Trial · NCT05001880
Chemotherapy With or Without Immunotherapy for Peritoneal Mesothelioma
NCT05001880, Phase 2, Recruiting, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Chemotherapy With or Without Immunotherapy for Peritoneal Mesothelioma. Trials, record NCT05001880. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05001880
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Chemotherapy With or Without Immunotherapy for Peritoneal Mesothelioma
- NCT number
- NCT05001880
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 66 participants, estimated
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Peritoneal Malignant Mesothelioma
- Interventions
- Atezolizumab, Bevacizumab, Biospecimen Collection, Carboplatin, Computed Tomography, Cytoreductive Surgery, Hyperthermic Intraperitoneal Chemotherapy, Pemetrexed Disodium, Positron Emission Tomography
- First posted
- 2021-08-12
- Last updated
- 2026-11-12
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response rate | Up to 4 years after study activation | Will be compared between arms. |
| Secondary | Major pathologic response rate | Up to 3 years | The proportion of patients with a pathologic response will be calculated and compared between arms and 95% confidence intervals reported. The chi-square test will be used to compare the rates between arms. |
| Secondary | Completeness of cytoreduction | Up to 3 years | Will be estimated. |
| Secondary | Conversion rate to surgical resection among those not deemed to be surgical candidates | Up to 3 years | Will estimate the conversion rate to surgical resection among those not deemed to be surgical candidates prior to treatment and provide the 95% confidence interval as well. |
| Secondary | Progression-free survival (PFS) | From study entry to the first of either disease progression or death from any cause, where disease progression will be determined based on Response Evaluation Criteria in Solid Tumors 1.1 criteria, assessed up to 3 years | Will be estimated using the Kaplan-Meier method, where the log-rank test will be used to compare the 2 treatment arms. |
| Secondary | Overall survival | From study entry to death from any cause, assessed up to 3 years | Will be estimated using the Kaplan-Meier method, where the log-rank test will be used to compare the 2 treatment arms. |
| Secondary | Incidence of adverse events | Up to 3 years | The maximum grade for each type of adverse event will be summarized using Common Terminology Criteria for Adverse Events version 5.0. The frequency and percentage of grade 3+ adverse events will be compared between the 2 treatment arms. Comparisons between arms will be made by using either the Chi-square or Fisher's Exact test. |
| Other | Soluble mesothelin-related peptides (SMRP) and megakaryocyte potentiating factor (MPF) | Up to 3 years | Will assess the association between two continuous biomarkers, MPF and SMRP, and best response to treatment prior to surgery, defined as response (complete response/partial response) versus no response (stable disease/progressive disease). Two separate logistic regression models will be used, one for each biomarker, with response status as the binary outcome and MPF or SMRP as the independent variable. The significance of the association will be evaluated using the Wald test from each model at a significance level of 0.05. Each biomarker will be assessed for skewness via visual inspection of histograms. If MPF or SMRP values appear markedly non-normal, will apply a logarithmic transformation to reduce skewness. To address zero values, a constant of 0.1 will be added to all observations before log transformation. Will explore the association of MPF and SMRP with the primary and secondary endpoints with and without accounting for treatment arm effects. |
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 |
|---|---|
| 37673112 | DERIVED |
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 |
|---|---|---|---|---|---|
| U10CA180821 | Alliance for Clinical Trials in Oncology Operations Center | Galanis, Evanthia; Hahn, Olwen; Kozono, David | ALLIANCE NCTN FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 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/NCT05001880
GET https://conductscience.org/api/trials/v1/NCT05001880/registered