Trial · NCT05101356
A Cancer Vaccine (Labvax 3(22)-23) and GM-CSF Alone or in Combination With Pembrolizumab for the Treatment of Advanced Stage Adenocarcinoma
NCT05101356, Phase 1, Phase 2, Suspended, University of California, Davis
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Cancer Vaccine (Labvax 3(22)-23) and GM-CSF Alone or in Combination With Pembrolizumab for the Treatment of Advanced Stage Adenocarcinoma. Trials, record NCT05101356. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05101356
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Cancer Vaccine (Labvax 3(22)-23) and GM-CSF Alone or in Combination With Pembrolizumab for the Treatment of Advanced Stage Adenocarcinoma
- NCT number
- NCT05101356
- Status
- Suspended
- Phases
- Phase 1, Phase 2
- Enrollment
- 77 participants, estimated
- Lead sponsor
- University of California, Davis
- Conditions
- Advanced Adenocarcinoma, Advanced Malignant Solid Neoplasm, Metastatic Adenocarcinoma, Metastatic Malignant Solid Neoplasm, Recurrent Adenocarcinoma, Recurrent Malignant Solid Neoplasm
- Interventions
- Antineoplastic Vaccine, Sargramostim, Pembrolizumab
- First posted
- 2021-11-01
- Last updated
- 2026-06-29
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1: Dose-limiting toxicities (DLT) | First LabVax 3(22)-23 injection through 14 days following the second LabVax 3(22)-23 injection | Will be assessed according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (V)5.0. The type, grade, frequency and proportion of toxicities noted during the treatment period will be reported, along with associated 95% two-sided exact confidence interval of proportion. All adverse events noted by the investigator will be tabulated according to the affected body system. |
| Primary | Phase 1: Adverse events (AEs) | Up to 30 days after the last dose of study treatment | Will be assessed according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (V)5.0. The type, grade, frequency and proportion of toxicities noted during the treatment period will be reported, along with associated 95% two-sided exact confidence interval of proportion. All adverse events noted by the investigator will be tabulated according to the affected body system. |
| Primary | Phase 2: Objective response rate (ORR) | Up to 12 months after last dose of study treatment | Will be assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version (V)1.1 guidelines. The fractions will be reported along with 95% two-sided exact confidence intervals. Comparisons between arms will be performed by Fisher's Exact tests. Investigators will also characterize the proportion who remain that either respond or have stable disease, compared to those who progress. |
| Secondary | Phase 1: Objective response rate (ORR) | Up to 12 months after last dose of study treatment | Will be assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version (V)1.1 guidelines. The fractions will be reported along with 95% two-sided exact confidence intervals. Comparisons between arms will be performed by Fisher's Exact tests. Investigators will also characterize the proportion who remain that either respond or have stable disease, compared to those who progress. |
| Secondary | Phase 2: Dose-limiting toxicities (DLT) | Up to 30 days after the last LabVax 3(22)-23 vaccination | Will be assessed according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (V)5.0. The type, grade, frequency and proportion of toxicities noted during the treatment period will be reported, along with associated 95% two-sided exact confidence interval of proportion. All adverse events noted by the investigator will be tabulated according to the affected body system. |
| Secondary | Phase 2: Adverse events (AEs) | Up to 30 days after the last dose of study treatment | Will be assessed according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (V)5.0. The type, grade, frequency and proportion of toxicities noted during the treatment period will be reported, along with associated 95% two-sided exact confidence interval of proportion. All adverse events noted by the investigator will be tabulated according to the affected body system. |
| Secondary | Phase 2: Progression free survival (PFS) | Up to 12 months after last dose of study treatment | PFS will be calculated as the time from initiation of immunotherapy to first documented evidence of disease progression or death, whichever comes first. Alive patients who have not been documented to have progression will be censored at the date of the latest clinical assessment that documented as being free of progression. |
| Secondary | Phase 2: Overall survival (OS) | Up to 12 months after last dose of study treatment | OS will be calculated as the time from diagnosis to death. Alive patients will be censored at the date of the latest follow-up visit. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36765881 | RESULT |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA093373 | Cancer Center Support Grant P30 | LARA, PRIMO N. | UNIVERSITY OF CALIFORNIA AT DAVIS | NATIONAL CANCER INSTITUTE | 2002 to 2026 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05101356
GET https://conductscience.org/api/trials/v1/NCT05101356/registered