Trial · NCT05898828
Phase I/II Evaluation of a Cancer Lysate Vaccine and Montanide(R) ISA-51 VG With Entinostat and Nivolumab as Adjuvant Therapy Following Chemoradiation Therapy With or Without Surgery for Locally Advanced Esophageal Cancer
NCT05898828, Phase 1, Phase 2, Withdrawn, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase I/II Evaluation of a Cancer Lysate Vaccine and Montanide(R) ISA-51 VG With Entinostat and Nivolumab as Adjuvant Therapy Following Chemoradiation Therapy With or Without Surgery for Locally Advanced Esophageal Cancer. Trials, record NCT05898828. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05898828
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Phase I/II Evaluation of a Cancer Lysate Vaccine and Montanide(R) ISA-51 VG With Entinostat and Nivolumab as Adjuvant Therapy Following Chemoradiation Therapy With or Without Surgery for Locally Advanced Esophageal Cancer
- NCT number
- NCT05898828
- Status
- Withdrawn
- Phases
- Phase 1, Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Neoplasms, Esophageal Neoplasms, Esophagus Neoplasm, Esophagus Cancer, Neoplasms, Esophageal, Esophageal Cancer (EsC)
- Interventions
- Nivolumab, Entinostat, Montanide(R) ISA-51 VG Adjuvant, H1299 Cell Lysates
- First posted
- 2023-06-12
- Last updated
- 2024-08-05
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase I Component: To determine the safe dose of adjuvant H1299 lung cancer cell lysate vaccines with Montanide(R) ISA-51 VG administered in conjunction with entinostat and nivolumab in participants with locally advanced esophageal cancers (EsC)... | before each cycle, every 2 weeks during Cycles 1 and 2 (AE only), at each treatment evaluation, and at the safety visit | Assessment of safety and tolerability as determined by the frequency and severity of adverse events |
| Primary | Phase II Component: To assess the frequency of immunologic responses to purified cancer-testis (CT) antigens in EsC participants receiving adjuvant vaccinations with H1299 cell lysate/Montanide(R) ISA-51 VG in combination with entinostat and niv... | within 2 weeks prior to initiation of treatment, prior to 1st vaccination, 1 month following first 6 vaccinations, and every 6 months (24 weeks) during treatment continuation | Assessment of immune response to CT antigens (new serologic reactivity or increase in existing antibody response to CT antigens, evidenced by IgM/IgG class switch or antibody titer) |
| Secondary | Phase I Component: To assess the frequency of immunologic responses to purified cancer-testis (CT) antigens in EsC participants receiving adjuvant vaccinations with H1299 cell lysate/Montanide(R) ISA-51 VG in combination with entinostat and nivo... | within 2 weeks prior to initiation of treatment, prior to 1st vaccine, one month following the first six vaccinations (start of cycle 7), and every 6 months (24 weeks) during treatment continuation | Analyses which investigate immunologic response (i.e., immune response to CT antigens); response to vaccine will be the appearance of new serologic reactivity or an increase in existing antibody response to CT antigens, evidenced by IgM/IgG class switch or antibody titer. |
| Secondary | Phase I + II Component: To assess safety of adjuvant H1299 lung cancer cell lysate vaccines with Montanide(R) ISA-51 VG administered in conjunction with entinostat and nivolumab in participants with locally advanced esophageal cancers (EsC) with... | before each cycle, every 2 weeks between vaccines 1 and 2, at each treatment evaluation, and at the safety visit | Assessment of safety and tolerability as determined by the frequency and severity of adverse events |
| Secondary | Phase II Component: To determine progression free survival (PFS) in EsC participants receiving the investigational adjuvant vaccine regimen | every 12 weeks while on treatment or continued treatment, and during follow up every 3 months for 3 years, every 6 months for another 2 years or through disease progression ending at time of final PFS evaluation at 5 years post-enrollment | Progression free survival (PFS) determined by RECIST using the Kaplan-Meier method |
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
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/NCT05898828
GET https://conductscience.org/api/trials/v1/NCT05898828/registered