line palliative chemotherapy must be advised regarding second-line therapy before being enrolled on this investigational study.
- Karnofsky performance score of 70% or higher
- Estimated life expectancy > 3 months
- Age ≥ 21 years, but < 75
Data sourced from ClinicalTrials.gov (NCT01147965). 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.